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

      Published on Sunday, 22 November , 2020      410 Views     
Pharmaceutical company Pfizer asks US regulators to allow emergency use of its experimental COVID-19 vaccine

  • Coronavirus

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.

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.

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.

Mr Hahn said the agency had been preparing for the review of emergency use authorisation for COVID-19 vaccines for several months and stood ready to do so as soon as a request was submitted.

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,” Anthony Fauci, the top US infectious disease expert, said on the eve of Pfizer’s announcement, adding that it was 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.”

How much vaccine is available and when is a moving target, but initial supplies will be scarce and rationed.

Globally, Pfizer has estimated it could have 50 million doses available by year’s end and up to 1.3 billion doses by the end of 2021.

About 25 million may become available for US use 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 would need two doses, three weeks apart.

The US Government has a contract to buy millions of Pfizer-BioNTech doses, as well as other candidates that pan out, and has promised shots will be free.

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Category Coronavirus, World News | 2020/11/22 latest update at 5:10 PM
Source : Internet | Photocredit : Google
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