Vaccines

Hospitalizations for COVID-19 in the United States have increased for 8 weeks in a row.

Data from Florida and Georgia signal that respiratory syncytial virus (RSV) season has begun.

As for flu shots, experts say patients with long COVID should get them in 2023, although federal health agencies have not addressed that specific question.

Paul G. Auwaerter, MD, MBA, an infectious disease consultant, said many patients in his primary care practice worry about “the big three” – COVID, influenza, and RSV.

This news organization spoke with Dr. Auwaerter, as well as family physician Santina J. G. Wheat, MD, MPH, and clinical pharmacist Spencer H. Durham, PharmD, about their approach to 2023’s respiratory virus season.

They discussed how to handle COVID boosters, the use of Paxlovid, vaccine hesitancy, and the correct order of operations for patients getting vaccinated against all three diseases.
 

Paul G. Auwaerter, MD, MBA, clinical director of the division of infectious diseases and the Sherrilyn and Ken Fisher Professor of Medicine at Johns Hopkins University, BaltimoreQuestion: How should primary care physicians be preparing to handle what everyone is predicting will be a major surge in cases of respiratory infections?

Auwaerter: Although I’m an infectious disease consultant, I still have a small primary care practice. So, I field questions for my patients all the time, and many patients, especially those with health problems, are worried about the big three: RSV, COVID, and influenza – at least, my more motivated patients are.

People frequently ask if they need the COVID booster. I think that’s been something many people think maybe they can avoid. The good news is that the early in vitro data suggest that the XBB1.5x-based vaccine seems to offer sufficient neutralizing activity against the circulating newer variants since the vaccine was approved earlier this year. I am suggesting that everyone get a booster, especially those at high risk, because we know that the risk for hospitalization decreases based on earlier studies for 4-6 months after a COVID booster. We can simultaneously administer the revised COVID booster vaccine and the annual influenza vaccine. The timing is good, as influenza immunization should be accomplished by October or early November at the latest. Like many parts of the country, we in Maryland are in the middle of a COVID boomlet. I have issued more Paxlovid prescriptions since mid-August than I did all spring and early summer.

Q: Are you seeing a lot of rebound COVID in your patients taking Paxlovid [nirmatrelvir/ritonavir]?

Dr. Auwaerter: I think the frequency is probably around 10%. It has been quoted much higher – at 20% – but careful studies have put it down at just single digits. I think it just depends on symptomatology and how you ask the question. But I think it’s important that I try to persuade people to take a direct-acting antiviral if they’re in a high-risk category rather than tough it out. Increasing data suggest taking an antiviral also reduces the risk for long COVID. Also, we know that rebound symptoms are not always infectious virus. Sometimes, they’re just inflammatory. Unless a person is immune suppressed, they rarely have a culturable virus 7-8 days after onset of symptoms. So, for most people, I don’t administer second courses of Paxlovid, although I know some physicians do. One has to realize the risk for hospitalization from a rebound is tiny, and many people don’t even have infectious virus when they take the second course of a drug such as Paxlovid.

Q: You mentioned motivated patients, which seems to be an important factor to consider, particularly for new vaccines.

Dr. Auwaerter: There are always early adopters who are less afraid. And then some people say: This is a brand-new vaccine; I’m going to wait for a year to let this shake out, and make sure it seems safe. People more engaged in their health have asked me about the RSV vaccine. For anyone who has cardiopulmonary problems and other major health problems, I’ve advised it. But if someone’s in good health and 65 or 70, the RSV illness is probably pretty mild if they get it. For them, I would say the vaccine is optional.

For people over 75, I have been advising the RSV vaccine because that is a group we tend to see hospitalized with RSV; they’re the highest-risk group, similar to COVID. The older you are, the more likely this infection will land you in the hospital. You can acquire RSV even if you don’t have young grandchildren around.

Q: You have called respiratory virus seasons unstable? What does it mean, and what is the significance for clinicians?

Dr. Auwaerter: It’s less predictable than in the past. If you had a cough and fever, you could think it was influenza if you knew you had influenza circulating in your community. Maybe you thought about RSV for your immunocompromised or older patients, but we didn’t have any therapy for it anyway. I sometimes refer to the respiratory virus season as a cage match between the major infections. Last year, RSV came out first, and we got some influenza and COVID. What does the situation look like this year? I don’t know at this point, but we are seeing more COVID earlier. What’s different is we continue to have the emergence of viral variants of SARS-CoV-2. Also, with both influenza and COVID, it’s harder to make a clinical judgment about what people have.

I think we have to rely more on tests to treat these patients. Options include having point of care testing in the office for rapid results (molecular assays preferred) for both influenza and SARS-CoV-2 or home antigen testing. There are home kits that do test for both if influenza is known to be circulating significantly in the community. But there are still barriers. For one, COVID and COVID/influenza antigen kits are no longer free, although some health insurance companies do provide COVID kits free of charge. In offices, you don’t want to have ill people with respiratory infections in your waiting room unless you can isolate or have negative pressure rooms. Do you ask for masking in your offices? Telemedicine has been a big help since the pandemic in managing nonsevere respiratory infections at home; however, you must be licensed in the state to practice, which limits helping your out-of-state patients.

Q: How has the advent of in-home antigen tests changed practice?

Dr. Auwaerter: Home antigen tests have been groundbreaking in facilitating care. When I see patients via telemedicine, I don’t want to prescribe medications for influenza and COVID to people simultaneously. I want to pick one or the other – and now I’m able to ask for a COVID test or a COVID/influenza test if the patient or family is able to get a kit. Some offices do have real-time molecular testing, which is the ideal and the CDC-recommended approach, but they’re expensive, and not everyone has access to them.

Q: People talk about the “tripledemic,” but does doing so ignore the fourth horseman of the respiratory apocalypse: pneumococcal pneumonia?

Dr. Auwaerter: Pneumonia remains a leading cause of hospitalization, except we’ve seen much more viral than bacterial pneumonia in recent years of the pandemic. We’ve lost sight, and pneumococcal pneumonia is important, especially in older patients. What we have seen pretty clearly is a rise in group A streptococcal infections. This is another consequence of the pandemic, where people did not socialize for a year or 2. There was much less group A strep infection in younger children, and even in adults, the amount of invasive group A streptococcal infections has clearly taken a jump, according to the NHS in Great Britain. Our pediatric practices here at Johns Hopkins are seeing far more cases of acute rheumatic fever than they’ve seen in decades. And I think, again, this is a consequence of the frequency of group A strep infections definitely taking an uptick. And that was no doubt probably from social mitigation measures and just an interruption in normal circumstances that bacterial and respiratory pathogens tend to circulate and colonize.

Q: Do you have any concerns about immunogenicity or side effects associated with receiving several vaccines at once?

Dr. Auwaerter: I think three injections at once is only for the heroic, and there is actually no guidance for getting all three at the moment. COVID, RSV, and influenza are not live vaccines. I’ve been recommending the new COVID booster and flu together, and then wait 2 weeks and then get RSV or vice-versa. A part of the reason is RSV is new. People have gotten COVID and flu vaccines before; they’re no different than in the past in terms of anticipating adverse effects. But RSV is new, so I’ve usually been recommending that as a standalone to gauge if there are issues as an RSV booster may be recommended at some point down the road.

Q: Unfortunately, some people are going to see or hear misinformation that the COVID boosters have not been properly tested or proven safe. What’s your response to the patient who says something to that effect?

Dr. Auwaerter: My response is, the basic components of the vaccine are the same, right? If you have the mRNA vaccine, you’re getting the vaccine components, the lipids, and the mRNA coding for spike proteins, which has just been modified slightly to adjust to the Omicron subvariant composition. We do the same thing with the influenza vaccine every year, and we don’t see much change in the side effect profile. I think it’s important for my staff in the office and myself to be very comfortable to field questions such as these.

We try to inform all of our staff about a vaccine, especially a new one like RSV, just so they have some comfort level with it, whether they’re getting it or not. Vaccine-hesitant patients need very little to dissuade and to take a pass – to the probable detriment of their health and their family’s health. We know the influenza vaccine helps reduce absenteeism and transmission in addition to reducing serious illness in high-risk patients. Even COVID vaccine efficacy is not as robust as initially reported, falling from 95% to under 70% depending on the study – you are provided with protection against serious illness and hospitalization. The same goes for influenza, and that’s how we try to pitch it to people. Are they going to get the flu? Maybe, but you didn’t land in the hospital. That’s why it’s these vaccines are so important.
 

Spencer H. Durham, PharmD, associate clinical professor in the department of pharmacy practice at Auburn (Ala.) University, and clinical pharmacist, Internal Medicine & Infectious Diseases, at the UAB Heersink School of Medicine in Huntsville.Q: What is known, if anything, about the risks/desirability of giving three vaccinations at once to patients (particularly older patients) – flu, COVID-19 and RSV? Any potential vaccine interactions physicians should know about?

Dr. Durham: There are currently no data about giving all three of these vaccines together at the same time. However, there is both data and practical experience of giving both the flu and COVID vaccines at the same time. The best approach right now for these three vaccines would be to get the flu and COVID vaccines at the same time, then give the RSV vaccine at a different date. In general, they should be separated by about 2 weeks, although it does not matter in what order they are given (that is, patients could get RSV first, then flu/COVID, or they could get flu/COVID first, followed by RSV).

Having said this, there is no theoretical reason why patients couldn’t get all three at once, so if there is only one opportunity to vaccinate a patient, then it would be okay to give all three. But, if the patient can come for two separate visits, the recommendation would currently be to separate these. In the future, there likely will be data on giving all three vaccines at once, so it may not be an issue to administer all three at the same time.

Lastly, I would point out that the RSV vaccine is not necessarily recommended for everyone age 60 and above. The Advisory Committee on Immunization Practices recommends using shared clinical decision-making to determine if that vaccine is right for the patient. In general, the flu and COVID vaccines are recommended for everyone, although the specific COVID recommendations for fall 2023 have not yet been released. There are no particular vaccine interactions that are concerning with these vaccines.

Q: What if any special considerations are there regarding the storage, handling, and ordering of these vaccines? Should primary care practices take any special steps they might not already be taking?

Dr. Durham: I don’t think there are any special considerations that providers might not already be doing. All of the vaccines do require refrigeration, but each individual product may vary some on beyond-use dates or how long they are good after being reconstituted. All providers administering these vaccines should carefully examine the labeling of each individual product to ensure correct storage and handling. In addition, the Centers for Disease Control and Prevention has an online toolkit for vaccine storage and handling and can be found at https://www.cdc.gov/vaccines/hcp/admin/storage/toolkit/index.html.

Santina J. G. Wheat, MD, MPH, vice chair of diversity, equity, and inclusion, department of family and community medicine, and associate professor of family and community medicine, Northwestern University, ChicagoQ: What can primary care doctors/family physicians and their staff do to increase patient access to the vaccines? Any lessons learned from the earlier phases of the pandemic that might pertain not only to COVID-19 but also to RSV and/or influenza?

Dr. Wheat: I think the most important thing family physicians can do is speak with their patients about the importance of vaccines and specific recommendations they have for the situations of individuals and families. When vaccines started becoming available, I had many patients who wanted to hear from me – as their primary physician – what I truly thought and what I was planning to do for my own family.

I also think if our teams can know where vaccines are easily accessible, that makes it much easier for our patients. I have heard great stories and seen my own clinical support staff look at websites with patients to help them find the best location to get vaccines. In particular, about the RSV vaccine, I have had a handful of patients already come to ask me about my recommendations. When vaccines are available at my location, I find it much easier for my patients to be willing to get vaccinated. Similarly, if I am sending patients to pick up a prescription and they can get it at the same time, I have found success in them being willing to be vaccinated while picking up their prescription. In both instances, they do not need to make an additional stop; they are just able to be vaccinated while already at the clinic or pharmacy.

Q: Do you see any extra difficulties involved in trying to get groups of patients – in this case, older people – to be receptive to three vaccines, especially in this climate where it appears a growing number of people are hostile to immunization?

Dr. Wheat: Recently, I have found myself negotiating vaccines with patients not just with these, but as recommendations have changed for vaccines such as the pneumococcal vaccines and the hepatitis B vaccines. I think primary care providers can recommend all of them, but still help patients prioritize what is most important for that patient and family. For example, if welcoming a new baby soon, they might prioritize the vaccines for pertussis or influenza over the hepatitis vaccine with a plan to revisit the conversations later.

I have had some patients tell me they have gotten enough vaccines – and we know that even before the pandemic there was resistance to the influenza vaccine for some. I think we need to be prepared to address the concerns and, at times, the apathy. We also need to ask every time, because we never know which visit will be the one when a patient agrees.

Dr. Auwaerter reported financial relationships with Pfizer, Shionogi, Gilead, and Wellstat. Dr. Durham and Dr. Wheat disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Hospitalizations for COVID-19 in the United States have increased for 8 weeks in a row.

Data from Florida and Georgia signal that respiratory syncytial virus (RSV) season has begun.

As for flu shots, experts say patients with long COVID should get them in 2023, although federal health agencies have not addressed that specific question.

Paul G. Auwaerter, MD, MBA, an infectious disease consultant, said many patients in his primary care practice worry about “the big three” – COVID, influenza, and RSV.

This news organization spoke with Dr. Auwaerter, as well as family physician Santina J. G. Wheat, MD, MPH, and clinical pharmacist Spencer H. Durham, PharmD, about their approach to 2023’s respiratory virus season.

