New FDA Data Shows Moderna Vaccine To Be Safe, Effective

By Jason Hall

December 15, 2020

New detailed analysis released by the Food and Drug Administration on Tuesday (December 15) shows support for the authorization of the Moderna COVID-19 vaccine for emergency use.

A briefing document shared on FDA.gov confirmed the FDA's support of the vaccine's effectiveness and safety during its initial review, which is expected to lead to Moderna's vaccine being granted emergency authorization this week, providing Americans access to a second vaccine as early as next week.

Last month, Moderna and the National Institutes of Health, which also developed the vaccine, both reported the shot appeared to be nearly 95% effective based on an ongoing 30,000-person study involving individuals of varying ages and racial groups. The main reported side effects included fatigue, muscle aches and injection-site pain on a required second dose, but flu-like reactions are common with many vaccines and show that they are working to strengthen the immune system to fight off a virus.

Hospitals nationwide began receiving shipments of the Pfizer-BioNTech vaccine on Monday (December 14,) the first made accessible in the United States, and the first doses were given to health care workers in Massachusetts as part of the state's COVID-19 vaccination timeline.

Both the Pfizer and Moderna vaccines will require individuals to get two shots.

Photo: Getty Images

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