Latest FDA Novavax approval, new long-term COVID study data, and updated CDC STI treatment guidelines | AMA update video

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Novavax’s updated COVID-19 vaccine will be available this week. AMA Vice President for Science, Medicine and Public Health Andrea Garcia, J.D., M.P.H., discusses the latest vaccines, the end of COVID-19 vaccination cards, and a new study finding differences in the blood of patients with COVID-19. Additionally, the CDC has drafted recommendations regarding Doxy-PEP for the prevention of sexually transmitted infections. Hosted by AMA Chief Experience Officer Todd Unger.

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• Andrea Garcia, J.D., M.P.H., vice president for science, medicine, and public health of the American Medical Association

Unger: Hello and welcome to the AMA update video and podcast. Today, we’re in Chicago with Andrea Garcia, AMA’s vice president for science, medicine and public health, to review the week’s top stories. I’m Todd Unger, chief experience officer at AMA, also in Chicago. Welcome back, Andrea.

Garcia: Hi Todd. Thanks. It’s great to be here.

Unger: Well, Andrea, let’s start with some of the big news from last week. It looks like we have another coronavirus vaccine option. What’s the story here?

Garcia: Yeah, that’s right. Last week, we saw the FDA approve the updated Novavax COVID-19 vaccine. This applies to anyone 12 years and older who has not yet received the newer mRNA vaccine.

As a reminder, the Novavax vaccine relies on protein-based technology. That’s training the immune system to fight the virus that causes COVID-19. This is a different technology than Pfizer and Moderna’s mRNA vaccines.

The Novavax vaccine has been updated to target the XBB1.5 Omicron subvariant. We know it has also been shown to be effective against EG.5, which is the dominant strain in the United States.Initial Novavax COVID-19 vaccine no longer authorized for use in U.S. as part of FDA authorization

Unger: So just to clarify, are we now waiting for recommendations from the CDC?

Garcia: In fact, the Novavax vaccine has been recommended by the CDC. In September, when the Advisory Committee on Immunization Practices met to review newer COVID-19 vaccines, Novavax’s information was included in the discussion. It was not yet FDA authorized at the time, but Novavax did submit their data to ACIP, and they voted to broadly recommend FDA authorization of the vaccine for the 2023-2024 season. And then we saw in a statement last Monday, Novavax said they had shipped millions of doses to distributors.

As a result, the vaccine should begin to be available in thousands of locations across the U.S., including pharmacies and doctors’ offices, sometime this week.

Unger: 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,” and then realized I no longer had to do that. So on that topic, the CDC shares information about the future of those now-iconic vaccination cards we’ve been using throughout the pandemic. What news is there?

Garcia: Yeah, so we’re seeing the CDC say they will no longer be distributing these vaccine cards, and so far, as you said, these vaccine cards have been regularly updated to update people with the updated enhanced information. CDC does encourage people to contact their state health department Immunization Information System (IIS) if they want to track their vaccination history, including the COVID-19 vaccine. To be clear, your state health department will not issue you a vaccination card. But they can provide a digital or paper copy of your vaccine records.

According to most drugstore chains, you don’t need an old card to get the newer vaccines. Some pharmacies said people will bring vaccination cards with them to appointments and pharmacists will still fill out information for new doses. It’s also worth noting that the U.S. government is no longer requiring people to show vaccination cards when entering the country from abroad. Most other countries also no longer require proof of vaccination upon entry.But of course, it’s still obviously wise to check your destination before leaving the United States

Unger: Oh, times are changing, and for the better. Let’s stay on the topic of COVID-19 for now. Findings from a new study may one day help better treat and diagnose long-term COVID-19. Andrea, tell us more about that?

Garcia: Yes, the study, published in the journal Nature, used a blood test to identify biomarkers that may be associated with long COVID. The researchers used machine learning to analyze immune markers and hormone levels in about 270 adult participants. They compared people with and without long-term COVID-19 symptoms at least a year after being infected with the virus. They found that the activity of T cells and B cells was irregular in patients with long-term infection with the new coronavirus.

