Pfizer asks US regulators to allow emergency use of experimental COVID-19 vaccine

Pfizer asks US regulators to allow emergency use of experimental COVID-19 vaccine

Pharmaceutical company Pfizer has formally asked 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.

Key points: How much vaccine is available and when is a moving target, but initial supplies will be scarce Globally, Pfizer has estimated it could have 50 million doses available by year’s end The US Government has a contract to buy millions of Pfizer-BioNTech doses

The action comes days after Pfizer Inc and its German partner BioNTech announced that its vaccine appeared 95 per cent effective at preventing mild to severe COVID-19 disease in a large, ongoing study.

The companies said protection plus a good safety record meant the vaccine should qualify for emergency use authorisation, something the Food and Drug Administration (FDA) can grant before the final testing is fully complete.

In addition to the FDA submission, they have already started “rolling” applications in Europe and the UK and intend to submit similar information soon.

“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.

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The meeting of the 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 has reported, citing a source, that an FDA panel tentatively plans to meet between December 8 and 10 to discuss the vaccine.…

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