U.S. health regulators are expected to weigh in soon on the evidence for giving the Covid-19 vaccine from Pfizer Inc. PFE 0.14% and BioNTech SE BNTX 6.29% to children 5 to 11 years old.
The U.S. Food and Drug Administration is expected as early as Friday morning to post online its written assessment of study data submitted by the companies. In early October, Pfizer and BioNTech asked the FDA to authorize the vaccine for children 5 to 11 years old.
The FDA also is expected to post a document from the companies outlining the rationale and evidence for expanding the vaccine’s use to the young children. The documents are being posted ahead of a meeting scheduled for Tuesday of a committee of vaccine experts advising the FDA.
The panel, the Vaccines and Related Biological Products Advisory Committee, will meet to review the evidence of the vaccine’s safety and effectiveness in children, and vote to recommend whether the FDA should authorize the use.
If the vote is in favor, FDA authorization could follow within days. And if the Centers for Disease Control and Prevention subsequently signs off, millions of younger children could get a Covid-19 vaccine for the first time.
There are more than 28 million children ages 5 to 11 in the U.S., according to the American Academy of Pediatrics.
Pfizer and BioNTech said in September that their vaccine was generally well-tolerated and induced strong immune responses in a study of nearly 2,270 children 5 to 11. Each child received two doses three weeks apart, and each shot contained one-third of the dosage used for adolescents and adults.
The vaccine induced neutralizing antibody levels in younger children that were comparable to those seen in people ages 16 to 25 who served as a control group in the study, the companies said.
The Pfizer-BioNTech Covid-19 compound being mixed for a trial in children under 12 in August.
Photo: Daniel Lozada for The Wall Street Journal
Pfizer also has tested the vaccine at an even lower dosage in children as young as six months.
Pfizer’s vaccine was authorized in December 2020 for people 16 years of age and older, an authorization expanded in May to adolescents 12 and older.
Earlier this week, the Biden administration outlined plans to distribute the Pfizer vaccine to children at doctors’ offices, pharmacies and schools if regulators clear the shots.
Moderna Inc. and Johnson & Johnson have been studying their Covid-19 vaccines in children, but currently their shots are authorized only for people 18 and older.
Write to Peter Loftus at [email protected] and Jared S. Hopkins at [email protected]
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