SOURCE US Food and Drug Administration
SILVER SPRING, Md., May 18, 2022 /PRNewswire-HISPANIC PR WIRE/ — Today, the U.S. Food and Drug Administration (FDA) amended the Emergency Use Authorization (USA) of the Pfizer-BioNTech COVID-19 vaccine, authorizing the use of a single booster dose for administration to persons 5 to 11 years of age at least five months after completion of a main schedule of vaccination with the Pfizer-BioNTech COVID-19 vaccine.
“While it is true that COVID-19 tends to be less severe in children than in adults, in the omicron wave there have been more children who have contracted the disease and have been hospitalized, and children can also experience effects to more long-term, even after initially mild illness,” said FDA Commissioner Robert M. Califf, M.D. “The FDA is authorizing the use of a single booster dose of Pfizer-BioNTech’s COVID-19 vaccine for children 5 through 11 years of age to provide ongoing protection against COVID-19. Vaccination remains the most effective way to prevent COVID-19 and its serious consequences, and it’s safe. If your child is eligible to receive the Pfizer-BioNTech COVID-19 vaccine and has not yet received their primary vaccination schedule, vaccinating can help protect you from the potentially serious consequences that may occur, such as hospitalization and death.”
On January 3, the FDA authorized the use of a single booster dose of Pfizer-BioNTech’s COVID-19 vaccine for administration to persons 12 to 15 years of age after completion of a primary vaccination course with the COVID-19 vaccine from Pfizer-BioNTech. Today’s action expands the use of a single booster dose of the vaccine for administration to persons 5 to 11 years of age at least five months after completing a primary vaccination schedule with Pfizer’s COVID-19 vaccine. -BioNTech. The FDA has authorized Pfizer-BioNTech’s COVID-19 vaccine for use in persons 5 years of age and older, and has approved Comirnaty (COVID-19, mRNA vaccine) for use in persons 16 years of age and older.
“Pfizer-BioNTech’s COVID-19 vaccine is effective in helping prevent the most serious consequences of COVID-19 in people 5 years of age and older,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biological Evaluation and Research. “Since the vaccine was licensed for children up to 5 years of age in October 2021, emerging data suggest that the efficacy of the COVID-19 vaccine declines after the second dose of the vaccine in all licensed populations. The FDA has determined that the known and potential benefits of a single booster dose of Pfizer-BioNTech’s COVID-19 vaccine for children 5 through 11 years of age at least five months after completion of a primary vaccination schedule, outweigh their known and potential risks, and that a booster dose may help provide continued protection against COVID-19 in this and older age groups.”
FDA safety evaluation
The safety of a single booster dose of Pfizer-BioNTech’s COVID-19 vaccine in this age group was evaluated in approximately 400 children who received a booster dose at least five months (between 5 and 9 months) after complete a two-dose primary vaccination schedule. The most commonly reported side effects 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 hold a meeting of its Vaccines and Related Biologics Advisory Committee on today’s action, as the agency previously convened the committee for extensive discussions on the use of booster doses of COVID-19 vaccines. and, after reviewing Pfizer’s US application, the FDA concluded that the application did not raise issues that would benefit from further discussion by committee members. The FDA will post the relevant documents regarding today’s authorization on its website.
The amendment to the US authorization was granted to Pfizer Inc.
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