They discussed how to handle COVID boosters, the use of Paxlovid, vaccine hesitancy, and the correct order of operations for patients getting vaccinated against all three diseases.
 

Paul G. Auwaerter, MD, MBA, clinical director of the division of infectious diseases and the Sherrilyn and Ken Fisher Professor of Medicine at Johns Hopkins University, BaltimoreQuestion: How should primary care physicians be preparing to handle what everyone is predicting will be a major surge in cases of respiratory infections?

Auwaerter: Although I’m an infectious disease consultant, I still have a small primary care practice. So, I field questions for my patients all the time, and many patients, especially those with health problems, are worried about the big three: RSV, COVID, and influenza – at least, my more motivated patients are.

People frequently ask if they need the COVID booster. I think that’s been something many people think maybe they can avoid. The good news is that the early in vitro data suggest that the XBB1.5x-based vaccine seems to offer sufficient neutralizing activity against the circulating newer variants since the vaccine was approved earlier this year. I am suggesting that everyone get a booster, especially those at high risk, because we know that the risk for hospitalization decreases based on earlier studies for 4-6 months after a COVID booster. We can simultaneously administer the revised COVID booster vaccine and the annual influenza vaccine. The timing is good, as influenza immunization should be accomplished by October or early November at the latest. Like many parts of the country, we in Maryland are in the middle of a COVID boomlet. I have issued more Paxlovid prescriptions since mid-August than I did all spring and early summer.

Q: Are you seeing a lot of rebound COVID in your patients taking Paxlovid [nirmatrelvir/ritonavir]?

Dr. Auwaerter: I think the frequency is probably around 10%. It has been quoted much higher – at 20% – but careful studies have put it down at just single digits. I think it just depends on symptomatology and how you ask the question. But I think it’s important that I try to persuade people to take a direct-acting antiviral if they’re in a high-risk category rather than tough it out. Increasing data suggest taking an antiviral also reduces the risk for long COVID. Also, we know that rebound symptoms are not always infectious virus. Sometimes, they’re just inflammatory. Unless a person is immune suppressed, they rarely have a culturable virus 7-8 days after onset of symptoms. So, for most people, I don’t administer second courses of Paxlovid, although I know some physicians do. One has to realize the risk for hospitalization from a rebound is tiny, and many people don’t even have infectious virus when they take the second course of a drug such as Paxlovid.

Q: You mentioned motivated patients, which seems to be an important factor to consider, particularly for new vaccines.

Dr. Auwaerter: There are always early adopters who are less afraid. And then some people say: This is a brand-new vaccine; I’m going to wait for a year to let this shake out, and make sure it seems safe. People more engaged in their health have asked me about the RSV vaccine. For anyone who has cardiopulmonary problems and other major health problems, I’ve advised it. But if someone’s in good health and 65 or 70, the RSV illness is probably pretty mild if they get it. For them, I would say the vaccine is optional.

For people over 75, I have been advising the RSV vaccine because that is a group we tend to see hospitalized with RSV; they’re the highest-risk group, similar to COVID. The older you are, the more likely this infection will land you in the hospital. You can acquire RSV even if you don’t have young grandchildren around.

Q: You have called respiratory virus seasons unstable? What does it mean, and what is the significance for clinicians?

Dr. Auwaerter: It’s less predictable than in the past. If you had a cough and fever, you could think it was influenza if you knew you had influenza circulating in your community. Maybe you thought about RSV for your immunocompromised or older patients, but we didn’t have any therapy for it anyway. I sometimes refer to the respiratory virus season as a cage match between the major infections. Last year, RSV came out first, and we got some influenza and COVID. What does the situation look like this year? I don’t know at this point, but we are seeing more COVID earlier. What’s different is we continue to have the emergence of viral variants of SARS-CoV-2. Also, with both influenza and COVID, it’s harder to make a clinical judgment about what people have.

I think we have to rely more on tests to treat these patients. Options include having point of care testing in the office for rapid results (molecular assays preferred) for both influenza and SARS-CoV-2 or home antigen testing. There are home kits that do test for both if influenza is known to be circulating significantly in the community. But there are still barriers. For one, COVID and COVID/influenza antigen kits are no longer free, although some health insurance companies do provide COVID kits free of charge. In offices, you don’t want to have ill people with respiratory infections in your waiting room unless you can isolate or have negative pressure rooms. Do you ask for masking in your offices? Telemedicine has been a big help since the pandemic in managing nonsevere respiratory infections at home; however, you must be licensed in the state to practice, which limits helping your out-of-state patients.

Q: How has the advent of in-home antigen tests changed practice?

Dr. Auwaerter: Home antigen tests have been groundbreaking in facilitating care. When I see patients via telemedicine, I don’t want to prescribe medications for influenza and COVID to people simultaneously. I want to pick one or the other – and now I’m able to ask for a COVID test or a COVID/influenza test if the patient or family is able to get a kit. Some offices do have real-time molecular testing, which is the ideal and the CDC-recommended approach, but they’re expensive, and not everyone has access to them.

Q: People talk about the “tripledemic,” but does doing so ignore the fourth horseman of the respiratory apocalypse: pneumococcal pneumonia?

Dr. Auwaerter: Pneumonia remains a leading cause of hospitalization, except we’ve seen much more viral than bacterial pneumonia in recent years of the pandemic. We’ve lost sight, and pneumococcal pneumonia is important, especially in older patients. What we have seen pretty clearly is a rise in group A streptococcal infections. This is another consequence of the pandemic, where people did not socialize for a year or 2. There was much less group A strep infection in younger children, and even in adults, the amount of invasive group A streptococcal infections has clearly taken a jump, according to the NHS in Great Britain. Our pediatric practices here at Johns Hopkins are seeing far more cases of acute rheumatic fever than they’ve seen in decades. And I think, again, this is a consequence of the frequency of group A strep infections definitely taking an uptick. And that was no doubt probably from social mitigation measures and just an interruption in normal circumstances that bacterial and respiratory pathogens tend to circulate and colonize.

Q: Do you have any concerns about immunogenicity or side effects associated with receiving several vaccines at once?

Dr. Auwaerter: I think three injections at once is only for the heroic, and there is actually no guidance for getting all three at the moment. COVID, RSV, and influenza are not live vaccines. I’ve been recommending the new COVID booster and flu together, and then wait 2 weeks and then get RSV or vice-versa. A part of the reason is RSV is new. People have gotten COVID and flu vaccines before; they’re no different than in the past in terms of anticipating adverse effects. But RSV is new, so I’ve usually been recommending that as a standalone to gauge if there are issues as an RSV booster may be recommended at some point down the road.

Q: Unfortunately, some people are going to see or hear misinformation that the COVID boosters have not been properly tested or proven safe. What’s your response to the patient who says something to that effect?

Dr. Auwaerter: My response is, the basic components of the vaccine are the same, right? If you have the mRNA vaccine, you’re getting the vaccine components, the lipids, and the mRNA coding for spike proteins, which has just been modified slightly to adjust to the Omicron subvariant composition. We do the same thing with the influenza vaccine every year, and we don’t see much change in the side effect profile. I think it’s important for my staff in the office and myself to be very comfortable to field questions such as these.

We try to inform all of our staff about a vaccine, especially a new one like RSV, just so they have some comfort level with it, whether they’re getting it or not. Vaccine-hesitant patients need very little to dissuade and to take a pass – to the probable detriment of their health and their family’s health. We know the influenza vaccine helps reduce absenteeism and transmission in addition to reducing serious illness in high-risk patients. Even COVID vaccine efficacy is not as robust as initially reported, falling from 95% to under 70% depending on the study – you are provided with protection against serious illness and hospitalization. The same goes for influenza, and that’s how we try to pitch it to people. Are they going to get the flu? Maybe, but you didn’t land in the hospital. That’s why it’s these vaccines are so important.
 

Spencer H. Durham, PharmD, associate clinical professor in the department of pharmacy practice at Auburn (Ala.) University, and clinical pharmacist, Internal Medicine & Infectious Diseases, at the UAB Heersink School of Medicine in Huntsville.Q: What is known, if anything, about the risks/desirability of giving three vaccinations at once to patients (particularly older patients) – flu, COVID-19 and RSV? Any potential vaccine interactions physicians should know about?

Dr. Durham: There are currently no data about giving all three of these vaccines together at the same time. However, there is both data and practical experience of giving both the flu and COVID vaccines at the same time. The best approach right now for these three vaccines would be to get the flu and COVID vaccines at the same time, then give the RSV vaccine at a different date. In general, they should be separated by about 2 weeks, although it does not matter in what order they are given (that is, patients could get RSV first, then flu/COVID, or they could get flu/COVID first, followed by RSV).

Having said this, there is no theoretical reason why patients couldn’t get all three at once, so if there is only one opportunity to vaccinate a patient, then it would be okay to give all three. But, if the patient can come for two separate visits, the recommendation would currently be to separate these. In the future, there likely will be data on giving all three vaccines at once, so it may not be an issue to administer all three at the same time.

Lastly, I would point out that the RSV vaccine is not necessarily recommended for everyone age 60 and above. The Advisory Committee on Immunization Practices recommends using shared clinical decision-making to determine if that vaccine is right for the patient. In general, the flu and COVID vaccines are recommended for everyone, although the specific COVID recommendations for fall 2023 have not yet been released. There are no particular vaccine interactions that are concerning with these vaccines.

Q: What if any special considerations are there regarding the storage, handling, and ordering of these vaccines? Should primary care practices take any special steps they might not already be taking?

Dr. Durham: I don’t think there are any special considerations that providers might not already be doing. All of the vaccines do require refrigeration, but each individual product may vary some on beyond-use dates or how long they are good after being reconstituted. All providers administering these vaccines should carefully examine the labeling of each individual product to ensure correct storage and handling. In addition, the Centers for Disease Control and Prevention has an online toolkit for vaccine storage and handling and can be found at https://www.cdc.gov/vaccines/hcp/admin/storage/toolkit/index.html.

Santina J. G. Wheat, MD, MPH, vice chair of diversity, equity, and inclusion, department of family and community medicine, and associate professor of family and community medicine, Northwestern University, ChicagoQ: What can primary care doctors/family physicians and their staff do to increase patient access to the vaccines? Any lessons learned from the earlier phases of the pandemic that might pertain not only to COVID-19 but also to RSV and/or influenza?

Dr. Wheat: I think the most important thing family physicians can do is speak with their patients about the importance of vaccines and specific recommendations they have for the situations of individuals and families. When vaccines started becoming available, I had many patients who wanted to hear from me – as their primary physician – what I truly thought and what I was planning to do for my own family.

I also think if our teams can know where vaccines are easily accessible, that makes it much easier for our patients. I have heard great stories and seen my own clinical support staff look at websites with patients to help them find the best location to get vaccines. In particular, about the RSV vaccine, I have had a handful of patients already come to ask me about my recommendations. When vaccines are available at my location, I find it much easier for my patients to be willing to get vaccinated. Similarly, if I am sending patients to pick up a prescription and they can get it at the same time, I have found success in them being willing to be vaccinated while picking up their prescription. In both instances, they do not need to make an additional stop; they are just able to be vaccinated while already at the clinic or pharmacy.

Q: Do you see any extra difficulties involved in trying to get groups of patients – in this case, older people – to be receptive to three vaccines, especially in this climate where it appears a growing number of people are hostile to immunization?

Dr. Wheat: Recently, I have found myself negotiating vaccines with patients not just with these, but as recommendations have changed for vaccines such as the pneumococcal vaccines and the hepatitis B vaccines. I think primary care providers can recommend all of them, but still help patients prioritize what is most important for that patient and family. For example, if welcoming a new baby soon, they might prioritize the vaccines for pertussis or influenza over the hepatitis vaccine with a plan to revisit the conversations later.

I have had some patients tell me they have gotten enough vaccines – and we know that even before the pandemic there was resistance to the influenza vaccine for some. I think we need to be prepared to address the concerns and, at times, the apathy. We also need to ask every time, because we never know which visit will be the one when a patient agrees.

Dr. Auwaerter reported financial relationships with Pfizer, Shionogi, Gilead, and Wellstat. Dr. Durham and Dr. Wheat disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Hospitalizations for COVID-19 in the United States have increased for 8 weeks in a row.

Data from Florida and Georgia signal that respiratory syncytial virus (RSV) season has begun.

As for flu shots, experts say patients with long COVID should get them in 2023, although federal health agencies have not addressed that specific question.

Paul G. Auwaerter, MD, MBA, an infectious disease consultant, said many patients in his primary care practice worry about “the big three” – COVID, influenza, and RSV.

This news organization spoke with Dr. Auwaerter, as well as family physician Santina J. G. Wheat, MD, MPH, and clinical pharmacist Spencer H. Durham, PharmD, about their approach to 2023’s respiratory virus season.

They discussed how to handle COVID boosters, the use of Paxlovid, vaccine hesitancy, and the correct order of operations for patients getting vaccinated against all three diseases.
 

Paul G. Auwaerter, MD, MBA, clinical director of the division of infectious diseases and the Sherrilyn and Ken Fisher Professor of Medicine at Johns Hopkins University, BaltimoreQuestion: How should primary care physicians be preparing to handle what everyone is predicting will be a major surge in cases of respiratory infections?

