On Thursday, a group of advisers to the U.S. Food and Drug Administration unanimously recommended the agency to approve a third (booster) dose of the Moderna COVID-19 vaccine at least six months after completion of the initial two-dose regimen, according to NPR.
The group’s recommendation applies to people aged 65 and above, and those aged 18 to 64 who are at high risk of severe COVID-19. The recommendation also applies to people in the same age group who are at high risk of catching the virus at work or institutional exposure.
In September, the FDA authorized the Pfizer-BioNTech COVID-19 booster doses after following the advice of its advisory committees.
Dr. Peter Marks, Director, FDA’s Center for Biologics Evaluation and Research, said Thursday, “It’s important to remember that the vaccines still provide strong protection against serious outcomes, especially for younger age groups.”
“The vaccine effectiveness against mild to moderate disease does appear to wane over time for the different vaccines,” he added. “And we do need to account for the fact that mild to moderate COVID-19 can be associated with adverse outcomes, such as blood clots and long COVID-19, even in those who have breakthrough infections after vaccination.”
The group heard from Israeli scientists who gave an update on the experience with the Pfizer-BioNTech booster dose, which uses the same kind of mRNA technology as Moderna’s vaccine.
Dr. Sharon Alroy-Preis, Deputy CEO at Carmel Medical Center, said, “The administration of the booster dose helped Israel dampen infections and severe cases in the fourth wave.
She said an analysis of side effects, including heart inflammation, was reassuring, especially for the most worrisome problems, adding, “I’m very confident about the serious events.”
Dr. Stanley Perlman of the University of Iowa said, “I support this [Emergency Use Authorization] because we’ve already approved it for Pfizer, and I don’t see how we can possibly not approve it for Moderna and not have most U.S. folks completely confused. I think it’s a pragmatic issue.”
However, before the group voted, Dr. Eric Rubin, Editor-in-chief, The New England Journal of Medicine, said that there was incomplete information and some unanswered questions about the Moderna booster, according to NPR.
He said, “The data are not perfect, but these are extraordinary times and we have to work with imperfect data.”
After the vote, the group discussed whether the Pfizer-BioNTech and Moderna boosters could be used in the general population younger than 65. The group was not inclined to support that. The article was published in NPR.
