AMA Update covers a range of health care topics affecting the lives of physicians, residents, medical students and patients. From private practice and health system leaders to scientists and public health officials, hear from the experts in medicine on COVID-19, medical education, advocacy issues, burnout, vaccines and more.
In today’s AMA Update, AMA's Vice President of Science, Medicine and Public Health, Andrea Garcia, JD, MPH, talks about the FDA's recent approval of a maternal RSV vaccine to protect infants, as well as the recent uptick in COVID cases and a new, highly mutated variant, BA.2.86, also known as Pirola, that has put the CDC and WHO on watch. 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. Hello, Andrea.
Garcia: Hi. How are you today? Great to be here.
Unger: Nice to talk to you. It's been a couple of weeks since we talked last and a lot has gone on in that time. For one, there's another RSV vaccine. We've talked a lot about different RSV vaccines. I'm sure folks out there could be confused. What's the news on the front today?
Garcia: So on Monday, we saw the FDA grant approval to a vaccine that is to be administered to pregnant people and it's to protect their babies from RSV through the first six months of life. It's a single-dose shot from Pfizer. It's called ABRYSVO.
And it's approved for use 32 to 36 weeks gestational age of pregnancy. This vaccine helps the pregnant person produce protective antibodies that are then passed on to the fetus through the placenta. This is the same vaccine that was approved in late May for people age 60 and up, so it is already available in some pharmacies.
However, this is the first vaccine that can protect babies from RSV, which, as we've discussed in recent weeks, can be severe in infants. I just want to clarify that this is different than the injectable RSV monoclonal antibody for infants that the FDA approved last month. That one is given to the infant and delivers a dose of antibodies directly into the bloodstream.
Unger: Right. So I think I understand. That last one you mentioned, of course, is the monoclonal antibodies and then the first ones, of course, that were approved earlier in this year for 60 and up, and now one that's approved for pregnant people. So did I get that right?
Garcia: You did.
Unger: All right. Excellent. Well, it's going to be great to have multiple options as we head into RSV season. Andrea, when are the latest shot's going to be available?
Garcia: Yeah, so before the Pfizer shot can be distributed to the public, the CDC's Advisory Committee on Immunization Practices must recommend who should receive it. And then, after that, we'll usually see the CDC director Dr. Mandy Cohen officially sign off on that recommendation for the vaccine.
Pfizer indicated that they expect ACIP will most likely meet sometime in early October. And then the company plans to make that vaccine publicly available shortly after it's officially recommended. Having those options, both for older adults and babies this fall, could really be a game changer. We know that RSV can lead up to 300 deaths a year among kids under five and then up to 160,000 hospitalizations among people age 65 and up.
Unger: Well, the good news is we've got a tool, a new tool, in our armament, so to speak, for one leg of what was the tripledemic last year. One of the other legs, COVID, is beginning to creep back into the headlines. Andrea, what do we to know there?
Garcia: Yeah, so most of the headlines have been about the highly mutated variant. Last Thursday, we saw the CDC announced that it's tracking this new lineage of the virus named BA.2.86 and it's nicknamed Pirola. Now, what makes this so different than the others that we've seen is the amount of mutations it carries.
It reportedly has 36 mutations in the spike protein compared to its next closest ancestor, which is the BA.2 subvariant of Omicron. The WHO has now classified this as a variant under monitoring. That means countries are encouraged to track and report sequences they find. So far, we know it's been detected here in the U.S., in Denmark, in the UK and in Israel. But it's likely going to be found in other countries in the coming weeks as well.
Unger: So Andrea, what do we know about this variant, besides the fact that it's highly mutated?
Garcia: At this point, we don't know a lot and those three main questions remain that are, how are the variants mutations going to affect symptoms and severity? Will it spread easily? And how will the new XBB.1.5 COVID vaccines, which we know are slated for release here in the U.S. in September, might hold up?
Of course, we also wonder how our existing immunity is going to hold up as well. But more data is going to be needed before we'll have answers to any of those questions. What we do know is the strain was first spotted by virus trackers in mid-August. The mutations will likely help the virus latch onto cells and cause infection, and that could make it better at evading immunity from vaccines and past infections.
