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Law360 (December 18, 2020, 7:47 PM EST) -- The U.S. Food and Drug Administration signed off on Moderna's request for emergency use authorization of its COVID-19 vaccine Friday, clearing the way for a second vaccine that is 94% effective at preventing infection and believed to prevent severe cases.
A nurse gives a volunteer in Binghamton, New York, an injection during a clinical trial of Moderna's COVID-19 vaccine. The Food and Drug Administration gave emergency authorization to the vaccine on Friday. (AP Photo/Hans Pennink)
"With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day," FDA Commissioner Stephen M. Hahn said in a statement.
With the FDA's emergency authorization, the vaccine can now be distributed in the U.S. to individuals 18 and older.
Massachusetts-based biotechnology company Moderna Inc. said when it filed for the emergency use authorization on Nov. 30 that once approved, it expects to be able to produce 20 million doses for U.S. distribution by the end of the year and 500 million to 1 billion doses for distribution around the world in 2021. Distribution will begin within hours of approval, the company said.
The decision follows the FDA's Dec. 10 approval of the COVID-19 vaccine developed by Pfizer Inc. and BioNTech SE after the same advisory panel backed its emergency use. The first doses of that vaccine were administered to front-line health care workers in the U.S. on Monday.
During Thursday's meeting on the Moderna vaccine, the company's chief medical officer Dr. Tal Zaks touted the vaccine's efficacy and safety.
"We have not seen a significant safety concern in any of our trials to date," Zaks said.
Moderna's trial consisted of roughly 30,000 participants, with half in the placebo group and the other half getting the vaccine. In the placebo group, 185 participants became ill. Thirty of them developed severe COVID-19 symptoms, and one person died. There were 11 cases of COVID-19 in the vaccine group, with none of those participants becoming severely ill.
The results showed the vaccine had a 94.1% efficacy rate and the most commonly reported side effects were widespread but faded quickly, according to a 54-page report released Tuesday by FDA staff. The most common adverse reactions were pain at the injection site, erythema, swelling, enlarged lymph nodes and a higher rate of severe reactions after the second dose, according to Moderna.
The report recommended monitoring for Bell's palsy, a condition that causes half of a person's face to droop. There were four cases of the condition among trial participants, with three of those occurring in the vaccine group. The report said there is no current information sufficient to determine a causal relationship but it can't yet be ruled out definitively.
Moderna has said it plans to continue to monitor all clinical trial participants for two years.
Dr. Rachel Zhang, a medical officer with the FDA, said during Thursday's FDA advisory meeting that there were no anaphylactic reactions in close proximity to vaccination in Moderna's trial, though there were cases of hives and itching. Severe allergic reactions have emerged as a potential concern with the Pfizer vaccine. A health care worker in Alaska was hospitalized with a severe allergic reaction after getting the vaccine.
There were also reports of several allergic reactions in the U.K. after Pfizer rolled out its vaccine there Dec. 8. Regulators there have advised those with severe allergies to hold off on getting the vaccine.
Marion Gruber of the FDA's Office of Vaccines Research and Review said last week during the advisory committee meeting on the Pfizer vaccine that the label will contain a warning about the potential for anaphylaxis. But she said it's not yet clear there's a connection between the vaccine and allergic reactions.
Although obtaining regulatory approval is a major milestone for the pharmaceutical companies, vaccine distribution poses another challenge, particularly because both Moderna's and Pfizer's vaccines use mRNA technology, which relies on a synthetic version of messenger RNA to create proteins that mimic the virus that causes COVID-19, and as a result, they need to be kept cold.
On Thursday, Moderna updated its guidance for handling its vaccine, saying the vaccine can be kept at refrigerator temperatures for up to 30 days, as opposed to the subzero temperatures that Pfizer and BioNTech's vaccine requires.
--Additional reporting by Kevin Stawicki and Dorothy Atkins. Editing by Kat Laskowski.
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