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The updated COVID-19 vaccine from Novavax will be available this week. AMA’s Vice President of Science, Medicine and Public Health, Andrea Garcia, JD, MPH, discusses the latest vaccine, the discontinuation of the COVID-19 vaccination card and a new study that found differences in the blood of people with Long COVID. Plus, CDC draft recommendations on Doxy-PEP for STI prevention. AMA Chief Experience Officer Todd Unger hosts.
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- Andrea Garcia, JD, MPH, vice president, science, medicine & public health, American Medical Association
Unger: Hello and welcome to the AMA Update video and podcast. Today, we have our weekly look at the headlines with the AMA's Vice President of Science, Medicine and Public Health, Andrea Garcia, in Chicago. I'm Todd Unger, AMA's chief experience officer, also in Chicago. Welcome back, Andrea.
Garcia: Hi, Todd. Thanks. It's great to be here.
Unger: Well Andrea, let's start with some big news from last week. It looks like we have another COVID vaccine to choose from. What's the story here?
Garcia: Yeah, that's right. Last week we saw the FDA authorize the updated Novavax COVID-19 vaccine. And that's for anyone aged 12 and older who has not already received their updated mRNA vaccine.
Just as a reminder, the Novavax vaccine relies on protein-based technology. And that's to train the immune system to fight that virus that causes COVID-19. It's a different technology from Pfizer and Moderna's mRNA vaccine.
That Novavax vaccine has been updated to target the XBB1.5 Omicron sub-variant. And we know it's also been shown to be effective against EG.5, which is the dominant strain here in the U.S. As a part of that FDA authorization, that original Novavax COVID-19 vaccine is no longer authorized for use in the U.S.
Unger: So just to clarify, are we waiting on the CDC's recommendation now?
Garcia: Actually, the Novavax vaccine has already been recommended by the CDC. In September, when the Advisory Committee on Immunization Practices met to review those updated COVID-19 vaccine, that discussion included information on Novavax. It wasn't yet authorized by FDA at the time, but Novavax did present their data to ACIP and they voted to broadly recommend the vaccines that are authorized by the FDA for the 2023-2024 season. And then we saw in a statement this past Monday, Novavax said that they've already shipped millions of doses to distributors.
So that vaccine should start to be available sometime this week in thousands of locations across the U.S., including pharmacies and physician offices.
Unger: Now Andrea, I just got my COVID vaccine over the weekend and I was walking out and I said, "Oh no, I forgot my vaccine card" before realizing this was no longer necessary. So on this topic, the CDC shared information about the future of those now iconic vaccination cards that we used to use in the pandemic. What's the news there?
Garcia: Yeah, so we saw CDC say they're no longer going to be distributing those vaccine cards, which up until this point, as you were saying, those have been updated regularly with people's updated booster information. The CDC did encourage people to contact their state health department Immunization Information System, or IIS, if they want to keep track of their vaccination history, including COVID-19 vaccines. Your state health department, to be clear, is not going to issue you a vaccination card. But they can provide a digital or paper copy of your vaccine record.
According to the majority of pharmacy chains, you don't need your old card to get that updated vaccine. Some pharmacies have said people are bringing in their vaccination cards to their appointments and pharmacists will still fill in that information with the new dose. It's also worth noting that the U.S. government is no longer requiring people to show their vaccination card when they're coming in from outside of the country. And most other countries have also stopped requiring that proof of vaccination to enter. But it's still, of course, obviously wise to check with your destination before leaving the U.S.
Unger: Oh, how times change—and for the better. Staying on COVID, that subject for a moment. There was a new study with findings that could one day help to treat and diagnose long COVID better. Andrea, tell us more about that?
Garcia: Yeah, so that study was published in Nature and it used blood tests to identify biological markers that could be associated with long COVID. The researchers took advantage of machine learning to analyze those immune markers and hormone levels in about 270 adult participants. They compared those with and without long COVID symptoms at least one year after having COVID. And they found the activity of T cells and B cells was irregular in those patients who had long COVID.
