Pfizer applies for emergency use of Covid-19 vaccine in US
If vaccine is approved by FDA first shots could be delivered in December
Pfizer has said it is asking US regulators to allow emergency use of its Covid-19 vaccine. File photograph: Justin Tallis/AFP/Getty Images.
Pfizer has said it is asking US regulators to allow emergency use of its Covid-19 vaccine.
The move could deliver a limited amount of first shots of the vaccine to people in the US as early as next month and eventually an end to the pandemic.
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.
The companies said that protection plus a good safety record means the vaccine should qualify for emergency use authorisation, something the Food and Drug Administration (FDA) can grant before the final testing is fully complete.
With coronavirus surging around the US and the world, the pressure is on for regulators to make a speedy decision.
“Help is on the way,” Dr Anthony Fauci, the top US infectious disease expert said on the eve of Pfizer’s announcement, adding that it is too early to abandon masks and other protective measures.
He said: “We need to actually double down on the public health measures as we’re waiting for that help to come.”
Friday’s filing sets off a chain of events as the FDA and its independent advisers debate if the shots are ready. If so, another government group will have to decide how the initial limited supplies are rationed out to anxiously awaiting Americans.
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.