ROCHESTER, Minn. -- With Pfizer having provided regulators strong preliminary data for the effectiveness of their COVID-19 vaccine in children ages 12-15, pediatricians have set a goal of full vaccination of the group in time for school in the fall.
In late March, the company released results from a trial of 2,260 adolescents, a study that found 100% efficacy in preventing symptomatic infection in children 12-15, and robust antibody responses and said the intervention "was well tolerated."
The Food and Drug Administration is reviewing those data to make a determination on an Emergency Use Authorization for the population, one that could come shortly. Trials are also under way for effectiveness of the vaccines in very young children. Pediatricians expect those results won't be ready until 2022, however.
In the meantime, the possibility of vaccinating the nation's pre-teens and teens is critical for public health goals of herd immunity.
"It's an exciting time as a father of six and someone who sees frontline pediatric patients in the clinic and hospital," said Dr. Joseph Poterucha, pediatric and critical care specialist, Mayo Clinic Health System in La Crosse, Wisconsin, during an afternoon press call on Wednesday, April 14.
"This is a reality and a hope that we've been really waiting for," Poterucha said. "It's just so exciting to know that we're extending this vaccine not just down to the teenager level, but the pre-teen level, with good safety and efficacy data."
Children make up 3.5 million of 30 million total cases in the U.S., or 13.5% of all people infected, said Dr. Nipunie Rajapakse, pediatric infectious diseases expert at Mayo Clinic. An increasing proportion of the nation's cases are in children, moreover.
Rajapakse said she believes this is due to vaccine rollout for older adults, and changes in behavior as areas start to open up and children return to school. While children tend to fare better with COVID-19, she added, over 300 in the U.S. have died, with many having had underlying risk factors.
"Some of these have been healthy children," Rajapakse said, "so we can't yet clearly predict which child may be at risk for more severe illness and which is not."
Kids are going to be the key
Children are roughly 20% of the U.S. population, and health officials believe 75% -80% vaccination will be required to get to herd immunity. Over one-third of the population has now received at least one dose.
"That hope of achieving herd immunity is coming closer," Poterucha said, "and it is so important to get those kids vaccinated to get there. . . Kids are going to be the key."
Besides an enormous population for the goal of herd immunity, vaccinating children is "a mechanism of liberation to connecting back with family, grandparents, loved ones," Poterucha said. "This is a mechanism to get back to reality."
"We all have concerns as parents about how our children are going to fare," he added. "What we know with this recent study of the Pfizer vaccine is that it's safe and it's effective. A lot of the reactions that may typically manifest in the six weeks after vaccination are not happening."
The adult useage for the vaccine is continuing to demonstrate safety as well.
"It's been now nine months and we're seeing good safety data.," Poterucha said. "No concerns with delayed immunization reaction. So we know that it's safe."
"From a bird's eye view we're really in a race against the variants," said Rajapakse. "We're trying to vaccinate as many people as possible before the variants take over and spread rapidly."
The FDA approves vaccines for age groups based upon those who have been tested in trials. There is nothing special about ages 12-15, the clinicians noted, only that it's just the age group studied most recently by Pfizer.