FDA to debate authorizing Pfizer’s Covid vaccine for kids aged five to 11

Independent experts with the Food and Drug Administration (FDA) will debate whether to recommend the Pfizer Covid-19 vaccine for children aged five to 11 on Tuesday. Vaccines are currently authorized for children 12 years of age and older.

Vaccine authorization for young children has been widely anticipated by parents in the US, as a wave of Covid-19 fueled by the Delta variant took hold across the country just as many students were returning to classrooms. The Biden administration also sees it as an important next step in the vaccine rollout program, which has slowed considerably.

The advisory committee will hear evidence from Pfizer and regulators, debate whether to recommend emergency authorization of kid-sized vaccines, then vote on a recommendation. Regulators do not always follow independent committees’ advice, but they usually do.

Vaccine authorization will then move to the Centers for Disease Control and Prevention (CDC), where a complementary panel of experts will weigh recommendations on who should receive them. Finally, regulators at both agencies must authorize the vaccines for emergency use in kids before they can be distributed.

If authorized, a campaign to vaccinate roughly 28 million elementary school-aged children will begin, with vaccines distributed through pharmacies, community clinics, pediatricians’ offices and some school-based clinics.

While hospitalization and death rates are lower among young children as compared to adults, kids have made up an increasing share of cases amid a Delta-driven summer surge, especially as in-person school has resumed. Children may also serve as reservoirs for disease, spreading Covid-19 to adults even if they are not themselves severely ill.

Roughly 6.1 million children have been infected with Covid-19 in the US, according to the American Academy of Pediatrics, and 143 have died since the pandemic began, according to the CDC.

Although children with underlying medical conditions such as asthma, diabetes and obesity made up the majority of severe Covid-19 cases, about one-third had no known health conditions, Pfizer’s application said.

To study the safety and efficacy of vaccines in kids, Pfizer undertook a study of 2,268 children aged five to 11. A total of 1,518 children received the vaccine and 750 received a placebo. Each received two shots spaced three weeks apart, and were followed for two months afterward.

The study found Pfizer’s vaccines were about 91% effective in children, based on 16 cases of Covid-19 in the placebo group and three cases in the vaccinated group.

Most side effects kids experienced occurred within a couple of days and included pain at the injection site, fatigue, headache, muscle pains and chills. The study did not find any cases of myocarditis, or heart inflammation, though the size of the study makes it unlikely for the condition to have presented itself.

There is probably a link between messenger RNA vaccines, such as the vaccine developed by Pfizer, and heart inflammation, the CDC has said. The exact rate of myocarditis has not been established. It is believed to be rare, and more common in young men than other groups.

About one-third of parents said they would get their young children vaccinated “right away”, and another one-third said they would “wait and see” whether to vaccinate their children, according to the Kaiser Family Foundation. Last week, the White House announced an education campaign targeted at parents.

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