Dr. Vivek Murthy.Photo: Samuel Corum/CNP/Bloomberg via Getty
The U.S. surgeon general is reassuring parents that the Food and Drug Administration will rigorously analyze data on Pfizer-BioNTech’s COVID-19 vaccine beforeapproving it for use in kids under 5 years old.
One day after Pfizer-BioNTech submitted data on how their vaccine worked in children 6 months to 4 years old to the FDA to start the approval process, Surgeon General Dr. Vivek Murthy said that it will be thoroughly researched.
“Please know that the FDA will not cut any corners in their review process. They know that they are the gold standard that all of us rely on,” he said during a White House news briefing on Wednesday,The Washington Postreported.
Pfizer-BioNTech had decided to submit their clinical data on Tuesday at the request of the FDA — a surprise move, as typically companies make that decision on their own, and because that data showed thattwo doses of the vaccine did not create much of an immune response in the age group. But the FDA said that it is necessary with omicron “having a much greater toll on children,“they told USA Today.
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Pfizer-BioNTech had reported in December that the two, small doses of their vaccine that they had tested on children 6 months to 4 years old in clinical trials did not create enough of an immune response, though there were no safety issues. Based on those results, the company began testing out giving a third dose of the vaccine, which they hope will offer more protection against COVID-19.
“In light of these new data and the rise in illnesses and hospitalization in this youngest age group, FDA believed that it was prudent to request that Pfizer submit the data it had available, including the data that it has recently collected during the omicron surge,” the FDA toldUSA Today.
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source: people.com
