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FDA authorizes Pfizer’s COVID-19 vaccine

By Bob D'Angelo, Cox Media Group National Content Desk

FDA authorizes Pfizer’s COVID-19 vaccine FDA Commissioner Stephen Hahn said Friday that the emergency use authorization of the vaccine was "a significant milestone" in battling the pandemic. ( Graeme Jennings/Washington Examiner/Bloomberg)

By Bob D'Angelo, Cox Media Group National Content Desk

The U.S. Food and Drug Administration gave emergency use authorization for the country’s first coronavirus vaccine on Friday. The decision clears the way for millions of people to begin receiving the vaccine within days.

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The EUA of the vaccine from Pfizer and BioNTech for people age 16 and older was approved 336 days after the genetic blueprint of the novel coronavirus was shared online by scientists in China, The Washington Post reported. Millions of doses of the vaccine, which has been found to be 95% effective, will be soon shipped around the country. meaning that vaccinations can begin within days, CNN reported.

Federal officials have said distribution of the first 2.9 million doses of the vaccine would begin within 24 hours of an authorization. the Post reported. However, before they can begin, a U.S. Centers for Disease Control and Prevention immunization advisory committee must vote to recommend the vaccine and the CDC must accept that recommendation.

With the decision, the United States becomes the sixth country -- following the United Kingdom, Bahrain, Canada, Saudi Arabia and Mexico -- to clear the vaccine. Other authorizations, including by the European Union, are expected within weeks, The New York Times reported.

The FDA has scheduled a news conference for Saturday at 9 a.m. to discuss the vaccination and answer questions.

“Today, we can begin to turn millions of Americans hopes into reality,” Pfizer CEO Albert Bourla said. “That’s because we have received the great news that the FDA has authorized the emergency use of our COVID-19 vaccine for people 16 or older.”

“The FDA’s authorization for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world,” FDA Commissioner Dr. Stephen Hahn said in a statement. “Today’s action follows an open and transparent review process that included input from independent scientific and public health experts and a thorough evaluation by the agency’s career scientists to ensure this vaccine met FDA’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization.

“The tireless work to develop a new vaccine to prevent this novel, serious, and life-threatening disease in an expedited timeframe after its emergence is a true testament to scientific innovation and public-private collaboration worldwide.”

President Donald Trump touted the announcement in a video from the Oval Office on Friday night. saying the United States has “achieved a medical miracle.”

“This is one of the greatest scientific accomplishments in history,” Trump said. “It will save millions of lives and soon end the pandemic, once and for all.”

The EUA was granted after the recommendation of the FDA’s Vaccines and Related Biological Products Advisory Committee on Thursday.

Pfizer has a deal with the U.S. government to supply 100 million doses of the vaccine by March, the Times reported. Those shots will be free to the public, the newspaper reported.

The FDA action came after White House Chief of Staff Mark Meadows on Friday told Hahn to be prepared to submit his resignation if the agency did not clear the vaccine by day’s end, the Post reported.

Pfizer and BioNTech formally asked the FDA on Nov. 20 to allow the emergency use of their COVID-19 vaccine in the United States, The Associated Press previously reported. The drugmakers said the vaccine was 95% effective in a clinical trial.


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