FDA plan to fast-track Pfizer vaccine for kids under 5 fails

Parents of children under 5 will have to wait until at least April to get their kids vaccinated against Covid-19, after the Food and Drug Administration and Pfizer this week abruptly delayed plans to get the shots authorized on a fast-track basis.

The FDA had originally planned to authorize the first two doses of what will ultimately be a three-dose vaccine as soon as this month. However, Dr. Peter Marks, head of the FDA’s vaccine division, said updated data submitted by Pfizer and BioNTech did not support the plan to get the first two doses out early. Marks acknowledged that the decision was abrupt, but said the FDA was following the science.

“The data that we saw made us realize that we needed to see data from a third dose in the ongoing trial in order to make a determination that we could proceed with doing an authorization,” Marks told reporters during a call Friday, without providing specifics on the data. 

Acting FDA Commissioner Janet Woodcock said the drug regulator had sought to act swiftly  to protect children against omicron as Covid hospitalizations among the youngest rose to record levels in recent weeks. However, the FDA’s safety and efficacy standards required the agency to wait for more information on the third dose, Woodcock said. 

“The goal was to understand if two doses would provide sufficient protection to move forward with authorizing the use of the vaccine in this age group,” Woodcock said in a statement. “Our approach has always been to conduct a regulatory review that’s responsive to the urgent public health needs created by the pandemic, while adhering to our rigorous standards for safety and effectiveness,” she said.

“Being able to begin evaluating initial data has been useful in our review of these vaccines, but at this time, we believe additional information regarding the ongoing evaluation of a third dose should be considered,” Woodcock said.

Dr. Paul Offit, a member of the FDA’s vaccine advisory committee, said the fast-track plan was based on the assumption that the third dose was safe and effective, but there’s no guarantee that will be the case once the final data is submitted.

“Imagine us approving it after two doses and then finding out later that the third dose was unsafe and then having to pull back,” said Offit, a pediatrician and director of the Vaccine Education Center at Children’s Hospital of Philadelphia. “I’m glad that we’re going to wait until we have all of the data to make that decision.”

The FDA had come under pressure in recent weeks from some parents and physicians to quickly expand eligibility to protect toddlers through 4-year-olds as the omicron variant swept the country. Children under 5-years-old are the only age group left in the U.S. that is not eligible for vaccination. 

Nearly 5,200 children were hospitalized with Covid on Jan. 18, according to a seven-day average of data from the Department of Health and Human Services, twice as many as the prior peak during the fall of 2021. That figure…