The US Food and Drug Administration (FDA) has authorized the use of a third dose of the Pfizer-BioNTech COVID-19 vaccine for children 12 to 15 years of age, and has reduced the time for all booster shots from one to five months after the initial doses.
On Monday, the agency also allowed a third injection to be given to children aged 5 to 11 who are immunocompromised.
Regulatory decisions come as COVID-19 cases increase 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 currently authorized vaccines may help provide better protection against both delta and omicron variants,” said Peter Marks, director of the FDA’s Center for Evaluation of Biology and Research.
“In particular, the Omicron variant appears to be slightly more resistant to the levels of antibodies produced in response to initial series doses than current vaccines,” he said.
Real-world data included in FDA review
Here in Canada, Health Canada does not approve a booster dose for young adults under the age of 18.
The US Food and Drug Administration said it reviewed real data from Israel, including safety data for more than 6,300 individuals aged 12 to 15 who received a booster dose of the Pfizer-BioNTech vaccine at least five months after completing the two base doses. Vaccination series.
The FDA said that no new cases of a rare type of carditis have been reported to date in these individuals.
Allowing the injection for five months instead of six months may provide better protection sooner against the Omicron variant, the agency said.
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Peer-reviewed data from multiple laboratories indicate that a booster dose of Pfizer-BioNTech COVID-19 significantly improves an individual’s antibody response to be able to counteract the Omicron variant, the health regulator said.
Two shots of the mRNA vaccine, on which Pfizer’s dose depends, is about 35% effective against infection from the Omicron variant, but a booster dose restores efficacy to 75%, according to the US Centers for Disease Control and Prevention, based on data from South Africa and the United Kingdom.