Pfizer shot good at least 6 months
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 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 study also showed that the vaccine is effective against a virus variant called B.1.351, first identified in South Africa.
The new data is likely sufficient for the vaccine to meet the criteria set by the 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.S. FDA,” Pfizer CEO Albert Bourla said in a prepared statement.
Others said the data suggests the vaccine deserves full approval. “It seems pretty safe” to assume that the agency will license the vaccine fully, said Luciana Borio, a biotech executive and former FDA chief scientist.
“It’s really wonderful news that these vaccines continue to progress very rapidly toward licensure,” she said.
Full licensure, she said, would be “one less reason for the skeptics to decline vaccination.”
But the general public will notice very little difference, said Jacob Sherkow, a law professor at the University of Illinois College of Law.
The main advantage of licensure, he said, is to provide security to the company that its authorization won’t expire. A biologics license usually provides a company 12 years of exclusivity for its product.
Emergency use authorizations, by contrast, are temporary, Sherkow said. “If the FDA grants an EUA, it can yank it any time it wants for any reason or no reason.” It would also expire when the emergency is over.
“I think (licensure) will give the company some solace that they’re not going to be victims of their own success,” he said. “If you have a very effective vaccine and the vaccine ends the pandemic, then you’ve ended the emergency that authorized the EUA and you’re not authorized anymore. The (biologics license) guarantees that you get to stay on the market indefinitely.”
The FDA will likely move quickly to consider full licensure, Borio said.
Pfizer and Biontech said Wednesday that they would ask the FDA for permission to provide their vaccine to adolescents ages 12 to 15.