U.S. FDA backs Pfizer COVID-19 booster shot for 12- to 15-year-olds


The U.S. Food and Drug Administration (FDA) has authorized the use of a third dose of the Pfizer-BioNTech COVID-19 vaccine for children aged between 12 and 15 years, and narrowed the time for all booster shots by a month to five months after the primary doses.

The agency on Monday also authorized a third shot in children aged five through 11 years who are immunocompromised.

The regulatory decisions come as COVID-19 cases surge due to the Omicron variant, with health authorities warning that its high transmissibility could overwhelm many health systems.

“Based on the FDA’s assessment of currently available data, a booster dose of the currently authorized vaccines may help provide better protection against both the Delta and Omicron variants,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.

“In particular, the Omicron variant appears to be slightly more resistant to the antibody levels produced in response to the primary series doses from the current vaccines,” he said.

Real-world data included in FDA review

Here in Canada, a booster dose is not approved by Health Canada for youth under 18.

The FDA said it had reviewed real-world data from Israel, including safety data from more than 6,300 individuals 12 through 15 years of age who received a booster dose of the Pfizer-BioNTech vaccine at least five months following completion of the primary two-dose vaccination series.

There were no new cases of a rare type of heart inflammation reported to-date in these individuals, the FDA said.

The agency said authorizing the shot at five months instead of six months may provide better protection sooner against the Omicron variant.

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Peer-reviewed data from multiple laboratories indicate that a booster dose of the Pfizer-BioNTech COVID-19 shot greatly improves an individual’s antibody response to be able to counter the Omicron variant, the health regulator said .

Two shots of the mRNA vaccine, which the Pfizer shot is based on, are about 35 per cent effective against infection from the Omicron variant, but a booster dose restores effectiveness to 75 per cent, according to the U.S. Centers for Disease Control and Prevention, based on data from South Africa and the United Kingdom. 

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