FDA panel OKs Moderna booster shot
Members of an independent Food and Drug Administration panel have voted unanimously to recommend authorization of Moderna’s coronavirus booster shot after hours of discussion and debate.
The Vaccines and Related Biological Products Advisory Committee voted to recommend the booster for people 65-plus, those with certain medical conditions and people facing workplace exposure.
The eligibility groups exactly mirror those of Pfizer’s booster shot, which was authorized last month.
Moderna’s booster will be 50 micrograms, which is half the amount of the primary shots. The booster can be given at least six months following the second dose.
Moderna representatives said the 50 microgram dose is still very effective, might trigger less side effects and will help to stretch supply.
The company said booster shots will help bolster waning immunity in the face of variants and offer a similar safety and side effect profile as the second shot.
Moderna’s Dr. Jacqueline Miller told FDA advisers that during the delta variant surge, people who were more recently vaccinated had a 36% lower rate of breakthrough infections compared with those vaccinated longer ago.
In a statement via Twitter, Moderna said, “We are grateful for the opportunity to present the clinical data package for our COVID-19 booster vaccine to the FDA’s advisory committee today. We thank the committee for their review & for their unanimous vote in support of EUA of the 50 (microgram) booster dose.”
Although the vote among VRBPAC members was unanimous, many noted that getting unvaccinated people to get the shot remains far more important than getting vaccinated people a booster.
Many questions during the eight-hour meeting were left unanswered. Members questioned whether there’s enough evidence to back a low-dose booster along with the durability of the vaccine.
The experts also noted that immunocompromised people can already get a third full dose. Whether that population can get a booster is unclear.
There still remain a few hurdles before Moderna’s booster can make its way into arms. The FDA must sign off on the recommendation and then the Advisory Committee on Immunization Practices, convened by the Centers for Disease Control and Prevention, will meet to review Moderna’s data.
After that, the CDC director will approve the rollout plan and the shots will be available to the public. That could happen sometime next week.
The VRBPAC members are meeting again tomorrow to decide whether to recommend Johnson & Johnson’s booster dose. They will also discuss the impacts of mixing vaccines and boosters from different drug makers.
There still remain a few hurdles before Moderna’s booster can make its way into arms.