Auwaerter: Although I’m an infectious disease consultant, I still have a small primary care practice. So, I field questions for my patients all the time, and many patients, especially those with health problems, are worried about the big three: RSV, COVID, and influenza – at least, my more motivated patients are.

People frequently ask if they need the COVID booster. I think that’s been something many people think maybe they can avoid. The good news is that the early in vitro data suggest that the XBB1.5x-based vaccine seems to offer sufficient neutralizing activity against the circulating newer variants since the vaccine was approved earlier this year. I am suggesting that everyone get a booster, especially those at high risk, because we know that the risk for hospitalization decreases based on earlier studies for 4-6 months after a COVID booster. We can simultaneously administer the revised COVID booster vaccine and the annual influenza vaccine. The timing is good, as influenza immunization should be accomplished by October or early November at the latest. Like many parts of the country, we in Maryland are in the middle of a COVID boomlet. I have issued more Paxlovid prescriptions since mid-August than I did all spring and early summer.

Q: Are you seeing a lot of rebound COVID in your patients taking Paxlovid [nirmatrelvir/ritonavir]?

Dr. Auwaerter: I think the frequency is probably around 10%. It has been quoted much higher – at 20% – but careful studies have put it down at just single digits. I think it just depends on symptomatology and how you ask the question. But I think it’s important that I try to persuade people to take a direct-acting antiviral if they’re in a high-risk category rather than tough it out. Increasing data suggest taking an antiviral also reduces the risk for long COVID. Also, we know that rebound symptoms are not always infectious virus. Sometimes, they’re just inflammatory. Unless a person is immune suppressed, they rarely have a culturable virus 7-8 days after onset of symptoms. So, for most people, I don’t administer second courses of Paxlovid, although I know some physicians do. One has to realize the risk for hospitalization from a rebound is tiny, and many people don’t even have infectious virus when they take the second course of a drug such as Paxlovid.

Q: You mentioned motivated patients, which seems to be an important factor to consider, particularly for new vaccines.

Dr. Auwaerter: There are always early adopters who are less afraid. And then some people say: This is a brand-new vaccine; I’m going to wait for a year to let this shake out, and make sure it seems safe. People more engaged in their health have asked me about the RSV vaccine. For anyone who has cardiopulmonary problems and other major health problems, I’ve advised it. But if someone’s in good health and 65 or 70, the RSV illness is probably pretty mild if they get it. For them, I would say the vaccine is optional.

For people over 75, I have been advising the RSV vaccine because that is a group we tend to see hospitalized with RSV; they’re the highest-risk group, similar to COVID. The older you are, the more likely this infection will land you in the hospital. You can acquire RSV even if you don’t have young grandchildren around.

Q: You have called respiratory virus seasons unstable? What does it mean, and what is the significance for clinicians?

Dr. Auwaerter: It’s less predictable than in the past. If you had a cough and fever, you could think it was influenza if you knew you had influenza circulating in your community. Maybe you thought about RSV for your immunocompromised or older patients, but we didn’t have any therapy for it anyway. I sometimes refer to the respiratory virus season as a cage match between the major infections. Last year, RSV came out first, and we got some influenza and COVID. What does the situation look like this year? I don’t know at this point, but we are seeing more COVID earlier. What’s different is we continue to have the emergence of viral variants of SARS-CoV-2. Also, with both influenza and COVID, it’s harder to make a clinical judgment about what people have.

I think we have to rely more on tests to treat these patients. Options include having point of care testing in the office for rapid results (molecular assays preferred) for both influenza and SARS-CoV-2 or home antigen testing. There are home kits that do test for both if influenza is known to be circulating significantly in the community. But there are still barriers. For one, COVID and COVID/influenza antigen kits are no longer free, although some health insurance companies do provide COVID kits free of charge. In offices, you don’t want to have ill people with respiratory infections in your waiting room unless you can isolate or have negative pressure rooms. Do you ask for masking in your offices? Telemedicine has been a big help since the pandemic in managing nonsevere respiratory infections at home; however, you must be licensed in the state to practice, which limits helping your out-of-state patients.

Q: How has the advent of in-home antigen tests changed practice?

Dr. Auwaerter: Home antigen tests have been groundbreaking in facilitating care. When I see patients via telemedicine, I don’t want to prescribe medications for influenza and COVID to people simultaneously. I want to pick one or the other – and now I’m able to ask for a COVID test or a COVID/influenza test if the patient or family is able to get a kit. Some offices do have real-time molecular testing, which is the ideal and the CDC-recommended approach, but they’re expensive, and not everyone has access to them.

Q: People talk about the “tripledemic,” but does doing so ignore the fourth horseman of the respiratory apocalypse: pneumococcal pneumonia?

Dr. Auwaerter: Pneumonia remains a leading cause of hospitalization, except we’ve seen much more viral than bacterial pneumonia in recent years of the pandemic. We’ve lost sight, and pneumococcal pneumonia is important, especially in older patients. What we have seen pretty clearly is a rise in group A streptococcal infections. This is another consequence of the pandemic, where people did not socialize for a year or 2. There was much less group A strep infection in younger children, and even in adults, the amount of invasive group A streptococcal infections has clearly taken a jump, according to the NHS in Great Britain. Our pediatric practices here at Johns Hopkins are seeing far more cases of acute rheumatic fever than they’ve seen in decades. And I think, again, this is a consequence of the frequency of group A strep infections definitely taking an uptick. And that was no doubt probably from social mitigation measures and just an interruption in normal circumstances that bacterial and respiratory pathogens tend to circulate and colonize.

Q: Do you have any concerns about immunogenicity or side effects associated with receiving several vaccines at once?

Dr. Auwaerter: I think three injections at once is only for the heroic, and there is actually no guidance for getting all three at the moment. COVID, RSV, and influenza are not live vaccines. I’ve been recommending the new COVID booster and flu together, and then wait 2 weeks and then get RSV or vice-versa. A part of the reason is RSV is new. People have gotten COVID and flu vaccines before; they’re no different than in the past in terms of anticipating adverse effects. But RSV is new, so I’ve usually been recommending that as a standalone to gauge if there are issues as an RSV booster may be recommended at some point down the road.

Q: Unfortunately, some people are going to see or hear misinformation that the COVID boosters have not been properly tested or proven safe. What’s your response to the patient who says something to that effect?

Dr. Auwaerter: My response is, the basic components of the vaccine are the same, right? If you have the mRNA vaccine, you’re getting the vaccine components, the lipids, and the mRNA coding for spike proteins, which has just been modified slightly to adjust to the Omicron subvariant composition. We do the same thing with the influenza vaccine every year, and we don’t see much change in the side effect profile. I think it’s important for my staff in the office and myself to be very comfortable to field questions such as these.

We try to inform all of our staff about a vaccine, especially a new one like RSV, just so they have some comfort level with it, whether they’re getting it or not. Vaccine-hesitant patients need very little to dissuade and to take a pass – to the probable detriment of their health and their family’s health. We know the influenza vaccine helps reduce absenteeism and transmission in addition to reducing serious illness in high-risk patients. Even COVID vaccine efficacy is not as robust as initially reported, falling from 95% to under 70% depending on the study – you are provided with protection against serious illness and hospitalization. The same goes for influenza, and that’s how we try to pitch it to people. Are they going to get the flu? Maybe, but you didn’t land in the hospital. That’s why it’s these vaccines are so important.
 

Spencer H. Durham, PharmD, associate clinical professor in the department of pharmacy practice at Auburn (Ala.) University, and clinical pharmacist, Internal Medicine & Infectious Diseases, at the UAB Heersink School of Medicine in Huntsville.Q: What is known, if anything, about the risks/desirability of giving three vaccinations at once to patients (particularly older patients) – flu, COVID-19 and RSV? Any potential vaccine interactions physicians should know about?

Dr. Durham: There are currently no data about giving all three of these vaccines together at the same time. However, there is both data and practical experience of giving both the flu and COVID vaccines at the same time. The best approach right now for these three vaccines would be to get the flu and COVID vaccines at the same time, then give the RSV vaccine at a different date. In general, they should be separated by about 2 weeks, although it does not matter in what order they are given (that is, patients could get RSV first, then flu/COVID, or they could get flu/COVID first, followed by RSV).

Having said this, there is no theoretical reason why patients couldn’t get all three at once, so if there is only one opportunity to vaccinate a patient, then it would be okay to give all three. But, if the patient can come for two separate visits, the recommendation would currently be to separate these. In the future, there likely will be data on giving all three vaccines at once, so it may not be an issue to administer all three at the same time.

Lastly, I would point out that the RSV vaccine is not necessarily recommended for everyone age 60 and above. The Advisory Committee on Immunization Practices recommends using shared clinical decision-making to determine if that vaccine is right for the patient. In general, the flu and COVID vaccines are recommended for everyone, although the specific COVID recommendations for fall 2023 have not yet been released. There are no particular vaccine interactions that are concerning with these vaccines.

Q: What if any special considerations are there regarding the storage, handling, and ordering of these vaccines? Should primary care practices take any special steps they might not already be taking?

Dr. Durham: I don’t think there are any special considerations that providers might not already be doing. All of the vaccines do require refrigeration, but each individual product may vary some on beyond-use dates or how long they are good after being reconstituted. All providers administering these vaccines should carefully examine the labeling of each individual product to ensure correct storage and handling. In addition, the Centers for Disease Control and Prevention has an online toolkit for vaccine storage and handling and can be found at https://www.cdc.gov/vaccines/hcp/admin/storage/toolkit/index.html.

Santina J. G. Wheat, MD, MPH, vice chair of diversity, equity, and inclusion, department of family and community medicine, and associate professor of family and community medicine, Northwestern University, ChicagoQ: What can primary care doctors/family physicians and their staff do to increase patient access to the vaccines? Any lessons learned from the earlier phases of the pandemic that might pertain not only to COVID-19 but also to RSV and/or influenza?

Dr. Wheat: I think the most important thing family physicians can do is speak with their patients about the importance of vaccines and specific recommendations they have for the situations of individuals and families. When vaccines started becoming available, I had many patients who wanted to hear from me – as their primary physician – what I truly thought and what I was planning to do for my own family.

I also think if our teams can know where vaccines are easily accessible, that makes it much easier for our patients. I have heard great stories and seen my own clinical support staff look at websites with patients to help them find the best location to get vaccines. In particular, about the RSV vaccine, I have had a handful of patients already come to ask me about my recommendations. When vaccines are available at my location, I find it much easier for my patients to be willing to get vaccinated. Similarly, if I am sending patients to pick up a prescription and they can get it at the same time, I have found success in them being willing to be vaccinated while picking up their prescription. In both instances, they do not need to make an additional stop; they are just able to be vaccinated while already at the clinic or pharmacy.

Q: Do you see any extra difficulties involved in trying to get groups of patients – in this case, older people – to be receptive to three vaccines, especially in this climate where it appears a growing number of people are hostile to immunization?

Dr. Wheat: Recently, I have found myself negotiating vaccines with patients not just with these, but as recommendations have changed for vaccines such as the pneumococcal vaccines and the hepatitis B vaccines. I think primary care providers can recommend all of them, but still help patients prioritize what is most important for that patient and family. For example, if welcoming a new baby soon, they might prioritize the vaccines for pertussis or influenza over the hepatitis vaccine with a plan to revisit the conversations later.

I have had some patients tell me they have gotten enough vaccines – and we know that even before the pandemic there was resistance to the influenza vaccine for some. I think we need to be prepared to address the concerns and, at times, the apathy. We also need to ask every time, because we never know which visit will be the one when a patient agrees.

Dr. Auwaerter reported financial relationships with Pfizer, Shionogi, Gilead, and Wellstat. Dr. Durham and Dr. Wheat disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

COVID vaccines will have a new formulation in 2023, according to a decision announced by the U.S. Food and Drug Administration, that will focus efforts on circulating variants. The move pushes last year’s bivalent vaccines out of circulation because they will no longer be authorized for use in the United States.

The updated mRNA vaccines for 2023-2024 are being revised to include a single component that corresponds to the Omicron variant XBB.1.5. Like the bivalents offered before, the new monovalents are being manufactured by Moderna and Pfizer.

The new vaccines are authorized for use in individuals age 6 months and older.  And the new options are being developed using a similar process as previous formulations, according to the FDA.
 

Targeting circulating variants

In recent studies, regulators point out the extent of neutralization observed by the updated vaccines against currently circulating viral variants causing COVID-19, including EG.5, BA.2.86, appears to be of a similar magnitude to the extent of neutralization observed with previous versions of the vaccines against corresponding prior variants.

“This suggests that the vaccines are a good match for protecting against the currently circulating COVID-19 variants,” according to the report.

Hundreds of millions of people in the United States have already received previously approved mRNA COVID vaccines, according to regulators who say the benefit-to-risk profile is well understood as they move forward with new formulations.

“Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. “The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality. We very much encourage those who are eligible to consider getting vaccinated.”
 

Timing the effort

On Sept. 12 the U.S. Centers for Disease Control and Prevention recommended that everyone 6 months and older get an updated COVID-19 vaccine. Updated vaccines from Pfizer-BioNTech and Moderna will be available later this week, according to the agency.

This article was updated 9/14/23.

A version of this article appeared on Medscape.com.

COVID vaccines will have a new formulation in 2023, according to a decision announced by the U.S. Food and Drug Administration, that will focus efforts on circulating variants. The move pushes last year’s bivalent vaccines out of circulation because they will no longer be authorized for use in the United States.

