Vaccinating millions of children ages 5 to 11 will help the country reach herd immunity against COVID-19, but parents should get their children vaccinated for their own good, says a doctor at Duke University who helped test the vaccine’s safety and effectiveness in children.
While young children are less likely to get seriously ill from the coronavirus, they aren’t totally spared, says Dr. Emmanuel “Chip” Walter Jr., a pediatrician and chief medical officer at the Duke Human Vaccine Institute. More than 8,300 kids from that age group have been hospitalized with COVID-19 nationwide and nearly 100 have died, according to data reported to the FDA this week.
“We have to be able to afford children the same protection from COVID through vaccination that we afford to adults. I think that is the right thing to do,” Walter said. “My advice to parents is this is the best way to protect your child from serious illness and potentially death from COVID.”
On Tuesday, an FDA advisory panel recommended the agency allow children ages 5 to 11 to receive child-size doses of the Pfizer-BioNTech vaccine. The panel recommended the doses be 10 micrograms, a third the amount given to older children and adults.
The advisory group concluded that the benefit of preventing COVID-19 in young children outweighed potential risks of using the vaccine. Walter agrees. He led a clinical trial at Duke in which 3,000 kids 5 to 11 were given the Pfizer vaccine and another 1,500 were given a placebo.
The FDA is not bound by recommendations from advisory panels but usually follows their advice. If the FDA agrees and the Centers for Disease Control and Prevention offers guidance, children could begin getting the first of two shots of the Pfizer vaccine in early November.
The shots for children would be available under the FDA’s emergency use authorization. That means studies suggest they work and are safe but long-term monitoring the agency normally requires has not been done yet. The Pfizer vaccine was authorized on an emergency basis for people 16 and older for eight months before receiving full approval in August.
Walter said testing under the emergency use process is done more quickly and with more urgency, but the process is the same. He said the children involved in the studies will be monitored for two years.
“There is a sense of rapidity, but it really is meeting all the same safety standards,” he said. “What may be slightly different is how long the follow-up is. .... But ultimately all of these children are being followed for the same period of time that you would normally do.”
During a press briefing Wednesday, Walter answered several other questions about giving COVID-19 vaccines to young children:
Is the vaccine given to children the same one given to teens and adults?
Yes. The only difference is the dose. The doses for children 5 to 11 will come in packages with orange caps and labels, to contrast them with the purple packaging for teens and adults.
What are the potential side effects?
The most common are low-grade fever, achiness and headaches. “Usually the symptoms are pretty mild in most cases,” Walter said. “Maybe a little bit moderate, but they resolve within a day or two.”
Researchers have been looking closely at the risk of developing inflammatory heart conditions, myocarditis and pericarditis, following vaccination. The FDA and CDC have found a slightly increased risk, particularly following the second dose of the Pfizer and Moderna vaccines, primarily in young men.
Walter said COVID-19 itself sometimes causes severe cases of myocarditis that keep people in the hospital for a long time. In contrast, he said, the heart conditions associated with the vaccines have been “fairly mild. It does often lead to hospitalizations, but it’s usually very easily treated once it’s recognized.”
There can be a size difference between 5- and 11-year-olds. Will the vaccine work the same in small and large kids?
Children in that age group should respond with a “good, robust immune response” regardless of their size, Walter said.
“In terms of safety, we did study a range of kids within that age group, and the safety really didn’t appear to be different across the age group,” he said.
If I have an 11-year-old, should I simply wait until he/she turns 12 to get the full 30-microgram dose of the vaccine?
Walter says he would not wait. “At age 11, children will develop as good an antibody response or protected level of neutralizing antibodies in the blood at 10 micrograms of vaccine as they do from 30 micrograms,” he said. “So I’m confident they’ll have the same protection.”
Will there be a COVID-19 vaccine for children under age 5?
Preliminary studies suggest that 3 micrograms of the vaccine, one-tenth of the adult dose, will provide the best immune response with the fewest side effects, Walter said. But the large-scale studies are still taking place.
He said very young children are being studied in two groups, those 6 months up to 2 years old and those 2 to 4. Depending on the study results, he expects the vaccine could be available for 2- to 4-year-olds early next year.
Will children ages 5 to 11 need to get booster shots in the future?
It’s too soon to tell, Walter said. The level of protection from vaccination decreases over time, but additional studies would be needed to determine if booster shots are safe and effective.
“And I think you would have to have a compelling need,” he said. “There would still have to be COVID in the community in order to do that.”