Three-dose Covid-19 vaccine produces strong immune responses in children aged six months to five years, say Pfizer and BioNTech – CBS Tampa

(CW44 News At 10 | CNN) – Three pediatric doses of the Pfizer/BioNtech Covid-19 vaccine have shown a strong immune response in children aged six months to five years, the companies said Monday. The vaccine makers said they will submit the trial data to the US Food and Drug Administration this week.

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 The data has not been peer-reviewed or published in a professional journal.

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Interim results found a vaccine effectiveness of 80.3% against symptomatic Covid-19 in this young 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 have been found in the vaccine group and compared to the number of symptomatic cases in the placebo group.

The companies said three pediatric doses for this age group were “well tolerated” and no new safety signals were identified.

“These top-line safety, immunogenicity and efficacy data are encouraging, and we look forward to completing our submissions to regulatory authorities worldwide shortly in the hopes of making this vaccine available to younger children as soon as possible, pending regulatory approval” , chairman and CEO of Pfizer. Albert Bourla reports this in a statement.

Vaccine doses for these children are smaller than those for older age groups. People aged 12 years and older receive two doses of a 30 microgram vaccine and children aged 5 to 12 years receive two doses of a 10 microgram vaccine. Both age groups are eligible for booster doses.

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

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dr. William Schaffner, a professor in the Division of Infectious Diseases at Vanderbilt University School of Medicine, said on Monday that vaccine scientists have been careful to adjust the dose for younger children to “get a good effect with a minimum of side effects.”

“We think of this as a three-dose vaccine, and the preliminary data obtained during the Omicron era says it’s actually 80% effective,” Schaffner told CNN’s Brianna Keilar. “We want to look at that very carefully, but so far that is good news.”

Children under the age of 5 are the only age group not eligible for vaccination against Covid-19. The vaccine for this age group was delayed when the results of a series of two doses 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 U.S. Food and Drug Administration asked the companies to file an emergency authorization application based on the two-dose data, but then postponed a meeting of the agency’s vaccine advisory board to allow the data on the third dose could be considered.

The FDA said Monday it will convene its advisory committee on vaccines and related biologics on June 14 to discuss Moderna’s EUA request against Covid-19 for people ages 6 to 17. On June 15, the committee will discuss Moderna and Pfizer’s EUA requests for vaccines for younger children.

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

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