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USFDA backs Pfizer booster shot for kids aged 12 to 15


NEW YORK: The US FDA has authorised the use of a third dose of the Pfizer and 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 authorised a third shot in children aged 5 through 11 years who are immunocompromised.
The decisions come as 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 authorised 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,” 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 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. It said authorising the shot at 5 months instead of 6 months may provide better protection sooner against Omicron. Two shots of the mRNA vaccine are about 35% effective against infection from Omicron but a booster restores effectiveness to 75%, according to the US CDC.

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