YOUTHS LIKELY TO BE LAST TO GET VACCINE
Kids may have to wait months longer as testing continues
As the United States eagerly awaits the availability of a safe, effective vaccine for the coronavirus that has plagued the nation for months, a significant group, making up more than onefifth of the population, will need to wait longer for immunization: children.
On Sunday, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, acknowledged it is going to take time, perhaps even months, before those younger than 18 can get a coronavirus vaccine, as trials to test the vaccine candidates’ immunogenicity are either under way or have yet to begin. Pfizer, which is developing a vaccine with German partner BioNTech, announced in October they were expanding testing of their vaccine to those 12 and older. A similar announcement is expected soon from Moderna, which has partnered with the National Institutes of Health on an experimental vaccine, with Fauci hinting an expedited process to test the vaccine in children would begin “very likely in January.”
“Before you put it into the children, you’re going to want to make sure you have a degree of efficacy and safety that is established in an adult population, particularly an adult, normal population,” he said Sunday on NBC’s “Meet the Press.” NIAID did not respond to requests for comment about the pediatric trials or Fauci’s suggested timeline.
Moderna posted a trial design Wednesday on the National Institutes of Health website but declined to offer additional information about when it will begin recruiting participants. The randomized study would include about 3,000 participants who are 12 to 18 years old.
The wait has prompted pediatricians and other public health experts to voice concerns that further delays endanger at-risk children, hinder efforts to return schools to normalcy and stall herd immunity.
Children’s immune responses are different from that of adults, so there is a consensus that pediatric trials are critical for testing the safety, efficacy and immunogenicity (or effective immune response) of vaccines on kids.
But some experts have said testing on children should have begun sooner, especially after the successful adult trials.
“To be completely frank, many of us are disappointed with this timeline,” said Andrew T. Pavia, the chief of the pediatric infectious diseases division at the University of Utah. “We think that there was enough safety data emerging and early efficacy data a month or six weeks ago that the adolescents could have been added earlier.”
Even after vaccine producers announce expanded trials for children, it will still take time to recruit young participants, gather data and get approval, not to mention scaling production, Pavia said.
A representative for Pfizer said the company had shared safety data on about 100 children between ages 12 and 15 when it submitted its emergency use authorization application to the U.S. Food and Drug Administration, but enrollment “may” expand and more information about efficacy and immunogenicity is being collected. The company could not say when the vaccine might be publicly available for children.
The inclusion of children in Pfizer’s third phase could mean that the FDA may expedite approval for the age group older than 12, depending on the data.
The lag in testing the experimental vaccines on children prompted American Association of Pediatrics President Sally Goza to write to federal leaders in September, arguing pediatric trials were essential for curbing the pandemic, as older children could transmit the virus as much as adults. More than 1.1 million U.S. children have tested positive for the novel coronavirus, according to the group of pediatricians.
Several experts have expressed hopes that a vaccine could be available for children before the start of the new school year, putting an end to the disruptions in learning. One is Evan Anderson, a pediatrician at Children’s Healthcare of Atlanta, who co-authored an article published in the journal Clinical Infectious Diseases in September that pushed for pediatric trials to begin immediately.
But, Anderson said, the window is quickly closing for those younger than 12 who have not yet been included in the trials.