In a new document, staff at the US Food and Drug Administration say the SARS-CoV-2 vaccine from Pfizer and BioNTech meets the expectations the agency has for an Emergency Use Authorization, Reuters reports.
After announcing its clinical trial indicated its vaccine has a 95 percent efficacy, Pfizer/BioNTech submitted an application to the FDA for an EUA, and an outside advisory panel to the agency is to review the companies' data on Thursday.
In a briefing document released ahead of the meeting, FDA staff say their analysis found that the two-dose vaccine regimen appears highly effective in preventing COVID-19 at least seven days after the last dose, Reuters says. It also notes that a single dose also appears to provide some protection, but that more data on that front is needed. NPR adds that side effects like injection site reactions and headache were common, but that the agency did not have any specific safety concerns.
NPR notes that the committee on Thursday is to determine whether the available data supports an EUA, and Reuters adds that the FDA typically follows the recommendations of its advisory boards.