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FDA has issued an Emergency Use Authorization for the Moderna and Pfizer-BioNTech COVID-19 vaccines in children as young as six months old.
FDA announced that it has issued an Emergency Use Authorization on June 17, 2022 for both the Moderna and Pfizer-BioNTech COVID-19 vaccines in children as young as six months old. The decision was made following an evaluation from FDA’s independent Vaccines and Related Biological Products Advisory Committee, who voted in support of the authorization.
“Many parents, caregivers and clinicians have been waiting for a vaccine for younger children and this action will help protect those down to [six] months of age. As we have seen with older age groups, we expect that the vaccines for younger children will provide protection from the most severe outcomes of COVID-19, such as hospitalization and death,” said Robert Califf, FDA commissioner, in an agency press release. “Those trusted with the care of children can have confidence in the safety and effectiveness of these COVID-19 vaccines and can be assured that the agency was thorough in its evaluation of the data.”
Previously, the Moderna vaccine had only been authorized for adults 18 and older. An FDA analysis of clinical trial data from Moderna found that the vaccine was 50.6% effective in preventing COVID-19 in children aged six months to 23 months two months after their second dose, and 36.8% effective in children aged six months to five years old. Individuals in the age six to 11 and 12 to 17 were found to have immune responses comparable to adults.
The Pfizer-BioNTech vaccine had previously been authorized for individuals five and older. An FDA analysis of clinical trial data from Pfizer found that the immune responses in children five months through four years old was comparable to the immune responses among individuals aged 16 to 25 who received two higher doses of the vaccine.
“As with all vaccines for any population, when authorizing COVID-19 vaccines intended for pediatric age groups, [FDA] ensures that our evaluation and analysis of the data is rigorous and thorough,” said Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, in the release. “In addition to making certain the data for these vaccines met FDA’s rigorous standards, the agency’s convening of an advisory committee was part of a transparent process to help the public have a clear understanding of the safety and effectiveness data supporting the authorization of these two vaccines for pediatric populations.”