The US Food and Drug Administration (FDA) has authorized emergency use of the Moderna and Pfizer-BioNTech vaccines for the prevention of COVID-19 starting at 6 months of age.
For the Moderna COVID-19 vaccine, the FDA modified the emergency use authorization (EUA) to include people 6 months to 17 years of age. The vaccine had previously been endorsed for use in adults over 18 years of age.
For the Pfizer-BioNTech COVID-19 vaccine, the FDA modified the EUA to include use in people 6 months to 4 years of age. Until now, the product had been authorized for use in people 5 years of age and older.
“The FDA’s evaluation and analysis of the safety, efficacy, and manufacturing data of these vaccines was rigorous and complete, which supports the EUAs,” a statement from the agency indicated.
“The agency 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 of each vaccine.”
Before making the decision to authorize these vaccines for the respective pediatric populations, the FDA’s Vaccines and Related Biological Products Advisory Committee was consulted and voted in favor of the authorizations.
The Moderna vaccine is administered with a primary two-dose schedule, one month apart, to people ages 6 months to 17 years. It is also authorized to provide a third dose at least one month after the second dose for people in this age group who have been determined to be certain types of immunosuppression.
The Pfizer-BioNTech vaccine is administered as a primary three-dose schedule in which the initial two doses are given three weeks apart followed by a third dose administered at least eight weeks after the second dose in people ages 6 months to 4 months. year old. years.
Information about each vaccine is available in fact sheets for healthcare providers administering the vaccine and fact sheets for recipients and caregivers.
