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FDA confirms safety and efficacy of Moderna vaccine ahead of Thursday meeting

Moderna's COVID-19 vaccine. (Jim Craven/KHN/TNS)
December 16, 2020

The FDA has confirmed the safety and efficacy of Moderna’s coronavirus vaccine, putting it on a similar path as the Pfizer vaccine and helping to clear the way for emergency use authorization.

“FDA considers that the totality of available data are sufficient to support an evaluation of this product for EUA,” read a 54-page briefing document from the Food and Drug Administration.

The FDA said the mRNA vaccine is 94.1% effective at preventing coronavirus, confirming earlier results released by the company.

The most common side effects reported in trial participants were injection site pain, fatigue, headache, muscle pain, joint pain and chills.

The vaccine boasts a good safety profile with no anaphylactic or severe hypersensitivity reactions closely related to the vaccine, according to the report.

One adverse event of interest, which could be related to the vaccine according to the briefing, was swelling of the lymph nodes which happened in 173 vaccine group participants and 95 in the placebo group.

FDA staffers found the shot was similarly effective across racial and ethnic groups and those with underlying medical conditions. It was 86.4% effective in people age 65 and over, according to the report, and 95.6% effective in those 18 to 65.

The proposed use of the vaccine is for adults age 18 and older. Pfizer’s coronavirus vaccine was granted emergency use authorization for patients 16 and older.

The report comes two days before the independent Vaccines and Related Biological Products Advisory Committee meets on Thursday to discuss the safety and efficacy data and vote on recommending emergency use authorization.

Though the FDA does not have to take the recommendation of VRBPAC, it often does.

Last week, the Pfizer coronavirus vaccine was granted emergency use authorization just one day after the VRBPAC meeting, under pressure from President Trump.

Doses were then administered on Monday, a process that could play out very similarly for Moderna.

Unlike Pfizer’s mRNA vaccine, Moderna’s has not yet been approved in any other countries. If granted the EUA, it will be the second coronavirus vaccine available in the United States.


(c) 2020 the Boston Herald

Distributed by Tribune Content Agency, LLC.