If granted, the Pfizer vaccine would be the first in the U.S. to be fully approved.
Vaccines can only be authorized in this manner during public health emergencies — in this case, the Covid-19 pandemic. Indeed, all Covid-19 vaccines currently in use in the U.S. are being administered through EUAs.
Last year, the FDA said that in order to apply for an EUA for a Covid-19 vaccine, a drugmaker needed to provide two months of safety and efficacy data.A biologics license application — needed for full approval of a drug or vaccine — requires six months of data. “We are proud of the tremendous progress we’ve made since December in delivering vaccines to millions of Americans, in collaboration with the U.S. Government,” Pfizer chairman and CEO Albert Bourla said in a statement Friday announcing the application.
“We look forward to working with the FDA to complete this rolling submission and support their review, with the goal of securing full regulatory approval of the vaccine in the coming months,” he added.Full approval may also make vaccine mandates"a little more feasible," said John Grabenstein, a former executive director of medical affairs for vaccines at Merck and a former Department of Defense immunologist.
To grant full approval would mean"the FDA has looked at a longer period of time after vaccination and is fully satisfied that all the I's are dotted and that all the T's are crossed," he added."We're at a point where there is enormous safety data for mRNA vaccines," said Dr.