Now, one of the strongest predictors of long COVID was that these patients tended to have lower cortisol levels. And that could help explain why many people with long COVID experience that profound fatigue. The study also found that some dormant viruses, like the ones that cause mononucleosis or Epstein-Barr can activate again in long COVID patients. It's not clear yet whether the dormant viruses are causing symptoms or they're fleeing a problem with the immune system. This was a small study, so more research is going to be needed to understand the significance of these results.
But still, I think finding those clear differences in blood biomarkers of people with long COVID could be a key first step in helping us develop a test to help diagnose the illness and develop future treatments.
Unger: That would be really, really important. Andrea, do we have any recent data on how many people have been affected by long COVID?
Garcia: Yes, so we have estimates of people in the U.S. with lingering COVID symptoms, which we know vary widely. In a new survey from the CDC's National Center for Health Statistics, they say long COVID may have affected as many as 962,000 children and 17.9 million adults. So in 2022, about 1.3% of kids and 6.9% of adults had ever had long COVID. The survey showed that long COVID was most prevalent in women and people who are Hispanic adults who lived in rural areas and adults aged 35 to 49. It also showed that Asian adults were the least likely to have long COVID, as were people whose family income was 400% more than the federal poverty level. Long COVID does remain rare in children. However, the survey showed that it was most prevalent in girls in kids ages 12 to 17 and in kids who are Hispanic.
Unger: We certainly still have a lot to learn there, but it's good that we're seeing those continued efforts at understanding long COVID. Andrea, we're going to switch gears from COVID to a different topic. The CDC also released guidance for a tool to help fight sexually transmitted infections. What do we need to know there?
Garcia: So last week we saw the CDC released draft recommendations on the use of post-exposure prophylaxis with doxycycline or Doxy-PEP for preventing some bacterial sexually transmitted infections or STIs. That includes chlamydia, gonorrhea and syphilis. Those recommendations are based on research that found 100 to 200 milligram dose of doxycycline may be effective in preventing infections if it's taken within 72 hours of unprotected sex. This is different from that traditional approach of prescribing antibiotics to treat an infection after they're diagnosed.
In that clinical trial, the combined incidence of gonorrhea, chlamydia and syphilis was lower by two-thirds with Doxy-PEP than following the standard of care. The CDC recommendations for Doxy-PEP would apply to men who have sex with men and transgender women. In an interview with CBS News, CDC's Dr. Jonathan Mermin, who was a coauthor of the draft recommendations, said it's going to take game-changing innovations for us to turn the STI epidemic around. And Doxy-PEP is the first major new prevention intervention we have for STIs in decades.
Dr. Mermin went on to say that the implementation of the Doxy-PEP approach could prevent an estimated tens of thousands of infections.
Unger: Those are some pretty sizable numbers. Andrea, you said that these are draft recommendations. So what happens next here?
Garcia: Yeah, so that's right. And the CDC right now is seeking public comment on its proposal. And that comment period is open until November 16. This gives clinicians, people affected by STIs and other partners the opportunity to weigh in before we see CDC finalize those recommendations. The FDA has not officially approved the medication for STI post-exposure prophylaxis. But Doxy-PEP will remain available as an off-label prescription when used for STI prevention.
These draft recommendations come at a time when the rates of STIs have risen across the U.S. We know there were 2.5 million STI cases reported in 2021. That represents a 7% increase from the year before.
I think it's also important to note that the CDC's experts on antimicrobial resistance and antibiotic stewardship did provide consultation during the development of these guidelines. And they're involved in planning how CDC is going to track the impact of these guidelines, because there are important questions that remain around the development of antimicrobial resistance for example, as well as the effectiveness of this approach for other populations and impacts on the microbiome. We don't know yet when the final recommendations are expected, but we'll continue to monitor the story and share any updates as they become available.
Unger: Well, Andrea, thank you so much for that update and for your perspective as usual. That wraps up today's episode. If you enjoyed this discussion, you can support more programming like this by becoming an AMA member. Find out more at ama-assn.org/join. We'll be back soon with another AMA Update. In the meantime, you can find all our videos and podcasts at ama-assn.org/podcasts. Thanks for joining us today. Please take care.
Disclaimer: The viewpoints expressed in this video are those of the participants and/or do not necessarily reflect the views and policies of the AMA.