The updated mRNA vaccines for 2023-2024 are being revised to include a single component that corresponds to the Omicron variant XBB.1.5. Like the bivalents offered before, the new monovalents are being manufactured by Moderna and Pfizer.

The new vaccines are authorized for use in individuals age 6 months and older.  And the new options are being developed using a similar process as previous formulations, according to the FDA.
 

Targeting circulating variants

In recent studies, regulators point out the extent of neutralization observed by the updated vaccines against currently circulating viral variants causing COVID-19, including EG.5, BA.2.86, appears to be of a similar magnitude to the extent of neutralization observed with previous versions of the vaccines against corresponding prior variants.

“This suggests that the vaccines are a good match for protecting against the currently circulating COVID-19 variants,” according to the report.

Hundreds of millions of people in the United States have already received previously approved mRNA COVID vaccines, according to regulators who say the benefit-to-risk profile is well understood as they move forward with new formulations.

“Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. “The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality. We very much encourage those who are eligible to consider getting vaccinated.”
 

Timing the effort

On Sept. 12 the U.S. Centers for Disease Control and Prevention recommended that everyone 6 months and older get an updated COVID-19 vaccine. Updated vaccines from Pfizer-BioNTech and Moderna will be available later this week, according to the agency.

This article was updated 9/14/23.

A version of this article appeared on Medscape.com.

COVID vaccines will have a new formulation in 2023, according to a decision announced by the U.S. Food and Drug Administration, that will focus efforts on circulating variants. The move pushes last year’s bivalent vaccines out of circulation because they will no longer be authorized for use in the United States.

The updated mRNA vaccines for 2023-2024 are being revised to include a single component that corresponds to the Omicron variant XBB.1.5. Like the bivalents offered before, the new monovalents are being manufactured by Moderna and Pfizer.

The new vaccines are authorized for use in individuals age 6 months and older.  And the new options are being developed using a similar process as previous formulations, according to the FDA.
 

Targeting circulating variants

In recent studies, regulators point out the extent of neutralization observed by the updated vaccines against currently circulating viral variants causing COVID-19, including EG.5, BA.2.86, appears to be of a similar magnitude to the extent of neutralization observed with previous versions of the vaccines against corresponding prior variants.

“This suggests that the vaccines are a good match for protecting against the currently circulating COVID-19 variants,” according to the report.

Hundreds of millions of people in the United States have already received previously approved mRNA COVID vaccines, according to regulators who say the benefit-to-risk profile is well understood as they move forward with new formulations.

“Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. “The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality. We very much encourage those who are eligible to consider getting vaccinated.”
 

Timing the effort

On Sept. 12 the U.S. Centers for Disease Control and Prevention recommended that everyone 6 months and older get an updated COVID-19 vaccine. Updated vaccines from Pfizer-BioNTech and Moderna will be available later this week, according to the agency.

This article was updated 9/14/23.

A version of this article appeared on Medscape.com.

To the Editor:

COVID-19 infection has resulted in 6.9 million deaths worldwide. India has the third highest mortality from COVID-19 infection after the United States and Brazil.¹ Vaccination plays a crucial role in containing COVID-19 infection and reducing its severity. At present, 11 vaccines have been approved by the World Health Organization. India started its vaccination program on January 16, 2021, with approval for use of Covaxin (Bharat Biotech) and Covishield (Oxford/AstraZeneca formulation)(Serum Institute of India). More than 2 billion doses have been administered since then.^2,3

Patients with psoriasis are prone to develop a severe form of COVID-19 due to comorbidities and the intake of immunosuppressive drugs.⁴ These patients often are hesitant to receive the vaccine without an expert opinion. COVID-19 vaccines are considered to increase tumor necrosis factor α (TNF-α) and IFN-γ production by CD4⁺ T cells. Tumor necrosis factor α is a key proinflammatory cytokine implicated in the pathogenesis of psoriasis. COVID-19 messenger RNA vaccines induce elevation of IL-6 and helper T cells (T_H17), which can induce a flare of psoriasis in a subset of patients.⁵The International Psoriasis Council recommends that patients with psoriasis receive one of the vaccines approved to prevent COVID-19 infection as soon as possible.⁶ Reports of new-onset psoriasis and flare of psoriasis after the use of COVID-19 vaccines, such as those manufactured by Pfizer-BioNTech, Moderna, and AstraZeneca, have been published from different parts of the world.⁷ India used locally developed whole virion inactivated BBV152 (Covaxin) and nonreplicating viral vaccine ChAdOx1 nCoV-19 (Covishield) in its vaccination program and exported them to other developing countries. There is a dearth of data on the safety of these vaccines in patients with psoriasis, which needs to be assessed. Later, Covaxin, ZyCoV-D (DNA plasmid vaccine; Cadila Healthcare), and CorbeVax (protein subunit vaccine; Biological E) were approved for usage in children.⁸ We conducted a cross-sectional study using the direct interview method.

Patients with psoriasis who attended the outpatient department of the Postgraduate Institute of Medical Education and Research (Chandigarh, India) from April 2022 to June 2022 were invited to participate in the study after written informed consent was received. Patients 18 years and older with chronic plaque psoriasis who had received a COVID-19 vaccine dose in the last 90 days were enrolled. Data on demographics, comorbidities, treatment received for psoriasis, vaccination concerns, history of COVID-19 infection, type of vaccine received with doses, adverse effects, and psoriasis flare after receiving the vaccine (considered up to 2 weeks from the date of vaccination) were collected. Ordinal logistic regression was used to identify factors associated with a psoriasis flare following vaccination. P<.05 was considered statistically significant.

A total of 202 patients with chronic plaque psoriasis who received either Covaxin or Covishield were enrolled during the study period. The mean age (SD) was 40.3 (13.1) years, and 149 (73.8%) patients were male. One hundred thirty-five (66.8%) patients completed 2 doses of the vaccine. eTable 1 provides the clinicodemographic details of the patients. Eighty-three (41.1%) patients had a fear of psoriasis flare after vaccination. Seventy-two (35.6%) patients received the vaccine after clearance from their treating physician/dermatologist. One hundred sixty-four (81.2%) patients received the Covishield vaccine, and 38 (18.8%) patients received Covaxin. Eighty-three (41.1%) patients reported flulike symptoms, such as fever, myalgia, or body pain, within the first week of vaccination. Sixty-one (30.2%) patients reported a psoriasis flare after vaccination in the form of new lesions or worsening of pre-existing lesions. Of these patients, 51 reported a flare after receiving the first dose of vaccine, 8 patients reported a flare after receiving the second dose of vaccine, and 2 patients reported a flare after receiving both doses of vaccine. The mean (SD) flare onset was 8.1 (3.4) days after the vaccination. Eighteen patients considered the flare to be severe. Seventeen (8.4%) patients reported a positive history of COVID-19 infection before vaccination. None of the patients reported breakthrough COVID-19 infection or pustular aggravation of psoriasis following the vaccination.

The self-reported psoriasis flare after receiving the COVID-19 vaccine was significantly higher in patients who experienced immediate adverse effects (P=.005), which included fever, myalgia, joint pain, and injection-site reaction. The reported postvaccination psoriasis flare was not significantly associated with patient sex, history of COVID-19 infection, type of vaccine received, comorbidities, or therapy for psoriasis (eTable 2).

Nearly 30% of our patients reported a postvaccination psoriasis flare, which was more common after the first vaccine dose. Sotiriou et al⁷ reported 14 cases of psoriasis flare in patients after receiving Pfizer-BioNTech, Moderna, and AstraZeneca COVID-19 vaccines. These patients experienced an exacerbation of disease soon after the second dose of vaccine (mean [SD], 10.36 [7.71] days), and 21% of the 713 enrolled patients wanted to forego the immunization due to concern of a postvaccination psoriasis flare.⁷ In another report, 14 (27%) patients developed a psoriasis flare after COVID-19 vaccination; the mean (SD) flare onset was 9.3 (4.3) days after vaccination.⁹

Data on the safety of the COVID-19 vaccine in patients using immunosuppressive drugs are limited. We did not find a significant association between the psoriasis flare and use of immunosuppressive drugs or type of vaccine received. Huang and Tsai⁹ observed similar results, with no association between psoriasis flare and use of immunosuppressive drugs or biologics, while Damiani et al¹⁰ demonstrated a protective role of biologics in preventing vaccine-induced psoriasis flare.

Similar to another study from India,¹¹ the immediate adverse effects due to immunization with Covaxin and Covishield were mild in our study and resolved within a week. The incidence of psoriasis flare was significantly higher in patients who reported adverse effects (P=.005). Activation of immune response after vaccination leads to the release of proinflammatory and pyrogenic cytokines (ie, IL-1, IL-6, TNF-α), which may explain the higher incidence of psoriasis flare in patients experiencing adverse effects to vaccination.¹²

Our study showed approximately 30% of patients developed a psoriasis flare after COVID-19 vaccination, with no patients experiencing any vaccine-related serious adverse events, which suggests that Covaxin and Covishield are safe for patients with psoriasis in India. Limitations of our study include potential inaccuracy of the patient’s self-assessment of symptoms and disease flare, recall bias that may lead to errors in estimating patient-reported outcomes, the flare of psoriasis potentially being a part of disease fluctuation, and flare being enhanced by the psychological stress of vaccination.

Considering a high risk for severe COVID-19 infection in patients with psoriasis with comorbidities and those using immunosuppressive drugs, Covaxin and Covishield can be safely recommended in India. However, caution needs to be exercised when vaccinating patients with an unstable disease or severe psoriasis.

To the Editor:

COVID-19 infection has resulted in 6.9 million deaths worldwide. India has the third highest mortality from COVID-19 infection after the United States and Brazil.¹ Vaccination plays a crucial role in containing COVID-19 infection and reducing its severity. At present, 11 vaccines have been approved by the World Health Organization. India started its vaccination program on January 16, 2021, with approval for use of Covaxin (Bharat Biotech) and Covishield (Oxford/AstraZeneca formulation)(Serum Institute of India). More than 2 billion doses have been administered since then.^2,3

Patients with psoriasis are prone to develop a severe form of COVID-19 due to comorbidities and the intake of immunosuppressive drugs.⁴ These patients often are hesitant to receive the vaccine without an expert opinion. COVID-19 vaccines are considered to increase tumor necrosis factor α (TNF-α) and IFN-γ production by CD4⁺ T cells. Tumor necrosis factor α is a key proinflammatory cytokine implicated in the pathogenesis of psoriasis. COVID-19 messenger RNA vaccines induce elevation of IL-6 and helper T cells (T_H17), which can induce a flare of psoriasis in a subset of patients.⁵The International Psoriasis Council recommends that patients with psoriasis receive one of the vaccines approved to prevent COVID-19 infection as soon as possible.⁶ Reports of new-onset psoriasis and flare of psoriasis after the use of COVID-19 vaccines, such as those manufactured by Pfizer-BioNTech, Moderna, and AstraZeneca, have been published from different parts of the world.⁷ India used locally developed whole virion inactivated BBV152 (Covaxin) and nonreplicating viral vaccine ChAdOx1 nCoV-19 (Covishield) in its vaccination program and exported them to other developing countries. There is a dearth of data on the safety of these vaccines in patients with psoriasis, which needs to be assessed. Later, Covaxin, ZyCoV-D (DNA plasmid vaccine; Cadila Healthcare), and CorbeVax (protein subunit vaccine; Biological E) were approved for usage in children.⁸ We conducted a cross-sectional study using the direct interview method.

Patients with psoriasis who attended the outpatient department of the Postgraduate Institute of Medical Education and Research (Chandigarh, India) from April 2022 to June 2022 were invited to participate in the study after written informed consent was received. Patients 18 years and older with chronic plaque psoriasis who had received a COVID-19 vaccine dose in the last 90 days were enrolled. Data on demographics, comorbidities, treatment received for psoriasis, vaccination concerns, history of COVID-19 infection, type of vaccine received with doses, adverse effects, and psoriasis flare after receiving the vaccine (considered up to 2 weeks from the date of vaccination) were collected. Ordinal logistic regression was used to identify factors associated with a psoriasis flare following vaccination. P<.05 was considered statistically significant.

A total of 202 patients with chronic plaque psoriasis who received either Covaxin or Covishield were enrolled during the study period. The mean age (SD) was 40.3 (13.1) years, and 149 (73.8%) patients were male. One hundred thirty-five (66.8%) patients completed 2 doses of the vaccine. eTable 1 provides the clinicodemographic details of the patients. Eighty-three (41.1%) patients had a fear of psoriasis flare after vaccination. Seventy-two (35.6%) patients received the vaccine after clearance from their treating physician/dermatologist. One hundred sixty-four (81.2%) patients received the Covishield vaccine, and 38 (18.8%) patients received Covaxin. Eighty-three (41.1%) patients reported flulike symptoms, such as fever, myalgia, or body pain, within the first week of vaccination. Sixty-one (30.2%) patients reported a psoriasis flare after vaccination in the form of new lesions or worsening of pre-existing lesions. Of these patients, 51 reported a flare after receiving the first dose of vaccine, 8 patients reported a flare after receiving the second dose of vaccine, and 2 patients reported a flare after receiving both doses of vaccine. The mean (SD) flare onset was 8.1 (3.4) days after the vaccination. Eighteen patients considered the flare to be severe. Seventeen (8.4%) patients reported a positive history of COVID-19 infection before vaccination. None of the patients reported breakthrough COVID-19 infection or pustular aggravation of psoriasis following the vaccination.

