Advisers to the U.S. Food and Drug Administration recommended authorizing Pfizer/BioNTech and Moderna Covid-19 vaccines for children as young as 6 months, reports said.
All 21 members of the FDA’s Vaccines and Related Biological Products Advisory Committee voted in favor of the decision for both companies’ vaccines, stating that the benefits outweigh their risks.
The Pfizer-BioNTech COVID-19 Vaccine will be administered as a 3-dose series, with 3 micrograms in each dose, for use in infants and children 6 months through 4 years of age.
Further, the Moderna COVID-19 Vaccine will be administered as a 2-dose series, with 25 micrograms in each dose, for use in infants and children 6 months through 5 years of age.
The FDA, which generally follows advisers’ recommendations, is expected to take a decision soon. The vaccines also require the recommendation by the advisers of U.S. Centers for Disease Control and Prevention or CDC. A committee of CDC advisers is expected to meet Friday and Saturday for the decision, which needs to be signed off by CDC Director Rochelle Walensky.
Children younger than 5 years are the only age group who are not eligible for vaccination against Covid-19 in the U.S. As per reports, there are about 17 million kids under this age group, who will become eligible for Covid-19 vaccines, if approved. The FDA noted that at least 442 children younger than 4 have died from COVID-19 during the pandemic.
Both Pfizer-BioNTech and Moderna vaccines are already authorized for people aged 18 and older. Pfizer’s vaccine has been available to children between 5 years and 17 years since last year.
The FDA advisers has recently recommended to authorize Moderna’s two-dose COVID-19 vaccine for children and teens aged 6 to 17 years. Moderna asked the FDA to authorize its vaccine for teenagers 12 to 17 in June 2021, and for the 6 to 11 age group in March this year.
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