Pfizer announced on Friday saying it has asked the US regulators to allow emergency use of its COVID-19 vaccine, starting the clock on a process that could bring limited first shots as early as next month. The action comes days after Pfizer Inc 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 can grant before the final testing is fully complete. In addition to its FDA submission, they have already started “rolling” applications in Europe and the UK and intend to submit similar information soon.
With the 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’s too early to abandon masks and other protective measures. “We need to actually double down on the public health measures as we’re waiting for that help to come.”
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.