December 17, 2020
Following the first week of vaccinations from Pfizer, a 20 to 0 vote—with one abstention—from the FDA’s Vaccines and Related Biological Products Advisory Committee supported Moderna’s COVID-19 vaccine option.
The decision made by the committee comes exactly one week after they made the choice to fully support Pfizer and BioNTech’s vaccine option. More importantly, the FDA granted emergency use authorization for the Pfizer vaccine the next day.
According to CNBC, Moderna has only submitted two months of follow-up safety data. Typically, the FDA requires six months for full approval, but the FDA committee recommended emergency authorization of the vaccine for patients 18 years of age and older.
Similar to Pfizer and BioNTech’s vaccine, the Moderna vaccine uses messenger RNA, or mRNA, technology. According to late-stage clinical trial data, the vaccine is more than 94% effective in preventing COVID-19. The FDA has said that it would authorize a COVID-19 vaccine that is safe and at least 50% effective.
This vaccine requires two doses taken four weeks apart in order to achieve total effectiveness. According to the FDA, the most common side effects of the vaccine recorded in clinical trials are fatigue, headaches, and muscle pain. Additionally, there are some rare symptoms including, intractable nausea or vomiting and facial swelling. Most side effects were resolved within a week, the FDA noted.
CNBC. FDA panel endorses second Covid vaccine in U.S. as Moderna wins key vote in path to emergency use. https://www.cnbc.com/2020/12/17/moderna-covid-vaccine-fda-panel-recommends-emergency-approval.html. December 17, 2020.