The pharmaceutical partners submitted their bid to the FDA for review. The agency, which typically takes six to 10 months for approval, is likely to speed it up
A woman watches a drone deliver a COVID-19 self collection test kit to her home in Texas. Pic/AFP
Pfizer said on Friday that it is asking 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 and eventually an end to the pandemic—but not until after a long, hard winter. 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 Friday's FDA submission, they have already started rolling applications in Europe and the UK and intend to submit similar information soon.
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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, 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."
Friday's filing sets off a chain of events as the FDA and its independent advisers debate if the shots are ready. If so, still another government group will have to decide how the initial limited supplies are rationed out.
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