After the first batch of FDA-authorized COVID-19 vaccine, made by Pfizer and BioNTech, arrived at hundreds of hospitals across the U.S. on Monday, Moderna’s equally effective vaccine got the green light to continue on its path to the public. The vaccine won a key FDA endorsement, paving the way toward an official emergency use authorization (EUA) as soon as this week and possible rollout next week.
In a report on Tuesday, the FDA confirmed Moderna’s earlier assessment that its vaccine was 94.1 percent effective against the coronavirus with minimal side effects. “[The] FDA has determined that the Sponsor [Moderna] has provided adequate information to ensure the vaccine’s quality and consistency for authorization of the product under an EUA,” the document said.
The agency’s vaccine panel (Vaccines and Related Biological Products Advisory Committee), consisting of independent scientists and advisors, is set to meet on Thursday to review Moderna’s request in detail. The same panel recommended Pfizer’s vaccine to the FDA last Thursday, and an official EUA was signed within 24 hours.
Update: The FDA’s vaccine panel voted to recommend Moderna’s vaccine for an EUA late Thursday. Health and Human Services Secretary Alex Azar said on Friday shipment will begin this weekend if the FDA grants EUA as expected on Friday.
The U.S. plans to ship just under six million doses of Moderna vaccine once the FDA approves emergency use, Gustave Perna, chief operating officer of the White House’s Operation Warp Speed program, said on Monday. Nearly three million doses of Pfizer’s vaccine have been distributed since Sunday.
Additional supply from Moderna will be critical in helping states vaccinate their high-risk population by the end of 2020. In 47 states (and Washington D.C.), the amount of Pfizer vaccines allocated to local governments are less than half of what’s needed to give every front-line health care worker and nursing home resident the required two-shot protection.
Moderna’s EUA request has sat at the FDA for two weeks. The company is asking the agency to authorize the use in people age 18 and above. Pfizer’s vaccine was approved for use in people age 16 and older.