mRNA Vaccines Authorized for Infants
The U.S. Food and Drug Administration (FDA) announced today that it authorized emergency use of the Moderna Inc. and Pfizer-BioNTech COVID-19 vaccines to prevent COVID-19 in children down to six months of age.
For the Moderna COVID-19 Vaccine known as SpikeVax, the FDA amended the emergency use authorization (EUA) to include the use of the vaccine in individuals six months through 17 years of age.
The vaccine had been authorized for use in adults 18 years of age and older.
And for the Pfizer-BioNTech COVID-19 Vaccine known as Comirnaty, the FDA amended the EUA to include the use of the vaccine in infants six months through 4 years of age.
This mRNA vaccine had been authorized for use in individuals five years of age and older.
“As with all vaccines for any population, when authorizing COVID-19 vaccines intended for pediatric age groups, the FDA ensures that our evaluation and analysis of the data is rigorous and thorough,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, in a related press release issued on June 17, 2022.
“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.”
Note: This FDA announcement was manually curated for mobile readers.