In late September, the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) authorized and recommended an additional shot of the Pfizer vaccine for select groups. Now, more than 9 million people have received a Pfizer booster shot, per the CDC. A panel for the FDA also just endorsed booster doses for certain Moderna recipients and all Johnson&Johnson recipients, but you still can't get an additional shot of either vaccine yet, as these boosters haven't gotten official authorization from the FDA and a recommendation from the CDC.
Moderna CEO Stéphane Bancel discussed his company's booster dose and the ongoing process to get it authorized during an Oct. 18 interview on Bloomberg Technology. When asked what he's heard about the potential timeline for the authorization of Moderna's booster, Bancel said he is hopeful that eligible adults in the U.S. will be able to get additional shots next week.
"We expect this week, potentially, the authorization of a booster," Bancel said. "There is a CDC meeting which is scheduled this week to make a recommendation and so I'm hopeful that by the end of the week, everything is wrapped up. And by next week, Americans who got the Moderna vaccine can get the Moderna booster."
After the Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted to endorse a Pfizer vaccine, it took the FDA five days to release their official authorization. The panel unanimously endorsed a Moderna booster on Oct. 14, and while the FDA is expected to align its authorization with the committee's recommendation, it does not have to. Once the FDA issues its official stance, the CDC's Advisory Committee on Immunization Practices (ACIP) will meet to make recommendations on who should be eligible for the booster. Their meeting is currently set for Oct. 20 and Oct. 21.
CDC Director Rochelle Walensky will sign off on the CDC's official recommendation afterwards, which also typically aligns with the ACIP. But when making decisions for Pfizer's booster, Walensky did slightly deviate from the panel's initial recommendation. As of right now, Moderna has proposed and the VRBPAC voted to make Moderna boosters only eligible for people 65 years and older, and people 18 to 64 years old who are at high risk of severe COVID due to medical reasons or institutional or occupational exposure—the same groups eligible for Pfizer's booster.
Bancel also referenced a recent study from the National Institutes of Health (NIH) and the National Institute of Allergy and Infectious Diseases (NIAID) which suggests that mixing and matching booster doses may provide certain individuals with more protection. Anthony Fauci, MD, a White House COVID adviser and director of the NIAID, told Bloomberg that the study was nine-parts, in which researchers used all three vaccines as boosters and compared them against each initial series to determine the safety, immunogenicity, and efficacy of each potential set of mixing and matching.
"The data last week from Dr. Fauci and all the hospitals in the U.S. who did that work is very clear, which is you can mix and match the vaccine, which is not surprising. If you think about it, this is true for flu shots. I don't think anybody remembers which brand they got this year and which brand they got last year," Bancel noted.
The study, which analyzed more than than 450 participants, not only found that getting a different booster was safe and effective, but that Moderna's booster raised antibody levels the highest among all recipients, no matter which vaccine they had initially received. The greatest difference was for those who had gotten Johnson&Johnson's one-shot vaccine first, as the additional Moderna dose boosted neutralizing antibodies for these recipients 76-fold, while Pfizer boosted the levels 35-fold and a Johnson&Johnson booster only increased the levels 4-fold.
"I think the data was very strong. It also shows that the Moderna vaccine provides a very strong protection," Bancel said. "As a reminder, this is highest level of antibody that you get over time, is with Moderna vaccine. And so I'm hopeful that the regulators will allow Americans that desire to get a higher dose, a booster for better protection to get the Moderna vaccine."