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FDA Authorizes Moderna and Pfizer-BioNTech COVID-19 Vaccines for Children Down to 6 Months of Age

June 17, 2022: “The U.S. FDA authorized emergency use of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include use in children down to 6 months of age. 

  • For the Moderna COVID-19 Vaccine, the FDA amended the emergency use authorization (EUA) to include use of the vaccine in individuals 6 months through 17 years of age. The vaccine had been authorized for use in adults 18 years of age and older.
  • For the Pfizer-BioNTech COVID-19 Vaccine, the FDA amended the EUA to include use of the vaccine in individuals 6 months through 4 years of age. The vaccine had been authorized for use in individuals 5 years of age and older. 

Key points:

  • The FDA’s evaluation and analysis of the safety, effectiveness and manufacturing data of these vaccines was rigorous and comprehensive, supporting the EUAs.
  • 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 for each vaccine.
  • Prior to making the decision to authorize these vaccines for the respective pediatric populations, the FDA’s independent Vaccines and Related Biological Products Advisory Committee was consulted and voted in support of the authorizations. 
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“Many parents, caregivers and clinicians have been waiting for a vaccine for younger children and this action will help protect those down to 6 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 FDA Commissioner Robert M. Califf, M.D. “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.” 

The Moderna COVID-19 Vaccine is administered as a primary series of two doses, one month apart, to individuals 6 months through 17 years of age. The vaccine is also authorized to provide a third primary series dose at least one month following the second dose for individuals in this age group who have been determined to have certain kinds of immunocompromise. 

The Pfizer-BioNTech COVID-19 Vaccine is administered as a primary series of three doses in which the initial two doses are administered three weeks apart followed by a third dose administered at least eight weeks after the second dose in individuals 6 months through 4 years of age. 

Information about each vaccine is available in the fact sheets for healthcare providers administering vaccine and the fact sheets for recipients and caregivers.

“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 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.” 

Evaluation of the Moderna COVID-19 Vaccine for Individuals 6 Months through 17 Years of Age

Effectiveness

The effectiveness and safety data evaluated and analyzed by the FDA for the Moderna COVID-19 Vaccine to support the EUA for these pediatric populations were generated in two ongoing, randomized, blinded, placebo-controlled clinical trials in the United States and Canada which enrolled infants, children and adolescents.

  • Children 6 months through 5 years of age: Immune responses of a subset of 230 children 6 through 23 months and a subset of 260 children 2 through 5 years of age who received a two-dose primary series of the Moderna COVID-19 Vaccine at 25 micrograms (mcg) of messenger RNA (mRNA) per dose were compared to immune responses among 290 adults 18 through 25 years who received two higher doses of the vaccine in a previous study which determined the vaccine to be effective in preventing COVID-19. In these FDA analyses, the immune response to the vaccine, of both age groups of children, was comparable to the immune response of the adults.  

    An analysis of cases of COVID-19 occurring at least 14 days after the second dose among approximately 5,400 children in this age group without evidence of prior infection with SARS-CoV-2 was conducted during the time period in which the omicron variant was the predominant circulating strain. In this analysis, among participants 6 through 23 months of age, 64% of whom had blinded follow-up for more than two months after the second dose, the vaccine was 50.6% effective in preventing COVID-19. Among participants 2 through 5 years of age, 72% of whom had blinded follow-up for more than two months after the second dose, the vaccine was 36.8% effective in preventing COVID-19.
  • Children 6 years through 11 years of age: Immune responses of a subset of 320 children in this age group who received a two-dose primary series of the Moderna COVID-19 Vaccine at 50 mcg of mRNA per dose were compared to immune responses among 295 adults 18 through 25 years who received two higher doses of the vaccine in a previous study which determined the vaccine to be effective in preventing COVID-19. In the FDA analysis, the immune response of the children to the vaccine was comparable to the immune response of the adults. An additional analysis pertaining to the occurrence of COVID-19 cases was determined not to be reliable due to the low number of COVID-19 cases that occurred in study participants. 
  • Adolescents 12 through 17 years of age: Immune responses of a subset of 340 adolescents in this age group who received a two-dose primary series of the Moderna COVID-19 Vaccine at 100 mcg of mRNA per dose were compared to immune responses among 296 adults 18 through 25 years who received two equivalent doses of the vaccine in a previous study which determined the vaccine to be effective in preventing COVID-19. In this analysis, the immune response of adolescents was comparable to the immune response of the older participants. 

    An analysis was also conducted of cases of COVID-19 occurring at least 14 days after the second dose among approximately 3,000 adolescents in this age group without evidence of prior infection with SARS-CoV-2, in which approximately 42% of participants had two or more months of blinded follow-up after the second dose. In this analysis, among participants 12 through 17 years of age, the vaccine was 93.3% effective in preventing COVID-19. The data for this analysis were obtained before the omicron variant became the predominant circulating strain.”
  • https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-and-pfizer-biontech-covid-19-vaccines-children

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