The self-reported psoriasis flare after receiving the COVID-19 vaccine was significantly higher in patients who experienced immediate adverse effects (P=.005), which included fever, myalgia, joint pain, and injection-site reaction. The reported postvaccination psoriasis flare was not significantly associated with patient sex, history of COVID-19 infection, type of vaccine received, comorbidities, or therapy for psoriasis (eTable 2).

Nearly 30% of our patients reported a postvaccination psoriasis flare, which was more common after the first vaccine dose. Sotiriou et al⁷ reported 14 cases of psoriasis flare in patients after receiving Pfizer-BioNTech, Moderna, and AstraZeneca COVID-19 vaccines. These patients experienced an exacerbation of disease soon after the second dose of vaccine (mean [SD], 10.36 [7.71] days), and 21% of the 713 enrolled patients wanted to forego the immunization due to concern of a postvaccination psoriasis flare.⁷ In another report, 14 (27%) patients developed a psoriasis flare after COVID-19 vaccination; the mean (SD) flare onset was 9.3 (4.3) days after vaccination.⁹

Data on the safety of the COVID-19 vaccine in patients using immunosuppressive drugs are limited. We did not find a significant association between the psoriasis flare and use of immunosuppressive drugs or type of vaccine received. Huang and Tsai⁹ observed similar results, with no association between psoriasis flare and use of immunosuppressive drugs or biologics, while Damiani et al¹⁰ demonstrated a protective role of biologics in preventing vaccine-induced psoriasis flare.

Similar to another study from India,¹¹ the immediate adverse effects due to immunization with Covaxin and Covishield were mild in our study and resolved within a week. The incidence of psoriasis flare was significantly higher in patients who reported adverse effects (P=.005). Activation of immune response after vaccination leads to the release of proinflammatory and pyrogenic cytokines (ie, IL-1, IL-6, TNF-α), which may explain the higher incidence of psoriasis flare in patients experiencing adverse effects to vaccination.¹²

Our study showed approximately 30% of patients developed a psoriasis flare after COVID-19 vaccination, with no patients experiencing any vaccine-related serious adverse events, which suggests that Covaxin and Covishield are safe for patients with psoriasis in India. Limitations of our study include potential inaccuracy of the patient’s self-assessment of symptoms and disease flare, recall bias that may lead to errors in estimating patient-reported outcomes, the flare of psoriasis potentially being a part of disease fluctuation, and flare being enhanced by the psychological stress of vaccination.

Considering a high risk for severe COVID-19 infection in patients with psoriasis with comorbidities and those using immunosuppressive drugs, Covaxin and Covishield can be safely recommended in India. However, caution needs to be exercised when vaccinating patients with an unstable disease or severe psoriasis.

To the Editor:

COVID-19 infection has resulted in 6.9 million deaths worldwide. India has the third highest mortality from COVID-19 infection after the United States and Brazil.¹ Vaccination plays a crucial role in containing COVID-19 infection and reducing its severity. At present, 11 vaccines have been approved by the World Health Organization. India started its vaccination program on January 16, 2021, with approval for use of Covaxin (Bharat Biotech) and Covishield (Oxford/AstraZeneca formulation)(Serum Institute of India). More than 2 billion doses have been administered since then.^2,3

Patients with psoriasis are prone to develop a severe form of COVID-19 due to comorbidities and the intake of immunosuppressive drugs.⁴ These patients often are hesitant to receive the vaccine without an expert opinion. COVID-19 vaccines are considered to increase tumor necrosis factor α (TNF-α) and IFN-γ production by CD4⁺ T cells. Tumor necrosis factor α is a key proinflammatory cytokine implicated in the pathogenesis of psoriasis. COVID-19 messenger RNA vaccines induce elevation of IL-6 and helper T cells (T_H17), which can induce a flare of psoriasis in a subset of patients.⁵The International Psoriasis Council recommends that patients with psoriasis receive one of the vaccines approved to prevent COVID-19 infection as soon as possible.⁶ Reports of new-onset psoriasis and flare of psoriasis after the use of COVID-19 vaccines, such as those manufactured by Pfizer-BioNTech, Moderna, and AstraZeneca, have been published from different parts of the world.⁷ India used locally developed whole virion inactivated BBV152 (Covaxin) and nonreplicating viral vaccine ChAdOx1 nCoV-19 (Covishield) in its vaccination program and exported them to other developing countries. There is a dearth of data on the safety of these vaccines in patients with psoriasis, which needs to be assessed. Later, Covaxin, ZyCoV-D (DNA plasmid vaccine; Cadila Healthcare), and CorbeVax (protein subunit vaccine; Biological E) were approved for usage in children.⁸ We conducted a cross-sectional study using the direct interview method.

Patients with psoriasis who attended the outpatient department of the Postgraduate Institute of Medical Education and Research (Chandigarh, India) from April 2022 to June 2022 were invited to participate in the study after written informed consent was received. Patients 18 years and older with chronic plaque psoriasis who had received a COVID-19 vaccine dose in the last 90 days were enrolled. Data on demographics, comorbidities, treatment received for psoriasis, vaccination concerns, history of COVID-19 infection, type of vaccine received with doses, adverse effects, and psoriasis flare after receiving the vaccine (considered up to 2 weeks from the date of vaccination) were collected. Ordinal logistic regression was used to identify factors associated with a psoriasis flare following vaccination. P<.05 was considered statistically significant.

A total of 202 patients with chronic plaque psoriasis who received either Covaxin or Covishield were enrolled during the study period. The mean age (SD) was 40.3 (13.1) years, and 149 (73.8%) patients were male. One hundred thirty-five (66.8%) patients completed 2 doses of the vaccine. eTable 1 provides the clinicodemographic details of the patients. Eighty-three (41.1%) patients had a fear of psoriasis flare after vaccination. Seventy-two (35.6%) patients received the vaccine after clearance from their treating physician/dermatologist. One hundred sixty-four (81.2%) patients received the Covishield vaccine, and 38 (18.8%) patients received Covaxin. Eighty-three (41.1%) patients reported flulike symptoms, such as fever, myalgia, or body pain, within the first week of vaccination. Sixty-one (30.2%) patients reported a psoriasis flare after vaccination in the form of new lesions or worsening of pre-existing lesions. Of these patients, 51 reported a flare after receiving the first dose of vaccine, 8 patients reported a flare after receiving the second dose of vaccine, and 2 patients reported a flare after receiving both doses of vaccine. The mean (SD) flare onset was 8.1 (3.4) days after the vaccination. Eighteen patients considered the flare to be severe. Seventeen (8.4%) patients reported a positive history of COVID-19 infection before vaccination. None of the patients reported breakthrough COVID-19 infection or pustular aggravation of psoriasis following the vaccination.

The self-reported psoriasis flare after receiving the COVID-19 vaccine was significantly higher in patients who experienced immediate adverse effects (P=.005), which included fever, myalgia, joint pain, and injection-site reaction. The reported postvaccination psoriasis flare was not significantly associated with patient sex, history of COVID-19 infection, type of vaccine received, comorbidities, or therapy for psoriasis (eTable 2).

Nearly 30% of our patients reported a postvaccination psoriasis flare, which was more common after the first vaccine dose. Sotiriou et al⁷ reported 14 cases of psoriasis flare in patients after receiving Pfizer-BioNTech, Moderna, and AstraZeneca COVID-19 vaccines. These patients experienced an exacerbation of disease soon after the second dose of vaccine (mean [SD], 10.36 [7.71] days), and 21% of the 713 enrolled patients wanted to forego the immunization due to concern of a postvaccination psoriasis flare.⁷ In another report, 14 (27%) patients developed a psoriasis flare after COVID-19 vaccination; the mean (SD) flare onset was 9.3 (4.3) days after vaccination.⁹

Data on the safety of the COVID-19 vaccine in patients using immunosuppressive drugs are limited. We did not find a significant association between the psoriasis flare and use of immunosuppressive drugs or type of vaccine received. Huang and Tsai⁹ observed similar results, with no association between psoriasis flare and use of immunosuppressive drugs or biologics, while Damiani et al¹⁰ demonstrated a protective role of biologics in preventing vaccine-induced psoriasis flare.

Similar to another study from India,¹¹ the immediate adverse effects due to immunization with Covaxin and Covishield were mild in our study and resolved within a week. The incidence of psoriasis flare was significantly higher in patients who reported adverse effects (P=.005). Activation of immune response after vaccination leads to the release of proinflammatory and pyrogenic cytokines (ie, IL-1, IL-6, TNF-α), which may explain the higher incidence of psoriasis flare in patients experiencing adverse effects to vaccination.¹²

Our study showed approximately 30% of patients developed a psoriasis flare after COVID-19 vaccination, with no patients experiencing any vaccine-related serious adverse events, which suggests that Covaxin and Covishield are safe for patients with psoriasis in India. Limitations of our study include potential inaccuracy of the patient’s self-assessment of symptoms and disease flare, recall bias that may lead to errors in estimating patient-reported outcomes, the flare of psoriasis potentially being a part of disease fluctuation, and flare being enhanced by the psychological stress of vaccination.

Considering a high risk for severe COVID-19 infection in patients with psoriasis with comorbidities and those using immunosuppressive drugs, Covaxin and Covishield can be safely recommended in India. However, caution needs to be exercised when vaccinating patients with an unstable disease or severe psoriasis.

The understanding that human papillomavirus (HPV) causes oropharyngeal squamous cell carcinoma (OPSCC) has been linked with increased likelihood of adults having been vaccinated for HPV, new research indicates.

In a study published online in JAMA Otolaryngology–Head and Neck Surgery, most of the 288 adults surveyed with validated questions were not aware that HPV causes OPSCC and had not been told of the relationship by their health care provider.

Researchers found that when participants knew about the relationship between HPV infection and OPSCC they were more than three times as likely to be vaccinated (odds ratio, 3.7; 95% confidence interval, 1.8-7.6) as those without the knowledge.

The survey was paired with a novel point-of-care adult vaccination program within an otolaryngology clinic. 

“Targeted education aimed at unvaccinated adults establishing the relationship between HPV infection and OPSCC, paired with point-of-care vaccination, may be an innovative strategy for increasing HPV vaccination rates in adults,” write the authors, led by Jacob C. Bloom, MD, with the department of otolaryngology–head and neck surgery at Boston Medical Center.

Current HPV vaccination recommendations include three parts:

• Routine vaccination at age 11 or 12 years
• Catch-up vaccination at ages 13-26 years if not adequately vaccinated
• Shared clinical decision-making in adults aged 27-45 years if the vaccine series has not been completed.

Despite proven efficacy and safety of the HPV vaccine, vaccination rates are low for adults. Although 75% of adolescents aged 13-17 years have initiated the HPV vaccine, recent studies show only 16% of U.S. men aged 18-21 years have received at least 1 dose of the HPV vaccine, the authors write.

Christiana Zhang, MD, with the division of internal medicine at Johns Hopkins University in Baltimore, who was not part of the study, said she was not surprised by the lack of knowledge about the HPV-OPSCC link.

Patients are often counseled on the relationship between HPV and genital warts or anogenital cancers like cervical cancer, she says, but there is less patient education surrounding the relationship between HPV and oropharyngeal cancers.

She says she does counsel patients on the link with OPSCC, but not all providers do and provider knowledge in general surrounding HPV is low.

“Research has shown that knowledge and confidence among health care providers surrounding HPV vaccination is generally low, and this corresponds with a low vaccination recommendation rate,” she says.

She adds, “Patient education on HPV infection and its relationship with OPSCC, paired with point-of-care vaccination for qualifying patients, is a great approach.”

But the education needs to go beyond patients, she says.

“Given the important role that health care providers play in vaccine uptake, I think further efforts are needed to educate providers on HPV vaccination as well,” she says.

The study included patients aged 18-45 years who sought routine outpatient care at the otolaryngology clinic at Boston Medical Center from Sept. 1, 2020, to May 19, 2021.

Limitations of this study include studying a population from a single otolaryngology clinic in an urban, academic medical center. The population was more racially and ethnically diverse than the U.S. population with 60.3% identifying as racial and ethnic minorities. Gender and educational levels were also not reflective of U.S. demographics as half (50.8%) of the participants had a college degree or higher and 58.3% were women.

Dr. Bloom reports grants from the American Head and Neck Cancer Society during the conduct of the study. Coauthor Dr. Faden reports personal fees from Merck, Neotic, Focus, BMS, Chrystalis Biomedical Advisors, and Guidepoint; receiving nonfinancial support from BostonGene and Predicine; and receiving grants from Calico outside the submitted work. Dr. Zhang reports no relevant financial relationships.

The understanding that human papillomavirus (HPV) causes oropharyngeal squamous cell carcinoma (OPSCC) has been linked with increased likelihood of adults having been vaccinated for HPV, new research indicates.

In a study published online in JAMA Otolaryngology–Head and Neck Surgery, most of the 288 adults surveyed with validated questions were not aware that HPV causes OPSCC and had not been told of the relationship by their health care provider.

Researchers found that when participants knew about the relationship between HPV infection and OPSCC they were more than three times as likely to be vaccinated (odds ratio, 3.7; 95% confidence interval, 1.8-7.6) as those without the knowledge.

