The FDA limits the use of the Johnson & Johnson vaccine in the US 1:59
(CNN) --
Three child-sized doses of the Pfizer/BioNTech COVID-19 vaccine appeared to be safe and showed a strong immune response in children between 6 months and 5 years of age, the companies reported Monday.
Vaccine makers said they will finish submitting trial data to the US Food and Drug Administration (FDA) this week.
The phase 2/3 trial included 1,678 children who received a third dose during the period when the omicron variant of the new coronavirus was dominant.
Antibody levels tested one month after the third dose showed that the vaccine produced a similar immune response to the two doses in 16- to 25-year-olds, the companies said in a news release.
The data has not yet been peer-reviewed or published.
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Interim trial results revealed a vaccine efficacy of 80.3% against symptomatic covid-19 in this younger age group.
The companies identified 10 symptomatic cases at least seven days after the third dose.
However, the efficacy rate will not be finalized until at least 21 symptomatic cases are found in the vaccine group and then compared to the number of symptomatic cases in the placebo group.
The companies stated that the three child-sized doses for this younger age group were "well tolerated" and no new safety signals were identified.
"These safety, immunogenicity and efficacy data are encouraging, and we look forward to completing our submissions to regulators globally soon in hopes of making this vaccine available to younger children as soon as possible, subject to regulatory approval." "Pfizer Chairman and CEO Albert Bourla said in a statement.
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Vaccines for this younger age group are smaller than those used in older age groups.
Those over 12 years of age receive two doses of a 30-microgram vaccine, and children 5 to 12 years of age receive two doses of a 10-microgram vaccine.
Both age groups can receive booster doses.
For children 6 months to 5 years old, the Pfizer/BioNTech vaccine consists of three 3-microgram doses.
The initial two doses are given three weeks apart, and the third dose is given at least two months after the second dose.
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Children under 5 years of age are the only age group that cannot yet be vaccinated against covid-19.
The vaccine for this age group was delayed when the results of a two-dose series of the Pfizer/BioNTech vaccine did not provide the expected level of protection.
The companies said they would modify the trial to add a third dose.
In February, the FDA asked the companies to submit an emergency use authorization application based on the data from the two doses, but then postponed a meeting of the agency's Vaccine Advisory Committee so that the data from the vaccine could be considered. third dose.
The FDA's Advisory Committee on Vaccines and Related Biologics has tentative meetings scheduled for June 8, 21, and 22 to discuss updates to emergency use authorizations that could make younger children eligible for vaccination. with Moderna or Pfizer/BioNTech vaccines.
Moderna submitted to the FDA, at the end of April, its data on the vaccine for children 6 months to 5 years of age.
Moderna's presentation is based on two 25-microgram doses given 28 days apart.
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