FDA authorizes Pfizer boosters for children aged 12 to 15 years, citing omicron
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The FDA on Monday amended an emergency use authorization for the Pfizer-BioNTech COVID-19 vaccine to add a booster dose for children aged 12 to 15 years, citing a need to protect them from the omicron variant.
Under the amended EUA, the FDA also shortened the suggested time between a primary two-dose series and a booster shot of the vaccine from 6 to 5 months for all eligible people aged 12 years or older.
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“Based on the FDA’s assessment of currently available data, a booster dose of the currently authorized vaccines may help provide better protection against both the delta and omicron variants,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a news release. “In particular, the omicron variant appears to be slightly more resistant to the antibody levels produced in response to the primary series doses from the current vaccines.”
The amended EUA also allows certain immunocompromised children aged 5 to 11 years — those “who have undergone solid organ transplantation, or who have been diagnosed with conditions that are considered to have an equivalent level of immunocompromise” — to receive a third primary series dose of the vaccine after at least 28 days, which was already authorized for people aged 12 years or older.
The FDA originally authorized booster shots of the Pfizer-BioNTech vaccine for adults in September. Older adolescents have been eligible for boosters of the vaccine since last month.
“Peer-reviewed data from multiple laboratories indicate that a booster dose of the Pfizer-BioNTech COVID-19 vaccine greatly improves an individual’s antibody response to be able to counter the omicron variant,” the FDA said in a statement. “Authorizing booster vaccination to take place at 5 months rather than 6 months may therefore provide better protection sooner for individuals against the highly transmissible omicron variant.”
Acting FDA Commissioner Janet Woodcock, MD, also cited omicron in her statement.
“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,” Woodcock said. “With the current wave of the omicron variant, it’s critical that we continue to take effective, life-saving preventative measures such as primary vaccination and boosters, mask wearing and social distancing to in order to effectively fight COVID-19.”
Perspective
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Amesh A. Adalja, MD
To me, the threshold for booster vaccinations with current vaccines is erosion of protection against serious disease. This is not happening in the healthy adult population — let alone the pediatric one. Boosting to transiently prevent mild illness — with current vaccines — in healthy populations has never made sense to me nor seemed justified. It is not people who lack boosters who are crowding hospitals, it is those who lack first and second doses. This blanket booster policy will, as the WHO has been saying for months, prolong the pandemic.
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