An influential Food and Drug Administration (FDA) advisory panel has unanimously recommended Moderna’s (NASDAQ:MRNA) COVID-19 vaccine for emergency use authorization in the United States.
The non-binding Moderna decision, which was adopted in a 20-0 vote by the FDA’s Vaccines and Related Biological Products Advisory Committee came exactly a week after the outside group of vaccine and infectious disease experts voted to recommend Pfizer’s (NYSE:PFE) vaccine for an emergency use authorization. The FDA formally approved Pfizer’s vaccine the next day.
The FDA advisory committee plays a key role in approving flu and other vaccines in the U.S., verifying the shots are safe for public use. While the FDA doesn’t have to follow the advisory committee’s recommendation, it often does. The U.S. plans to ship just under six million doses of the COVID-19 vaccine next week.
Emergency Use Authorization means the FDA will allow some people to receive the vaccine as the agency continues to evaluate data. It isn’t the same as full approval, which requires more data and can typically take several months longer.
Moderna has submitted only two months of follow-up safety data. The agency usually requires six months for full approval. The committee recommended emergency authorization of the vaccine for people who are 18 or older.
Initial doses will be limited as manufacturing ramps up, with officials predicting it will take months to immunize everyone in the U.S. who wants to be vaccinated. The Centers for Disease Control and Prevention has provided states with an outline that recommends prioritizing health-care workers and nursing homes, but states can distribute the vaccine as they see fit.