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Pfizer Vaccine Gets FDA Final Review - How to Follow in Real-Time

Pfizer's Covid-19 vaccine will get a final review from an FDA advisory committee that could authorize the first coronavirus vaccine in the U.S.

Pfizer's  (PFE) - Get Pfizer Inc. Report Covid-19 vaccine, already approved on an emergency use basis and already rolling out in other countries, will receive a final review from a Food and Drug Administration advisory committee that could authorize the first coronavirus vaccine in the U.S.

The FDA's 17-member Vaccines and Related Biological Products Advisory Committee, or VRBPAC, will meet Thursday to discuss Pfizer and German partner BioNTech’s  (BNTX) - Get BioNTech SE Report Covid-19 vaccine, and then vote on whether the FDA should authorize the shot.

The FDA isn’t required to follow the committee’s recommendations but often does. FDA officials are expected to make a decision within four days of the meeting.

The companies have requested an “emergency use authorization,” which is just shy of a full approval. If the FDA grants the Pfizer vaccine an EUA, distribution in the U.S. could begin within 24 hours, according to Health and Human Services Secretary Alex Azar.

The FDA’s decision comes as U.S. infections, hospitalizations and deaths from Covid-19 all hit records. As of Thursday, 15.392 million cases have been recorded in the U.S., with nearly 250,000 Americans having died from the disease, according to John Hopkins University.

It also comes less than 12 months after the pathogen was formally labelled a global pandemic by the World Health Organization - a historic feat that even a few months ago was widely considered a long shot, given that previous vaccines have taken years of testing and analysis to be deemed both safe and effective for the public.  

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Regulators globally are racing to review inoculation data, with governments eager to begin vaccinating their populations to curb the pandemic. Earlier this week, the United Kingdom started using the vaccine, which is currently known by the working name BNT162b2. 

On Wednesday, Canada’s drug regulator announced it had approved emergency use of the vaccine, with plans to begin distributing it to healthcare, front-line workers and vulnerable groups immediately.  

The FDA panel meeting will be public and live-streamed. FDA officials hope the discussion will show the care with which the vaccine’s safety has been reviewed. It's part of a broader effort to convince the public that the vaccine hasn’t been rushed to market for political expediency.

Moderna (MRNA) - Get Report, another Covid-19 vaccine maker, last month requested clearance in the U.S. and Europe for its vaccine candidate

Shares of Pfizer were down 0.41% at $41.70 in trading on Thursday.