FDA Panel Endorses Updated COVID Shots for All, Regardless of Vaccination Status

The original monovalent COVID vaccines should be phased out, and all people, regardless of vaccination status, should receive a bivalent shot when being vaccinated, a Food and Drug Administration (FDA) advisory committee said on Thursday. 

Twenty-one members from the the Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously to recommend the measure, which they said would work to simplify the COVID-19 vaccination process. 

“Our job here is really to protect against severe disease,” Adam Berger, PhD, VRBPAC member and Director of the Division of Clinical and Healthcare Research Policy at the National Institutes of Health, said during the committee discussion. “It really makes a difference if you can actually have a strain that’s matched to the currently circulating stains themselves, and what we’re trying to do is really offer that best protection possible.”

Currently, people who get vaccinated for the first time receive two shots (a primary series) of the monovalent COVID vaccine, which only targets the original SARS-CoV-2 virus. The Omicron booster, or bivalent vaccine, is aimed at both the original virus and the BA.4/BA.5 Omicron variants. The FDA panel recommendation would effectively retire the monovalent vaccine and rely solely on the bivalent vaccine.

The advisory committee’s vote does not make the decision final for now—the FDA will still need to approve the measure before it’s implemented. 

Merging Efficacy and Simplicity 

As is evidenced by the committee’s unanimous vote, the hops is that retiring the original COVID shot would make things less complicated and give everyone access to the shot that’s best equipped to handle the variants circulating right now.

“Simplicity leads to ease of administration, both on the part of the patients who are getting vaccinated as well as the providers,” William Schaffner, MD, professor of infectious diseases at Vanderbilt University Medical Center, told Health. “Also, the new variants are out there—this bivalent vaccine works against the new variants, so let’s use that for primary vaccination also.”

In general, the move is one that acknowledges that the country is in a much different place than it was when the original vaccines were developed, added Matthew Laurens, MD, MPH, professor of pediatrics and medicine at the University of Maryland School of Medicine and pediatric infectious disease specialist at the University of Maryland Children’s Hospital.

“It is shifting our focus from [a] pandemic to endemic response to COVID-19,” he told Health. “We have immunity to the virus whether through vaccination and/or through natural infection. So we can shift from, ‘Let's get some immunity in the population,’ to, ‘Let's think about how to best boost the immunity that we do have.’”

By May of 2022, the CDC estimated that about 91% of all Americans had immunity to COVID, either from vaccination or prior infection. The bivalent shots could help boost this pre-existing immunity, and since they tackle the newest Omicron variants that are currently circulating, experts agree they’re likely a better choice than the original monovalent vaccine. 

The FDA committee also pointed to studies that prove the bivalent shot’s efficacy as another reason to make the switch. 

Data published earlier this week found that the vaccine effectiveness for preventing hospitalizations was 25.2% for the monovalent booster, as compared to the bivalent booster’s 58.7%. The latter was also more effective against hospitalization and death from COVID-19, particularly for those over the age of 65.

A recent CDC report also found that the bivalent shots seem to hold up against XBB.1.5, the newest Omicron variant to become dominant in the U.S.

“We were able to predict which variants to include in the bivalent booster in June, even though the variants would not be circulating for months later,” Dr. Laurens said. “We’ve prevented both symptomatic disease and, most likely, really prevented a lot of deaths and hospitalizations. So the studies are ongoing but it’s successful.”

Other Booster Questions Discussed, But Not Voted On

Despite the committee’s consensus on phasing out original COVID shots, there was much more debate regarding two other discussion questions that were put before it. 

First, the committee discussed the idea of recommending a more clear and broad COVID vaccine schedule, which would have some young children, seniors, and the immunocompromised get a multiple-shot vaccine series annually, while those who’ve had COVID or been previously vaccinated would receive one COVID booster annually.

Committee members did not come to a firm consensus about this, but raised questions about whether there was sufficient data on bivalent booster intervals and dosing best-practices for people depending on their age and vaccination status, among other questions.

The group also discussed ideas about updates to COVID vaccines, and what that would potentially look like going forward. But again, questions still remain about what would work best.

“[Should] there be an annual update of the vaccine the way we do with our influenza vaccine, and could it then be recommended that in the fall, we get both influenza vaccine and COVID vaccine?,” Dr. Schaffner asked. “That was left much discussed.”

Some important questions to consider, he added, are whether the public would accept a sort of “dual-vaccination campaign,” along with when COVID shots would have to be updated and which strains they would contain.

These questions of when to update the COVID booster and how frequently we should get it will likely continue to be researched and discussed in the months ahead.

“We’ve experienced three years of COVID-19 now, and we think we might be able to predict how it’s going to behave in the future. But we’re not always the best at predicting,” Dr. Laurens said. “The vaccines that are approved and implemented in, say, the fall of this year, [will] still have to be very carefully monitored to make sure that we’re doing the right thing.”

Confidence in the Bivalent Booster Despite Hurdles 

Earlier in January, the CDC and FDA announced that the agencies had picked up on a statistical signal that may have potentially linked the shot to an increase in ischemic stroke risk for seniors. 

Despite the concerns, the CDC and FDA reiterated at their Thursday meeting that recommendations have not changed because all other evidence points to no connection between the bivalent booster and stroke.

“It shows that the surveillance system that we have in the United States for adverse events associated with vaccines is working,” Dr. Schaffner explained. “There was no sense—either in this committee, or in the CDC Advisory Committee on Immunization Practices—that we need to change our recommendations in any way at the present time.”

The CDC’s announcement has fanned some of the flames of vaccine hesitancy and misinformation online, however. Despite the distrust, moving forward with bivalent shots may not be a bad thing, Dr. Schaffner said.

“We’re going to continue to deal with indifference, vaccine fatigue, as well as hesitancy and skepticism,” he said. “But this was an attempt to start making things a bit simpler and easier for the public to understand.”

This is an important piece of the puzzle, as 81% of Americans received at least one dose of the COVID vaccine, but only about 15% have gotten an updated bivalent booster.

“One of the most frequently asked questions I get is, ‘What’s the plan going forward? How often will we be required to have a vaccine?’ And the public has told us—they’ve voted with their feet. They don’t want to be vaccinated too frequently,” Dr. Schaffner.

If public officials can streamline COVID vaccinations with this adoption of the bivalent shot for all, and make it something that’s annual and routine, Dr. Laurens added, that may help the situation.

“I think, hopefully, we’ll be successful in shaping public opinion in terms of a successful vaccine strategy,” he said, “and that we’ll retain the faith of public opinion going forward as the shift goes to a bivalent annual booster—if that is indeed the case.”