Pfizer and BioNTech are seeking to receive full approval in the US for their mRNA-based COVID-19 vaccine, which is currently only approved for emergency use in that country.
The companies announced on Friday that they had initiated a biologics licence application (BLA) with the US Food and Drug Administration (FDA) for their vaccine – BNT162b2 – to prevent COVID-19 in people aged 16 years and older.
Pfizer and BioNTech added that the data to support this application will be submitted to the FDA on a rolling basis, adding that they will also request for a priority review.
in December 2020, BNT162b2 was the first COVID-19 vaccine to be approved on an emergency basis in the US. Under the emergency use approval, Pfizer and BioNTech have delivered over 170 million doses of their vaccine across the US.
The initial information submitted for the BLA includes non-clinical and clinical data for the vaccine, with the most recent analyses from the companies’ phase 3 clinical trial to be included.
The most recent analyses include data on the vaccine’s efficacy and safety profile six months after the second dose.
Pfizer and BioNTech will also submit the ‘required’ manufacturing and facility data for the licensing of their vaccine in the ‘coming weeks’ in order to complete the BLA submission.
Alongside the BLA, Pfizer and BioNTech have asked the FDA to expand the current emergency use approval criteria for their vaccine to include individuals aged 12 to 15 years of age.
They will also submit a supplemental BLA to support the licensing of their vaccine in this younger age group, when data six months after the vaccine dose becomes available.
Pfizer chief executive officer Albert Bourla also said last week that the company has deals in place or is in discussion with countries to supply 2.7 billion doses of BNT162b2 in 2021.
Of these doses, 40% are expected to be delivered to middle- and low-income countries, said Bourla.
In an open letter to Pfizer employees, Bourla also responded to the news that the US is supporting a proposal to waive intellectual property (IP) protections on COVID-19 vaccines.
“The proposed waiver for COVID-19 vaccines, threatens to disrupt the flow of raw materials. It will unleash a scramble for the critical inputs we require in order to make a safe and effective vaccine,” said Bourla.
“Entities with little or no experience in manufacturing vaccines are likely to chase the very raw materials we require to scale our production, putting the safety and security of all at risk,” he added.