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Featured topic and speakers
COVID summer surge: Are COVID cases rising? Is there fake semaglutide? Is compounded tirzepatide the same as Mounjaro? Plus latest FDA VRBPAC Meeting 2024 news.
Our guest is AMA's Vice President of Science, Medicine and Public Health, Andrea Garcia, JD, MPH. AMA Chief Experience Officer Todd Unger hosts.
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Speaker
- Andrea Garcia, JD, MPH, vice president, science, medicine & public health, American Medical Association
Transcript
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. I'm Todd Unger, AMA's chief experience officer. Andrea, welcome back.
Garcia: Thanks, Todd. It's great to be here.
Unger: Well, last week, the big news was the heat. I know we set multiple records, as predicted. A lot of impacts on health out there. Andrea, how are things looking now?
Garcia: Well, Todd, I think they're better in some areas of the country, particularly along the east coast, but in the regions of the Southeast and the Southern plains, it's expected to remain hot and dangerously so. As we discussed, this is unusually early to see these temperatures, much of which is being driven by climate change. So, it doesn't bode especially well for the rest of the summer.
According to the National Oceanic and Atmospheric Administration, 2024 is on track to be among the five hottest years on record. And there's a 50% chance that it'll be the warmest ever. Given this, it's definitely important to stay hydrated and watch for signs of mild heat illness, including heat rash, swelling in the hands and feet, muscle cramps, heat syncope or a fainting episode after standing too long or getting up suddenly.
And then people with heat exhaustion may have even more severe symptoms, including headache, nausea and vomiting, and dizziness. And in these scenarios, it's definitely important to get medical attention as soon as possible.
Unger: Good advice. Andrea, Let's turn to another big headline that's been the subject of many of our conversations over the last couple of months, and that's bird flu. Later this week, we're going to be talking to the CDC about bird flu. But in the meantime, what's the big picture looking like right now?
Garcia: Well, to date, we know that there have been three human cases reported of H5N1, and all three of those people had direct contact with sick cows. So the CDC's current risk assessment for the general public does remain low. The CDC is looking at the receptor binding profiles of recent avian flu viruses to see how well adapted they are to causing infections in people compared to birds. Humans and birds have different types and distributions of receptors that influenza viruses can bind to and cause infection.
So far, they've found that this virus has not yet adapted to—to easily infect people, which is good news. However, we know that that could change. Viruses mutate. So it's something that we need to continue to monitor and prepare for.
Unger: And that's interesting, the receptor story there. How is the cases now among cows and other recipients?
Garcia: Well, the USDA is reporting that 118 herds in 12 U.S. states have confirmed cases of avian flu in their dairy cows, and that number continues to grow. Testing here is critically important. And right now, surveillance and response to infections on dairy farms is largely voluntary.
And as a rule, it hasn't been systematic or quick enough to protect against spread. So many health officials are calling for a better approach.
Unger: Well, Andrea, thanks so much for that update. And as we mentioned, we'll be looking forward to talking with the CDC about all of this later this week. Unfortunately, bird flu isn't the only virus out there. We haven't talked a while about COVID. What are we seeing there, Andrea?
Garcia: Well, there have been some COVID headlines over the past few weeks. It's been swirling under the radar. It's still here and ticking back up in some states. There was a recent article from ABC News, and it showed that early indications are suggesting that we're going to see an increase in cases this summer. Some are already seeing signs of that.
According to the CDC, for that week ending June 8, COVID test positivity was 5.4% across the U.S. That's an increase of 0.8% from the previous week. In the west, which includes Arizona, California, Hawaii and Nevada, COVID test positivity was 12.8%, and that's higher than any other region in the U.S.
And in New England, which is made up of Connecticut, Maine, Massachusetts, New Hampshire, Rhode island and Vermont, they had the next highest positivity rate at 5.4%, and that matches that national rate. Wastewater data shows that overall, the virus levels are low nationally, but levels have more than doubled in the western U.S. over the last month.
Unger: Now, Andrea, I thought we were going to get some time off here in the summer months. Is this pattern something now that we should expect to be typical of summer months?
Garcia: Well, traditionally, we do see increases in COVID in the summer, and those typically happen after the 4th of July. According to some public health experts this summer, we're likely going to see a drift upwards rather than a surge in cases. We know that COVID-19 can make anyone seriously ill, but for some, the risk is higher and individuals who could develop serious illness will need to be more careful.
Behind these increases are two new variants known as KP3 and KP2, or collectively as the FLiRT variants. Symptoms of these variants are relatively the same, sneezing, congestion, headaches, sore muscles, nausea and vomiting. Many people are also reporting exhaustion and a general blah feeling.
