Meissner abstained from the committee’s vote Thursday that supported, by a 17-4 vote, an emergency authorization of the Pfizer vaccine for people 16 and older.
“I have trouble justifying it for children so unlikely to get the disease,” he said during debate on the measure.
But panel member Dr. Ofer Levy, director of the Precision Vaccines Program at Boston Children’s Hospital, said the 16-and-up authorization would speed the vaccine’s testing in and approval for younger children. That is vital for the world’s protection from COVID-19, he said, since in the United States and most places “most vaccines are delivered early in life.”
While vaccines given to tens of thousands of people so far appear to be safe, the lack of understanding of the inflammatory syndrome means that children in any trials should be followed closely, said Dr. Emily Erbelding, director of the Division of Microbiology and Infectious Diseases at the National Institute of Allergy and Infectious Diseases.
Under a 2003 law, vaccine companies are required eventually to test all their products on children. By late last month, Pfizer had vaccinated approximately 100 children 12-15 years of age, said spokesperson Jerica Pitts.
Moderna has started enrolling 3,000 children 12 and over in another clinical trial, and other companies have similar plans. Assuming the trials show the vaccines are safe and provide a good immune response, future tests could include progressively younger children, moving to, say, 6- to 12-year-olds next, then 2- to 6-year-olds. Eventually, trials could include younger toddlers and infants.
Similar stepdown approaches were taken to test vaccines against human papillomavirus (HPV), influenza and other diseases in the past, Erbelding noted. Such trials are easiest to conduct when researchers know that a measurable immune response, like antibody levels in the blood, translates to effective protection against disease. Armed with such knowledge, they can see whether children were protected without them having to be exposed to the virus. Federal scientists hope to get that data from the Moderna and Pfizer adult vaccine trials, she said.
Vaccine trials geared to tweens or younger children may involve testing half-doses, which, if protective, would require less vaccine and might cause fewer incidents of sore arms and fevers that afflicted many who’ve received the Pfizer and Moderna vaccines, Campbell said.
But unless additional studies begin quickly, the window for having an FDA-authorized vaccine available before the next school year “will be closed even for our oldest children,” said Dr. Evan Anderson, a pediatrics professor at Emory University. “Our younger children are almost certainly going into next school year without a vaccine option available for them.”
In the meantime, teachers are likely to be high on the priority list for vaccination. Protecting school staff could allow more schools to reopen even if most children can’t be vaccinated, Erbelding said.
Eventually, if the SARS-CoV-2 virus remains in circulation, governments may want to mandate childhood vaccination against the virus to protect them as they grow up and protect society as a whole, Plotkin said.
In the 1960s, Plotkin invented the rubella vaccine that has been given to hundreds of millions of children since. Like COVID-19, rubella, or German measles, is not usually a serious illness for children. But congenital rubella syndrome afflicted babies in the womb with blindness, deafness, developmental delays and autism. Immunizing toddlers, which, in turn, protects their pregnant mothers, has indirectly prevented hundreds of thousands of such cases.
“We don’t want to use children to protect everyone in the community,” said Campbell. “But when you can protect both children and their community, that’s important.”
And while a coronavirus infection may not be bad for most children, missed school, absent friends and distanced families have caused them immense suffering, he said.
“It’s a huge burden on a child to have their entire world flipped around,” Campbell said. “If vaccinating could help to flip it back, we should begin testing to see if that’s possible.”