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

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The agency on Monday also authorized a third shot in children aged 5 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 https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-multiple-actions-expand-use-pfizer-biontech-covid-19-vaccine, 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.

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 5 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 5 months instead of 6 months may provide better protection sooner against the Omicron variant.

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% effective against infection from the Omicron variant but a booster dose restores effectiveness to 75%, according to the U.S. Centers for Disease Control and Prevention, based on data from South Africa and the United Kingdom.