December 16, 2020 -- A review document released by a Food and Drug Administration advisory committee on Tuesday says the Moderna coronavirus vaccine is safe and highly protective, with an efficacy of 94.5%.
The briefing document said an analysis of 30,350 participants, half of whom got a placebo, “supported a favorable safety profile, with no specific safety concerns identified that would preclude issuance of an EUA.”
FDA officials will use the information when they meet Thursday morning to consider granting an emergency use authorization for the Moderna vaccine.
If authorized, the Moderna vaccine would be the second one available to Americans. The vaccine developed by Pfizer and BioNTech was approved last Thursday and was administered to healthcare workers across the country on Monday.
The company has said up to 20 million doses will be delivered by the end of the year, enough to vaccinate 10 million people with the two-dose vaccine. Another 100 million doses are expected to be available by July 1. The U.S. government announced Monday it had agreed to buy an 100 million more doses, in addition to its original order for 100 million.
Like the Pfizer vaccine, the Moderna vaccine is a two-shot treatment that uses genetic material called m-RNA to stimulate the immune system to make antibodies. Unlike the Pfizer vaccine, the Moderna vaccine doesn’t require supercold temperatures, making it easier to ship and store.
“Moderna is the one that I would take out to rural areas and community health centers and private doctors’ offices,” Barry R. Bloom, a professor of public health at Harvard, told the New York Times.
Much of the FDA documents confirmed information Moderna previously released, such as the efficacy rating. The document said clinical trials showed predictable adverse reactions such as swelling at the injection site, fatigue, headaches, and chills.
Three people in clinical trials and one person who received the placebo reported facial paralysis called Bell’s palsy. “Currently available information is insufficient to determine a causal relationship with the vaccine,” the document said.
There were 13 deaths among people in clinical trials as of Dec. 3 -- six who received the vaccine and seven who got the placebo. "These deaths represent events and rates that occur in the general population of individuals in these age groups," the document said.
“Based on the totality of scientific evidence available ... it is reasonable to believe that the product may be effective to prevent, diagnose, or treat such serious or life-threatening disease or condition that can be caused by SARS-CoV-2,” the document said.