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Jamie Clean (L) holds her son, Ari Clean’s hand as he receives the Pfizer-BioNTech Covid-19 vaccine from healthcare employee Jen Feinberg (R) on the Jewish Federation/JARC’s places of work in Bloomfield Hills, Michigan on Might 13, 2021.
Jeff Kowalsky | AFP | Getty Photos
Pfizer mentioned Thursday it requested the Meals and Drug Administration to authorize its Covid-19 vaccine with BioNTech for youths ages 5 to 11.
The information could not come any sooner for fogeys anxious to get their youngsters vaccinated as youngsters begin the brand new college 12 months with the delta variant surging throughout America. The pressure has led to a surge in U.S. hospitalizations, together with amongst younger youngsters who’re presently ineligible to get vaccinated.
Final month, Pfizer launched new information that confirmed a two-dose routine of 10 micrograms — a 3rd of the dosage used for teenagers and adults – is secure and generates a “strong” immune response in a scientific trial of younger youngsters. It mentioned the pictures had been properly tolerated and produced an immune response and negative effects comparable with these seen in a research of individuals ages 16 to 25.
Frequent negative effects for teenagers and adults embody fatigue, headache, muscle ache, chills, fever and nausea, in keeping with the Facilities for Illness Management and Prevention.
The corporate’s request Thursday might imply the pictures will not be accessible till round November if the FDA spends as a lot time reviewing the information for that age group because it did for 12- to 15-year-olds. Pfizer and BioNTech requested expanded use of their shot in adolescents on April 9 and had been approved by the FDA on Might 10.
A key FDA vaccine advisory group is scheduled to satisfy on Oct. 26 to debate Pfizer’s information. The pictures may very well be permitted shortly after that assembly, relying on how rapidly the FDA and the CDC transfer.
Dr. Scott Gottlieb, who sits on Pfizer’s board and served as FDA commissioner for 2 years within the Trump administration, advised CNBC final week that the pictures for younger youngsters might come by Halloween.
The FDA has a whole lot of expertise with the Pfizer vaccine, Gottlieb famous, including the Covid shot for younger youngsters is the identical two-dose routine as adults however is run in smaller portions. The company has already cleared the pictures for People age 12 and up.
“I would not foreclose the chance that this may very well be out in October,” he mentioned.
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