Pfizer commences process for full FDA approval of COVID-19 vaccine
pharmafile | May 10, 2021 | News story | Sales and Marketing | BioNTech, COVID-19 vaccine, FDA, Pfizer, Pfizer vaccine, pharma, pharma news
Pfizer and BioNTech have begun a Biologics Licence Application (BLA) with the FDA for full approval of their mRNA COVID-19 vaccine in the US in people aged 16 years or older.
The jab is currently available in the North American country under an Emergency Use Authorization awarded by the FDA in December last year.
Submission of a BLA usually requires longer-term follow up data for acceptance and approval. As such, the companies will submit their most recent analyses from a recent Phase III trial, where the vaccine’s efficacy and favourable safety profile were observed up to six months after the second dose.
To date, Pfizer and BioNTech have delivered more than 170 million doses across the US alone, enough for the vaccination of 85 million people.
The news comes as the daily average of COVID-19 jabs given has fallen below 2 million in the country for the first time since early March. Officials in the US believe this is due to demand in the vaccine falling, due in part to the sheer amount of shots given so far – with many others seemingly uninterested in being administered.
As such, there is still a further need for vaccines in the US, with 46% of the country having received at least one vaccine dose, and 34% of the population fully vaccinated.
The Pfizer-BioNTech vaccine is also being used in several other countries across the world, including the UK, where more than 53 million vaccine doses of the Pfizer, AstraZeneca, and Moderna jabs, have been administered so far.
Albert Bourla, Chairman and CEO at Pfizer, said: “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.
“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.”
Dr Ugur Sahin, CEO and Co-founder of BioNTech, added: “Following the successful delivery of more than 170 million doses to the US population in just a few months, the BLA submission is an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future.”
Jack Goddard
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