The trouble we run into in the summer is that these symptoms can be very similar to allergies. So the best way to tell the difference is to test.
Unger: And Andrea, on that topic, can you just give us a little bit more information and remind us about testing?
Garcia: Yeah. The New York Times actually did a nice job of mapping this out for us, since many of us don't have the stacks of tests at home that we once did. Ideally, you would test as soon as you notice symptoms or learn you've been exposed, and then again 48 hours later. As a reminder, a single negative antigen test can't rule out an infection. If you want to be confident that you do not have COVID, FDA actually recommends two negative antigen tests for individuals with symptoms or three antigen tests for those without symptoms performed 48 hours apart.
If you're older, immunocompromised or have underlying health issues, you should test as soon as you have symptoms or learn that you've been exposed. And remember to check the date on your test. If it's past the due date, you can check and see if it's still usable by going through the FDA database of tests online.
And in light of our earlier conversation, it's also worth noting that leaving tests in extreme heat for several days makes them less accurate. Health officials have also advised recently against using tests made by Cue Health, and that's due to the increased risk of false results.
Unger: All right. Well, thank you for those reminders. So looking ahead to the fall, even though it seems early to do that, what can we expect? And is there another booster on the horizon for most of us?
Garcia: Yeah, and we'll learn more about that in the coming weeks following the next ACIP meeting as well, which is happening later this week. Earlier this month, VRBPAC, which is the FDA's vaccine advisory committee, actually voted to update the formula for the COVID vaccine in the fall to offer better protection against the variants in circulation.
That committee supported a monovalent JN. 1 lineage composition for the 2024-2025 year. On June 13, we saw the FDA advised drugmakers to update the COVID vaccine to target the KP2 strain if feasible. So KP2 is a descendant of the JN. 1 variant. Pfizer and Moderna's vaccines are mRNA based, so they've said that they do have the capability. They'll be updating the vaccine to target that variant by the fall.
However, Novavax is a protein-based vaccine and it takes much longer to manufacture. So Novavax has indicated that they won't be able to make a KP2 vaccine for the fall. Instead, they're going to be expected to distribute a JN. 1 vaccine which had already been producing. All of these vaccines, though, are expected to be more effective than our current vaccine, which targets XBB. 1.5, and that is a subvariant that is no longer in circulation.
Unger: Now, Andrea, I thought I read something about a combined COVID and flu vaccine. Am I wrong? Is that still something that's on the table?
Garcia: You're right. Moderna does have a combined COVID/flu vaccine in trials, which has shown promising results so far. The earliest that would be ready for the market is probably fall 2025. Of course, that would be pending regulatory approval.
We've been following the clinical trial. There's a recent Washington Post article as well, and it noted that so far, the combined shot has produced a higher immune response in older adults than separate vaccines for those viruses administered together. That's according to data released by the company on June 10. Those results have not yet been peer reviewed or published in a medical journal, though.
Unger: All right. Thank you, Andrea. That's something we're going to definitely continue to follow. Let's turn now to a different topic we've talked about before, continues to make headlines week after week, and that's weight loss drugs. There was a warning issued last week. Andrea, what do we need to know?
Garcia: Yeah. That warning was about fake versions of certain weight loss drugs that are in circulation. And in an article released by the Associated Press last Thursday, the WHO and drugmaker Eli Lilly said to be wary of these fake versions. The WHO in particular has fielded several reports of fake semaglutide, which is the active ingredient in Novo Nordisk, Wegovy and Ozempic, and that's in all geographic regions of the world since 2022.
Eli Lilly said in an open letter that it was deeply concerned about the growing online sales and social media posts involving phony or compounded versions of tirzepatide, which is the active ingredient behind its drugs Mounjaro and Zepbound. Lilly said that the fake versions, which are often sold online, are never safe to use. They've not been approved by the FDA. And Novo Nordisk has issued similar warnings in the past about its medications. The WHO said patients can protect themselves by always using prescriptions from licensed physicians.
Unger: That's always good advice. Andrea, that's all we've got for this week. Thank you so much for joining us today. If you found this discussion valuable, you can support more programming like it by becoming an AMA member at ama-assn.org.
We'll be back soon with another AMA Update. And in the meantime, you can find all our videos and podcasts at ama-assn.org/podcasts. Thanks for joining us today. Let's take care.
Disclaimer: The viewpoints expressed in this podcast are those of the participants and/or do not necessarily reflect the views and policies of the AMA.
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