The United States Food and Drug Administration (FDA) has authorized the use of a third dose of Pfizer-BioNTech COVID-19 vaccine for children aged 12 to 15 years, and has reduced the duration of all injections of booster one month to five months after the primary doses.
The agency also authorized a third injection on Monday in immunocompromised children aged five to 11.
Regulatory decisions come as cases of COVID-19 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 licensed vaccines may help provide better protection against Delta and Omicron variants,” said Peter Marks, director of the Center for Biologics Evaluation and FDA Research.
“In particular, the Omicron variant appears to be slightly more resistant to the levels of antibodies produced in response to doses of the primary series of current vaccines,” he said.
Real-world data included in FDA review
Here in Canada, a booster dose is not approved by Health Canada for young people under the age of 18.
The FDA said it looked at real-world data from Israel, including safety data from more than 6,300 people aged 12 to 15 who received a booster dose of the Pfizer-BioNTech vaccine at least five months after. the end of the first two-dose dose. series of vaccinations.
No new cases of a rare type of heart inflammation have been reported in these people to date, the FDA said.
The agency said allowing shooting at five months instead of six months may offer better protection earlier against the Omicron variant.
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Peer-reviewed data from multiple labs indicate that a booster dose of Pfizer-BioNTech COVID-19 vaccine dramatically improves an individual’s antibody response to be able to counter the Omicron variant, the health regulator said.
According to the United States Centers for Disease Control and Prevention, two injections of the mRNA vaccine, on which Pfizer’s injection is based, are about 35% effective against infection with the Omicron variant, but a booster dose restores 75% efficiency. based on data from South Africa and the UK.