Pfizer says it’s ready to seek approval from the FDA to give its coronavirus vaccine to kids ages 5-to-11, and Chicago area doctors are hailing that news as an important step forward in finally stamping out the COVID-19 pandemic.
“We have been anticipating this. We’re really excited about it. Waiting for the EUA (Emergency Use Authorization) to go in before we can look at the final data,” said Dr. Frank Belmonte,Chief Medical Officer at Advocate Children’s Hospital.
After clinical trials involving more than 2,268 children, age 5 to 11, Pfizer and BioNTech say the vaccine showed “robust neutralizing antibody responses," and that research shows that it is safe for children to take.
The clinical trial consisted of a two-dose regimen, 21 days apart, with children in the younger age group getting a smaller dose of vaccine than what’s been authorized for individuals ages 12 and up.
“They actually decreased the dose to about a third of what they’re using for the older age groups. But despite the smaller dose, in the smaller children, it actually showed to be as vigorous as the other data that we have for older age groups,” said Dr. Frank Esper, with the Cleveland Clinic.
Pfizer didn’t release the data set to the public. It will be submitted when the drug maker requests an emergency use authorization, likely within one to two weeks, the company said.
“Based on what we’ve seen in kids ages 12 to 16, I think it’s going to be quite successful, but of course as physicians we all want to see the numbers and the data to make sure before we talk to parents about it,” Dr. Belmonte said.
The American Academy of Pediatrics continues to support getting a vaccine approved for children.
“AAP is eager to see the FDA review the full set of data as a next step for approval for the 5-11 children’s age group. Pediatricians are well-aware of the power and importance of vaccines. Vaccines have the power to stop epidemics,” said Dr. Lee Savio Beers, AAP President.
The news comes at a critical time in the battle against COVID, with doctors saying that the virus' delta variant is impacting kids differently.
“Whatever that resistance that children had before it is not as effective now. Children are at risk. We are seeing children with severe disease,” Dr. Esper said.
Belmonte says the situation in Illinois isn’t as dire, because of mitigations like masking in schools.
“You know, the state has done a good job mitigating, so we are seeing a lot of diagnoses but we’re not seeing a lot of hospitalizations,” Dr. Belmonte said.
Dr. Belmonte says vaccine for kids ages 5 to 11 would offer another layer of protection.
If the FDA signs off, shots could be authorized for the younger age group by Halloween.