Even if our vaccines don't hold up as well, I think there is hope that our antivirals, like Paxlovid, that don't target the highly mutated spike protein will still work. And we did hear CDC director Dr. Mandy Cohen say on Friday that the new variant shouldn't be cause for alarm. She said that while these mutations do make it distinct from other lineages circulating, they're still determining what those difference will mean. So in other words, it's still too early to tell all.
Unger: All right. Well, in addition to that new variant, Andrea, what is the variant that is dominant right now?
Garcia: So if we look at the CDC variant tracker, the XBB descendent EG.5, which is better known as Eris. It's currently the dominant variant here in the U.S. It's causing about 20% of all new COVID cases in the country. And then the next most common variant is FL.1.5.1, or Fornax, which has grown pretty quickly and is now causing about 13% of all new cases.
Unger: What do we know about the variant called Eris?
Garcia: Well, according to the Washington Post, Eris is a descendant of the XBB strain, which are offshoots of the current variant. The WHO has said that, right now, Eris poses a low risk to global public health and is currently classified as a variant of interest, although it's growing in prevalence in comparison to some of the other strains and appears to be better at evading the body's immune system. They went on to see that there is no evidence that it causes more severe disease or can spread more easily than other variants. In terms of vaccine effectiveness, we know that Pfizer and Moderna have both said that their updated COVID vaccines, which we know are formulated to target the XBB.1.5 variant, have been protective against Eris in early studies.
Unger: Are the symptoms that people are experiencing with Eris, basically similar to those that are experienced with other subvariants?
Garcia: Yeah, for the most part, they are. The most common symptoms we're seeing right now are a runny nose, headache, fatigue, sore throat and sneezing. But as with other subvariants, people who are older, who have compromised immune systems or who suffer from multiple other conditions are at higher risk for some of those more severe symptoms, which can include lower respiratory disease, chest pain and shortness of breath. Of course, the best thing to do is, if you're experiencing symptoms, is to get tested so that you can start treatment as soon as possible.
Unger: Yeah, you're right. A lot of those symptoms sound just common cold symptoms. So everybody out there, remember to test and make sure you know the difference. Andrea, over the past few weeks, we've also talked about hospitalizations that are ticking up. Is that on account of Eris?
Garcia: Yeah, some of those may be due to Eris. I think it's worth noting that the uptick in cases as in hospitalization we've seen overall has been lower than in previous summers. And some researchers believe that we continue to see these summer upticks because more people are traveling. And of course with this summer in particular, we may be seeing more people heading indoors just because of the extreme temperatures a lot of places have been experiencing. It's also been months since most people have gotten a vaccine, so we know that immunity may be waning as well.
Unger: So that's a good segue way to the next question. Heading into fall, immunity waning, thinking about a COVID shot—you mentioned that a new vaccine is set out to come in September. Tell us more about that.
Garcia: Yeah. So we know that Pfizer, Moderna and Novavax are working now to update test and mass produce their vaccines, which will then need to be officially authorized by the FDA and recommended by the CDC. Experts estimate that those shots will be available to the public by late September or early October. I think I've gotten questions—and I know a lot of people are asking whether they should get a booster now or if they should wait for the new ones. A New York Times article that was published recently suggests that, for most people, it's best to wait. And that's because the new vaccine will be a better match for variants that are currently circulating.
It was also suggested that waiting for that new vaccine will increase odds that your defenses against the virus will be strongest when cases are expected to peak. And historically, we know that's then between December and February. As been the case with past formulations, the new COVID vaccines will be especially important for those populations that we know are at greatest risk for severe outcomes. So it will be up to physicians to help their patients understand the importance of these vaccines once these new formulations are ready.
Unger: Andrea, when you look into your crystal ball, do you have any sense of what we can expect this fall?
Garcia: It's always tough to predict, but we know last winter was really tough with the tripledemic of flu, RSV and COVID. This year, we have vaccines for all three of those viruses. The biggest challenge is going to be making sure that people get them.
We know that experts are predicting a COVID surge. Many are suggesting that it may not be as severe as last year. They also suspect that RSV and flu, which are at low levels now, will go back to their usual seasonal patterns this year. So while we do have challenges ahead, it's not terrible news as kids head back to school and, of course, as we prepare for the impending respiratory virus season.
Unger: No, that's certainly a very different scenario than we've had for the past few years. So let's just call it right there on a high note, Andrea. Thanks so much for joining us today. That's it for today's episode. Thanks for joining us. 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. 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.