Pfizer, Moderna win over FDA for 2nd round of COVID-19 boosters in older adults

Amid the ongoing debate over the need for another round of COVID-19 boosters, the FDA has acted quickly on the matter. 

Only two weeks after Pfizer and its partner BioNTech asked the agency for an emergency use authorization (EUA) for a second round of COVID-19 boosters in people 65 and older, the FDA has granted the nod. The new FDA authorization covers those who have already been boosted with any COVID vaccine and are either 50 and older or 12 and older if they are immunocompromised.

At around the same time on Tuesday morning, Moderna said the FDA had granted its application for a second booster. The Moderna nod covers adults over 50 who have been boosted once, plus immunocompromised adults over 18. Moderna applied for a second booster on March 17.

Pfizer's EUA for the latest round of the Comirnaty vaccine is based on a small open-label study in 154 healthcare workers in Israel, plus data from the U.S. and elsewhere showing that effectiveness drops 3 to 6 months after the initial booster and data from Israel showing that another booster can improve protection against severe disease and death.

Likewise, Moderna's EUA expansion for its Spikevax shot is based on Israel data "indicating the safety and effectiveness of administering a fourth dose of mRNA vaccine during the omicron variant surge," the company said Tuesday.

"The virus continues to evolve, and we are currently on the verge of another potential wave driven by the BA.2 variant," Moderna CEO Stéphane Bancel said in a statement. "Data continue to show that mRNA boosters remain the best defense against severe infection and death, and vaccines are a foundational part of our public health protection. Now, healthcare providers have the opportunity to advise higher-risk people about when and how to get boosted and build immunity in advance of future outbreaks."

But some experts aren't sold on the need for another round of boosters just yet. For instance, Anna Durbin, M.D., professor of international health and director of the center for immunization research at Johns Hopkins Bloomberg School of Public Health, told ABC News that "very few" people, if any, need a fourth dose.

And vaccine design expert Paul Goepfert, M.D., told the outlet that, in general, it's "too early to recommend a fourth dose, except for those who are immune-compromised."

Meanwhile, COVID-19 trends have improved significantly in the U.S. from earlier this year. After a winter peak, when new cases reached around 800,000 per day on average, case numbers have fallen significantly to around 30,000 per day, according to The New York Times. Still, officials have warned that the omicron subvariant BA.2 has been gaining steam in certain states.