- Pfizer has formally asked the FDA to authorize its
COVID-19 vaccine for emergency use among kids ages 5 to 11. - A doctor who helped run Pfizer's
vaccine trial told Insider he wants his kids to be "first in line." - Here are the answers to common questions parents might have about the vaccine.
On Thursday, Pfizer formally requested that Food and Drug Administration authorize its
"With new cases in children in the US continuing to be at a high level, this submission is an important step in our ongoing effort against COVID-19," Pfizer wrote on Twitter.
The FDA has tentatively scheduled a meeting on October 26 to review Pfizer's request.
While adults and teenagers have been benefitting from vaccine protection for months, young kids have had few options beyond masks and social distancing in the face of the Delta variant and while returning to school in person.
"Delta has made COVID a pediatric problem," said Dr. Andrew Pavia, pediatric infectious disease specialist at the University of Utah.
But if all goes well and the government green-lights Pfizer's shot, here's what parents will need to know.
How can I be sure the vaccine is safe?
Pavia has served on advisory groups that review and suggest improvements to the US vaccine safety system - "I've been under the hood," he said.
The COVID-19 vaccine, he added, "isn't brand new - this isn't understudied."
So far, Pfizer's vaccine has been administered to more than 230 million Americans and has proven safe in teenagers, Pavia explained. Another factor that should reassure parents is that the US has a robust reporting system for detecting vaccine safety issues and side effects.
"It's been able to detect very rare side effects very effectively," Pavia said. He gave the example of myocarditis, inflammation of the heart muscle.
"Myocarditis in women occurs with a frequency of about two to five per million, and our safety systems are good enough to pick something up that's that rare," Pavia said.
Dr. Simon Li, too, has peered behind the curtain. He's a principal investigator helping run the vaccine study on kids in New Jersey alongside Pfizer, and an associate professor of pediatrics at Rutgers.
"The studies that are being done have been extremely, extremely cautious and careful and very well run," Li said.
Li's own kids are 4, 8, and 10, so not old enough to get the shots yet. The only reason he hasn't enrolled then in a vaccine study, he said, is that his role with Pfizer prohibits him from doing so.
"When it comes out, I'll be first in line" Li said of vaccinating his children.
Is the Pfizer shot for children the same one adults get?
Not exactly. The kids' vaccine is a two-shot formula, but it comes in smaller doses. Pfizer gave 30-milligram doses to adults, but 5- to 11-year-olds are receiving less than half of that.
Li likened the process to the comparatively small doses of other medicines, like Tylenol, that we give children. Children don't need the same dosage because they are smaller than adults and because their bodies process drugs differently.
"It's size and their ability to break down and react," Li said.
Should I give my kid an over-the-counter medicine like ibuprofen before their shot?
Some doctors say that taking pain medication to dim potential vaccine side effects isn't a big deal. But other experts and the CDC recommend against taking it, since "it is not known how these medications might affect how well the vaccine works." (A caveat: If your child takes regular medication for another reason, they should maintain their normal routine.)
Side effects are a sign that your body is learning how to respond to the virus and building immunity. While there's not research pain medicine would interrupt that process, the CDC is erring on the side of caution.
Once his kids can get the shots, Li said, "I will not be giving them anything - I want them to have that full immune reaction to build immunity against the virus."
I heard Moderna's vaccine is more effective than Pfizer's. Should my kids wait?
There is not yet data on how well Moderna's vaccine works among children, but real-world study published in the New England Journal of Medicine last month found that among adults, Pfizer's vaccine had an efficacy rate of 88.8%, compared to Moderna's 96.3%.
Li says the difference is tiny compared to the risk of leaving your child unvaccinated for weeks or months while Moderna seeks FDA authorization. So it's best not to wait.
"I would advise them to get vaccinated as soon as they can. Those differences are so small. That's just silly," he said.
Nearly 5.9 million children have tested positive for the virus since the start of the pandemic, according to the American Academy of Pediatrics. COVID-19 deaths among children are uncommon - the CDC has recorded 650 so far. But there have been 5,217 cases of multisystem inflammatory syndrome in children, a rare but serious condition associated with COVID-19 in which body parts like the heart, lungs, brain, or other organs become inflamed.
If my kid experiences vaccine side effects, who should I contact?
Call your pediatrician if your child has any issue - "they'll be ready," Li said.
Most pediatricians are by now well-versed in the vaccine and its side effects. They are also required to report any clinically significant side effects to the Vaccine Adverse Event Reporting System, an early warning system run by the CDC and FDA.