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 authorise a vaccine.
Three other companies “” Johnson & Johnson, Novavax and AstraZeneca “” also plan to test their vaccines in children, but are further behind.
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 paediatric diseases. But it made sense for coronavirus vaccines to be first tested in and authorised 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 prioritising 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 United States, but they make up less than 1% of deaths from COVID-19. Still, about 2% of children who get COVID-19 require hospital care, and at least 227 children in the United States have died of the disease.
Children will also need to be vaccinated in order for the United States to approach herd immunity “” that long-promised goal at which the pandemic slows to a halt because the virus runs out of people to infect.
“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 immunise children in racial and ethnic populations that are 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 authorised 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 vaccine, which was also authorised in December, is on a similar track for paediatric 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.
The trials will also assess the vaccine’s safety in children “” and hopefully ease any fears that parents have. One-third of adults in the United States have said they do not plan to have their children immunised against the coronavirus, according to a recent poll conducted by Verywell Health.
Given the low risk of COVID-19 in children, some parents might be sceptical of the urgency to inoculate their children with a brand-new jab, 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 immunised so far, with few lasting side effects. And the FDA has set up multiple systems to carefully monitor any serious reactions to the vaccine.
“They’re really looking at the data very, very closely,” Oliver said. “As a paediatrician and a mom, I have really good confidence that those systems work.”
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. “We should be planning now for opening schools.”
Oliver also urged parents to make sure children are immunised for other diseases. According to the CDC, orders for nonflu childhood vaccines through the Vaccines for Children Program are down approximately 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.”
