Pfizer released trial results Monday of a COVID vaccine for children ages 5 to 11 that uses one-third the dosage given adults, a move one pediatric expert called a foretaste of developments to come.
Pfizer should have the results before the Food and Drug Administration later this month, said Dr. David Kimberlin, professor and co-director of UAB and Children’s of Alabama’s Division of Pediatric Infectious Diseases.
“(Dr. Anthony) Fauci has said it would be authorized before Halloween,” he added.
Pfizer said its study shows “a favorable safety profile and robust neutralizing antibody” for the 5-11 age group.
The study gave Pfizer the results the company wanted to see, Kimberlin said. The study used one-third the adult dosage for children, which was selected for its safety, tolerability and immunogenicity, according to Pfizer.
“It’s the same vaccine, just in a smaller amount,” Kimberlin said. He said Moderna is expected to submit its study of a children’s dose to the FDA in October.
During a briefing on Monday, Kimberlin and Dr. Rachael Lee, associate professor of UAB’s Department of Infectious Diseases, discussed the the latest developments with COVID cases and deaths from the disease in Alabama.
They acknowledged that the number of cases of cases of the delta variant is slowly coming down, but said there has not been a similar drop in the death rate.
“We had a 177% increase in the number of deaths over the past 14 days,” Lee said.
Through Sunday, Alabama had averaged 3,255 new cases and 76 deaths from the coronvirus over the previous seven days. That was down from a seven-day average of 5,206 cases on Sept. 1 but up from an average of 32 cases a day at the beginning of the month.
UAB Hospital has seen a slow downtick in the number of cases, Lee said.
Kimberlin said the age demographic for a vaccine for children is important.
“We have treated a lot of children under the age of 12 for Covid. There is no way to protect them at this time other than masks and distancing,” he said. “Now we will have something that will protect children in schools, and schools can stay open.
“But we won’t put this behind us until all are vaccinated.”
Kimberlin said schools should not rescind mask mandates, but should follow the advice of the Center for Disease Control.
“As rates decline, then we can loosen up,” he added.
Over the past few weeks Children’s has seen two to three times more Covid cases than it experienced last January.
“A third are on ventilators, and some are on heart-lung bypass machines,” Kimberlin said.
The body surface area of children does not factor in to studies of Covid vaccines for them, he said.
“The vaccine is based on the maturation of the immune system as we know it” and not the person’s size.
But, he added, he has not seen Pfizer’s data set.
Kimberlin said he expects to see more data next year about vaccines for children from 6 months to 4 years old.
Both doctors suggested that vaccinated persons should urge business to impose mask requirements.
“We have to be polite, but we don’t have to be silent,” Kimberlin said.