The Food and Drug Administration (FDA) on Friday officially authorized Pfizer-BioNTech’s lower-dose Covid-19 vaccine for children ages 5 to 11, making it available to 28 million children in the United States.
The FDA’s move comes several days after its advisory committee voted 17-0, with one abstention, in favor of recommending the vaccine for children. The committee concluded that the benefits of vaccination outweigh its risks.
The committee’s vote Tuesday came at the end of a vigorous debate about the potential risks and benefits of the shots for younger children, as advisers voiced concerns about the unknown rates of myocarditis, an inflammatory heart condition, and whether or not children would even need protection from Covid. Although children are less susceptible to severe illness from Covid, more than 1.9 million children ages 5 to 11 have tested positive for the coronavirus over the course of the pandemic, and more than 8,400 have been hospitalized. Ninety-four children have died of Covid, making it the eighth leading cause of death in this age group,
NEW: FDA authorizes Pfizer vaccine for children as young as 5.
— Andy Slavitt 🇺🇸💉 (@ASlavitt) October 29, 2021
Kids who test positive for Covid are also at risk for multisystem inflammatory syndrome in children, or MIS-C, a rare inflammatory condition. As of October 4th, as many as 5,217 children of all ages have developed MIS-C, and 46 have died, although the condition is most common in children ages 5 to 11.
Today, we authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of #COVID19 to include children 5 through 11 years of age. https://t.co/Tz0S9s4eyz pic.twitter.com/dc18AWIHKQ
— U.S. FDA (@US_FDA) October 29, 2021
In its presentation to the FDA, Pfizer said its vaccine was nearly 91 percent effective at preventing symptomatic illness in children, adding that it appears to hold up well against the highly transmissible Delta variant.
The FDA has authorized emergency use of the Pfizer vaccine for 5–11 year olds. https://t.co/gmyWjGVmAp
— Kaitlan Collins (@kaitlancollins) October 29, 2021
The vaccine for children ages 5 to 11 is a smaller dose than the one given to those 12 and older, but like in adults, the full vaccination series consists of two doses given three weeks apart.