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The Food and Drug Administration has approved a Pfizer-BioNTech COVID-19 vaccine for children ages 5-11. This lower-dose formulation of the company’s adult vaccine was found to be safe and 90.7% effective in preventing COVID-19.
The agency acted Friday after a panel of independent scientists advising the FDA backed the approval on Tuesday. The FDA says the emergency approval is based on a study of approximately 4,700 children aged 5 to 11 years.
“As a mother and doctor, I know that parents, carers, school staff and children have been waiting for today’s approval. Vaccinating younger children against COVID-19 will bring us closer to a return to a sense of normalcy, “said FDA Acting Commissioner Dr. Janet Woodcock, in a statement.
She assured the parents that the agency had carefully evaluated the data and that “this vaccine meets our high standards”.
The next step in the process before the vaccine can be made available to pediatricians, pharmacies and other distribution outlets will be an advisory board meeting of the Centers for Disease Control and Prevention next Tuesday.
Depending on the outcome of the deliberations of this committee, the director of the CDC, Dr. Rochelle Walensky, have the final say on whether and under what circumstances the vaccine can be used.
According to Walensky’s cradle, children in this age group could possibly be begin to receive their first recording in early November.
One dose of Pfizer’s vaccine for young children contains one third of the amount of active substance used in the vaccine for people 12 years and older. Children received a second dose 21 days or more after their first injection.
The vaccine is also different from the existing formulation that teenagers and adults received that it can be stored in the refrigerator for up to 10 weeks – which makes it easier for private medical offices, schools, and other places to store and administer the vaccine.
Children ages 5-11 made up about 9% of reported COVID-19 cases in the United States as a whole and currently account for about 40% of pediatric COVID-19 cases, according to Dr. Doran Fink, FDA’s assistant clinical director for Vaccine and Related Product Applications. Right now, he says, the case rate is of COVID-19 among children aged 5 to 11 years is “almost the highest” of any age group.
Unvaccinated children who get COVID-19 can develop a serious complication called multisystem inflammatory syndrome, or MIS-C. According to Dr. Fiona Havers, a doctor with the CDC who presented data to the FDA committee this week, has reported the disease to more than 5,000 children to date.
In the deliberations of the advisory board on Tuesday, scientists and clinicians discussed the risks of side effects of the vaccine. Myocarditis and pericarditis – which can occur after viral infections including COVID-19 – have been seen as rare side effects after vaccination with the two mRNA vaccines Pfizer and Moderna, particularly in young men.
In the Pfizer BioNTech study, which was submitted to the FDA, there were no cases of myocarditis in the children examined. However, since teenage males are at highest risk for these rare side effects, the agency assessed the risks and benefits of vaccinating younger children and concluded that the benefits of preventing hospitalization from COVID-19 outweigh the potential risks of the side effects.
During Tuesday’s advisory panel discussion, Captain Amanda Cohn, a doctor and medical officer for the CDC and also a voting member of the FDA committee, said that vaccinating young children against COVID-19 can save lives and keep children out of the hospital.
“We have incredible safety systems in place to monitor the potential for myocarditis in this age group and we can act quickly,” she said. “To me the question is pretty clear. We don’t want children to die from COVID, even if there are far fewer children than adults, and we don’t want them to stay in intensive care.”