Vaccines for children coming, just not soon
As adults at high risk for COVID-19 line up to be immunized against the coronavirus, many parents want to know: When will my child get a vaccine?
The short answer: Not before late summer.
Pfizer and Moderna have enrolled children 12 and older in clinical trials of their vaccines and hope to have results by the summer. Depending on how the vaccines perform in that age group, the companies may then test them in younger children. The Food and Drug Administration usually takes a few weeks to review data from a clinical trial and authorize a vaccine.
Two other companies — Johnson & Johnson and Novavax — also plan to test their vaccines in children, but are further behind.
Meanwhile, the University of Oxford announced Saturday that it plans to test its vaccine in children, according to The Associated Press. The trial seeks to recruit 300 volunteers between the ages of 6 and 17, with up to 240 receiving the COVID-19 vaccine and the remainder a control meningitis vaccine.
The Oxford vaccine is being produced and distributed by AstraZeneca.
When researchers test drugs or vaccines in adults first, they typically then move down the age brackets, watching for any changes in the effective dose and for unexpected side effects.
“It would be pretty unusual to start going down into children at an early stage,” said Dr. Emily Erbelding, an infectious diseases physician at the National Institutes of Health who oversees testing of COVID-19 vaccines in special populations.
Some vaccines — those that protect against pneumococcal or meningococcal bacteria or rotavirus, for example — were tested in children first because they prevent pediatric diseases.
But it made sense for coronavirus vaccines to be first tested in and authorized for adults because the risk of severe illness and death from COVID-19 increases sharply with age, said Paul Offit, a professor at the University of Pennsylvania and a member of the FDA’s vaccine advisory panel.
“We’re trying to save lives, keep people out of the ICU, keep them from dying,” Offit said. That means prioritizing vaccines for the oldest people and for those with underlying conditions.
People younger than 21 account for about one-quarter of the population in the U.S., but they make up less than 1% of deaths from COVID-19. Still, about 2% of children who get COVID19 require hospital care, and at least 227 children in the country have died of the disease.
Children will also need to be vaccinated in order for the U.S. to approach herd immu
nity — that long-promised goal at which the pandemic slows to a halt because the virus runs out of people to infect. Scientists have estimated that 70% to 90% of the population might need to be immunized against the coronavirus to reach herd immunity, especially with more contagious variants expected to circulate widely in the country.
“Not all adults can get the vaccine because there’s some reluctance, or there’s maybe even some vulnerable immune systems that just don’t respond,” Erbelding said. “I think we have to include children if we’re going to get to herd immunity.”
It will also be important to immunize children in racial and ethnic populations hit hardest by the pandemic, she added.
Pfizer and Moderna’s clinical trials in adults each enrolled about 50,000 participants. They had to be that
large to show significant differences between the volunteers who received a vaccine and those who got a placebo. But because it is rarer for children to become seriously ill with COVID-19, that kind of trial design in children would not be feasible, because it would require many more participants to show an effect.
Instead, the companies will look at vaccinated children for signs of a strong immune response that would protect them from the coronavirus.
The Pfizer-BioNTech vaccine was authorized in December for anyone 16 and older. The company has continued its trial with younger volunteers, recruiting 2,259 adolescents from 12 to 15 years of age. Teenagers are roughly twice as likely to be infected with the coronavirus as younger children, according to the Centers for Disease Control and Prevention.
Results from that trial should be available by summer, said Keanna Ghazvini, a spokeswoman for Pfizer.
“Moving below 12 years of age will require a new study and potentially a modified formulation or dosing schedule,” Ghazvini said. Those trials will most likely start later in the year, but the plans will be made final after the company has data from older children, she added.
Moderna’s va c c i n e, which was also authorized in December, is on a similar track for pediatric testing. In December, the company began testing adolescents ages 12 through 17, and plans to enroll 3,000 volunteers in this age group. The company expects results “around midyear 2021,” said Colleen Hussey, a spokeswoman for Moderna.
Based on the results, Moderna plans to assess the vaccine later this year in children between the ages of 6 months and 11 years.
Infants may have some antibodies at birth from vaccinated or infected mothers, but that maternal protection is unlikely to last through the first year of age. And with their relatively weak immune systems, babies might be particularly susceptible to infection if community transmission is high.
The trials will also assess the vaccine’s safety in children — and hopefully ease any fears that parents have.
Given the low risk of COVID-19 in children, some parents might be skeptical of the urgency to inoculate their children, Offit said.
“For that reason, the vaccine would have to be held to a very high standard of safety,” he said.
More than 42 million people in the United States have been immunized, with few lasting side effects. And the FDA has set up multiple systems to monitor any serious reactions to the vaccine.
“They’re really looking at the data very, very closely,” said Dr. Kristin Oliver, a pediatrician and vaccine expert at Mount Sinai Hospital in New York.
Once a vaccine for children is available, schools can reintroduce extracurricular activities that involve close contact, like band practice, team sports and choir. But in the meantime, there is ample evidence that schools can reopen with other precautions in place, Oliver said.
“I don’t think we need to anticipate having a vaccine in order to open schools in the fall,” she said. Oliver also urged parents to make sure children are immunized for other diseases. According to the CDC, orders for nonflu childhood vaccines through the Vaccines for Children Program are down 10.3 million doses overall.
“Now’s the time to really catch up on missed doses of those vaccines,” she said. “Measles, HPV, tetanus boosters, pertussis boosters — all of that is really important.”