This post has been update to fix an error regarding the group in which the severe cases occurred.
An analysis of updated data indicates the experimental SARS-CoV-2 vaccine from Pfizer and BioNTech has a 95 percent efficacy, the Wall Street Journal reports.
More than 43,000 individuals have been enrolled in the companies' Phase III trial, with half receiving two shots of the mRNA-based candidate vaccine and half receiving placebo. Last week, the companies announced that an analysis of initial data suggested their mRNA-based candidate vaccine had a more than 90 percent efficacy. The new analysis is based on the development of 170 COVID-19 cases within their trial cohort. According to the companies, 162 cases occurred in the placebo group and eight occurred in the vaccine group, indicating the vaccine is highly effective. Ten of the COVID-19 cases were severe, and nine of those were among participants who received the placebo.
Pfizer and BioNTech add that their candidate vaccine appears to work just as well across age, gender, race, and ethnic demographics, and that it appears to be well tolerated.
The Journal adds that the companies have also gathered the two months of safety data that the US Food and Drug Administration has requested, which the companies are reviewing and analyzing. Still, the Washington Post reports that Pfizer and BioNTech may be ready to submit an application for Emergency Use Authorization for the vaccine within days. According to ScienceInsider, the FDA may assemble its independent vaccine advisory committee to review EUA applications as early as December 9. It notes that Moderna, which reported promising initial results this week on its prospective vaccine, is also expected to apply for an EUA.