RALEIGH, N.C.(WNCN) – Pfizer has moved closer to the approval of its COVID-19 vaccine for children under the age of 12. The next phase of their study will look at the safety, tolerability, and immune response of the vaccine.
Twins Marisol and Alejandra were the first kids under 12 to get a Pfizer COVID-19 vaccine in the company’s phase 1 clinical trials. They are nine years old.
“They were kind of eager to be first in line,” said their mom Dr. Susanna Naggie. She and the children’s father work in healthcare and research at Duke.
An infectious diseases doctor, Naggie thinks kids play an important role in overcoming the pandemic.
“We understand the importance of vaccination for us to be able to achieve the level of immunity that’s needed,” Naggie said.
The clinical trials at Duke tested different vaccine dosing levels for children to determine which offers the best level of protection.
“Children have the ability to transmit the disease even if they’re not symptomatic so that’s a major thing we want to cut off,” said professor of infectious disease, Dr. Tony Moody.
Moody leads the child vaccine studies at Duke.
“Kids are not small adults and you can see all kinds of surprises when you study drugs or vaccines at younger age ranges,” he said.
Pfizer is now expanding their clinical trial from 48 to 4,500 participants in the U.S., Spain, Finland and Poland. The company has now settled on the following dosing levels for children:
- 3 micrograms for children 6 months to 5 years old
- 10 micrograms for children 5 to 11 years old
People 12 and up are currently receiving 30 micrograms.
“It was a balance of strong immune response with an acceptable side effect profile,” said Moody.
As with the 12 and older group, children 11 and under will receive two doses three weeks apart. Trial participants are monitored for a total of two years.
So far, Moody said side effects in children are mimicking those in adults like fever or chills.
Naggie’s children both got the dose Pfizer is moving forward with. They only felt sore arms.
“They both said, I think that means it’s working so they were very excited to have the sore arms because they also remember mom and dad having the sore arms too,” Naggie said.
The most common side effects Pfizer reported are:
- Injection site
- Muscle pain
- Joint pain
Moody, his wife and daughter all participated in trials themselves.
“I’m a believer personally and I think it’s important to have skin in the game if you’re really going to get out there and say what you think,” Moody said. He thinks participating in vaccine trials and getting your shot is how we can ultimately slow down this virus.
The Pfizer vaccine won’t be alone in its differences in boosters. Moody said many vaccines including flu shots have lower dosing for children than for adults.
When it comes to booster shots, Moody said dosing often goes the other way around.
“The theory of boosters that you get as an adult is actually a lower dose than the dose you get as a child. We just have to a do the study to find out which one works,” Moody said.
As far as timing, Pfizer has said it expects to ask the FDA for Emergency Use Authorization between September and October for children 5 to 11. It expects to request authorization soon after for children 6 months to 5 years old.
Moderna revealed this week, they expect to have authorization for children as young as 5 years old to use their vaccine by early fall.