The Phase 2/3 trial included 1,678 children who received a third dose during the period when the omicron coronavirus variant was predominant. Antibody levels tested one month after the third dose showed that the vaccine provided an immune response similar to the two doses aged 16 to 25 years, the two companies said in a news release. The data has not yet been peer-reviewed or published.
Mid-term results showed that the vaccine efficacy against symptomatic Covid-19 was 80.3% in this youngest age group. Both companies identified 10 symptomatic cases at least 7 days after the third dose. However, efficacy rates will not be determined 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 two companies said the three child-sized doses in this youngest age group were “tolerable” and no new safety signal was identified.
“These top-line safety, immunogenicity, and efficacy data are promising and, subject to regulatory approval, in the hope that this vaccine will be available to young children as soon as possible, worldwide. We look forward to completing the submission to the regulatory authorities in the near future, “Pfizer Chairman and CEO Albert Bourla said in a statement.
Vaccines in this youngest age group are smaller than those used in older age groups. People over the age of 12 will be vaccinated twice with 30 micrograms, and children aged 5 to 12 will be vaccinated twice with 10 micrograms. Both age groups are eligible for booster immunization.
For children 6 months to 5 years, the Pfizer / BioNTech vaccine is given in 3 doses of 3 micrograms. The first two doses were given at 3-week intervals, and the third dose was given at least 2 months after the second dose.
Children under the age of 5 are the only age group not eligible for vaccination against Covid-19. Vaccines in this age group were postponed because the results of the Pfizer / BioNTech vaccine double dose series did not provide the expected level of protection. The two companies said they would modify the study to add a third dose.
In February, the U.S. Food and Drug Administration requested companies to submit an emergency use authorization application based on double-dose data, but the authorities’ Vaccine Advisory Board was able to review the third-dose data. The meeting has been postponed.
The FDA’s Vaccine and Related Biologics Advisory Board will hold an interim meeting scheduled for June 8, 21 and 22 to vaccinate younger children with Moderna or Pfizer / BioNTech vaccines. Discuss the renewal of certain emergency licenses.
Moderna submitted vaccine data to the FDA in late April for children aged 6 months to 5 years. Moderna’s submission is based on two 25 microgram doses given at 28-day intervals.
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Pfizer states that the 3-shot COVID vaccine for young children is 80% effective against symptomatic Omicron in new data
Source link Pfizer states that the 3-shot COVID vaccine for young children is 80% effective against symptomatic Omicron in new data