2/14/2022
PITTSBURGH - The Food and Drug Administration’s decision Friday to delay the review of a COVID-19 vaccine for children under 5 is likely to push the shots’ availability until at least April.
An advisory panel to the Food and Drug Administration had been scheduled to vote Tuesday on whether to recommend authorizing the COVID-19 vaccine for children from 6 months to 5 years old, but in a reversal on Friday, the meeting was postponed.
“This will give the agency time to consider the additional data, allowing for a transparent public discussion as part of our usual scientific and regulatory processes for COVID-19 vaccines,” an FDA statement said.
The process would have been different from previous vaccine approvals because the FDA would have needed to consider whether to approve giving two doses of the Pfizer-BioNTech vaccine while the companies were still researching whether three doses would be more effective.
In December, Pfizer released an update from a clinical trial showing that two doses of the vaccine worked well for children between 6 months and 2 years old but were not as effective in provoking an immune response in 2- to 4-year-olds. The children were given 3 micrograms of the vaccine — one-tenth of the adult dose.
Now the company will have more time to generate data on the three-dose trial and submit it to the FDA panel in early April, officials said Friday.
The Post-Gazette asked Dr. Judy Martin, a professor of pediatrics at the University of Pittsburgh School of Medicine and director of the Pittsburgh Vaccine Clinical Trials Unit, to explain what it would mean for parents of young children, when a decision comes.
“I really want to emphasize the process is to ensure that it’s safe and it can make a difference,” she said.
In her line of work, the panel’s eventual decision will be very exciting, she said. “This is my Super Bowl. We’ll be watching them vote.”
She said that if the vaccine is authorized, parents will be able to take their children to get it through their pediatric practices, which are a trusted resource for parents and a familiar setting for young children.
The needles used would be the same size as those for the 5- to 11-year-olds, Dr. Martin said, but the dose would be smaller. The vials will be identified by a maroon color. Also, for very young children vaccines are often offered in the thigh instead of in the arm, she said.
There are 19 million children in the United States under age 5, and they are the only group not yet eligible for vaccination. While some parents are aching for the chance to get their children vaccinated, some are hesitant.
In a recent poll by the Kaiser Family Foundation, three in 10 parents of children under 5 said they would get their child vaccinated right away once a vaccine is approved for their age group. But 26% responded “definitely not.”
Dr. Martin said that when she speaks with skeptics, she tries to understand what the basis of parents’ hesitancy concerns are, whether they are from a lack of information or concerns about taking a child into a health care facility when the omicron variant is surging. “The bottom line is to try to individualize it,” she said.
However, she noted, “Most people that I speak to are very eager to have the vaccine available.”