The survey was paired with a novel point-of-care adult vaccination program within an otolaryngology clinic. 

“Targeted education aimed at unvaccinated adults establishing the relationship between HPV infection and OPSCC, paired with point-of-care vaccination, may be an innovative strategy for increasing HPV vaccination rates in adults,” write the authors, led by Jacob C. Bloom, MD, with the department of otolaryngology–head and neck surgery at Boston Medical Center.

Current HPV vaccination recommendations include three parts:

• Routine vaccination at age 11 or 12 years
• Catch-up vaccination at ages 13-26 years if not adequately vaccinated
• Shared clinical decision-making in adults aged 27-45 years if the vaccine series has not been completed.

Despite proven efficacy and safety of the HPV vaccine, vaccination rates are low for adults. Although 75% of adolescents aged 13-17 years have initiated the HPV vaccine, recent studies show only 16% of U.S. men aged 18-21 years have received at least 1 dose of the HPV vaccine, the authors write.

Christiana Zhang, MD, with the division of internal medicine at Johns Hopkins University in Baltimore, who was not part of the study, said she was not surprised by the lack of knowledge about the HPV-OPSCC link.

Patients are often counseled on the relationship between HPV and genital warts or anogenital cancers like cervical cancer, she says, but there is less patient education surrounding the relationship between HPV and oropharyngeal cancers.

She says she does counsel patients on the link with OPSCC, but not all providers do and provider knowledge in general surrounding HPV is low.

“Research has shown that knowledge and confidence among health care providers surrounding HPV vaccination is generally low, and this corresponds with a low vaccination recommendation rate,” she says.

She adds, “Patient education on HPV infection and its relationship with OPSCC, paired with point-of-care vaccination for qualifying patients, is a great approach.”

But the education needs to go beyond patients, she says.

“Given the important role that health care providers play in vaccine uptake, I think further efforts are needed to educate providers on HPV vaccination as well,” she says.

The study included patients aged 18-45 years who sought routine outpatient care at the otolaryngology clinic at Boston Medical Center from Sept. 1, 2020, to May 19, 2021.

Limitations of this study include studying a population from a single otolaryngology clinic in an urban, academic medical center. The population was more racially and ethnically diverse than the U.S. population with 60.3% identifying as racial and ethnic minorities. Gender and educational levels were also not reflective of U.S. demographics as half (50.8%) of the participants had a college degree or higher and 58.3% were women.

Dr. Bloom reports grants from the American Head and Neck Cancer Society during the conduct of the study. Coauthor Dr. Faden reports personal fees from Merck, Neotic, Focus, BMS, Chrystalis Biomedical Advisors, and Guidepoint; receiving nonfinancial support from BostonGene and Predicine; and receiving grants from Calico outside the submitted work. Dr. Zhang reports no relevant financial relationships.

The understanding that human papillomavirus (HPV) causes oropharyngeal squamous cell carcinoma (OPSCC) has been linked with increased likelihood of adults having been vaccinated for HPV, new research indicates.

In a study published online in JAMA Otolaryngology–Head and Neck Surgery, most of the 288 adults surveyed with validated questions were not aware that HPV causes OPSCC and had not been told of the relationship by their health care provider.

Researchers found that when participants knew about the relationship between HPV infection and OPSCC they were more than three times as likely to be vaccinated (odds ratio, 3.7; 95% confidence interval, 1.8-7.6) as those without the knowledge.

The survey was paired with a novel point-of-care adult vaccination program within an otolaryngology clinic. 

“Targeted education aimed at unvaccinated adults establishing the relationship between HPV infection and OPSCC, paired with point-of-care vaccination, may be an innovative strategy for increasing HPV vaccination rates in adults,” write the authors, led by Jacob C. Bloom, MD, with the department of otolaryngology–head and neck surgery at Boston Medical Center.

Current HPV vaccination recommendations include three parts:

• Routine vaccination at age 11 or 12 years
• Catch-up vaccination at ages 13-26 years if not adequately vaccinated
• Shared clinical decision-making in adults aged 27-45 years if the vaccine series has not been completed.

Despite proven efficacy and safety of the HPV vaccine, vaccination rates are low for adults. Although 75% of adolescents aged 13-17 years have initiated the HPV vaccine, recent studies show only 16% of U.S. men aged 18-21 years have received at least 1 dose of the HPV vaccine, the authors write.

Christiana Zhang, MD, with the division of internal medicine at Johns Hopkins University in Baltimore, who was not part of the study, said she was not surprised by the lack of knowledge about the HPV-OPSCC link.

Patients are often counseled on the relationship between HPV and genital warts or anogenital cancers like cervical cancer, she says, but there is less patient education surrounding the relationship between HPV and oropharyngeal cancers.

She says she does counsel patients on the link with OPSCC, but not all providers do and provider knowledge in general surrounding HPV is low.

“Research has shown that knowledge and confidence among health care providers surrounding HPV vaccination is generally low, and this corresponds with a low vaccination recommendation rate,” she says.

She adds, “Patient education on HPV infection and its relationship with OPSCC, paired with point-of-care vaccination for qualifying patients, is a great approach.”

But the education needs to go beyond patients, she says.

“Given the important role that health care providers play in vaccine uptake, I think further efforts are needed to educate providers on HPV vaccination as well,” she says.

The study included patients aged 18-45 years who sought routine outpatient care at the otolaryngology clinic at Boston Medical Center from Sept. 1, 2020, to May 19, 2021.

Limitations of this study include studying a population from a single otolaryngology clinic in an urban, academic medical center. The population was more racially and ethnically diverse than the U.S. population with 60.3% identifying as racial and ethnic minorities. Gender and educational levels were also not reflective of U.S. demographics as half (50.8%) of the participants had a college degree or higher and 58.3% were women.

Dr. Bloom reports grants from the American Head and Neck Cancer Society during the conduct of the study. Coauthor Dr. Faden reports personal fees from Merck, Neotic, Focus, BMS, Chrystalis Biomedical Advisors, and Guidepoint; receiving nonfinancial support from BostonGene and Predicine; and receiving grants from Calico outside the submitted work. Dr. Zhang reports no relevant financial relationships.

A new strain of COVID-19 that was identified only a week ago in the United States has prompted the Centers for Disease Control and Prevention to take the rare step of issuing a formal message that it could evade vaccines or the protection of natural immunity. 

The strain is called BA.2.86 and is of particular concern because of its more than 30 mutations, which means it may behave very differently than previous versions of the virus. That number of mutations is on par with the difference between variants so serious that they were formally named, such as between Delta and Omicron, the CDC explained in the risk assessment issued Aug. 23.

Worldwide, health agencies are issuing a flurry of updates on BA.2.86. The strain only recently landed on the World Health Organization’s radar when it was named a “variant under monitoring” on Aug. 17. The CDC announced the same day that it had been detected in the United States.

Among the characteristics the CDC monitors for are how contagious a strain is, how well it responds to treatment, and how severely it affects people.

“BA.2.86 may be more capable of causing infection in people who have previously had COVID-19 or who have received COVID-19 vaccines,” the CDC risk assessment stated.

The agency is evaluating how well the forthcoming updated vaccine, due out in September, performs against BA.2.86.

A new forecast also released this week by the CDC predicts hospitalizations due to the virus will continue their upward trend through at least mid-September. Currently, about 1,800 people are hospitalized daily with COVID-19. The new prediction shows that number has a small potential to drop as low as 1,100 daily, but it could also increase by as many as 7,500 per day. The most likely scenario lands somewhere in the middle of that range, with daily hospital admissions of between 2,000 and 4,000 people by Sept. 18.

The CDC said there is “no evidence” that BA.2.86 is causing more severe illness but said that could change as more information becomes available. Health experts typically gauge severity by the rate of COVID hospitalizations.

The journal Nature reported that many scientists see similarities between the emergence of BA.2.86 and that of Omicron, which rapidly spread around the world in late 2021.

“There’s a little bit of déjà vu all over again,” University of Michigan virologist Adam Lauring, MD, PhD, whose lab detected one of the first U.S. cases of BA.2.86, told Nature.

Dr. Lauring, as well as the CDC and the WHO, all caution that more data is needed to truly understand the threat posed by BA.2.86.

“There’s good reason to think it won’t be like the Omicron wave, but it’s early days,” Dr. Lauring said.

A version of this article first appeared on Medscape.com.

A new strain of COVID-19 that was identified only a week ago in the United States has prompted the Centers for Disease Control and Prevention to take the rare step of issuing a formal message that it could evade vaccines or the protection of natural immunity. 

The strain is called BA.2.86 and is of particular concern because of its more than 30 mutations, which means it may behave very differently than previous versions of the virus. That number of mutations is on par with the difference between variants so serious that they were formally named, such as between Delta and Omicron, the CDC explained in the risk assessment issued Aug. 23.

Worldwide, health agencies are issuing a flurry of updates on BA.2.86. The strain only recently landed on the World Health Organization’s radar when it was named a “variant under monitoring” on Aug. 17. The CDC announced the same day that it had been detected in the United States.

Among the characteristics the CDC monitors for are how contagious a strain is, how well it responds to treatment, and how severely it affects people.

“BA.2.86 may be more capable of causing infection in people who have previously had COVID-19 or who have received COVID-19 vaccines,” the CDC risk assessment stated.

The agency is evaluating how well the forthcoming updated vaccine, due out in September, performs against BA.2.86.

A new forecast also released this week by the CDC predicts hospitalizations due to the virus will continue their upward trend through at least mid-September. Currently, about 1,800 people are hospitalized daily with COVID-19. The new prediction shows that number has a small potential to drop as low as 1,100 daily, but it could also increase by as many as 7,500 per day. The most likely scenario lands somewhere in the middle of that range, with daily hospital admissions of between 2,000 and 4,000 people by Sept. 18.

The CDC said there is “no evidence” that BA.2.86 is causing more severe illness but said that could change as more information becomes available. Health experts typically gauge severity by the rate of COVID hospitalizations.

The journal Nature reported that many scientists see similarities between the emergence of BA.2.86 and that of Omicron, which rapidly spread around the world in late 2021.

“There’s a little bit of déjà vu all over again,” University of Michigan virologist Adam Lauring, MD, PhD, whose lab detected one of the first U.S. cases of BA.2.86, told Nature.

Dr. Lauring, as well as the CDC and the WHO, all caution that more data is needed to truly understand the threat posed by BA.2.86.

“There’s good reason to think it won’t be like the Omicron wave, but it’s early days,” Dr. Lauring said.

A version of this article first appeared on Medscape.com.

A new strain of COVID-19 that was identified only a week ago in the United States has prompted the Centers for Disease Control and Prevention to take the rare step of issuing a formal message that it could evade vaccines or the protection of natural immunity. 

The strain is called BA.2.86 and is of particular concern because of its more than 30 mutations, which means it may behave very differently than previous versions of the virus. That number of mutations is on par with the difference between variants so serious that they were formally named, such as between Delta and Omicron, the CDC explained in the risk assessment issued Aug. 23.

Worldwide, health agencies are issuing a flurry of updates on BA.2.86. The strain only recently landed on the World Health Organization’s radar when it was named a “variant under monitoring” on Aug. 17. The CDC announced the same day that it had been detected in the United States.

Among the characteristics the CDC monitors for are how contagious a strain is, how well it responds to treatment, and how severely it affects people.

“BA.2.86 may be more capable of causing infection in people who have previously had COVID-19 or who have received COVID-19 vaccines,” the CDC risk assessment stated.

The agency is evaluating how well the forthcoming updated vaccine, due out in September, performs against BA.2.86.

A new forecast also released this week by the CDC predicts hospitalizations due to the virus will continue their upward trend through at least mid-September. Currently, about 1,800 people are hospitalized daily with COVID-19. The new prediction shows that number has a small potential to drop as low as 1,100 daily, but it could also increase by as many as 7,500 per day. The most likely scenario lands somewhere in the middle of that range, with daily hospital admissions of between 2,000 and 4,000 people by Sept. 18.

The CDC said there is “no evidence” that BA.2.86 is causing more severe illness but said that could change as more information becomes available. Health experts typically gauge severity by the rate of COVID hospitalizations.

The journal Nature reported that many scientists see similarities between the emergence of BA.2.86 and that of Omicron, which rapidly spread around the world in late 2021.

“There’s a little bit of déjà vu all over again,” University of Michigan virologist Adam Lauring, MD, PhD, whose lab detected one of the first U.S. cases of BA.2.86, told Nature.

Dr. Lauring, as well as the CDC and the WHO, all caution that more data is needed to truly understand the threat posed by BA.2.86.

“There’s good reason to think it won’t be like the Omicron wave, but it’s early days,” Dr. Lauring said.

A version of this article first appeared on Medscape.com.

With COVID-19 hospitalizations up by 22% and deaths up by 8% as of Aug. 12, primary care clinicians are readying to distribute the new COVID-19 booster that is expected to arrive in September.

David Cutler, MD, is hoping to vaccinate as many of his patients who want the shots. He and other primary care clinicians are finally back in the business of prevention after being sidelined during the pandemic.

Most primary care clinicians weren’t provided with the vaccine through the height of the pandemic, when federal officials instead focused their efforts on vaccine distribution through hospital systems and retail pharmacies. The consequence, primary care clinicians say, is that they have no records for patients who need the vaccine; they cannot send patients reminders; and they have no idea if an at-risk patient is ready for a booster.

