Public Health

FDA-authorized COVID boosters, plus Pirola variant & reinfection studies with Andrea Garcia, JD, MPH


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COVID-19 cases continue to rise, and the FDA authorizes new COVID-19 boosters. AMA Vice President of Science, Medicine and Public Health Andrea Garcia, JD, MPH, also discusses the latest news about the Eris (EG.5) and Pirola (BA.2.86) variants, the effects of COVID-19 reinfection and its relationship with Long COVID. Plus, the CDC’s health advisory on RSV. AMA Chief Experience Officer Todd Unger hosts.

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  • Andrea Garcia, JD, MPH, vice president, science, medicine & public health, American Medical Association

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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: Thanks. It's good to be here.

Unger: Well, for several weeks, we've been reporting that COVID cases and hospitalizations have been increasing Andrea, what's the story this week? Are we still seeing that trend?

Garcia: Yeah. We absolutely are. That upward trend is continuing and if we look at that CDC data for the week ending August 26, there were about 17,000 people who were hospitalized in the U.S. with COVID. That's about a 16% increase from the previous week. And those average daily hospitalizations due to COVID are close to 4,000, which is almost a 30% increase from the two weeks prior.

We've talked about this before. Even with these increases, overall, those hospitalizations are low compared to those numbers we were seeing at the height of the pandemic. The majority of people who are getting COVID now are experiencing mild symptoms.

And those who are hospitalized tend to be those with pre-existing conditions or people who are immunocompromised. And we know they've been disproportionately impacted throughout the course of the pandemic

Unger: Now, Andrea we've talked a lot recently about COVID variants Eris and Pirola. When we start with Eris, what's the latest news there?

Garcia: Yeah. So EG.5 or Eris, as it's being called, is still the dominant variant here in the U.S. And if we look at the CDC's genomic surveillance data, Eris is driving about 21.5% of all new COVID cases.

As we said last week, it doesn't seem to be causing more serious illness than other circulating variants. Of course, people who are older, those with underlying conditions who are at increased risk for severe outcomes are always a concern.

We know that both Moderna and Pfizer in separate studies last month reported that their fall vaccines, which we know are targeting the Omicron sub-variant XBB.1.5, do generate a robust immune response against Eris. So that is definitely good news.

Unger: And is good news. Now, what about the other variant of concern here, Pirola?

Garcia: Yeah, so scientists and the medical community have certainly been keeping a close eye on BA.2.86, or Pirola. There have been a few cases reported in the U.S. It's now been found in the United States, and that's as of last Friday. That's up from the five states we reported in last week's episode.

Pirola has more than 30 mutations, and experts really feared that that might make it either more transmissible and/or less susceptible to our vaccine-induced protection. But there's been some real sense of relief from the results of some early studies that came out last week.

Unger: Why that sense of relief? What did those studies show?

Garcia: Well, so Moderna said in a statement that human clinical trial data confirmed that their updated COVID-19 vaccines generates about an 8.7-fold increase in neutralizing antibodies in humans against BA.2.86. This data was released in a press statement, but it's also been submitted to both regulators and for peer-review publication.

And then we saw Pfizer say that their updated vaccine elicited a strong antibody response against BA.2.86 in a preclinical study in mice. These findings align with a handful of lab studies that found, across a range of different types of immunity, people have been able to neutralize BA.2.86 as well as and sometimes even more effectively as some of the other circulating variants. So I think experts feared the worst for Pirola, but it seems like that may not be the case, at least coming out of some of these recent studies.

Unger: Now, that is really good news. And it's a great segue because the FDA authorized those vaccines this past Monday. Andrea, in terms of timing and next steps, what do we need to know?

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Garcia: Yeah, so FDA approved the mRNA vaccines for individuals 12 and older, and they authorized them for emergency use in individuals six months through 11 years of age. These vaccines have been updated to include a monovalent component, as we just talked about, targeting XBB.1.5. Those bivalent Moderna and Pfizer vaccines are no longer authorized in the U.S.

Before these vaccines can be administered, they have to be recommended by the CDC's Advisory Committee on Immunization Practices. And after ACIP takes a vote, CDC director Mandy Cohen must sign off on those recommendations. These mRNA vaccines, we know they're shipping out as we speak.

So assuming all goes smoothly with ACIP and CDC, they could be administered as early as later this week. I would just note that there was also an application for the Novavax updated vaccine. And that is still pending with FDA.

