May 10, 2021 – The U.S. Food and Drug Administration (FDA) on Monday granted authorization for emergency use of the Coronavirus Pfizer vaccine for children between the ages of 12 and 15.
The long-awaited decision increases the likelihood that schools in the United States will fully reopen in the fall – a goal of both the Biden and Trump administrations.
Acting Food and Drug Administration Commissioner Janet Woodcock, MD, described the decision as an “important step” in “returning to a sense of normalcy.”
“Today’s action allows for the protection of the younger population from COVID-19, bringing us closer to returning to a sense of normality and ending the epidemic,” she said in a statement. “Parents and guardians can rest assured that the agency has conducted a strict and thorough review of all available data, as we have done with all clearances for emergency use of the COVID-19 vaccine.”
Pfizer adolescent vaccine is not final.
Then, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will decide whether to recommend the use of the vaccine in this age group, CNN reported. That group is due to meet on Wednesday. Then, CDC director Rochelle Wallinski, MD, will decide whether to give the go-ahead for the vaccine to be given for that age group.
Monday’s FDA action amends the December 11 emergency use license that allowed the Pfizer vaccine to be given to people 16 years of age or older. Pfizer was the first company to acquire the EUA for its adult vaccine, and the first to obtain a license for its adolescent vaccine. Pfizer is also conducting clinical trials in younger children.
Moderna and Johnson & Johnson vaccines are permitted for people 18 years of age and older. Moderna has also launched clinical trials in children.
Most health experts have said that the United States needs to vaccinate children before controlling the COVID pandemic. The group between the ages of 12 and 15 represents 17 million people, which is about 5% of the population. To date, 58% of adults in the United States have received at least one dose of the vaccine and 34.8% of all Americans have been fully vaccinated.
The president of the American Academy of Pediatrics, Lee Savio Bears, praised the agency’s decision, describing it as “a very important step in providing life-saving vaccines for children and adolescents,” Pears 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 begin to experiment with all the activities that are very important to their health and development.”
President Joe Biden last week announced a new strategy to expand vaccinations in which vaccinating children between the ages of 12 and 15 was a major component. He said the department is ready to ship the teen vaccine directly to pharmacies and pediatricians to speed up the vaccination rate.
In March, Anthony Fauci, the managing director, told a Senate committee, “We don’t really know what the magic point of herd immunity is, but we do know that if the vast majority of the population gets vaccinated, we will be in good shape … We ultimately want to make it. Children participate in this mix and we must make them so. ”
Pfizer submitted data to the FDA in late March showing that its mRNA vaccine was 100% effective in preventing COVID-19 infection in children ages 12 to 15 in clinical trials.
Although most children experience milder symptoms when infected with the coronavirus, about 1.5 million cases in children between the ages of 11 and 17 have been reported to the Centers for Disease Control and Prevention between March 1, 2020 and April 30 of this year. According to the Food and Drug Administration statement.
Albert Poria, CEO of Pfizer, tweeted, “Today brings us very encouraging news for families and teens across the United States.”
“While this is a meaningful step forward, we are still at a critical period in the fighting # COVID19 around the world. In the coming weeks, we hope to continue receiving clearances from global regulators to support vaccination efforts around the world.
“I would like to thank all of the brave participants, who raised their hands relentlessly to join our clinical trial. Without them – and their families and caregivers, this achievement would not be possible.”