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April 27, 2022

Pfizer asks FDA to approve COVID-19 booster for children ages 5 through 11

A third dose raised antibody levels against the Omicron variant by 36 times, the company said

Children's Health Pfizer
COVID-vaccines for children Briana Sanchez/El Paso Times/USA Today Network

Pfizer has requested the U.S. Food and Drug Administration authorize a COVID-19 booster dose for children between the ages of 5 and 11. Pablo Peralta, 5 years old, receives his COVID-19 vaccine at the El Paso Children's Hospital in November 2021.

Pfizer has requested the U.S. Food and Drug Administration authorize a COVID-19 booster dose for children between the ages of 5 and 11, saying a third shot will help people in the age group keep high levels of protection.

The request was based on data from a Phase 2/3 clinical trial of 140 children. The study showed a booster dose triggered six times higher antibody levels against the original strain of SARS-CoV-2 than the primary vaccine series. Further analysis of 30 children found that with a third shot, children's antibody levels were 36 times higher against the Omicron variant.

Previous studies have raised concerns about waning immunity after the original two-dose vaccine series, especially as the virus continues to mutate. 

A study from the New York State Department of Health found that during the omicron surge from Dec. 13 through Jan. 24, the effectiveness of Pfizer's vaccine dropped from 68% to 12% in children ages 5 to 12. However, the two doses still offered protection against serious illness, hospitalization and death.

U.S Centers for Disease Control and Prevention data has shown the two-dose primary series reduced the risk of omicron infection by 31% among children ages 5 to 11. The drop in risk for children ages 12 to 15 was 59%.

Pfizer and BioNTech have enrolled over 10,000 children between the ages of 6 months and 12 years in ongoing COVID-19 vaccine trials worldwide. Currently, there is no authorized vaccine for children younger than 5, but the companies say they hope to submit data on these youngest children to the FDA in the next few months.

Earlier this year, Pfizer and BioNTech postponed their emergency use application for a two dose vaccine in children ages 6 months to 4 years old. The companies said they wanted to wait for data on a three-dose vaccine course that may offer stronger protection.

The initial two-dose Pfizer vaccine series was authorized for children 5 to 11 years old in the U.S. in October 2021.

Pfizer and BioNTech's COVID-19 Vaccine is currently authorized for a third primary series dose to certain immunocompromised individuals 5 years of age and older. A first booster dose is available to people 12 years of age and older who have received Pfizer's primary series. Individuals 18 years of age and older who have completed an initial vaccine series with one of the other authorized COVID-19 vaccines are also eligible.

A second booster dose is available for people 50 years of age and older and for certain individuals 12 years of age and older who are immunocompromised.

Pfizer is also planning to submit booster data on children ages 5 through 11 to the European Medicines Agency and other global regulatory agencies for authorization.

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