AdChoices USA TODAY 'No surprises': 53-page FDA report reinforces safety and effectiveness of Pfizer's COVID-19 vaccine candidate Karen Weintraub, USA TODAY 39 mins ago Flynn Judge Makes Parting Shot in Tossing Case After Pardon He set a car on fire with

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'No surprises': 53-page FDA report reinforces safety and effectiveness of Pfizer's COVID-19 vaccine candidate

Karen Weintraub, USA TODAY 39 mins ago

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'No surprises': 53-page FDA report reinforces safety and effectiveness of Pfizer's COVID-19 vaccine candidate











The U.S. Food and Drug Administration on Tuesday released a 53-page report summarizing data from Pfizer and BioNTech's COVID-19 candidate vaccine trial. The data supports earlier findings that the vaccine is safe and will prevent 95% of people from becoming sick with COVID-19.




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AP Images A vial of the COVID-19 candidate vaccine developed by BioNTech and Pfizer is displayed at the headquarters in Puurs, Belgium.
The companies are asking the FDA for authorization to use the vaccine in people ages 16 and up. They have also begun testing the vaccine in ages 12-15, but have not yet accumulated enough data to request authorization in that age group.

The FDA panel that must review the vaccine before authorization meets all day Thursday, with authorization expected as soon as that evening. Another candidate vaccine, made by Moderna, will be reviewed next week.
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Dr. William Schaffner, an infectious disease expert at the Vanderbilt University School of Medicine in Nashville, Tennessee, said he recently received a briefing on the Pfizer/BioNTech data, though he would not say who presented it or who else received it.
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"The group I was with who heard the data arrived interested and left the presentation enthusiastic," Schaffner said. "The extraordinary thing is that there were no major areas of concern."
Others also seemed impressed by the results.
"FDA did not note any surprise finding," said Dr. John Grabenstein, a former Merck executive and former director of US Department of Defense military immunization program. The efficacy and product quality look good, Grabenstein said in an email, and there were few severe cases of COVID-19 in the vaccine group.
The report provides more detail on how certain groups of people fared with the vaccine, called BNT162b2, including people over 65, those with pre-existing medical conditions, like diabetes, and those who are Black and/or Hispanic – all of whom appeared to be as well protected as the general population.