Vaccine advisers to the US Food and Drug Administration voted 17-0 with one abstention Tuesday to recommend emergency use authorization of Pfizer’s Covid-19 vaccine in children 5 to 11.
Members of the FDA’s Vaccines and Related Biological Products Advisory Committee agreed that the benefits of vaccinating younger children appeared to outweigh the risks, but some members appeared troubled about voting to vaccinate a large population of younger children based on studies of a few thousand.
“It is reassuring to me that we are giving a lower dose,” said Dr. Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia. Pfizer has cut its vaccine to one-third of the adult dose for the children under 12.
“I am just worried that if we say yes, then the states are going to mandate administration of this vaccine for children to go to school and I do not agree with that,” said Dr. Cody Meissner, a professor of pediatrics at Tufts University School of Medicine. “I think that would be an error at this time.”
But Dr. Amanda Cohn of the US Centers for Disease Control and Prevention reminded the committee that children have died of Covid-19. According to CDC, more than 700 children 18 and under have died of Covid-19. “We don’t want children dying of Covid,” she said. “And we don’t want children in the ICU.”
The FDA had said that, under most of the scenarios it projected, the benefits of vaccinating younger children would outweigh any risks and Pfizer said clinical trials showed the vaccine was more than 90% effective in preventing symptomatic infection in children.
What happens next: The FDA will take the committee’s vote into consideration and then make the final decision about whether to authorize it. Then, the US Centers for Disease Control and Prevention's independent advisory committee meets Nov. 2 and 3, and will vote on whether to recommend the vaccine for this age group.
Finally, CDC Director Dr. Rochelle Walensky will decide whether to accept or modify the committee's recommendation.
Once Walensky signs off, younger children could start getting Covid-19 shots immediately.
The US federal government has a plan in place for delivering the smaller-sized vaccines to pediatricians’ offices, pharmacies and other venues across the country.