Unger: Now, Andrea, the formulation isn't the only change that comes with these boosters. It's going to be the first time that the government isn't paying for COVID vaccines since they first became available. In regard to that, what should physicians and patients expect?

Garcia: So for most people with either private or public health insurance, they should continue to pay nothing out of pocket for these vaccines. If a person gets the vaccine out of network, it could carry a cost. For people without insurance, they may be able to get the boosters for free from some safety net providers, so your community health center or your health department. But others may have to pay that full cost. The Biden administration has announced a Bridge program that is going to be offering those who are uninsured free access to the boosters through the end of 2024.

Unger: Well, thank you for that additional information. And we're also going to be covering the updated vaccines even more in depth with Dr. Sandra Fryhofer, the AMA's liaison to the CDC's Advisory Committee on Immunization Practices, and you can look for that next week. As these new vaccines begin to roll out, many people may think that they've already had COVID, they don't need to get one, Andrea. What is the latest on reinfections?

Garcia: Yeah, so we do of course get immunity when we have a COVID infection. And we know that many people at this point have had COVID two or more times. There has been some research on how reinfection with COVID affects people. There was a recent New York Times article looking at some of the emerging data on severity of reinfection, and it shows that, for many people, those subsequent infections will be as mild or milder than their first. And that's likely because of partial immunity from those previous infections or vaccination.

I think there are a few exceptions there, especially for those people who are immunocompromised, older adults, or those who had a particularly severe previous infection. Those early data show people who had that severe first infection are more likely to end up hospitalized or to require medical attention for a reinfection.

Unger: All right. Andrea, I know there's an additional concern about reinfection and long COVID. What do we know about any connection there?

Garcia: Long COVID from a reinfection is a little less predictable. We do have some research that shows that having more infections raises your risk of long COVID. But I think that risk is still not well understood. I think the good news is that the risk of getting long COVID is lower than it was at the start of the pandemic. And vaccines and boosters do offer some level of protection against long COVID.

Vaccines, of course, also help protect against reinfection, severity and duration of symptoms. So physicians should make that really clear to patients who may be debating getting one of the new vaccines because they've already had COVID.

Unger: A really, really important consideration there. Andrea, in other news, the CDC issued a health advisory regarding RSV. I thought that the cases were low at the moment. Is something changing out there?

Garcia: Well, that really depends on where you live, and that's why it's important to keep an eye on that surveillance data. In recent weeks, the CDC has observed an increase in RSV activity. That's particular to parts of the southeastern United States. And historically, these regional increases have predicted the beginning of RSV season nationally with increased RSV activity spreading North and West over the next two to three months.

We know RSV is an RNA virus. And transmission primarily occurs via respiratory droplets, so when a person coughs or sneezes, or through direct contact with a contaminated surface. Infants, young children, older adults, especially those with chronic medical conditions, are at increased risk of severe disease from RSV infection.

And we've talked about the numbers before. But RSV causes approximately 58 to 80,000 hospitalizations and 100 to 300 deaths in children under five years old. And if we look at adults 65 and older, we know that the estimated hospitalizations are 60,000 to 160,000 and there are about 6,000 to 10,000 deaths from RSV each year.

Unger: So very significant numbers. Andrea, given that, is there any guidance on how physicians should prepare for the upcoming RSV season?

Garcia: Yeah, so CDC definitely encourages clinicians to adopt and implement those new RSV prevention options that are available to protect patients. Those include the vaccines for people aged 60 and older and that monoclonal antibody treatment that's available to protect infants and some young children who are at increased risk. That vaccine for use in pregnant people for the prevention of RSV in infants through birth through six months of age has been approved by the FDA. But that is still awaiting review by the ACIP.

CDC is also recommending that physicians consider testing symptomatic patients with high-risk conditions for COVID, influenza and RSV. And that's to help inform treatment decisions. And I think it goes without saying that health personnel, childcare providers or staff at long-term care facilities should stay home when they have a fever or symptoms of a respiratory infection to help reduce the spread. That's going to be really important for all of us to remember as we head into the fall.

Unger: Yeah. It looks like there's a lot percolating. So thank you for that guidance. Andrea, we'll continue to track all of this in the upcoming months. That's it for today's episode. And of course, we'll be back with another AMA Update soon. In the meantime, you can find all our videos and podcasts at Thanks for joining us and 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.