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(CNN) – Safety and efficacy data for Pfizer and BioNTech’s Covid-19 vaccine were published in the New England Journal of Medicine Thursday morning; At the same time, an advisory committee from the US Food and Drug Administration met to discuss a possible emergency use authorization for the vaccine.
The data from the phase 3 trial in the published article matches what the committee published in an information paper this week before its meeting.
The data comes from more than 43,000 trial participants: 21,720 who received the vaccine randomly and 21,728 who randomly received a placebo. The data shows that there were only eight cases of Covid-19 among those who received the vaccine, compared to 162 cases among those who received the placebo.
The document notes that a two-dose regimen of the vaccine, called BNT162b2, is 95% effective in people 16 years of age and older. “BNT162b2 was 95% effective in preventing covid-19,” states the abstract of the article. “Safety for an average of 2 months was similar to other viral vaccines.”
The data will be discussed at a meeting Thursday of the FDA’s Advisory Committee on Vaccines and Related Biologics, which will provide recommendations to the FDA on whether the vaccine is effective in preventing COVID-19 in people 16 years of age and older and whether Potential benefits of the vaccine outweigh the risks.
