Editor's note: On Feb. 11, Pfizer and BioNTech said they'd delay their request for the Food and Drug Administration to authorize their Covid vaccine for children under age 5 until at least April.
Children under age 5, the last remaining age group still ineligible for Covid vaccines in the U.S., could finally become vaccine-eligible soon — and some parents have questions about it.
The U.S. Food and Drug Administration's vaccine advisory committee is set to meet on Feb. 15 to discuss a potential emergency use authorization for Pfizer and BioNTech's child-sized Covid vaccine, intended for kids ages 6 months to 5 years. On Tuesday, Pfizer CEO Albert Bourla told CNBC he thinks "the chances are very high for FDA to approve it."
On Wednesday, CNBC reported that the CDC plans to start distributing the kid-sized doses, once approved, to state and local health officials by Feb. 21. Here's the catch: Full data on the two-shot regimen isn't expected to be available until Friday, and the data from its first set of trials was underwhelming.
In December, Pfizer reported that two doses did not produce the desired immune response in children ages 2 to 5. Ultimately, the company says, small children will likely need a third dose at least two months after the second one — but that third dose is still in trials, and its data will likely be submitted to the FDA in the coming months.
It may be difficult for parents to sift through those details and make informed decisions for their small children. Here's what you need to know:
The push to get young kids vaccinated follows a rise in child hospitalizations last month, as Covid's omicron variant continues to sweep across the country.
During the first full week of January, the CDC charted 15.5 Covid-associated hospitalizations per 100,000 children under the age of 4. That's a nearly seven-fold increase over the first full week of December, which saw only 2.4 hospitalizations per 100,000 children. Hospitalizations have since decreased to 6 per 100,000 children for the week ending on Jan. 29, according to the agency.
Last week, Pfizer and BioNTech said their FDA request is due to an "urgent public health need" — and by getting the first two doses authorized, parents can start getting their kids vaccinated while waiting for the third dose's approval.
The early data from December could be confusing and concerning to parents hoping to get their kids vaccinated, but many pediatric infectious disease experts are hopeful that the next round of data will show more effectiveness, particularly in preventing hospitalizations.
"I think that it's worthwhile, vaccinating kids under [age] 5, because even though most kids at that age who get Covid just have a mild illness, some of them do not," says Dr. Juan Dumous, a pediatric infectious disease specialist at Johns Hopkins All Children's Hospital in Saint Petersburg, Florida. "Even right now, we have children that age in our hospital with Covid."
Dumous says some young children who catch severe cases of Covid require oxygen to breathe. Other children can develop a rare but serious post-Covid condition called MIS-C, a multisystem inflammatory syndrome that causes various body parts — including the heart, lungs, skin and eyes — to become severely inflamed.
Dr. Matthew Harris is the medical director for Northwell Health's vaccine program, and a pediatric emergency doctor at Cohen Children's Medical Center in Queens, New York. He's also the father of two 7-year-old twins and a 4-month old.
As such, he says, the most common question he gets is: Are you going to give this vaccine to your kids?
"And I can very clearly say to them, yes," Harris says. "My school-aged kids are already fully vaccinated, and my infant who will [hopefully] be eligible in about a month and a half will certainly be vaccinated."
Harris doesn't blame parents for asking the question, saying "it's appropriate to have a healthy sense of skepticism" when making decisions for your children. For him, the data from the tens of millions of doses already handed out to older children and young adolescents show the vaccines' robust safety profiles, and a proven amount of protection against Covid.
Some parents are concerned about potential long-term vaccine side effects popping up years, or even decades, later. But Dr. Mark Sawyer, an infectious disease specialist at Rady Children's Hospital who served on the U.S. Food and Drug Administration advisory committee that approved Covid vaccines in 2020, says the odds are practically nonexistent.
"It hasn't happened, ever," Sawyer says, noting the long history of vaccines in the U.S. "So why would this vaccine suddenly be different?"
Dumous notes that with all vaccines, side effects typically occur within a day or two — and almost always within four to six weeks. "So if something hasn't developed in that period of time, then it's not something you can even blame on the vaccine," he says.
For anyone ages 12 and older, Pfizer and BioNTech's vaccine has a dosage of 30 micrograms per shot. Kids aged 5 to 11 get 10 micrograms per shot.
For the new group of small children, the drugmakers have proposed just 3 micrograms per shot.
Dr. Sonja Rasmussen, a pediatrics and epidemiology professor at the University of Florida College of Medicine and College of Public Health, says that while she's waiting to see the newest data before recommending the vaccine to young kids, she's encouraged by the effort to select an appropriately low dosage for the age group.
"The company has worked really hard to get the lowest dose that gives an immune response, but keeps the side effects very low," she says.
If the data shows that the doses are safe and effective, Rasmussen says, their benefits outweigh the potential risks.
It remains to be seen whether parents will be eager to embrace the shots, once approved. Only three in ten parents of children under age 5 say they'll get their children vaccinated right away, according to a poll published last week by the Kaiser Family Foundation, a health policy and research nonprofit.