The vaccine is currently available under an Emergency Use Authorization (EUA), which was granted in December. The companies have now started the process for a BLA: sending longer-term follow-up data to the FDA for assessment.
Pfizer/BioNTech are seeking a BLA for ages 16+, with younger ages (12-15) set to be covered by an expanded EUA for the time being. The companies will then submit information on younger ages for the BLA once available (requiring six months of data past the administration of the second dose).
The BLA submission includes the most recent analyses from the Phase 3 trial (including a longer timeframe with six months of data). Detailed information on manufacturing and facility data is to follow.
“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,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer.
“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.”
Ugur Sahin, M.D., 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.”
The vaccine, BNT162b2, is now available in 91 countries and territories around the world: many of which use a similar emergency use authorization to the US.
While three COVID-19 vaccines are authorized in the US (Pfizer, Moderna, J&J), these are all under EUA and Pfizer/BioNTech is the first to start a submission for a BLA. Moderna, however, also plans to start its rolling submission this month.
Earlier this week, Pfizer upped its 2021 sales forecast for its mRNA COVID-19 vaccine to $26bn.
In February, Pfizer was predicting $15bn in COVID-19 vaccine sales for this year. Fast-forward just three months and the pharmaceutical giant has now revised that figure up 70% to $26bn.
That would mean the vaccine would account for nearly 30% of overall revenues in 2021. And the $26bn figure is based on 1.6 billion doses ordered as of mid-April: and could yet rise with more orders.