FDA authorizes COVID-19 vaccine for kids under 5

As we have seen with older age groups, we expect that the vaccines for younger children will provide protection from the most severe outcomes of COVID-19, such as hospitalization and death.

U.S. Food & Drug Administration Commissioner Dr. Robert Califf. On Friday, the FDA gave emergency use authorization (EUA) to the Moderna and Pfizer COVID-19 vaccines for use in children as young as 6 months old.

Why It Matters: This authorization of the Moderna and Pfizer COVID-19 vaccines means that children 6 months to 5 years old will likely soon have access to both the Moderna and Pfizer COVID-19 vaccines *after* the official sign-off from the CDC. President Biden says these children (the approx. 18 million kids in the U.S. under age 5) could have access to vaccines as early as next week.

Important to Note: The CDC still needs to sign off on the FDA’s authorization. The final recommendation from the CDC is expected on Saturday, and CDC Director Dr. Rochelle Walensky will likely sign off on this recommendation shortly after.

• The FDA also authorized the Moderna vaccine for those under age 17; previously, this age group only had access to the Pfizer vaccine.
• EUA for Pfizer’s vaccine in children under age 5: Three shots, given at a dosage of one-tenth the amount given to adults. The first two shots are to be given three weeks apart, and the third shot given at least eight weeks after the second.
• EUA for Moderna’s vaccine in children under age 6: Two shots given at one-quarter the adult dosage, and around four weeks apart. The FDA also authorized a third dose which may be given at least one month after the second dose to those who are most vulnerable to serious outcomes from COVID-19.
• This decision follows the FDA advisory panel’s recommendation on Wednesday to authorize the Pfizer and Moderna vaccines for young children, when “outside experts voted unanimously that the benefits of the shots outweigh any risks for children under 5” (Associated Press).
• Although this news comes as a relief to many, there remains a question of how many young children in this age group will actually be vaccinated once shots are available: “By some estimates, three-quarters of all (U.S.) children have already been infected. And only about 29% of children aged 5 to 11 have been vaccinated since Pfizer’s shots opened to them last November, a rate far lower than public health authorities consider ideal” (Associated Press).

FDA authorizes 1st COVID-19 shots for infants, preschoolers (Associated Press)

Coronavirus (COVID-19) Update: FDA Authorizes Moderna and Pfizer-BioNTech COVID-19 Vaccines for Children Down to 6 Months of Age (U.S. Food & Drug Administration)

FDA authorizes Covid vaccines for the youngest kids (NBC News)

FDA authorizes COVID vaccines for children as young as 6 months (Axios)