FDA authorizes Pfizer, Moderna Covid-19 vaccines for children as young as 6 months
More than 18 months after adults were able to start receiving Pfizer-BioNTech’s and Moderna’s Covid-19 vaccines, kids as young as six months are on the verge of being able to get inoculated against the pandemic virus.
The FDA authorized the Pfizer-BioNTech and Moderna vaccines Friday morning under EUA after the agency’s outside advisors unanimously favored (21-0) administering the shots. Parents and caregivers just have to wait for the CDC to sign off before the youngest of America’s kids can get the vaccine.
Unlike the original adult emergency greenlight, kids will take a three-dose primary series of the Pfizer-BioNTech shot. Moderna’s shot will be delivered as two doses. The vaccines have reaped billions of dollars for the companies in the past year and a half and have helped cement mRNA technology in biopharma R&D.
All states but Florida have already ordered the Covid-19 vaccine for children, according to news reports.
“We are grateful to all the parents and caregivers who made today’s authorization possible by choosing to enroll their children in our COVID-19 vaccine clinical trial,” Pfizer CEO Albert Bourla said in a statement.
Efficacy of Pfizer’s three-dose series was determined by 376 kids who received the vaccine and 179 who received placebo in a group of children aged 6 to 23 months. One Covid-19 case occurred in the vaccine arm and two in the placebo arm. In the 2- to 4-year age range, 589 received the Pfizer vaccine and 271 kids got the placebo. Two cases occurred in the vaccine group and five in the placebo group.
During the advisory committee meeting on Wednesday, advisors had a few reservations given the two-dose data appeared to show little efficacy, but the experts supported the overall risk-benefit ratio.
One advisor, Paul Offit, director of the vaccine education center at the Children’s Hospital of Philadelphia, said those low levels of efficacy after the second vaccine dose were concerning, and noted the vaccine may end up being a four-dose series.
Efficacy of Moderna’s vaccine series was 36.8% for the 2 to 5 age group and 50.6% for kids 6 to 23 months of age. Those responses occurred when Omicron was predominant. In the 2 to 5 age group, 4.6% of kids with the vaccine ended up getting the pandemic disease after the second dose, compared to 7.1% of the kids on placebo.
A Kaiser Family Foundation survey in May found that just 18% of parents with children under age 5 were “eager” to get their kid vaccinated right away. About 38% of parents said they would wait to see how the vaccine is working for other people, and 27% of parents said they will “definitely not” take their kids to get vaccinated against SARS-CoV-2. And just over one in 10 said they would only get their child vaccinated if they were required to do so.