US FDA clears Pfizer's Covid-19 booster shot for kids aged 12-15
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Washington: The US Food and Drug Administration on Monday authorized the use of a third dose of the Pfizer and BioNTech Covid-19 vaccine for children aged between 12 and 15 years.
On Monday, the FDA also narrowed down the time for booster shots from at least six months after completion of the initial series to at least five months, for everyone aged 12 and older, reports Xinhua news agency.
The agency has determined that the protective health benefits of a single booster dose of the Pfizer-BioNTech Covid-19 vaccine to provide continued protection against the virus and the associated serious consequences outweigh the potential risks in individuals aged 12 to 15.
The agency also authorized a third shot in children aged 5 through 11 years who are immunocompromised.
The FDA said it reviewed published data and real world evidence on the safety of booster doses provided by the Israeli Ministry of Health including data from over 6,300 individuals 12-to-15 years of age who received a Pfizer shot.
The agency said that it found "no new safety concerns" following a booster shot in young teenagers, and that there were no new reports of two types of heart inflammation called myocarditis or pericarditis linked to the boosters.
The decision came as the Omicron variant is spreading rapidly across the US and has led to record high hospitalisations among younger people.