A decision on whether COVID-19 vaccinations should be approved for children as young as 6 months old has been postponed by the federal Food and Drug Administration, likely until mid-April.
The Utah Department of Health had expected to receive the first shipment of 23,000 scaled-down doses of the Pfizer COVID-19 vaccine as soon as Feb. 21, and had plans to quickly distribute the shots to local health departments, doctors and pharmacies around the state.
But Friday, the CDC announced regulators would wait for the results of an ongoing study of the effects of a third dose of vaccine in children under 5 years old, rather than fast-track approval for a two-dose regime based on earlier data showing that failed to produce a strong enough immune response.
The intent was to get vaccinations underway as soon as possible for the youngest Americans and consider the need for a third dose later. The latest COVID-19 surge driven by the incredibly transmissible omicron variant appears to have peaked, but cases of “stealth” omicron, a subvariant, are rising in other parts of the world.
Rich Lakin, the state health department’s immunization director, said he believed the questions surrounding a third dose of vaccine would be confusing for parents. A recent national survey found many parents are already unsure about vaccinating very young children.
Friday, state health department spokesman Tom Hudachko said the postponement won’t affect Utah’s plans.
“Despite today’s announcement, we will continue to prepare for the possible authorization of the Pfizer vaccine for children ages 6 months to 5 years. Science and data around safety and effectiveness have always been paramount in approving vaccines, and today’s announcement is consistent with those principles,” he said.
A meeting of the CDC’s vaccine advisory panel had been set to consider the COVID-19 shots for infants and toddlers on Tuesday. The New York Times reported Friday that meeting has been postponed and Dr. Peter Marks, head of the FDA’s vaccine division, said parents now will have to wait two more months for a decision.
“Yes, some of this was late breaking, but that’s what our job is — to adjust to it,” he said.
In a statement, the CDC said, “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.”
Pfizer said in December that two doses failed to produce a strong enough immune response and announced a third dose was being tested. Pfizer CEO Albert Bourla said earlier this week he believed the chances of FDA approval were “very high” for the initial two doses.
Pfizer and the other company behind the vaccine, BioNTech, said Friday in a statement, “Given that the study is advancing at a rapid pace, the companies will wait for the three-dose data as Pfizer and BioNTech continue to believe it may provide a higher level of protection in this age group.”
There are approximately 18 million children under 5 years old in the United States and nearly 300 in that age group have died from COVID-19, according to the CDC. In Utah, five young people have been killed by the virus, including two from Salt Lake County and one from Davis County who were 1-14 years old, according to health department data.