Pfizer-BioNTech seeks full FDA approval for COVID-19 vaccine
Pfizer Inc and German partner BioNTech SA seek full approval for their COVID-19 vaccine from the U.S. Food and Drug Administration on Friday.
Pfizer’s CEO, Albert Bourla said in a statement that the vaccine was the first to be authorized in the United States for emergency use in December based on two months of safety data for a 44,000-person.
“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.
“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 said.
Also, it would allow the companies to market the vaccine directly to people above 16 years of age as well as help corporations and government agencies mandate vaccinations.
The FDA makes a product available to the public during an emergency based on the best available evidence, without waiting for all the evidence needed for a full approval or clearance.
According to the U.S. Centers for Disease Control and Prevention, over 170 million doses of Pfizer-BioNTech’s vaccine have been delivered across the United States, with roughly 134 million shots administered as of Thursday.
The companies asked the United States to allow the emergency use of their vaccine in adolescents aged 12 to 15, with the FDA expected to give the nod by next week.
Pfizer and BioNTech aims to submit a supplemental application for full approval of the vaccine in adolescents once the required six-month data after the second vaccine dose are available.