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Pfizer COVID Vaccine Gets FDA Backing Ahead of Emergency Authorization Meeting

The FDA said Tuesday that the Pfizer/BioNTech coronavirus vaccine could provide benefits after just one dose, with no significant side-effects.

Pfizer  (PFE) - Get Pfizer Inc. Report and BioNTech's  (BNTX) - Get BioNTech SE Report coronavirus vaccine could provide benefit to recipients after just one dose, the U.S. Food & Drug Administration said Tuesday as it prepares to approve the pair's request for Emergency Use Authorization.

In a briefing note issued ahead of its Thursday meeting to assess the Emergency Use Authorization (EUA) request filed by Pfizer last month, the FDA said individuals infected with COVID 19 could still be at risk and could benefit from the Pfizer vaccine, known as BNT162b2, and that it hasn't noted any specific concerns from late-stage trials that would preclude the EUA approval.

The FDA added that the vaccine's efficacy after one dose, but before the second dose, was around 52% in the phase III trial. Its efficacy rate for trial participants over the age of 55 was 94% after both doses, the FDA said.

The FDA briefing comes as Britain became the first major economy in the world to begin treating its citizens with the Pfizer vaccine, with plans to distribute around 800,000 doses in the coming weeks. Britain has secured around 40 million doses in total, enough to protect around 20 million people. 

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Pfizer shares were marked 1.14% higher in early trading Tuesday to change hands at $41.71 each. BioNTech's U.S.-listed shares, meanwhile, were marked 1.8% higher on the Nasdaq at $127.94 each.

Pfizer said last month that BNT162b2 reached a 95% efficacy rate across all age and race demographics and based on a total case cohort of 170 and reiterated their aim of having 1.3 billion doses available next year and 50 million doses before the end of the year.

Pfizer also said it would be ready to distribute the vaccine 'within hours' of approval by the FDA, with the Centers for Disease Control taking the final decision on allocation at both a state and national level. 

Operation Warp Speed, the U.S. government's vaccine effort run by the Department of Health and Human Services, expects to distribute around 6.4 million doses of BNT162b2 initially, with the aim of releasing around 40 million before the end of the year.