The Food and Drug Administration has granted Pfizer-BioNTech authorization to administer a low booster dose of its COVID-19 vaccine to children ages five to 11.
The companies submitted clinical data to the FDA last month showing that a 10 microgram dose, which is one-third of the dose for adults, significantly boosted elementary-age children’s neutralizing antibodies against the original strain of the coronavirus, as well as the omicron variant.
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“While it has largely been the case that COVID-19 tends to be less severe in children than adults, the omicron wave has seen more kids getting sick with the disease and being hospitalized, and children may also experience longer-term effects, even following initially mild disease,” said FDA Commissioner Robert Califf.
Young children are significantly less vulnerable to severe infection caused by the coronavirus than older adults, who were prioritized for vaccines. Most countries have yet to approve a vaccine for children in this age group. The few exceptions are countries such as China, Bahrain, and Chile, which rely on the Chinese-developed vaccines.
Pfizer-BioNTech jointly announced last month that their clinical trial had yielded positive results. The trial information was gleaned from testing the lower doses in 140 children between the ages 5 and 11 six months after they completed the standard two-dose vaccine regiment. In a subset of those children studied, the booster shot led to a 36-fold increase in antibodies that neutralized the omicron variant.
“The Pfizer-BioNTech COVID-19 Vaccine is effective in helping to prevent the most severe consequences of COVID-19 in individuals 5 years of age and older,” said Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research. “The FDA has determined that the known and potential benefits of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age ... outweigh its known and potential risks.”
Children under 5 remain the only age group currently ineligible for any COVID-19 vaccine. Many parents of young children are anxiously awaiting the approval to get them vaccinated. Nevertheless, uptake for older children is far lower than among adults, suggesting that parents might not flock to get their children vaccinated as soon as they are able. Federal data show that roughly 35% of children 5 through 11 have gotten at least one dose, with only 28.6% having completed the vaccination regimen.
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The Centers for Disease Control and Prevention’s panel of experts will meet Thursday, and they are expected to vote to recommend the boosters, with CDC Director Rochelle Walensky’s final approval expected soon after.