Sep 13, 2021 -- Though parents may be worried, they should not ask their health care providers to give a COVID-19 vaccine to children under 12 until the government approves a vaccine for that age group, the U.S. Food and Drug Administration said Friday in a statement.
FDA Commissioner Janet Woodcock, MD, and Peter Marks, MD, of the FDA’s Center for Biologics Research and Evaluation said they hoped a vaccine for younger children would be authorized in coming months, but they didn’t say when that might happen.
Different age groups may need different doses of vaccine, they said. The vaccines for children under 12 being studied in clinical trials may not be the same as those authorized for older children, they said.
“Children are not small adults – and issues that may be addressed in pediatric vaccine trials can include whether there is a need for different doses or different strength formulations of vaccines already used for adults,” Woodcock and Marks said.
The FDA is coming under pressure to speed up the development of pediatric vaccines because the Delta variant is infecting a growing number of people in the United States, most of whom are unvaccinated. Children under 12, for whom no vaccine has been authorized, make up a large part of that unvaccinated population.
While children generally don’t get as sick with COVID-19 as other age groups, a growing number of children are being hospitalized because of the Delta variant, especially in states with low vaccination rates.
In May, the government authorized Pfizer/BioNTech vaccines for children 12-15. The Moderna and Johnson & Johnson vaccines are authorized for 18 and up. Clinical trials for younger age groups are now under way.
Woodcock and Marks said the government would “follow the science” in developing vaccines and would not cut corners in clinical trials.
“Just like you, we are eager to see our children and grandchildren vaccinated against COVID-19 as soon as possible,” the statement said. “We have to let the science and data guide us. The FDA is working around the clock to support the process for making COVID-19 vaccines available for children.”