On Friday, the FDA granted Pfizer Inc.’s (NYSE:PFE) COVID-19 vaccine Emergency Use Authorization, clearing the path for millions of Americans to start receiving the vaccine immediately.
Pfizer’s COVID-19 vaccine receives Emergency Use Authorization in the US
The approval is a massive turning point considering the COVID-19 pandemic has claimed over 290,000 lives across the US. The US becomes the sixth country to approve the vaccine after Bahrain, Saudi Arabia, Mexico, the UK, and Canada. Pfizer is also expecting authorizations in the coming weeks from the European Union. The first shipment to the US of around 2.9 million vaccine doses could be in the coming week.
According to sources, the FDA’s decision came after a sequence of extraordinary events on Friday. The source said that White House chief of staff Mark Meadows told FDA commissioner Stephen Hahn that he should consider looking for another job if the agency didn’t approve the vaccine. Dr Hahn then ordered FDA regulators to authorize the vaccine by end of Friday.
In a statement, Hahn said that the authorization of the Pfizer vaccine for Emergency Use Authorization is a massive milestone in the fight against the COVID-19. Pfizer’s vaccine candidate is set to roll out of the Michigan manufacturing facilities and high-priority recipients in long-term care facilities could receive the vaccines as early as on Monday.
Long-term care facilities prioritized to receive the COVID-19 vaccine
Peter Marks, the FDA’s Centre for Biologics Evaluation and Research director, said that although the EUA for the Pfizer vaccine is not an FDA approval it does change the course of the pandemic in the US. He said that science is guiding the decision-making process and the available efficacy and safety data support authorization of the vaccine. This is because the potential benefit of the Pfizer-BioNTech COVID-19 vaccine outweighs known and possible risks.
The distribution of the vaccine will be a joint effort between the state and local health officials, hospitals, pharmacy chains, private shipping companies, and the military. Most importantly healthcare workers, staff, and residents at nursing will receive the vaccine first.