“The role of primary care is educating people about COVID-19, testing for COVID-19 and other infections, providing access to vaccines and treatment, and sustaining our health care system to provide care, fight disease, and save lives,” said Dr. Cutler, a family physician at Providence Saint John’s Health Center in Santa Monica, Calif.

A study published in Health Affairs confirmed that primary care practices were not included in the federal vaccine strategy. The researchers found that by the end of 2021, 43.1% of 2,000 primary care practices had no records of COVID-19 vaccinations for patients. More than 90% had records for historically routine immunizations, such as influenza and shingles.

“I do believe if PCPs had earlier access to the vaccine, we could have done a better job vaccinating more people,” said Ann Greiner, MCP, president and chief executive officer of the Primary Care Collaborative, a nonprofit organization. “We need to make sure they’re back in that seat, providing the lion’s share of those vaccines.”
 

The roadblocks to vaccines

More than 20,000 primary care clinicians applied to distribute vaccines to patients as of April 2021, according to the Centers for Disease Control and Prevention. A quarter of those received the shots. Fewer than 5% of all vaccine doses were provided to primary care offices during that early stage of rollout.

Natasha Beauvais, MD, MPH, a family physician at Northern Virginia Family Practice in Alexandria, Va., said trying to vaccinate patients back then was a herculean task.

“We were desperate to get the vaccine, like many practices,” Dr. Beauvais said.

It was only by chance – through one of the physician’s work connections – that they got in touch with the city’s health department to request a supply of immunizations.

The requirements for becoming a vaccine provider were stringent: Dr. Beauvais had to show that her practice could appropriately refrigerate or freeze doses at much colder temperatures than most immunizations, monitor the storage unit at all times, and accurately record and schedule every dose. What’s more, most primary care practices lacked the bandwidth to conduct mass vaccinations like larger medical systems.

Robert L. Phillips Jr., MD, MSPH, founding executive director at the American Board of Family Medicine Foundation, said that the decision to sideline primary care practices, along with a poor records system, left clinicians struggling to leverage relationships with patients to boost rates of vaccination.

“Primary care is where most people have trusted health relationships, and it should be more than a footnote in the nation’s epidemic response plans,” said Dr. Phillips, a corresponding author of the Health Affairs study.

The exclusion of primary care has deep roots: These clinicians were mentioned as a footnote in the CDC’s 2017 Pandemic Influenza Plan, according to Dr. Phillips.

“There’s no one in the federal government who wakes up in the morning thinking of primary care,” Dr. Phillips said. “It’s not the only reason the numbers were down, but a big reason.”

Other countries, including Australia, utilized the specialty for vaccine distribution. A 2022 article in Australian Health Review noted that the success of Australia’s COVID-19 vaccine rollout came down to the involvement of primary care.

Dr. Cutler said his clinic also did as much as they could during the early pandemic – from keeping their urgent care clinic open to providing COVID-19 antibody testing and infusions. His practice was able to start vaccinating patients in March 2021, and by that summer, the office had provided the immunization to 4,000 patients. Dr. Cutler was also able to address any health problems these patients reported during their vaccination visit.

“A vaccine is not just a vaccine: It’s an opportunity to have a conversation between a primary care physician and a patient about other health issues, and it encultures people to get important preventive care,” Ms. Greiner said.

The Health Affairs study was supported by the CDC.

A version of this article first appeared on Medscape.com.

With COVID-19 hospitalizations up by 22% and deaths up by 8% as of Aug. 12, primary care clinicians are readying to distribute the new COVID-19 booster that is expected to arrive in September.

David Cutler, MD, is hoping to vaccinate as many of his patients who want the shots. He and other primary care clinicians are finally back in the business of prevention after being sidelined during the pandemic.

Most primary care clinicians weren’t provided with the vaccine through the height of the pandemic, when federal officials instead focused their efforts on vaccine distribution through hospital systems and retail pharmacies. The consequence, primary care clinicians say, is that they have no records for patients who need the vaccine; they cannot send patients reminders; and they have no idea if an at-risk patient is ready for a booster.

“The role of primary care is educating people about COVID-19, testing for COVID-19 and other infections, providing access to vaccines and treatment, and sustaining our health care system to provide care, fight disease, and save lives,” said Dr. Cutler, a family physician at Providence Saint John’s Health Center in Santa Monica, Calif.

A study published in Health Affairs confirmed that primary care practices were not included in the federal vaccine strategy. The researchers found that by the end of 2021, 43.1% of 2,000 primary care practices had no records of COVID-19 vaccinations for patients. More than 90% had records for historically routine immunizations, such as influenza and shingles.

“I do believe if PCPs had earlier access to the vaccine, we could have done a better job vaccinating more people,” said Ann Greiner, MCP, president and chief executive officer of the Primary Care Collaborative, a nonprofit organization. “We need to make sure they’re back in that seat, providing the lion’s share of those vaccines.”
 

The roadblocks to vaccines

More than 20,000 primary care clinicians applied to distribute vaccines to patients as of April 2021, according to the Centers for Disease Control and Prevention. A quarter of those received the shots. Fewer than 5% of all vaccine doses were provided to primary care offices during that early stage of rollout.

Natasha Beauvais, MD, MPH, a family physician at Northern Virginia Family Practice in Alexandria, Va., said trying to vaccinate patients back then was a herculean task.

“We were desperate to get the vaccine, like many practices,” Dr. Beauvais said.

It was only by chance – through one of the physician’s work connections – that they got in touch with the city’s health department to request a supply of immunizations.

The requirements for becoming a vaccine provider were stringent: Dr. Beauvais had to show that her practice could appropriately refrigerate or freeze doses at much colder temperatures than most immunizations, monitor the storage unit at all times, and accurately record and schedule every dose. What’s more, most primary care practices lacked the bandwidth to conduct mass vaccinations like larger medical systems.

Robert L. Phillips Jr., MD, MSPH, founding executive director at the American Board of Family Medicine Foundation, said that the decision to sideline primary care practices, along with a poor records system, left clinicians struggling to leverage relationships with patients to boost rates of vaccination.

“Primary care is where most people have trusted health relationships, and it should be more than a footnote in the nation’s epidemic response plans,” said Dr. Phillips, a corresponding author of the Health Affairs study.

The exclusion of primary care has deep roots: These clinicians were mentioned as a footnote in the CDC’s 2017 Pandemic Influenza Plan, according to Dr. Phillips.

“There’s no one in the federal government who wakes up in the morning thinking of primary care,” Dr. Phillips said. “It’s not the only reason the numbers were down, but a big reason.”

Other countries, including Australia, utilized the specialty for vaccine distribution. A 2022 article in Australian Health Review noted that the success of Australia’s COVID-19 vaccine rollout came down to the involvement of primary care.

Dr. Cutler said his clinic also did as much as they could during the early pandemic – from keeping their urgent care clinic open to providing COVID-19 antibody testing and infusions. His practice was able to start vaccinating patients in March 2021, and by that summer, the office had provided the immunization to 4,000 patients. Dr. Cutler was also able to address any health problems these patients reported during their vaccination visit.

“A vaccine is not just a vaccine: It’s an opportunity to have a conversation between a primary care physician and a patient about other health issues, and it encultures people to get important preventive care,” Ms. Greiner said.

The Health Affairs study was supported by the CDC.

A version of this article first appeared on Medscape.com.

With COVID-19 hospitalizations up by 22% and deaths up by 8% as of Aug. 12, primary care clinicians are readying to distribute the new COVID-19 booster that is expected to arrive in September.

David Cutler, MD, is hoping to vaccinate as many of his patients who want the shots. He and other primary care clinicians are finally back in the business of prevention after being sidelined during the pandemic.

Most primary care clinicians weren’t provided with the vaccine through the height of the pandemic, when federal officials instead focused their efforts on vaccine distribution through hospital systems and retail pharmacies. The consequence, primary care clinicians say, is that they have no records for patients who need the vaccine; they cannot send patients reminders; and they have no idea if an at-risk patient is ready for a booster.

“The role of primary care is educating people about COVID-19, testing for COVID-19 and other infections, providing access to vaccines and treatment, and sustaining our health care system to provide care, fight disease, and save lives,” said Dr. Cutler, a family physician at Providence Saint John’s Health Center in Santa Monica, Calif.

A study published in Health Affairs confirmed that primary care practices were not included in the federal vaccine strategy. The researchers found that by the end of 2021, 43.1% of 2,000 primary care practices had no records of COVID-19 vaccinations for patients. More than 90% had records for historically routine immunizations, such as influenza and shingles.

“I do believe if PCPs had earlier access to the vaccine, we could have done a better job vaccinating more people,” said Ann Greiner, MCP, president and chief executive officer of the Primary Care Collaborative, a nonprofit organization. “We need to make sure they’re back in that seat, providing the lion’s share of those vaccines.”
 

The roadblocks to vaccines

More than 20,000 primary care clinicians applied to distribute vaccines to patients as of April 2021, according to the Centers for Disease Control and Prevention. A quarter of those received the shots. Fewer than 5% of all vaccine doses were provided to primary care offices during that early stage of rollout.

Natasha Beauvais, MD, MPH, a family physician at Northern Virginia Family Practice in Alexandria, Va., said trying to vaccinate patients back then was a herculean task.

“We were desperate to get the vaccine, like many practices,” Dr. Beauvais said.

It was only by chance – through one of the physician’s work connections – that they got in touch with the city’s health department to request a supply of immunizations.

The requirements for becoming a vaccine provider were stringent: Dr. Beauvais had to show that her practice could appropriately refrigerate or freeze doses at much colder temperatures than most immunizations, monitor the storage unit at all times, and accurately record and schedule every dose. What’s more, most primary care practices lacked the bandwidth to conduct mass vaccinations like larger medical systems.

Robert L. Phillips Jr., MD, MSPH, founding executive director at the American Board of Family Medicine Foundation, said that the decision to sideline primary care practices, along with a poor records system, left clinicians struggling to leverage relationships with patients to boost rates of vaccination.

“Primary care is where most people have trusted health relationships, and it should be more than a footnote in the nation’s epidemic response plans,” said Dr. Phillips, a corresponding author of the Health Affairs study.

The exclusion of primary care has deep roots: These clinicians were mentioned as a footnote in the CDC’s 2017 Pandemic Influenza Plan, according to Dr. Phillips.

“There’s no one in the federal government who wakes up in the morning thinking of primary care,” Dr. Phillips said. “It’s not the only reason the numbers were down, but a big reason.”

Other countries, including Australia, utilized the specialty for vaccine distribution. A 2022 article in Australian Health Review noted that the success of Australia’s COVID-19 vaccine rollout came down to the involvement of primary care.

Dr. Cutler said his clinic also did as much as they could during the early pandemic – from keeping their urgent care clinic open to providing COVID-19 antibody testing and infusions. His practice was able to start vaccinating patients in March 2021, and by that summer, the office had provided the immunization to 4,000 patients. Dr. Cutler was also able to address any health problems these patients reported during their vaccination visit.

“A vaccine is not just a vaccine: It’s an opportunity to have a conversation between a primary care physician and a patient about other health issues, and it encultures people to get important preventive care,” Ms. Greiner said.

The Health Affairs study was supported by the CDC.

A version of this article first appeared on Medscape.com.

People may get more protection against COVID-19 if they get their vaccinations and boosters in the same arm, a new study says.

Scientists in Germany looked at health data for 303 people who got the mRNA vaccine and then a booster shot. Their antibody levels were measured two weeks after the second shot. None of the people had had COVID before the vaccinations.

Scientists found that the number of protective “killer T cells” was higher in the 147 study participants who got both shots in the same arm, said the study published in EBioMedicine.

The killer cells were found in 67% of cases in which both shots went into the same arm, compared with 43% of cases with different arms.

“That may suggest that that ipsilateral vaccination (in the same arm) is more likely to provide better protection should the vaccinated person become infected with the SARS-CoV-2 virus,” Laura Ziegler, a doctoral student at Saarland University, Germany, said in a news release.

William Schaffner, MD, a professor in the Division of Infectious Diseases at Vanderbilt University Medical Center, Nashville, Tenn., told CBS News that same-arm vaccinations may work better because the cells that provide the immune response are in local lymph nodes.

There’s greater immunological response if the immune cells in the lymph nodes are restimulated in the same place, said Dr. Schaffner, who was not involved in the German study.

The scientists from Saarland University said more research is needed before they can be certain that having vaccinations in the same arm is actually more effective for COVID shots and sequential vaccinations against diseases such as the flu.

A version of this article first appeared on Medscape.com.

People may get more protection against COVID-19 if they get their vaccinations and boosters in the same arm, a new study says.

Scientists in Germany looked at health data for 303 people who got the mRNA vaccine and then a booster shot. Their antibody levels were measured two weeks after the second shot. None of the people had had COVID before the vaccinations.

Scientists found that the number of protective “killer T cells” was higher in the 147 study participants who got both shots in the same arm, said the study published in EBioMedicine.

The killer cells were found in 67% of cases in which both shots went into the same arm, compared with 43% of cases with different arms.

“That may suggest that that ipsilateral vaccination (in the same arm) is more likely to provide better protection should the vaccinated person become infected with the SARS-CoV-2 virus,” Laura Ziegler, a doctoral student at Saarland University, Germany, said in a news release.

