Six months after getting a second dose of the Pfizer-BioNTech vaccine as part of a 46,000-person clinical trial, volunteers remained more than 90% …
Six months after getting a second dose of the Pfizer-BioNTech vaccine as part of a 46,000-person clinical trial, volunteers remained more than 90% protected against symptomatic COVID-19 and even better protected against severe disease, a new company study found. Out of 927 trial participants who fell ill with COVID-19 more than a week after their second dose, only 77 had received the active vaccine, compared with 850 who got a placebo. There were no serious safety concerns among the 12,000 volunteers who are least six months past their second dose, according to the newly released findings. Many, however, did have typical, short-term side effects such as fatigue and sore arms. The new data is likely sufficient for the vaccine to meet the criteria set by the U.S. Food and Drug Administration for full approval. All three COVID-19 vaccines authorized so far – from Pfizer-BioNTech, Moderna and Johnson & Johnson – are being distributed under emergency use authorizations rather than full FDA biologics licenses because they did not have long-term safety and effectiveness data. The FDA allowed the companies to present only two months of data so they could get the COVID-19 shots to the public faster during a global emergency. The agency has said it would consider issuing a full license once a vaccine has a track record of at least six months – the same requirement for vaccines that prevent other infectious diseases. Pfizer and its German collaborator BioNTech, whose vaccine has been administered nearly 77 million times in the U.S., are expected to submit their application for full licensure to the FDA some time this month. „These data confirm the favorable efficacy and safety profile of our vaccine and position us to submit a Biologics License Application to the U.
