FDA delays meeting on vaccines for children under 5

Federal health regulators on Friday delayed next week’s public meeting to review Pfizer’s COVID-19 vaccine for children under 5, saying they want to see more data.

The surprise announcement by the Food and Drug Administration raises questions about how soon youngsters could get the shots. The FDA’s outside experts were set to evaluate the first data on COVID-19 vaccinations in toddlers and babies.

The FDA said Pfizer has new data available from its ongoing vaccine study, and the agency needs more time to evaluate it.

The expert panel had been scheduled to meet Tuesday to determine if children under 5 should start getting extra-low doses of Pfizer’s vaccine before it is clear if they will need two shots or three.

The nation’s 18 million children under 5 are the only age group not yet eligible for vaccination. The FDA had pushed Pfizer and its partner BioNTech to apply for authorization of its extra-low doses for tots before final study data was in, as the hugely contagious omicron variant took a toll on children.

“Based on the agency’s preliminary assessment, and to allow more time to evaluate additional data, we believe additional information regarding the ongoing evaluation of a third dose should be considered as part of our decision-making for potential authorization,” Acting Commissioner Janet Woodcock and Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, said in a statement.

Concerned about the emergence of new, highly transmissible variants like omicron, some parents are eager for their younger children to get vaccinated. However, enthusiasm for the Pfizer formulation was tempered in December when a study showed two doses failed to meet a laboratory standard for effective immune response in 2to 4-year olds, although it did in those from six to 24 months of age.

Data on a third dose are expected in April, the companies said. That stands to delay U.S. plans are underway for a special vaccination program for children under 5. The government has secured sufficient supplies for all 18 million children from 6 months through 4 years old, White House coronavirus response coordinator Jeff Zients said Wednesday in a press conference.

Yet there are already signs that some parents could be slow to get shots for younger children. COVID-19 vaccinations among children ages 5 to 11 years have fallen to their lowest levels since the shots were first cleared, according to recent data from the CDC.