KANSAS CITY, Mo. — Pfizer announced the initial findings about the safety of its COVID-19 vaccine for children ages five to 11 Monday.
In a news release, the company said its phase 2/3 trial showed the vaccine was safe and produced a robust immune response.
The trial included 2,268 participants in children ages five to 11. They received a two-dose regimen administered 21 days apart.
As a pediatrician and a mother of an 11-year-old, Dr. Natasha Burgert is excited to see the initial findings.
"I wasn't expecting it this early," Burgert said. "I thought it would be closer to Thanksgiving before we'd be hearing anything."
It's still too early for Burgert to recommend the vaccine for use in the 5 to 11 age group as she awaits further data.
"We still have a lot of data to review, but today is a good day," Burgert said.
There are still quite a few steps ahead as Pfizer plans to submit data to the U.S. Food and Drug Administration for emergency use authorization.
Burgert said the process could take a month or so considering prior EUA applications.
"I think the message that's important for eager parents and pediatricians who are waiting for this vaccine is we have waited this long, we want to make sure that we let our experts get this right," Burgert said.
Trial participants received 10 micrograms of the vaccine, which is one-third of the amount those 12 and over received.
Burgert said the dosage is smaller for younger children because of their hyper-active immune systems.
"They don't need as much medicine in the vaccine as an older person does and this is true for many of the vaccines that we give for kids," Burgert said.
Burgert expects side effects would be similar to what those 12 and over have experienced, such as headache, fever and arm soreness.
Burgert said her 12 and older patients who have received the vaccine have done quite well with it. If Pfizer receives an EUA for the 5 to 11 age group, she plans to recommend it to her patients.
"These kids want this vaccine, they want to be able to take their masks off and have fun with their friends and this is the way they're going to be able to do it," Burgert said.