William Schaffner, MD, a professor in the Division of Infectious Diseases at Vanderbilt University Medical Center, Nashville, Tenn., told CBS News that same-arm vaccinations may work better because the cells that provide the immune response are in local lymph nodes.

There’s greater immunological response if the immune cells in the lymph nodes are restimulated in the same place, said Dr. Schaffner, who was not involved in the German study.

The scientists from Saarland University said more research is needed before they can be certain that having vaccinations in the same arm is actually more effective for COVID shots and sequential vaccinations against diseases such as the flu.

A version of this article first appeared on Medscape.com.

People may get more protection against COVID-19 if they get their vaccinations and boosters in the same arm, a new study says.

Scientists in Germany looked at health data for 303 people who got the mRNA vaccine and then a booster shot. Their antibody levels were measured two weeks after the second shot. None of the people had had COVID before the vaccinations.

Scientists found that the number of protective “killer T cells” was higher in the 147 study participants who got both shots in the same arm, said the study published in EBioMedicine.

The killer cells were found in 67% of cases in which both shots went into the same arm, compared with 43% of cases with different arms.

“That may suggest that that ipsilateral vaccination (in the same arm) is more likely to provide better protection should the vaccinated person become infected with the SARS-CoV-2 virus,” Laura Ziegler, a doctoral student at Saarland University, Germany, said in a news release.

William Schaffner, MD, a professor in the Division of Infectious Diseases at Vanderbilt University Medical Center, Nashville, Tenn., told CBS News that same-arm vaccinations may work better because the cells that provide the immune response are in local lymph nodes.

There’s greater immunological response if the immune cells in the lymph nodes are restimulated in the same place, said Dr. Schaffner, who was not involved in the German study.

The scientists from Saarland University said more research is needed before they can be certain that having vaccinations in the same arm is actually more effective for COVID shots and sequential vaccinations against diseases such as the flu.

A version of this article first appeared on Medscape.com.

The long-awaited vaccine for respiratory syncytial virus (RSV) that can be given during pregnancy has been approved by the Food and Drug Administration.

The vaccine, known as Abrysvo, can be given between weeks 32 and 36 of pregnancy and is designed to protect infants from the virus from birth to 6 months of age.

Administered as a single-dose, intramuscular injection, the FDA approved Abrysvo at the end of May for the prevention of lower respiratory tract illness caused by RSV in people aged 60 years and older.

However, “RSV is a common cause of illness in children, and infants are among those at highest risk for severe disease, which can lead to hospitalization,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, pointed out in a news release. “This approval provides an option for health care providers and pregnant individuals to protect infants from this potentially life-threatening disease.”

Most children are infected with the contagious virus at least once by the time they reach age 2 years. Very young children are at particular risk of severe complications, such as pneumonia or bronchitis, and in clinical trials, the new vaccine reduced that risk by up to 82%.

Before the vaccine became available, up to 3% of infants infected with RSV needed to be hospitalized, according to the Centers for Disease Control and Prevention. In the hospital, treatment typically includes oxygen, intravenous fluids, and mechanical ventilation.

RSV often causes common cold symptoms, but the virus poses the risk of severe complications that can lead to death among young children and older people. The CDC estimates 100-300 deaths of children younger than 5 years and 6,000-10,000 deaths of people aged 65 years and older are linked to RSV annually.

This is also the first year that an antibody shot is available to be given after birth to prevent severe RSV in infants younger than 1 year.

In its approval announcement, the FDA pointed out that preeclampsia occurred in 1.8% of pregnancies after Abrysvo, compared with 1.4% of those who received placebo. The FDA also reported that, in infants, low birth weight and jaundice occurred at a higher rate among the pregnant Abrysvo recipients, compared with the placebo group.

Studies have also shown that pregnant vaccine recipients experienced preterm birth at a rate of 5.7%, compared with a rate of 4.7% among those who received placebo. The FDA called the difference “a numerical imbalance” but said in the approval announcement that a “causal relationship” could not be established.

The FDA also noted that people already at high risk of preterm birth were excluded from clinical trials and that Pfizer must conduct ongoing studies to monitor the risk of preeclampsia as well as preterm birth.

A version of this article first appeared on Medscape.com.

The long-awaited vaccine for respiratory syncytial virus (RSV) that can be given during pregnancy has been approved by the Food and Drug Administration.

The vaccine, known as Abrysvo, can be given between weeks 32 and 36 of pregnancy and is designed to protect infants from the virus from birth to 6 months of age.

Administered as a single-dose, intramuscular injection, the FDA approved Abrysvo at the end of May for the prevention of lower respiratory tract illness caused by RSV in people aged 60 years and older.

However, “RSV is a common cause of illness in children, and infants are among those at highest risk for severe disease, which can lead to hospitalization,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, pointed out in a news release. “This approval provides an option for health care providers and pregnant individuals to protect infants from this potentially life-threatening disease.”

Most children are infected with the contagious virus at least once by the time they reach age 2 years. Very young children are at particular risk of severe complications, such as pneumonia or bronchitis, and in clinical trials, the new vaccine reduced that risk by up to 82%.

Before the vaccine became available, up to 3% of infants infected with RSV needed to be hospitalized, according to the Centers for Disease Control and Prevention. In the hospital, treatment typically includes oxygen, intravenous fluids, and mechanical ventilation.

RSV often causes common cold symptoms, but the virus poses the risk of severe complications that can lead to death among young children and older people. The CDC estimates 100-300 deaths of children younger than 5 years and 6,000-10,000 deaths of people aged 65 years and older are linked to RSV annually.

This is also the first year that an antibody shot is available to be given after birth to prevent severe RSV in infants younger than 1 year.

In its approval announcement, the FDA pointed out that preeclampsia occurred in 1.8% of pregnancies after Abrysvo, compared with 1.4% of those who received placebo. The FDA also reported that, in infants, low birth weight and jaundice occurred at a higher rate among the pregnant Abrysvo recipients, compared with the placebo group.

Studies have also shown that pregnant vaccine recipients experienced preterm birth at a rate of 5.7%, compared with a rate of 4.7% among those who received placebo. The FDA called the difference “a numerical imbalance” but said in the approval announcement that a “causal relationship” could not be established.

The FDA also noted that people already at high risk of preterm birth were excluded from clinical trials and that Pfizer must conduct ongoing studies to monitor the risk of preeclampsia as well as preterm birth.

A version of this article first appeared on Medscape.com.

The long-awaited vaccine for respiratory syncytial virus (RSV) that can be given during pregnancy has been approved by the Food and Drug Administration.

The vaccine, known as Abrysvo, can be given between weeks 32 and 36 of pregnancy and is designed to protect infants from the virus from birth to 6 months of age.

Administered as a single-dose, intramuscular injection, the FDA approved Abrysvo at the end of May for the prevention of lower respiratory tract illness caused by RSV in people aged 60 years and older.

However, “RSV is a common cause of illness in children, and infants are among those at highest risk for severe disease, which can lead to hospitalization,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, pointed out in a news release. “This approval provides an option for health care providers and pregnant individuals to protect infants from this potentially life-threatening disease.”

Most children are infected with the contagious virus at least once by the time they reach age 2 years. Very young children are at particular risk of severe complications, such as pneumonia or bronchitis, and in clinical trials, the new vaccine reduced that risk by up to 82%.

Before the vaccine became available, up to 3% of infants infected with RSV needed to be hospitalized, according to the Centers for Disease Control and Prevention. In the hospital, treatment typically includes oxygen, intravenous fluids, and mechanical ventilation.

RSV often causes common cold symptoms, but the virus poses the risk of severe complications that can lead to death among young children and older people. The CDC estimates 100-300 deaths of children younger than 5 years and 6,000-10,000 deaths of people aged 65 years and older are linked to RSV annually.

This is also the first year that an antibody shot is available to be given after birth to prevent severe RSV in infants younger than 1 year.

In its approval announcement, the FDA pointed out that preeclampsia occurred in 1.8% of pregnancies after Abrysvo, compared with 1.4% of those who received placebo. The FDA also reported that, in infants, low birth weight and jaundice occurred at a higher rate among the pregnant Abrysvo recipients, compared with the placebo group.

Studies have also shown that pregnant vaccine recipients experienced preterm birth at a rate of 5.7%, compared with a rate of 4.7% among those who received placebo. The FDA called the difference “a numerical imbalance” but said in the approval announcement that a “causal relationship” could not be established.

The FDA also noted that people already at high risk of preterm birth were excluded from clinical trials and that Pfizer must conduct ongoing studies to monitor the risk of preeclampsia as well as preterm birth.

A version of this article first appeared on Medscape.com.

The Centers for Disease Control and Prevention is tracking a newly discovered strain of COVID-19 called BA.2.86.

On Aug. 17, the agency posted on X, formerly known as Twitter, that the lineage has been detected in the United States, Denmark, and Israel. 

“As we learn more about BA.2.86, CDC’s advice on protecting yourself from COVID-19 remains the same,” the CDC said on X. 

A case of BA.2.86 was detected at a laboratory at the University of Michigan, CBS News reported. It’s not clear how the university obtained the sample that was sequenced. A case was also detected in the United Kingdom, the news outlet said. 

The World Health Organization is also tracking BA.2.86 and has classified it as a “variant under monitoring.” 

“More data are needed to understand this COVID-19 variant and the extent of its spread, but the number of mutations warrants attention. WHO will update countries and the public as we learn more,” the WHO said on X.

The strain is so new that scientists don’t know if BA.2.86 is more easily spread, causes more severe symptoms than existing strains, or will be more resistant to vaccines and natural immunity developed over the last few years. 

Early research indicates BA.2.86 “will have equal or greater escape than XBB.1.5 from antibodies elicited by pre-Omicron and first-generation Omicron variants,” Jesse Bloom, PhD, a virologist at the Fred Hutchinson Cancer Center, said in a slide deck published Aug. 17. (XBB.1.5 is the Omicron subvariant that is targeted in the updated COVID booster shot to be released soon.)

Still, Dr. Bloom noted that “even if a highly mutated new variant like BA.2.86 starts to spread, we will be in a far better place than we were in 2020 and 2021, since most people have some immunity to SARS-CoV-2 now.”

A version of this article first appeared on WebMD.com.

The Centers for Disease Control and Prevention is tracking a newly discovered strain of COVID-19 called BA.2.86.

On Aug. 17, the agency posted on X, formerly known as Twitter, that the lineage has been detected in the United States, Denmark, and Israel. 

“As we learn more about BA.2.86, CDC’s advice on protecting yourself from COVID-19 remains the same,” the CDC said on X. 

A case of BA.2.86 was detected at a laboratory at the University of Michigan, CBS News reported. It’s not clear how the university obtained the sample that was sequenced. A case was also detected in the United Kingdom, the news outlet said. 

The World Health Organization is also tracking BA.2.86 and has classified it as a “variant under monitoring.” 

“More data are needed to understand this COVID-19 variant and the extent of its spread, but the number of mutations warrants attention. WHO will update countries and the public as we learn more,” the WHO said on X.

The strain is so new that scientists don’t know if BA.2.86 is more easily spread, causes more severe symptoms than existing strains, or will be more resistant to vaccines and natural immunity developed over the last few years. 

Early research indicates BA.2.86 “will have equal or greater escape than XBB.1.5 from antibodies elicited by pre-Omicron and first-generation Omicron variants,” Jesse Bloom, PhD, a virologist at the Fred Hutchinson Cancer Center, said in a slide deck published Aug. 17. (XBB.1.5 is the Omicron subvariant that is targeted in the updated COVID booster shot to be released soon.)

Still, Dr. Bloom noted that “even if a highly mutated new variant like BA.2.86 starts to spread, we will be in a far better place than we were in 2020 and 2021, since most people have some immunity to SARS-CoV-2 now.”

A version of this article first appeared on WebMD.com.

The Centers for Disease Control and Prevention is tracking a newly discovered strain of COVID-19 called BA.2.86.

On Aug. 17, the agency posted on X, formerly known as Twitter, that the lineage has been detected in the United States, Denmark, and Israel. 

“As we learn more about BA.2.86, CDC’s advice on protecting yourself from COVID-19 remains the same,” the CDC said on X. 

A case of BA.2.86 was detected at a laboratory at the University of Michigan, CBS News reported. It’s not clear how the university obtained the sample that was sequenced. A case was also detected in the United Kingdom, the news outlet said. 

The World Health Organization is also tracking BA.2.86 and has classified it as a “variant under monitoring.” 

“More data are needed to understand this COVID-19 variant and the extent of its spread, but the number of mutations warrants attention. WHO will update countries and the public as we learn more,” the WHO said on X.

The strain is so new that scientists don’t know if BA.2.86 is more easily spread, causes more severe symptoms than existing strains, or will be more resistant to vaccines and natural immunity developed over the last few years. 

Early research indicates BA.2.86 “will have equal or greater escape than XBB.1.5 from antibodies elicited by pre-Omicron and first-generation Omicron variants,” Jesse Bloom, PhD, a virologist at the Fred Hutchinson Cancer Center, said in a slide deck published Aug. 17. (XBB.1.5 is the Omicron subvariant that is targeted in the updated COVID booster shot to be released soon.)

Still, Dr. Bloom noted that “even if a highly mutated new variant like BA.2.86 starts to spread, we will be in a far better place than we were in 2020 and 2021, since most people have some immunity to SARS-CoV-2 now.”

A version of this article first appeared on WebMD.com.