The US FDA just authorised the Pfizer booster dose for 5-11 year-old kids!
Here is what you need to know…
US FDA Approves Pfizer Booster Dose For 5-11 Yo Kids!
On 17 May 2022, the US Food and Drug Administration (US FDA) authorised the use of a single booster dose of the Pfizer-BioNTech COVID-19 vaccine for 5-11 year old kids.
This booster dose is to be given at least 5 months after the primary series of two doses is given.
This follows the US FDA approval of a booster dose of the Pfizer-BioNTech COVID-19 vaccine for 12-15 year old kids on 3 January 2022.
FDA Commissioner Robert M. Califf, M.D. said :
While it has largely been the case that COVID-19 tends to be less severe in children than adults, the omicron wave has seen more kids getting sick with the disease and being hospitalized, and children may also experience longer term effects, even following initially mild disease.
The FDA is authorizing the use of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age to provide continued protection against COVID-19. Vaccination continues to be 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 primary series, getting them vaccinated can help protect them from the potentially severe consequences that can occur, such as hospitalization and death.
Read more : Pfizer COVID-19 Vaccine For Kids : What You Need To Know!
Why US FDA Approved Pfizer Booster Dose For 5-11 Yo Kids
The US FDA approved the Pfizer booster dose for 5-11 year-old kids based on their analysis of the immune response data in a subset of children from the ongoing randomised placebo-controlled trial that supported the earlier October 2021 approval of the vaccine for this age group.
Increased Antibody Levels
The antibody response of 67 study participants who received the booster dose 7-9 months after completing their primary series vaccination, were evaluated, and found to increase antibody levels one month after receiving the booster dose.
The US FDA also assessed the safety of the booster dose in approximately 400 children who received the booster dose 5-9 months after completing their primary series vaccination.
The most commonly reported side effects were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, and chills and fever.
Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, said :
The Pfizer-BioNTech COVID-19 Vaccine is effective in helping to prevent the most severe consequences of COVID-19 in individuals 5 years of age and older.
Since authorizing the vaccine for children down to 5 years of age in October 2021, emerging data suggest that vaccine effectiveness against COVID-19 wanes after the second dose of the vaccine in all authorized populations.
The FDA has determined that the known and potential benefits of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age at least five months after completing a primary series outweigh its known and potential risks and that a booster dose can help provide continued protection against COVID-19 in this and older age groups.
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