Pfizer Seeks U.S. FDA Approval To Give COVID-19 Vaccine To Kids Ages 5 To 11 years

• Pfizer and BioNTech announced they have officially submitted a request for an Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) that would allow the COVID-19 vaccine to be administered to children ages 5 to 11.

  Pfizer made the announcement on Thursday, October 7, 2021 through a tweet, calling the request an “important step in our ongoing effort against COVID-19.”

  The U.S. FDA has already scheduled a meeting to discuss the request on October 26 and is expected to release a ruling by the end of October, The New York Times reported.

  Pfizer’s request comes as the Delta variant continues to pose a threat in many parts of the world. In the U.S., the Delta variant, which is said to be more infectious, was responsible for the hospitalization of almost 30,000 children, according to data collated by the American Academy of Pediatrics.

  Last month, Pfizer and BioNTech first submitted to the regulators the initial trial data for their COVID-19 vaccine used on the younger age group. The trial included over 2,200 children, and the companies said that results show that the vaccine is safe and effective to be used on children 5 to 11. Now, FDA will determine its efficacy by comparing immune responses among the adult population.

  In the U.S., the Pfizer vaccine can be used in ages 16 and up and can be given to 12- to 15-year-olds under FDA EUA. If the latest request will be approved, Pfizer’s COVID-shot will be the first to be available to children as young as 5 in the U.S.

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  In the Philippines, Pfizer’s COVID-19 vaccine is already approved to be given to children 12 to 15, but protocols on priority groups for the vaccination drive remains given the limited supply of the vaccine brand in the country.

  It is expected that the call will grow for the vaccination to include more children with the Department of Education (DepEd) starting to ease restrictions on face-to-face classes. On Wednesday, DepEd has released the list of schools included in the first batch of the pilot implementation of in-person classes amid the pandemic.

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Pfizer Seeks U.S. FDA Approval To Give COVID-19 Vaccine To Kids Ages 5 To 11 years
Source: Progress Pinas