FDA authorizes Pfizer’s COVID-19 vaccine

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The Food and Drug Administration authorized Pfizer’s coronavirus vaccine for emergency use on Friday, the first allowed to be administered in the U.S.

President Donald Trump called the achievement a “medical miracle” considering the injection was developed in mere months.

What are the details?

The president released a video message to the country announcing the news, saying, “Today our nation has achieved a medical miracle. We have delivered a safe and effective vaccine in just nine months. This is one of the greatest scientific accomplishments in history.”

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Trump said the vaccine “will save millions of lives, and soon end the pandemic, once and for all.”

The New York Times reported that shipments of the vaccine will begin immediately, with roughly 2.9 million doses expected to be distributed across the United States over the next week. The outlet noted that Pfizer has an agreement with the federal government to supply 100 million doses of the vaccine by March, and they will be administered free of charge to the public.

According to NBC News, the initial shots are “earmarked for front-line health care workers, as well as staff working at long-term care facilities.”

Pfizer partnered with BioNTech in developing the vaccine, and after studying its effectiveness and safety, the FDA cleared it for administering to the public.

Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research said in a statement, “While not an FDA approval, today’s emergency use authorization of the Pfizer-BioNTech COVID-19 Vaccine hold the promise to alter the course of this pandemic in the United States.”

He added, “With science guiding our decision-making, the available safety and effectiveness data support the authorization of the Pfizer-BioNTech COVID-19 Vaccine because the vaccine’s known and potential benefits clearly outweigh its known and potential risks.”

Prior to the U.S. clearing the vaccine, it had been approved in Great Britain, Canada, Mexico, Saudi Arabia and Bahrain.

The authorization of the vaccine has been highly anticipated, and Pfizer-BioNTech said in a joint statement that they plan to produce up to 50 million doses distributed globally by the end of the year, and more than 1 billion doses by the end of 2021.



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