4:13 PM, Feb 27, 2020


FDA preparing to 'ok' Pfizer shot for kids ages 12-15

Approval could be granted by early next week
Posted at 9:31 PM, May 04, 2021
and last updated 2021-05-04 21:31:18-04

WXMI — As early as next week, the FDA is expected to amend Pfizer’s emergency use authorization to allow their vaccine to be given to children ages 12-15 years old.

Pfizer’s clinical trials involving 2,000 participants, half who got the vaccine and half who received a placebo, showed none of the vaccine recipients contracted COVID-19.

“It’s pretty much a foregone conclusion that the FDA will authorize it,” said Dr. Liam Sullivan, an infectious disease specialist with Spectrum Health. “The results of it were impressive to say the least. They did not have one case of COVID-19 in any of the vaccine recipients.”

It comes at a time in the pandemic where younger patients are contributing more and more to case numbers. In the first year of the pandemic, children made up roughly 3% of U.S. cases. As of this week, children made up 22% of U.S. cases.

“The pediatric audience certainly can get COVID, they can spread COVID and our older children, adolescents and teenagers can do so just as efficiently as our older population,” said Dr. Rosemary Olivero a pediatric infectious disease physician, also with Spectrum Health. “This is a population that’s highly mobile, that’s highly interactive, they do a lot of activities, they participate in school, extracurriculars, and this is a population that’s really important to trying to get past the pandemic and avoid more novel variants from surfacing.”

Because of new variants, children, left unvaccinated, are increasingly more vulnerable to the ever-evolving virus. They also make up a large percent of the U.S. population and doctors are now getting out ahead of concerns and misinformation; Dr. Olivero says there’s one in particular she sees consistently.

“It really centers around these myths about the mRNA vaccine potentially impacting fertility,” she said. “And I just want to say that those myths have been busted, they are not true.”

Olivero and other health experts are recommending schools incentivize vaccinations, tying prom, graduation ceremonies and maskless sports to kids getting their shots. As for mandating it, though Dr. Olivero believes that will be the case at some point, there’s no avenue for that right now in Michigan.

“Just from a complete regulatory perspective, we cannot mandate a vaccination that has only been authorized by the FDA and has not been approved,” she said.

Tuesday, Pfizer’s CEO also said the company was hoping to amend its EUA again in September for kids ages 2-to-11 years of age as soon as those ongoing trials wrap up.