FDA Approves Pfizer COVID-19 Vaccine For Children 5-11 Years Old, Citing Safety And Effectiveness
The Food and Drug Administration has cleared a Pfizer-BioNTech COVID-19 vaccine for children aged 5 to 11. This lower dose formulation of the companies’ adult vaccine has been shown to be 90.7% safe and effective in preventing COVID-19.
The agency acted on Friday after a panel of independent scientists advising the FDA strongly backed the authorization on Tuesday. The FDA says the emergency use authorization is based on a study of approximately 4,700 children aged 5 to 11.
“As a mother and doctor, I know that parents, caregivers, school staff and children are waiting for clearance today. Vaccinating young children against COVID-19 will bring us closer to a return to a sense of normalcy, ”Acting FDA Commissioner Janet Woodcock, MD said in a statement.
She then assured parents that the agency had rigorously evaluated the data and that “this vaccine meets our high standards.”
The next step in the process before the vaccine can be distributed to pediatricians, pharmacies and other distribution points will be an advisory group meeting with the Centers for Disease Control and Prevention next Tuesday.
Depending on the outcome of this committee’s deliberations, CDC director Dr Rochelle Walensky would then have the final say on whether the vaccine is used and under what circumstances.
After Walensky weighs in, children in this age group could, in theory, start receiving their first injection in early November.
One dose of Pfizer vaccine for young children contains one-third of the amount of the active ingredient used in the vaccine for ages 12 and older. Children would receive a second dose 21 or more days after their first injection.
The vaccine also differs from the existing formulation that adolescents and adults use in that it can be stored in the refrigerator for up to 10 weeks, allowing private doctor’s offices, schools and other places to keep. and administer the vaccine more easily.
Children aged 5 to 11 make up about 9% of reported COVID-19 cases in the United States overall, and currently represent about 40% of all pediatric COVID-19 cases, according to Dr. Doran Fink, assistant clinical director of the division. of vaccines and related products for the FDA. Currently, he says, the rate of COVID-19 cases among children aged 5 to 11 is “almost the highest” of any age group.
Unvaccinated children who contract COVID-19 can develop a serious complication called multisystem inflammatory syndrome or MIS-C. More than 5,000 children have contracted the disease so far, according to Dr. Fiona Havers, a CDC doctor who presented data earlier this week to the FDA committee.
During Tuesday’s advisory group deliberations, scientists and clinicians discussed the risks of side effects from the vaccine. Myocarditis and pericarditis – which can occur after viral infections, including COVID-19 – have been considered rare side effects after vaccination with the two mRNA vaccines, Pfizer and Moderna, especially in young men.
In the Pfizer-BioNTech study submitted to the FDA, there were no cases of myocarditis in the children studied. However, since the highest risk of these rare side effects is in adolescent males, the agency assessed the risks and benefits of vaccinating young children and concluded that the benefits of preventing hospitalization from COVID-19 outweighed the possible risks of side effects.
During Tuesday’s advisory group discussion, Captain Amanda Cohn, physician and physician at the CDC and also a voting member of the FDA committee, said vaccinating young children against COVID-19 can save lives and prevent children to go to the hospital.
“We have amazing security systems in place to monitor the potential for myocarditis in this age group and we can respond quickly,” she said. “For me, the question is pretty clear. We don’t want children to die from COVID, even though there are far fewer children than adults, and we don’t want them in intensive care. »Copyright 2021 NPR. To learn more, visit https://www.npr.org.