The FDA’s panel of independent vaccine advisors on Tuesday voted 17-0 to recommend Pfizer’s Covid vaccine for children ages 5 to 11.
An advisory panel with the CDC is expected to approve the vaccine after a formal approval from the FDA.
Following the formal approval from the FDA and a stamp of approval from the CDC, the agency’s director, Rochelle Walensky will give a final approval.
Children could start getting their vaccines as early as next week.
Data presented by the Centers for Disease Control and Prevention at the panel’s meeting Tuesday showed that children ages 5-11 are “at least as likely” as adults to contract Covid-19, and surveillance testing suggests pediatric cases are widely underreported. Hospitalization rates also are three times higher for children of color than for white kids, highlighting racial disparities also seen among adult patients.
An FDA staff analysis released late Friday suggested the product’s benefits outweigh the risks of adverse side effects to kids. However, the document also noted that balance could change if Covid case rates again fell to those seen in June, depending on the extent to which instances of myocarditis — an inflammatory heart condition linked to messenger RNA vaccines — occur in that age group.
Children are at virtually zero risk from dying of Covid and the FDA admitted they don’t know the long term risks to children.
“We’re never gonna learn about how safe the vaccine is until we start giving it,” one of the FDA’s voting members said on Tuesday.
FDA Voting Member:
“We’re never gonna learn about how safe the vaccine is until we start giving it.”
— Techno Fog (@Techno_Fog) October 26, 2021