- For immediate posting:
Today, the U.S. Food and Drug Administration amended the Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine, allowing the use of a single booster dose for administration in individuals 5 to 11 years of age at least five months after completing a primary series with the Pfizer-vaccine. BioNTech COVID-19.
“While it has largely been the case that COVID-19 tends to be less severe in children than in adults, the Omicron wave has seen more children fall ill and be hospitalized, and children may also experience long-term effects, Even then initially, FDA Commissioner Robert M. Califf, MD, said, “The FDA allows the use of a single booster dose of the Pfizer BioNTech COVID-19 vaccine for children 5 to 11 years old. To provide continuous protection against COVID-19. Vaccination remains the most effective way to prevent COVID-19 and its severe consequences, and it is safe. If your child is eligible for the Pfizer-BioNTech COVID-19 vaccine and has not yet received their initial series, vaccinating them can help protect them from potentially serious consequences that could occur, such as hospitalization and death.”
On January 3, the US Food and Drug Administration authorized the use of a single booster dose of the Pfizer BioNTech COVID-19 vaccine for administration to individuals 12 to 15 years of age after completion of the initial vaccination with the Pfizer BioNTech COVID-19 vaccine. . Today’s action expands the use of a single booster dose of the vaccine to give individuals 5 to 11 years of age at least five months after completion of the initial series of the Pfizer-BioNTech COVID-19 vaccine. The US Food and Drug Administration has approved the Pfizer-BioNTech COVID-19 vaccine for use in individuals 5 years of age and older, and has approved Comirnaty (COVID-19 vaccine, mRNA) for use in individuals 16 years of age and older.
Peter Marks, MD, director of the FDA’s Center for Biology Evaluation and Research, said. Since the vaccine was approved for children up to 5 years of age in October 2021, emerging data indicates that the vaccine’s efficacy against COVID-19 diminishes after the second dose of the vaccine in all authorized populations. The U.S. Food and Drug Administration (FDA) has determined that the known and potential benefits of a single booster dose of the Pfizer-BioNTech COVID-19 vaccine for children 5 to 11 years of age at least five months after completing the initial series outweigh its known and potential risks and that a booster dose can help Provide ongoing protection against COVID-19 in this age group and older age groups.”
Data Backup Efficiency
The EUA for a single booster dose of the Pfizer-BioNTech COVID-19 vaccine for children 5 to 11 years of age is based on a US Food and Drug Administration analysis of immune response data in a subgroup of children from the ongoing randomized, placebo-controlled trial that supported OCT. 2021 approval of the initial Pfizer-BioNTech COVID-19 vaccine series in this age group. Antibody responses were evaluated in 67 study participants who received a booster dose 7 to 9 months after completing two baseline doses of the Pfizer-BioNTech COVID-19 vaccine. The level of antibody against SARS-CoV-2 was increased 1 month after the booster dose compared to before the booster dose.
FDA safety assessment
The safety of a single booster dose of the Pfizer-BioNTech COVID-19 vaccine in this age group was evaluated in approximately 400 children who received a booster dose for at least five months (5 to 9 months) after completing two baseline doses of the series. The most common side effects reported were pain, redness, and swelling at the injection site, as well as fatigue, headache, muscle or joint pain, chills, and fever.
The FDA did not convene an Advisory Committee meeting on Vaccines and Related Biological Products on today’s action, as the agency had previously held the committee for extensive discussions regarding the use of booster doses of COVID-19 vaccines, and after reviewing Pfizer’s request for the EUA, the FDA concluded The Food and Drug Administration indicated that the request did not raise questions that would benefit from additional discussion by committee members. The Food and Drug Administration will make available on its website relevant documentation regarding today’s authorization.
The amendment to the EUA was granted to Pfizer Inc.
The Food and Drug Administration, an agency of the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and security of human and veterinary medicines, vaccines, and other biological products for human use and medical devices. The agency is also responsible for the safety and security of our nation’s food, cosmetics, and dietary supplement supplies, products that emit electronic radiation, and for regulating tobacco products.