Story at a glance

  • The move had some asking how Britain beat the U.S. and other European countries to the punch.
  • Drug regulators in the U.K. rely more on reports summarizing data submitted by drug manufacturers, while the FDA analyzes all aspects of the data submitted with a vaccine application, including manufacturing and individual patient data, The Washington Post reports.
  • British regulators also did not hold a public meeting on the Pfizer application, while the FDA has committed to convene a public meeting of its vaccine advisory committee in an effort to be more transparent amid vaccine hesitancy in the U.S.

On Tuesday, a 90-year-old woman in the United Kingdom became the first person to receive Pfizer and BioNTech’s COVID-19 vaccine as part of Britain’s mass vaccination campaign. 

The milestone came roughly one week after the U.K. became the first Western country to grant emergency approval for a COVID-19 vaccine, clearing the shot developed by Pfizer that is still being reviewed by the U.S. Food and Drug Administration (FDA).  


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The move had some asking how Britain beat the U.S. and other European countries to the punch. 

President Trump reportedly expressed disappointment following the news while his chief of staff, Mark Meadows, met with FDA Commissioner Stephen Hahn to discuss how they could accelerate the approval process. 

The FDA is scheduled to meet Thursday to assess the vaccine that showed to be 95 percent effective in late-stage clinical trials. Vaccinations could kick off as early as Friday once the drug receives approval. 

So, how did the U.K. beat the U.S.? 

The U.S. authorities do things differently than their British counterparts. 

Drug regulators in the U.K. rely more on reports summarizing data submitted by drug manufacturers, while the FDA analyzes all aspects of the data submitted with a vaccine application, including manufacturing and individual patient data, The Washington Post reports. 

British Health Secretary Matt Hancock said in an interview last week drug regulators were able to “look at the data as it’s come through and do things in parallel,” allowing more flexibility to review data and allowing multiple reviews simultaneously. 

The European Union also kicked off a rolling review of vaccine data in October, but it may have been slowed down as drug regulators are required to assess the views of the EU’s 27 member states. 

British regulators also did not hold a public meeting on the Pfizer application, while the FDA has committed to convene a public meeting of its vaccine advisory committee in an effort to be more transparent amid vaccine hesitancy in the U.S., The Washington Post notes

Anthony Fauci, the nation’s top infectious diseases expert, recently apologized after saying publicly the U.K. did not review the vaccine as carefully as U.S. health regulators. He told CBS News that the U.K. had “rushed” the approval. 

He later walked back those comments, saying he has a great deal of confidence in the U.K.’s process. 

“Our process is one that takes more time than it takes in the U.K. And that’s just the reality,” Fauci said in an interview with the BBC


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CORONAVIRUS EPIDEMIC WAS SPREADING IN US LAST CHRISTMAS, LONG BEFORE IT WAS IDENTIFIED IN CHINA, NEW STUDY FINDS

FAUCI CONFIRMS COVID-19 VACCINE COULD BE READY BY LATE DECEMBER, EARLY 2021


 

Published on Dec 08, 2020