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The Food and Drug Administration (FDA), at the request of Pfizer and BioNTech, allowed its COVID-19 vaccine to be given to children between 12 and 15 years of age on emergency use on Monday.
The much-awaited decision raises the possibility that schools in the United States will reopen completely in the fall – a goal of both Biden and the Trump administration. Acting FDA Commissioner Janet Woodcock, MD, called the decision “an important step in returning to normalcy”.
Janet said, “Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic”. She further added in her statement, “Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations.”
The Pfizer juvenile vaccine is not yet a done deal, though. Next, the Center for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices will decide on Wednesday whether to recommend the use of the vaccine in this age group. After that, CDC director Rochelle Wallensky, MD, will decide whether to give the green light for the vaccine to be administered to that age group.
The FDA action on Monday amends the December 11 Emergency Use Authority, which introduced Pfizer vaccines to people 16 and older. Pfizer was the first company to receive the EUA for its adult vaccine and is the first to receive authorization for its juvenile vaccine. Pfizer is also conducting clinical trials on very young children.
Modern and Johnson & Johnson vaccines are authorized for people 18 and older. Modern has also started clinical trials in children. Most health experts have said that America needs to vaccinate children before the COVID epidemic is truly brought under control. The 12- to 15-year-old group represents 5% of the total US population, which is accounted for 17 million people. Thus, 58% of US adults have had at least one vaccine dose so far and 34.8% of all Americans have been fully vaccinated.
Last week, President Joe Biden announced a new strategy for the expansion of vaccination in which vaccination of children between 12 and 15 years old was an important component. He said that to speed up the rate of vaccination, the administration was willing to directly administer the vaccine to juveniles and pediatricians.
Pfizer submitted data to the FDA in late March showing that its mRNA vaccine was 100% effective in preventing COVID-19 infection in 12 to 15-year-old children in clinical trials.
Although most children have symptoms of mild coronavirus infection, approximately 1.5 million cases in children between 11 to 17 older were reported to the CDC between March 1, 2020, and April 30 of this year.
Source: MedScape
