Pfizer and its partner BioNTech SE have asked US regulators for full approval of their Covid-19 vaccine, which may help ease vaccine hesitancy in the community.
The Food and Drug Administration granted emergency authorisation of their vaccine in late December. Since then, Pfizer has distributed 170 million doses in the US, with the goal of delivering 300 million doses by the end of July.
By Riley Griffin
If the FDA grants full approval, it could also help raise confidence in the vaccine and potentially help to offset worries by some Americans that the shot may have been produced too quickly.
The full approval would also shift the legal status of the shot, clearing the way for employers and other organisations to mandate vaccination, Peter Marks, director of the FDA’s Centre for Biologics Evaluation and Research, said.
“Once the vaccine is approved there is a different legal status in terms of what employers can potentially require,” Marks said on April 14, during a webinar sponsored by the American Medical Association. He added that such a mandate may particularly impact the US military.
Moderna says it plans to initiate a rolling submission for a BLA for its COVID-19 vaccine this month.
The submission follows the “tremendous progress” they have made in delivering vaccines to millions of Americans and is the next step in a “rigorous FDA review process,” the companies said a statement.
As part of the application, they have submitted nonclinical and clinical data, including the most recent analysis from the Phase 3 clinical trial, where the vaccine’s efficacy and safety profile were observed for as long as six months after the second dose. The duo will also submit required manufacturing and facility data in the coming weeks.
The companies will first seek approval for the vaccine’s use in individuals 16 years of age and older, but also intend to submit a supplemental biologics license application for those aged 12 to 15 once the required data is available.
With full approval in hand, Pfizer and BioNTech would finally be able to advertise the product under its branded name, Comirnaty, and distribute the two-shot regimen directly to a wider marketplace.
“Right now we can only commercialise the vaccine in the US through the government,” Pfizer CEO Albert Bourla said in an interview on Tuesday. “That will open our ability to commercialise the vaccine through all the channels that exist.”
Bourla said that being granted such a license wouldn’t immediately change the way the Pfizer-BioNTech vaccine reaches people around the world, given governments have secured significant supply.
Pfizer and BioNTech aim to make 3 billion doses in 2021, much of which has already been purchased by governments around the world. Through year-end, Pfizer expects the vaccine to yield $26 billion in sales. Half of the profits will go to BioNTech.
