FDA's vaccine adcomm unanimously supports Moderna's booster in same populations as Pfizer's booster
The FDA’s vaccine advisory committee on Thursday voted 19-0 in support of expanding Moderna’s Covid-19 vaccine EUA for booster doses for certain high-risk individuals. FDA is expected to authorize the Moderna booster shortly.
Similarly to the Pfizer booster shot, Moderna’s will likely be authorized for those older than 65, adults at high risk of severe Covid-19, and adults whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of Covid-19. But unlike the Pfizer adcomm, where FDA had to scramble to get the committee to vote in favor of a booster, this committee was unanimous with the Moderna shot.
Israeli scientists once again presented the latest in their experience with boosters, which showed reduced Covid-19 cases. Several panelists praised how compelling the Israeli data presented were.
Paul Offit, a VRBPAC panelist and professor of pediatrics at Children’s Hospital of Philadelphia, called the data clear for 70- to 79-year-olds, but said he was less impressed with the data for those who are younger.
Others also questioned the data behind the booster, particularly as for Moderna is applying to administer a half-dose of what was provided in the primary, two-shot series.
“The data we have is only limited to about 149 patients on Moderna. So I have some hesitation,” VRBPAC member Jeannette Lee, a professor of biostatistics at the University of Arkansas for Medical Sciences, said.
Panelist Eric Rubin, editor in chief of the New England Journal of Medicine and an expert on infectious diseases at Harvard’s public health school, noted “the data are not perfect,” but these are “extraordinary times.” He also reiterated the idea that the overall effect of a booster is much less than primary vaccines, both here and abroad.
“We need to vaccinate the unvaccinated,” Rubin said.
Other members of the committee explained how the Moderna booster needs to win EUA as it wouldn’t make sense as a practical matter to have a Pfizer booster and not one for Moderna.
FDA’s top vaccine leader Peter Marks offered a similar sentiment in noting that the CDC’s committee, which is likely next up to review the Moderna booster, may decide to further manipulate the recommendations from VRBPAC, “but to the extent that we can come to place that’ll be acceptable for ACIP, that’ll be appreciated.”
VRBPAC panelist Steven Pergam, an expert on infectious diseases at the Fred Hutchinson Cancer Research Center in Seattle, said he is “very supportive” of those with occupational Covid-19 risks receiving the booster, particularly as the US seeks to protect health institutions from outbreaks.
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