Covid vaccine: Pfizer to request emergency approval today

Once approved, the CDC must meet before Americans can receive the vaccine

Graig Graziosi
Friday 11 December 2020 16:30
Pfizer Covid vaccine is safe and 95% effective, data shows

Pfizer and BioNTech announced that they will submit their coronavirus vaccine candidate to the US Food and Drug Administration today for emergency use authorisation.  

This will be the first coronavirus vaccine to seek regulatory approval in the US.  

The company said if approved by the FDA, the vaccine — designated BNT162b2 — will be available for high-risk populations in the US by the middle or end of December.  

The vaccine is reportedly 95 per cent effective in preventing coronavirus infections, including in older adults. Thus far there have been no reported safety concerns or serious side effects associated with the vaccine.  

Pfizer's Phase-3 clinical trial included 43,000 volunteers and began on 27 July. The test took place in the US. 

According to Pfizer, about 30 per cent of the US test population came from racially or ethnically diverse backgrounds. Pfizer also said that about 45 per cent of US participants were ages 56 to 85.  

Moderna is also applying for the FDA's emergency use authortisation for its coronavirus vaccine later this month. The company's vaccine is reportedly 94.5 per cent effective.  

The FDA is expected to decide whether the companies will receive their EUAs for their vaccines on 10 December.  

Once authorised, distribution of the vaccines to the states can begin immediately.  

General Gustave Perna, the cheif operations officer for Operation Warp Speed, told ABC News that the military had "about 40 million doses of vaccine" ready for distribution "exactly when the EUA comes out".  

While the EUA permits the government to distribute the vaccine, it does not allow for Americans to receive it as a vaccination.  

The US Centers for Disease Control and Prevention must first sign-off on the vaccine before anyone can actually take it.  

If the vaccine receives an EUA, the CDC's Advisory Committee on Immunisation Practices would meet sometime in the following two days to review the data and make a ruling on who should take the vaccine.  

The first groups expected to have access to the vaccine are health care workers, essential workers like police officers, the elderly and individuals who are immunocompromised.

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