Pfizer: submits Covid-19 vaccine for FDA approval today

(CercleFinance.com) - Pfizer said on Friday that it will submit its Covid-19 vaccine for emergency use authorization with US health regulators, taking the product a step closer towards the market.


The drugmaker said the move could potentially enable the use of the vaccine in high-risk populations in the US by mid-to-end December, with the companies ready to distribute the vaccine within hours after authorization.

A phase III study showed last week that the vaccine had an efficacy rate of 95%.

The news is also a boost for it German partner BioNTech, which has developed its manufacturing expertise in mRNA-based therapies over almost a decade.

Pfizer and BioNTech said that they could supply up to 50 million vaccine doses globally in 2020 and up to 1.3 billion doses by the end of 2021.

They have already initiated regulatory submissions worldwide, including in Australia, Canada, Europe, Japan and the UK.

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