May 10, 2021 – The FDA on Monday granted emergency use authorization for the Pfizer coronavirus vaccine to children ages 12 to 15.
The long-awaited decision increases the likelihood that U.S. schools will reopen completely in the fall, a goal of both the Biden and Trump administrations.
FDA Acting Commissioner Janet Woodcock, MD, described the decision as an “important step” to “return to the feeling of normalcy.”
“Today’s action protects the younger population of COVID-19, which brings us closer to returning to the sense of normalcy and ending the pandemic,” it said in a statement. “Parents and guardians can be assured that the agency has conducted a rigorous and thorough review of all available data, as we do with all of our emergency use authorizations for COVID-19 vaccines.”
The Pfizer teen vaccine is not entirely done.
The CDC Advisory Committee on CDC Immunization Practices will then decide whether to recommend vaccine use in this age group, CNN reported. This group is scheduled to meet on Wednesday. Then CDC director Rochelle Walensky, MD, will decide whether to give the green light to the vaccine to be given to that age group.
The FDA’s action on Monday modifies the December 11 emergency use authorization that allowed the Pfizer vaccine to be administered to people over the age of 16. Pfizer was the first company to receive a U.S. for its adult vaccine and is the first to receive authorization for its adolescent vaccine. Pfizer is also conducting clinical trials in much younger children.
Moderna and Johnson & Johnson vaccines are licensed for ages 18 and up. Modern has also launched clinical trials in children.
Most health experts have said the United States needs to vaccinate children before the COVID pandemic can actually be controlled. The 12- to 15-year-old group represents 17 million people, about 5% of the population. To date, 58% of American adults have had at least one dose of vaccine and 34.8% of all Americans are fully vaccinated.
The president of the American Academy of Pediatrics, Lee Savio Beers, MD, praised the agency’s decision, considering it “a very important step in bringing life-saving vaccines to children and adolescents,” Beers said in a statement. “Our younger generations have taken on heavy burdens over the past year, and the vaccine is a hopeful sign that they will be able to start experiencing all the activities that are so important to their health and development.”
Last week, President Joe Biden announced a new strategy to expand vaccines in which 12- to 15-year-old vaccination was a key component. He said the administration was prepared to send the teen vaccine directly to pharmacies and pediatricians to speed up the vaccination rate.
In March, Anthony Fauci, MD, told a Senate committee, “We really don’t know what this magic point of the herd’s immunity is, but we know that if we vaccinate the overwhelming population, we’ll be fine. … Ultimately.” , we would like to get the children involved in this mix and we should incorporate them. ”
Pfizer sent data to the FDA in late March showing that its mRNA vaccine was 100% effective in preventing COVID-19 infection in children 12 to 15 years old in clinical trials.
Although most children have milder symptoms when they become infected with coronavirus, the CDC reported 1.5 million cases among children ages 11 to 17 between March 1, 2020 and April 30 this year, according to the FDA statement.
Albert Bouria, CEO of Pfizer, tweeted that “today brings very encouraging news for families and teens in the United States.”
“Although this is a significant step forward, we are still in a critical period of struggle # COVID-19[FEMALE[FEMININE around the world. In the coming weeks, we look forward to continuing to receive authorizations from global regulators to support vaccination efforts around the world.
“I would like to thank all the brave participants, who selflessly raised their hands to join our clinical trial. Without them, and their families and caregivers, this milestone would not have been possible.”