Ahead of a scheduled Advisory Committee meeting this week, the FDA released favorable remarks about the Pfizer-BioNTech and Moderna COVID-19 vaccines for children under the age of five.
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Ahead of the scheduled meeting of the U.S. Food and Drug Administration’s Vaccine and Related Biological Products Committee, the regulatory agency released favorable remarks about the Pfizer-BioNTech and Moderna COVID-19 vaccines for children under the age of five.
Earlier this month, Pfizer and BioNTech completed an application to the FDA requesting approval for a three-dose series of its COVID-19 vaccine for children ages six months to five years. The application was based on data shared in late May in which the vaccine demonstrated 80.3% efficacy in young children, elicited a strong immune response and had a favorable safety and tolerability profile.
On Sunday, FDA staffers released briefing documents that stated three doses of the Pfizer and BioNTech COVID-19 vaccine were safe and effective for the prevention of symptoms associated with the disease in children aged six months to four years old. Although the statements made are by no means an official approval, the sentiment bodes well for the vaccine in the upcoming regulatory meeting.
The comments followed reports made Friday in which FDA staff reviewers said Moderna’s COVID-19 vaccine appears safe and effective for children aged six months to 17 years. In April, the company submitted an Emergency Use Authorization request to the FDA for its COVID-19 vaccine based on data that showed that the two-dose series provided a robust neutralizing antibody response during the Omicron variant surge in children. Overall, Moderna reported that the vaccine provided efficacy in preventing infections of 38% in children ages two to five and 44% in children ages six months to two years.
On June 15, the Committee will convene to fully review data and materials submitted by the companies to issue non-binding recommendations. Then, the FDA is anticipated to follow with a final decision on authorizations. If both vaccines are approved for the younger age groups, a panel of the Centers for Disease Control and Prevention will evaluate the results and if the agency finds them favorable, the vaccines could be available nationwide to children by the end of June.
“Given the uncertainty of the COVID-19 pandemic and likelihood of continued SARS-CoV-2 transmission during the ensuing months, deployment of the vaccine for use among children 6 months through 4 years of age will likely have a beneficial effect on COVID-19 associated morbidity and mortality in this age group,” FDA staffers wrote in the briefing documents released on Sunday.
As of Friday, the CDC reports that the seven-day moving average of reported COVID-19 cases in the U.S. is 108,548. However, a press briefing in May by the White House noted that the country is likely undercounting cases due to at-home testers who do not report their results to health agencies.
The press briefing also covered emerging variants that could drive more surges of infections. Unvaccinated children are of particular concern when it comes to new infections, with a nationwide analysis reporting that about two in every three children between one and four years old in the U.S. have contracted COVID-19.
