May 10, 2021 – The FDA on Monday granted emergency use authorization for Pfizer’s coronavirus vaccine to be administered to children 12 to 15 years of age.
The long-awaited decision increases the likelihood that schools in the United States will fully reopen in the fall – a goal of the Biden and Trump administrations.
Acting FDA Commissioner Janet Woodcock, MD, called the decision a “big step” in “returning to a sense of normalcy.”
“Today’s action allows a younger population to be protected against COVID-19, which brings us closer to a return to a sense of normalcy and the end of the pandemic,” she said stated in a press release. “Parents and guardians can rest assured that the agency has undertaken a rigorous and in-depth review of all available data, as we have done with all of our emergency use permits for the COVID-19 vaccine.”
The Pfizer vaccine for adolescents is not quite finished.
Next, the CDC’s Advisory Committee on Immunization Practices will decide whether or not to recommend the vaccine for use in this age group, CNN reported. This group is due to meet on Wednesday. After that, CDC director Rochelle Walensky, MD, will decide whether to give the go-ahead for the vaccine to be given to this age group.
The FDA’s action on Monday changes the Dec. 11 emergency use authorization that allowed Pfizer vaccine to be administered to people 16 years of age and older. Pfizer was the first company to receive EUA for its adult vaccine and the first to receive approval for its adolescent vaccine. Pfizer is also conducting clinical trials in much younger children.
Moderna and Johnson & Johnson vaccines are approved for people 18 years of age and older. Moderna has also started clinical trials in children.
Most health experts have said the United States must immunize children before the COVID pandemic can truly be brought under control. The 12-15 age group represents 17 million people, or about 5% of the population. So far, 58% of American adults have received at least one dose of a vaccine and 34.8% of all Americans are fully vaccinated.
American Academy of Pediatricians President Lee Savio Beers, MD, praised the agency’s decision, calling it “not of critical importance in bringing life-saving vaccines to children and adolescents,” Beers said in a press release. “Our younger generations have taken on a heavy load over the past year, and the vaccine is a sign of hope that they can begin to experience all of the activities that are so important to their health and development.”
Last week, President Joe Biden announced a new strategy to expand immunizations in which immunization of 12 to 15 year olds was a key component. He said the administration was prepared to ship the adolescent vaccine directly to pharmacies and pediatricians to speed up the vaccination rate.
In March, Anthony Fauci, MD, told a Senate committee, “We don’t really know what this magic point of herd immunity is, but we do know that if we get the overwhelming population vaccinated, we’ll be healthy. shape.… Ultimately, we would like and need to get kids into this mix.
Pfizer submitted data to the FDA in late March showing that its mRNA vaccine was 100% effective in preventing COVID-19 infection in children aged 12 to 15 in clinical trials.
Although most children show milder symptoms when infected with the coronavirus, an estimated 1.5 million cases in children ages 11 to 17 were reported to the CDC between March 1, 2020 and April 30, 2020. this year, according to the FDA press release.
Albert Bouria, CEO of Pfizer, tweeted that “Today brings very encouraging news for families and teens across the United States.”
“Although this is a significant step forward, we are still in a critical period of struggle against # COVID-19[FEMALE[FEMININE around the world. In the coming weeks, we hope to continue to receive clearances from global regulators to support global immunization efforts.
“I want to thank all of the courageous participants, who selflessly raised their hands to join our clinical trial. Without them – and their families and caregivers, this step would not be possible. “
Our sincere thanks to