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SALT LAKE CITY — COVID-19 vaccines for infants and toddlers are now scheduled to be considered by the Food and Drug Administration in June, and a top official of the federal agency pledged at least some shots should be available later that month.
"We are not going to delay things unnecessarily here," Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, told the Washington Post, adding that if safety and other data from the vaccine makers hold up to scrutiny, "we would anticipate June authorizations for one or more of the pediatric vaccinations."
The FDA has announced that an outside advisory panel is tentatively scheduled to meet June 8, 21 and 22, to discuss extending the use of Pfizer and Moderna COVID-19 vaccines to younger children. Currently Pfizer is available to everyone 5 and older while Moderna is only authorized for adults.
Last week, Moderna requested emergency use authorization to use its vaccine in children 6 months to 6 years old, while Pfizer is still several weeks away from submitting data on the effectiveness of a third dose in children 6 months to 5 years old.
Pfizer had sought approval to use its vaccine in that age group earlier this year, but the process stalled when two doses produced disappointing results. The Utah Department of Health had been prepared in February to distribute 23,000 infant and toddler doses of the Pfizer vaccine statewide.
Both companies are using much smaller doses in infants and toddlers than given to adults.
The FDA had been criticized by parents, politicians and others for plans to wait until the requests from both Pfizer and Moderna could be reviewed at the same time. In Utah, Dr. Anthony Pavia told the Deseret News last week that the wait has been "frustrating" for everybody.
Marks spelled out to the Washington Post that each vaccine maker's application will be considered as soon as the data are ready, even if that means holding separate meetings of the advisory panel. He said neither company's application was "fully complete."
All of the remaining data needed by Moderna is expected to be filed by early in the second week of May, the Washington Post reported, citing "a senior Biden administration official, who spoke on the condition of anonymity because the official was not authorized to discuss the matter publicly."
Pavia, chief of the pediatric infectious diseases division at University of Utah Health and director of hospital epidemiology at Intermountain Primary Children's Hospital in Salt Lake City, said making the Moderna vaccine available as soon as possible is something "a lot of parents would find very comforting and important."
But he said waiting until the Pfizer data can also be reviewed so a single set of recommendations is seen by some as less confusing. Pavia's preference is clear.
"As a pediatrician who cares a lot about children and COVID, I think we've waited a long time and we should be moving as quickly as we can safely move," he said.
