The US Food and Drug Administration (FDA) has cleared the use of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine for COVID-19 prevention in infants as young as 6 months old.
“For the Moderna COVID-19 Vaccine, the FDA amended the emergency use authorization (EUA) to include use of the vaccine in individuals 6 months through 17 years of age. The vaccine had been authorized for use in adults 18 years of age and older,” the FDA said in a statement. “For the Pfizer-BioNTech COVID-19 Vaccine, the FDA amended the EUA to include use of the vaccine in individuals 6 months through 4 years of age. The vaccine had been authorized for use in individuals 5 years of age and older,” the statement added.
This decision was made after the FDA conducted a thorough examination and analysis of the safety, efficacy, and manufacturing data for these vaccines, which supported the emergency use permission (EUA).
The agency judged that the known and prospective benefits of the Moderna and Pfizer-BioNTech COVID-19 vaccines exceed the known and potential hazards in the paediatric groups for which each vaccine is approved for use.
The FDA’s independent Vaccinations and Related Biological Products Advisory Committee was contacted and voted in favour of the authorizations prior to reaching the decision to licence these vaccines for the relevant paediatric populations.
Meet to recommend vaccine
Following vaccine approval, US Centers for Disease Control and Prevention experts will meet later this week to determine whether to recommend the vaccinations for young children.
According to the Hill, CDC Director Rochelle Walensky might sign off on a positive recommendation as early as Saturday. The Biden administration hopes to begin vaccines on June 21, according to the article.
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