Pfizer Inc cleared the next hurdle in the race to get its COVID-19 vaccine approved for emergency use on Tuesday after the US. Food and Drug Administration (FDA) released documents that did not raise any new issues about its safety or efficacy, according to Reuters. Data on the vaccine submitted to the agency was in line with its guidance on emergency use authorization, FDA staff said in documents released ahead of Thursday's meeting of outside experts. Experts will discuss whether the shot developed with German partner BioNTech SE should be authorized for emergency use. A two-dose vaccination was highly effective in preventing confirmed cases of COVID-19 at least seven days after the last dose, FDA staff said. The FDA said there was currently insufficient data to make conclusions about the safety of the vaccine in those less than 16 years of age, pregnant women and those whose immune systems were compromised. FDA is expected to decide on whether to authorize the vaccine within days or weeks. The FDA released a detailed analysis of the vaccine ahead of a Thursday meeting of a group of independent experts that will advise the agency on whether to grant the vaccine an emergency use authorization. The agency's analysis finds "no specific safety concerns identified that would preclude issuance of an EUA." Serious reactions were rare. Side effects are common, however, with a majority of study volunteers experiencing reactions at the site of injection, headaches and fatigue. The analysis also affirms the previously stated vaccine effectiveness of 95%, assessed a week after two doses of vaccine. The vaccine doses are given 21 days apart. The clinical data also suggest that the vaccine may be able to prevent COVID-19 after the first dose — 82% effective — though the FDA analysis says the available information doesn't allow for a firm conclusion on that potential effect. The vaccine authorization under consideration is "for active immunization for the prevention of COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older." On Thursday, the Vaccines and Related Biological Products Advisory Committee, an advisory group, will discuss the vaccine in an open public meeting. The agency will ask the experts to assess whether the available scientific evidence supports the proposed emergency use of the vaccine. Specifically, the committee will be asked whether the known and potential benefits of the vaccine outweigh its known and potential risks in people 16 and older. The FDA will also ask the experts to weigh in on what additional studies should be done by the companies to further elucidate the safety and effectiveness of the vaccine after it is available under an EUA. — Agencies
