Omicron update: FDA amends emergency use of Pfizer booster dose for more teens
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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 US Food and Drug Administration has amended the use of Pfizer booster doses for teenagers from 12 through 15 years of age.
It has also reduced the time between the completion of primary vaccination of the Pfizer-BioNTech COVID-19 vaccine and a booster dose to at least five months.
The federal agency has also allowed the third dose for immunocompromised children 5 through 11 years of age.
According to Acting FDA Commissioner Janet Woodcock, “Throughout the pandemic, as the virus that causes COVID-19 has continuously evolved, the need for the FDA to quickly adapt has meant using the best available science to make informed decisions with the health and safety of the American public in mind.”
“With the current wave of the omicron variant, it’s critical that we continue to take effect, life-saving preventative measures such as primary vaccination and boosters, mask-wearing and social distancing to in order to effectively fight COVID-19,” she added.
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 vaccine made by Pfizer and its partner BioNTech is the only US option for children of any age. About 13.5 million 12- to 17-year-olds, just over half that age group, have received two Pfizer shots, according to the CDC.
Global COVID-19 cases are surging due to the Omicron variant and health authorities have warned that its extremely high transmissibility could overwhelm many health systems.
Laboratory tests have shown that two doses of the Pfizer-BioNTech and Moderna vaccines generate low immune responses against Omicron, while boosters appear to be protective against the highly-mutated variant.
(With inputs from agencies)