Regulators in the United States will meet on December 10th to discuss whether to authorise the Covid-19 vaccine developed by Pfizer and German partner BioNTech for emergency use, the US Food and Drug Administration has said.
The move could deliver a limited amount of first shots of the vaccine as early as next month and eventually an end to the pandemic – but not after a long, hard winter.
The action comes days after Pfizer and its German partner BioNTech announced that its vaccine appears 95 per cent effective at preventing mild to severe Covid-19 disease in a large, ongoing study.
“While we cannot predict how long the FDA’s review will take, the FDA will review the request as expeditiously as possible,” FDA commissioner Stephen Hahn said in a statement.
The meeting of Vaccines and Related Biological Products Advisory Committee will discuss the safety and effectiveness of the vaccine candidate.
The FDA is not obligated to abide by its advisory panel recommendations, but typically does.
Reuters had reported, citing a source, that an FDA panel tentatively plans to meet between December 8th and 10th to discuss the vaccine.
Mr Hahn said the agency has been preparing for the review of emergency use authorisation for Covid-19 vaccines for several months and stands ready to do so as soon as a request is submitted.
The FDA intends to make background materials available to the public, including the meeting agenda and committee roster, no later than two business days prior to the meeting.
Initial supplies of the vaccine will be scarce and rationed. About 25 million doses of the Pfizer vaccine may become available in December, 30 million in January and 35 million more in February and March, according to information presented to the National Academy of Medicine this week. Recipients will need two doses, three weeks apart.
Not far behind is competitor Moderna’s Covid-19 vaccine. Its early data suggests the shots are as strong as Pfizer’s, and the company expects to also seek emergency authorisation within weeks.