In December, the vaccine received emergency use authorisation from the FDA to be used in those 16 years and older. But now Pfizer/BioNTech becomes the first to apply for full approval of its vaccine.
More than 170 million doses of the mRNA two-shot vaccine have been administered in the United States to date, the companies said, with the goal to deliver 300 million doses by the end of July.
“We are proud of the tremendous progress we’ve made since December in delivering vaccines to millions of Americans, in collaboration with the US Government,” Albert Bourla, chairman and chief executive officer of Pfizer, said in a statement. “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.”
Pfizer will now have to demonstrate that it can reliably produce its Covid-19 vaccine in order to receive full approval. This would include providing the FDA with data on the manufacturing processes and facilities, as well as information from its preclinical and clinical trials.
If approved, the companies could then market their shots directly to consumers and possibly alter the pricing of the doses. Currently the vaccine is available for free to Americans through the federal government.
The approval would also allow the vaccine to remain on the market after the pandemic because it would no longer have “emergency” authorisation.
Pfizer/BioNTech will submit the necessary information to the FDA on a rolling basis over the next couple of weeks, the companies said. Once all the information is received by the FDA, the agency will then provide a goal date for when it will make a decision.
The companies requested a “priority review”, which would take up to six months compared to the standard 10 months.
Usually, the FDA can take one year or longer to give a drug full approval. But the pandemic encouraged the federal health agency to issue emergency use authorisation to three different companies for their Covid-19 vaccines. The emergency use authorisation allowed for companies to apply for the approval with just two months of clinical data.
Moderna, a competitor of Pfizer/BioNTech, revealed on Thursday it would also seek full approval for its mRNA this month. The submission would also be on a rolling basis, similar to what Prizer/BioNTech started on Friday.
Pfizer/BioNTech has also applied for emergency use authorisation for its vaccine to be used in children ages 12 to 15.