SAN DIEGO (KGTV) — Infectious disease experts say it may take months before the first doses of a COVID-19 vaccine reach an important population: kids.
Some doctors worry it may already be too late to get a vaccine authorized for younger kids before the start of the next school year because of the time it takes to recruit children and conduct a new round of clinical trials.
“Our children under 12 years of age are almost certainly going into next school year without a vaccine option available for them,” said Dr. Evan Anderson, a pediatrician at Children’s Healthcare of Atlanta and associate professor at Emory University.
Dr. Anderson said such a delay could further impact school reopenings and have resulting consequences on children’s mental health, among other concerns. He said the window is rapidly closing to get a vaccine authorized in time for children older than 12 unless more trials begin immediately.
In October, Pfizer tested its vaccine candidate for the first time in 100 kids aged 12 to 15. Moderna is expected to begin testing in that age group in January, according to Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases. However, neither company has announced plans to begin testing their candidates in children under 12.
That’s concerning to the American Academy of Pediatrics, which has been calling on vaccine-makers to include children in clinical trials since September. The AAP argues immunization is critical to stemming the pandemic.
“We know that children can be infected with COVID-19 and can transmit it to others. To reduce the spread of this virus and control the pandemic as well as for their own safety, it’s crucial that children be included in the national vaccination program, and that vaccines are made available to children as soon as possible,” said Dr. Yvonne Maldonado, chair of the AAP Committee on Infectious Diseases, in another push last month.
Although COVID-19 takes a more severe toll on older adults, children make up about 12 percent of the infections in the U.S. and recent studies have shown kids over 10 years old can transmit disease as efficiently as adults, the AAP noted.
More than 1.3 million kids had been infected with COVID-19 as of Nov. 26.
Experts say it’s important that drug companies test COVID-19 vaccines in children separately from adults.
“Kids' immune systems are really different than adults. As any pediatrician will tell you, kids are not just small adults, their immune systems behave really differently,” said Dr. Christian Ramers of Family Health Centers of San Diego.
Dr. Ramers said testing is needed to find the right vaccine dose for kids and see if there are any unexpected side effects.
But there are challenging logistics in any pediatric trial. Since children’s immune systems change as they grow, vaccine-makers have to separate their trials into several age groups. That means more child volunteers are needed.
“I mean it's more challenging, as an investigator myself for research, to enroll a kid into a study because you have to get permission [from parents],” said UC San Francisco infectious disease expert Dr. Peter Chin-Hong.
Because parents have to sign off, experts say it can take much longer to enroll enough kids for a study.
In a statement to ABC 10News, Pfizer said it is “working actively with regulators on a potential pediatric study plan.”
“As we do with all vaccines which are initially studied in adult populations, we are following a careful, stepwise approach as we move down to younger age groups,” said Jerica Pitts, Pfizer’s director of global media relations.
“Global regulatory agencies require evaluation of the candidate vaccine in pediatric populations. Moving below 12 years of age will require a new study and potentially a modified formulation or dosing schedule,” she added.
Could a vaccine become mandatory at schools?
Once a vaccine is approved for kids, a lot of parents are wondering if and when it might become mandatory at California schools.
The California Department of Public Health told ABC 10News several things would need to be in place before it would consider making a vaccine mandatory at either schools or child care facilities.
The vaccine would need to reviewed and approved by the FDA and recommended for use in children by the federal Advisory Committee on Immunization Practices. The state would also look for a recommendation by the American Academy of Pediatrics, and there would need to be "sufficient vaccine supply to enable access for all children."