FDA Releases First Evaluation Of Pfizer-BioNTech Coronavirus Vaccine Data, Showing Antibody Response Within 10 Days; Final Decision Expected This Week
AP: Pfizer vaccine moves closer to getting the OK in the U.S.
“U.S. regulators Tuesday released their first scientific evaluation of Pfizer’s COVID-19 vaccine and confirmed it offers strong protection, setting the stage for the government to green light the biggest vaccination effort in the nation’s history. The analysis by Food and Drug Administration scientists comes ahead of a Thursday meeting where the agency’s independent advisers will debate if the evidence is strong enough to recommend vaccinating millions of Americans. A final FDA decision and the first shots could follow within just days…” (Neergaard/Perrone, 12/8).
New York Times: Pfizer’s Vaccine Offers Strong Protection After First Dose
“The coronavirus vaccine made by Pfizer and BioNTech provides strong protection against Covid-19 within about 10 days of the first dose, according to documents published on Tuesday by the Food and Drug Administration before a meeting of its vaccine advisory group. The finding is one of several significant new results featured in the briefing materials, which include more than 100 pages of data analyses from the agency and from Pfizer…” (Weiland/Zimmer, 12/8).
Additional coverage of the data and FDA’s expected approval of the Pfizer-BioNTech vaccine is available from Bloomberg, CNBC (2), Financial Times, NBC News, Reuters, Wall Street Journal, and Washington Post.