Now, one of the strongest predictors of long COVID is that these patients tend to have lower cortisol levels. This may help explain why many people with long-term COVID-19 infection experience such severe fatigue. Studies have also found that some dormant viruses, such as the virus that causes mononucleosis or the Epstein-Barr virus, can reactivate in patients who have been infected with the new coronavirus for a long time. It’s unclear whether dormant viruses are causing symptoms or if they are evading problems with the immune system. This was a small study, so more research is needed to understand the significance of these results.

But I still think that finding clear differences in blood biomarkers in people with long-term COVID-19 infection could be a critical first step in helping us develop tests to help diagnose the disease and develop future treatments.

Unger: This is really, really important. Andrea, do we have the latest data on how many people have been affected by long Covid?

Garcia: Yeah, so we have estimates for people in the United States who have lingering symptoms of COVID, and we know there’s a lot of variation among those. In a new survey from the CDC’s National Center for Health Statistics, they said long-term COVID-19 may have affected as many as 962,000 children and 17.9 million adults. Therefore, by 2022, approximately 1.3% of children and 6.9% of adults will have had a long-term infection with COVID-19. Long-term COVID-19 infection is most common among women, Hispanic adults living in rural areas and adults aged 35 to 49, the survey shows. The survey also showed that Asian adults are the least likely to be infected with the long-term coronavirus, as are those with lower household incomes. That’s 400% above the federal poverty level. Mid- to long-term infection with COVID-19 in children remains rare. However, surveys show that the condition is most prevalent among girls ages 12 to 17 and Hispanic children.

Unger: Of course, we still have a lot to learn, but it’s good to see continued efforts to understand long-term COVID-19. Andrea, we’re going to move on from COVID-19. The CDC has also released guidance on tools to help fight sexually transmitted infections. What do we need to know there?

Garcia: So last week we saw the CDC release draft recommendations for the use of doxycycline or doxycycline post-exposure prophylaxis to prevent certain bacterial sexually transmitted infections, or STIs. These include chlamydia, gonorrhea and syphilis. These recommendations are based on research findings that doxycycline at doses of 100 to 200 mg may be effective in preventing infection if taken within 72 hours of unprotected sex. This differs from the traditional approach of prescribing antibiotics to treat the infection after diagnosis.

In that clinical trial, the combined incidence of gonorrhea, chlamydia and syphilis was reduced by two-thirds with Doxy-PEP compared with standard care. CDC recommendations for Doxy-PEP will apply to men who have sex with men and transgender women.during an interview cbs newsDr. Jonathan Mermin of the CDC, who co-authored the draft recommendations, said we need game-changing innovations to reverse the STI epidemic. Doxy-PEP is our first major new preventive intervention for sexually transmitted infections in decades.

Dr. Mermin went on to say that implementing the Doxy-PEP approach could prevent an estimated tens of thousands of infections.

Unger: These are pretty big numbers. Andrea, you said these are draft recommendations. So what happens next?

Garcia: Yes, that’s right. The CDC is currently seeking public comment on its proposal. The comment period is open until November 16. This gives clinicians, people affected by STIs, and other partners an opportunity to weigh in before CDC finalizes these recommendations. The FDA has not officially approved this drug for STI post-exposure prophylaxis. But when used to prevent sexually transmitted infections, Doxy-PEP will still be prescribed off-label.

The draft recommendations come amid rising rates of sexually transmitted infections across the United States. We know that 2.5 million cases of sexually transmitted infections were reported in 2021. This is a 7% increase from the previous year.

I think it’s also important to note that CDC’s antimicrobial resistance and antibiotic stewardship experts did provide consultation during the development of these guidelines. They are involved in planning how the CDC will track the impact of these guidelines, as important questions remain around the development of antimicrobial resistance and the effectiveness of this approach in other populations and on the microbiome. We don’t yet know when final recommendations will be released, but we will continue to monitor the report and share any updates as they become available.

Unger: Well, Andrea, thank you so much for the update and your perspective as always. That concludes today’s episode. If you enjoyed this discussion, you can support more shows like it by becoming an AMA member. For more information, visit ama-assn.org/join. We’ll be back soon with another AMA update. In the meantime, you can find all of our videos and podcasts at ama-assn.org/podcasts. Thank you for joining us today. take care.

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Disclaimer: The views expressed in this video are solely those of the participants and/or do not necessarily reflect the views and policies of the AMA.