FDA Panel Votes To Recommend Moderna Coronavirus Vaccine For Emergency Approval

The FDA’s vaccine advisory panel voted 20-0 to recommend that Moderna’s coronavirus vaccine be authorized for emergency use, clearing the way for its approval and distribution nationwide.

After scouring over Moderna’s data during a multi-hour meeting Thursday, the panel affirmed Moderna’s vaccine as safe for the millions of Americans hoping to receive it in the coming weeks. Though the panel’s decision is merely advisory, the FDA has signaled that it would follow the panel’s guidance.

Moderna’s vaccine could be given approval as soon as Friday, becoming the second coronavirus vaccine to be approved in the United States.

The vote follows the agency’s release of clinical trial data from Moderna on Tuesday reaffirming the vaccine’s safety and effectiveness.

The FDA underwent a similar process last week regarding Pfizer’s vaccine. It released analogous data last Tuesday underscoring its effectiveness and safety, voted to recommend it last Thursday, and officially authorized it for emergency use last Friday.

Distribution of Moderna’s vaccine could begin just hours after FDA authorization, and vaccinations could begin as soon as next week. Moderna said that it was prepared to ship approximately 6 million doses once FDA approval was given, over twice the amount initially shipped by Pfizer last weekend.

The panel’s meeting was live-streamed in an attempt to ensure maximum transparency and strengthen public confidence in the coming coronavirus vaccines. Though Americans’ collective confidence in coronavirus vaccines hit a low-point in late summer, it has steadily increased throughout the fall, with 63% of Americans surveyed in November saying that they would receive a vaccine once available to them.

While Pfizer’s vaccine was approved in several foreign countries, including the United Kingdom and Canada, before it was in the United States, the U.S. stands to be the first country to approve Moderna’s vaccine. If approved Friday, it could help alleviate the extraordinary demand for effective vaccines across the country as coronavirus cases, hospitalizations and deaths surge.

Moderna released the results of its clinical trials in November that showed its vaccine to be nearly 95% effective and free of major safety concerns. Pfizer released its data a week earlier, showing its vaccine to be over 90% effective as well.

The virus has infected over 17 million Americans to date and killed over 308,000, with approximately 20,000 deaths coming in just over a week, according to a Johns Hopkins University database.