The earliest Pfizer’s COVID-19 vaccine could become approved for children under 12 is November, according to Dr. Barbara Pahud, who is leading a clinical trial at Children’s Mercy in Kansas City.
The hospital’s study, which began in April, includes a group of children over the age of five and a group under five.
Those over five are getting their second doses and doing follow-up visits. Those younger are still in the initial phase of visits.
Pahud said there was a huge interest in the trial with more than 5,000 people vying for the 72 spots available locally. Other sites across the country are conducting the study, too.
The dosages are less than the Pfizer vaccine currently being distributed to people age 12 and older.
The FDA requires a minimum of two months of safety follow-up data.
“Multiple steps need to happen before this can be in the kids’ arms and I’m guessing at the earliest, that will be probably November,” Pahud said.
After Pfizer submits data from the study, the FDA will review it and decide whether to issue emergency use authorization. If an EUA is approved, the Advisory Committee on Immunization Practices then meets to make a recommendation.
Pahud said the November time frame is the best case scenario.
In the spring, concerns about blood clotting with the Johnson & Johnson vaccine delayed the FDA’s decision on expanding the Pfizer vaccine to kids ages 12 to 15. That age group became eligible in mid-May.
An unforeseen issue could delay approval of the vaccine for those under age 12 into December or next year.
Once children under 12 are eligible, Pahud said she thinks the vaccination rate will lag behind adult vaccinations because kids have not been affected by COVID-19 as hard as adults.
“That doesn’t mean they have not been affected — they have been,” she said. “This is still a pretty severe vaccine-preventable disease that is killing more kids than influenza.”
In Kansas, there have been 13,421 COVID-19 cases in children age zero to nine and 26,937 cases in youth age 10 to 17. In Missouri, there have been 19,863 cases in children age zero to nine and 40,198 in the 10 to 17 age group, according to state data.
There are also concerns about the vaccine causing myocarditis in rare instances, but Pahud said once diagnosed, it is manageable.
“I’m very afraid of seeing kids in the hospital with COVID and knowing that one of them could be one of your own kids when you could prevent it,” she said.
While Children’s Mercy collects more data from its trial in the coming months, Pahud said the most important step people can take to keep kids safe is for family members to get vaccinated.
“That’s a ring of protection around the child,” she said.
“Number two, the child that is unvaccinated should continue to wear masks whenever he’s around people that are not vaccinated ... I know that some schools are eager to get rid of the masks, because the world is eager to get rid of the masks. But if you’re asking me what is the best thing, the best protection truly for your child, either get the vaccine if you’re eligible and if you’re not, keep your mask on until you are. It’s really that simple.”