FDA authorizes Pfizer, Moderna vaccines for youngest children

Regulatory NewsRegulatory News | 17 June 2022 |  By 

The US Food and Drug Administration (FDA) on Friday authorized the emergency use of Moderna and Pfizer-BioNTech’s COVID-19 vaccines for children as young as 6 months of age, asserting that the benefits of the vaccines outweigh the risks.
This action comes two days after the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted to support expanding the emergency use authorizations (EUAs). (RELATED: VRPAC recommends Pfizer, Moderna COVID vaccines for youngest children, Regulatory Focus 15 June 2022)
Moderna’s vaccine was authorized in children 6 months through 17 years of age; the vaccine was previously authorized, and later approved, for use in adults 18 years of age and older. Pfizer’s vaccine was expanded to allow its use in children 6 months through four years of age. Previously, the vaccine was authorized in children five years of age and older as a two dose series. The Pfizer-BioNTech vaccine is approved as a two-dose series in individuals 16 years of age and older.
FDA authorized the Moderna’s vaccine as a two-dose series to be administered one month apart and allows a third dose one month following the second dose for children who are immunocompromised. Pfizer-BioNTech’s vaccine was authorized as a three dose series; the initial two doses are administered three weeks apart, followed by a third dose eight weeks after the second.
FDA announced its “evaluation and analysis of the safety, effectiveness and manufacturing data of these vaccines was rigorous and comprehensive, supporting the EUAs.” The agency also determined that the “known and potential benefits of the Moderna and Pfizer-BioNTech COVID-19 vaccines outweigh the known and potential risks in the pediatric populations authorized for use for each vaccine.”
FDA officials said in a press call that authorizing these vaccines was necessary to combat the high rate of coronavirus hospitalizations in young children and based on sound scientific data.
“While COVID-19 does affect older and immunocompromised populations more adversely than young children, young children can still suffer the severe consequences of COVID-19, including severe illness and death,” said FDA Commissioner Robert Califf. “Notably, since the surge of the omicron variant, children zero to four years of age have been hospitalized at a rate of approximately five times higher than the previous peak experience during delta variant predominance. Further, although the number of deaths is small compared to adult standards, any death of a child is tragic and should be prevented.”
Peter Marks, the director of the FDA’s Center for Biologics and Research (CBER) said the vaccines met the agency’s rigorous standards for safety and effectiveness. The immune responses of adults and children were also similar.
When asked which vaccine they would give their families, Marks said he would opt for whichever vaccine was available from the pharmacy.
“I would say that parents should feel comfortable getting any one of these vaccines for their child. They both have their own nuanced benefits and risks compared to each other," said Marks. "It may be that the Moderna vaccine brings an immune response slightly more rapidly. On the other hand, the Pfizer vaccine may bring a greater immune response after the third dose.” He added that there are also some “subtle differences” in their safety profiles.
FDA announcement


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