Pfizer (PZE) and BioNTech have completed an application to the U.S. Food and Drug Administration seeking emergency use authorization of their Covid-19 vaccine for children ages 6 months to 5 years.
The companies said that data from a phase 2/3 trial of the vaccine included 1,678 children who received the third dose during the Omicron wave. The trial results, which were released on May 23 revealed that the vaccine was safe and had a strong immune response among the children.
Antibody levels tested one month after the third dose revealed that the vaccine produced a similar immune response as two doses would bring about in 16-to 25-year-olds.
The companies said that mid-trial results found vaccine efficacy of 80.3 percent against symptomatic Covid-19 among these young children. The companies identified 10 symptomatic cases at least seven days after the third dose. However, the efficacy rate can’t be finalized until at least 21 symptomatic cases are found in the vaccine group and then studied against the number of symptomatic cases in the placebo group.
The vaccines meant for the youngest ones are smaller than those used in older groups. For children 6 months to 5 years, the Pfizer/BioNTech vaccine is three 3-microgram doses. The first two doses were given three weeks apart, and the third one was given at least two months after the second dose.
Commenting on the vaccine, Pfizer Chairman and CEO Albert Bourla recently said, “These top line safety, immunogenicity and efficacy data are encouraging, and we look forward to soon completing our submissions to regulators globally with the hope of making this vaccine available to younger children as quickly as possible, subject to regulatory authorization.”
Children younger than 5 years are the only age group who are not eligible for vaccination against Covid-19 in the U.S. The vaccine for this group was delayed when brought about the two-dose series of the Pfizer/BioNTech vaccine but that did not show the expected level of protection. The companies then said that they would amend the trial to add a third dose.
In February, the FDA asked the companies to submit a request for emergency use authorization based on the two-dose data but then delayed a meeting of its vaccine advisory board so the third-dose data could be considered.
The FDA will now convene its Vaccines and Related Biological Products Advisory Committee on June 14 to discuss Moderna’s Covid-19 vaccine EUA request for people ages 6 through 17. Moderna submitted its vaccine data for children 6 months through 5 years to the FDA in late April. Its submission is based on two 25-microgram doses given 28 days apart.
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