White House chief medical adviser Dr. Anthony Fauci said Wednesday the FDA is awaiting data from a trial determining the adequate dosage for the Pfizer-BioNTech vaccine. If the data looks favorable, the FDA could sign off in short order.
“My hope is that it’s going to be within the next month or so and not much later than that,” Fauci told Blue Star Families, a nonprofit group that helps military families.
“But I can’t guarantee that because I can’t out-guess the FDA,” he cautioned. “I’m going to have to leave that to them.”
Pfizer said last month it expects to submit the data in the first half of 2022.
Early results suggest children age 6 to 24 months would receive a high degree of protection from a two-dose regimen, while children between the age of 2 and 5 years would receive three.
The likely dose per shot for younger children, 3 micrograms, is much smaller than the 10-microgram pediatric formulation that’s been approved for children age 5 to 12. Adults, meanwhile, get a per-shot dose of 30 micrograms.
Children under 5 are the only group so far who aren’t eligible for a vaccine, leaving them especially vulnerable to COVID-19 amid a nationwide surge in the omicron variant, which is infecting children in record numbers.
While age seems to be a significant risk factor in the severity of the disease, children nevertheless remain at risk, Fauci said.
“It is true that a child that gets infected is much less likely to get a severe manifestation of COVID,” he told Blue Star Families. “However, the risk is not zero and when you look at children’s hospitals throughout the country, we have plenty of children who are severely ill with COVID-19, requiring hospitalization, some even dying.
“So even though the risk is less than an adult, you have to balance.”