FDA's Recommendation On COVID Kids Vaccine: Latest On PA Rollout

PENNSYLVANIA — A children’s dose of the Pfizer-BioNTech COVID-19 vaccine has been recommended for emergency use authorization by a Food and Drug Administration advisory committee for individuals 5 to 11 years old.

The unanimous Tuesday vote (with a simple abstention) precedes the FDA’s final ruling, which is expected in the coming days. After that meeting, the FDA is expected to approve the shot for kids as early as Halloween or by early November.

Upon approval, vaccine providers in Pennsylvania will work directly with school districts to establish local clinics for children.

According to a statement from the White House, the needles and vials used to administer and store the childrens’ vaccine will both be smaller. The children's dose also contains 10 micrograms (rather than the 30-microgram dose used for individuals over the age of 12). These vials can be stored for up to 10 weeks at regular refrigeration temperatures and up to six months in colder conditions.

The vaccine will also be administered in two shots given 21 days apart.

Pfizer tested its COVID vaccine on 2,268 children in the 5-11 age group, announcing on Sept. 20 that the vaccine showed positive results when children were given a third of the dose that was given to adults.

While experts say that the data points to the children’s dose as largely being safe, the FDA has pointed to one risk with a very low likelihood: myocarditis, or inflammation of the heart, as a potential side effect.

Per Centers for Disease Control and Prevention data, hospitalizations and COVID-19 related deaths are uncommon in children, though experts still warn of serious complications that could arise in the long-term.

"Millions of adolescents ages 12-17 have been safely vaccinated, and we know vaccines work," the White House said in a statement. "Fully vaccinated individuals are 10 times less likely to be hospitalized with COVID-19 and have a high degree of protection, including against the Delta variant. The consequences of a pediatric COVID-19 case can be serious and potentially last months."