US FDA authorizes world’s first COVID Vaccine, Pfizer/BioNTech’s BNT162b2

December 11 brought the news that we’ve all been anxiously waiting for since last twelve months; a COVID vaccine has been approved by the US FDA.



It’s been a year since the novel coronavirus outbreak, which began in Wuhan, China, in December. As President Donald Trump put it, a COVID vaccine that works is no less than a ‘medical miracle’ that could treat the infected population. This milestone was recently achieved by Pfizer/BioNTech’s experimental coronavirus vaccine BNT162b2 for temporary emergency use. The Pfizer vaccine has received regulatory approval in the UK, Canada, Mexico, Bahrain, Saudi Arabia, and now the United States of America.

On Friday, the U.S. Food and Drug Administration (FDA) announced it authorized the use of the Pfizer COVID vaccine, with the first inoculations expected within days. The COVID vaccine candidate developed by Pfizer and its German partner BioNTech has an overall efficacy rate of 95% in preventing the infection in a late-stage trial, and efficacy of 94% in people 65 and older.

Addressing COVID Vaccine Distribution Priorities

Healthcare workers and seniors in nursing homes and assisted living centers will be among the first Americans vaccinated, following recommendations by a federal advisory panel. Elderly people living at home will need to wait longer. The decision recognizes the burden of novel coronavirus outbreak in long-term care facilities. While their residents represent less than 1% of the U.S. population, they account for 40% of COVID-19 deaths.

The approval comes despite a lack of evidence that Pfizer’s vaccine is safe and effective among the senior population in long-term care. Researchers will continue checks after approval to ensure they are no side effects or long-term risks associated with the coronavirus vaccine candidate.

FDA approved coronavirus COVID-19 vaccine BioNTech Pfizer BNT162b2

The approval comes despite a lack of evidence that Pfizer’s vaccine is safe and effective among the senior population in long-term care. (Image Credit: Pfizer)

Pfizer-Biontech Vaccine Has Favorable Safety

The FDA released two separate analyses, i.e. one from Pfizer and its German partner BioNTech, and another from its own researchers. The 53-page review report provided a detailed independent analysis of Pfizer’s coronavirus vaccine. The vaccine which needs two doses helped in ““reduction in the risk of confirmed COVID-19 occurring at least seven days after Dose 2” including “reduction in the risk of confirmed severe COVID-19 any time after dose 1,” it highlighted in the report.

The Pfizer vaccine requires two doses administered three to four weeks apart. Now that the US agency has granted emergency use authorization, the pharmaceutical companies will take immediate action to begin the delivery of vaccine doses.

The Federal Aviation Administration (FAA) is supporting the “first mass air shipment” of COVID-19 vaccines, as drugmakers gear for large-scale and wide geographic distribution of vaccines. US states are ramping up to ensure equitable and rapid distribution of the FDA approved vaccine candidates.

Under FDA regulations, vaccine cannot be delivered to healthcare workers until it has been either licensed or authorized by the federal body. Until now, Pfizer’s BNT162b2 vaccine was pre-positioned at major distribution centers to allow rapid delivery once it achieved approved status.

Pfizer’s vaccine was evaluated by a 15-member FDA advisory panel on Thursday. Moderna’s COVID-19 vaccine is expected to go before the panel on Dec. 17. 

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Christy Gren
Christy Gren is an Industry Specialist Reporter at Industry Leaders Magazine; she enjoys writing about Unicorns, Silicon Valley, Startups, Business Leaders and Innovators. Her articles provide an insight about the Power Players in the field of Technology, Auto, Manufacturing, and F&B.

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