Pfizer says its 3-shot infant COVID vaccine is 80% effective against symptomatic omicron in new data

NEW YORK — Three child-size doses of the Pfizer/BioNTech Covid-19 vaccine appeared to be safe and demonstrated a strong immune response in children ages 6 months to 5 years, the companies said Monday. The vaccine makers said they will complete filing the study data with the U.S. Food and Drug Administration this week.

The phase 2/3 study included 1,678 children who received a third dose during the period when the Omicron variant coronavirus was dominant. Antibody levels tested one month after the third dose showed the vaccine elicited an immune response similar to two doses in 16- to 25-year-olds, the companies said in a press release. The data has not yet been peer-reviewed or published.

The results of the interim study showed a vaccine efficacy of 80.3% against symptomatic Covid-19 in this youngest age group. The companies identified 10 symptomatic cases at least seven days after the third dose. However, the efficacy rate will not be definitive 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 said three child-sized doses for this youngest age group were “well tolerated” and no new safety signals had been identified.

“These top-line safety, immunogenicity and efficacy data are encouraging and we look forward to completing our submissions to regulatory authorities worldwide soon with the hope of making this vaccine available in younger children as soon as possible, subject to regulatory approval ‘ Pfizer Chairman and CEO Albert Bourla said in a statement.

Vaccines for this youngest age group are smaller than those for older age groups. People aged 12 and over will receive two doses of a 30 microgram vaccine and children aged 5 to 12 will receive two doses of a 10 microgram vaccine. Both age groups are eligible for booster doses.

For children 6 months to 5 years, the Pfizer/BioNTech vaccine consists of three 3 microgram doses. The first two doses were given three weeks apart, and the third dose was given at least two months after her second dose.

Children under the age of 5 are the only age group not yet eligible for vaccination against Covid-19. The vaccine for this age group was delayed because results from a two-dose series of the Pfizer/BioNTech vaccine did not provide the expected level of protection. The companies said they would amend the study to add a third dose.

In February, the U.S. Food and Drug Administration asked companies to file an emergency use application based on the two-dose data, but then postponed a meeting of the agency’s Vaccine Advisory Board to allow the third-dose data could be taken into account.

The FDA’s Vaccines and Related Biological Products Advisory Committee has scheduled preliminary meetings for June 8, 21, and 22 to discuss updates to emergency use authorizations that allow younger children to be vaccinated with Moderna or Pfizer/ BioNTech could question.

Moderna submitted its vaccine data for children ages 6 months to 5 years to the FDA in late April. Moderna’s application is based on two 25-microgram doses given 28 days apart.

The CNN Wire
& 2022 Cable News Network, Inc., a WarnerMedia company. All rights reserved. Pfizer says its 3-shot infant COVID vaccine is 80% effective against symptomatic omicron in new data

Dais Johnston

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