A Food and Drug Administration review this week determined that Pfizer/BioNTech’s Covid-19 vaccine is safe and effective for children ages 5 to 11, paving the way for a shot to be authorized for that age group as soon as early November.
Pfizer also announced on Friday that the vaccine is more than 90 percent effective at protecting school-age children from serious illness or hospitalization from Covid-19, similar to the level of protection it provides in adults.
The FDA analysis looked at data from Pfizer clinical trials in four different scenarios and concluded that any risks — in particular, a vaccine-related pediatric myocarditis that typically lasts a few days — were negligible in comparison to the benefits for the age group.
Previous data from Pfizer showed young children were able to tolerate the vaccine well and produced a strong immune response, and the results of Friday’s FDA review are further confirmation of its effectiveness.
The 2,268 children ages 5 through 11 in Pfizer’s clinical trials received doses a third the size of an adult vaccine dose, spaced 21 days apart.
Now that the initial review is complete, there are just a few steps left before Pfizer’s coronavirus vaccine can be authorized for the approximately 28 million American children ages 5 through 11.
Next week, the FDA’s panel of independent experts will examine the research and make specific recommendations to the FDA about administering the Pfizer vaccine to this age group.
Much as with recommendations about booster shots, the advisory committee is able to offer specific, granular guidance about the vaccine’s safety and necessity. For example, in September, after the Biden administration had planned a widespread rollout of vaccine boosters, the FDA panel recommended that only certain populations receive an additional shot.
However, as Vox’s Dylan Scott points out, “the groups already okayed by the FDA and Centers for Disease Control and Prevention for booster shots are quite broad and cover much of the adult population.”
The FDA panel will meet Tuesday and offer its assessment. The FDA typically follows the advice of its expert panel, but its guidance isn’t binding.
If the committee’s advice conforms with the agency’s initial review of the data, the FDA will likely authorize the vaccine soon after.
After that, Pfizer then must present its data to the CDC’s Advisory Committee on Immunization Practices, or ACIP. It’s a similar body to the FDA’s advisory committee — a rotating, independent panel of scientists and other experts who can make specific recommendations to the CDC about administering the vaccine. That panel is scheduled to meet November 2 and 3 to discuss pediatric vaccines, according to CNN.
Then, ultimately, it’s up to CDC director Dr. Rochelle Walensky to guide the CDC’s decision on pediatric Covid-19 vaccines. As with the FDA’s advisory body, ACIP’s recommendations aren’t binding, but the CDC typically follows them.
Both bodies have to authorize the vaccine; the FDA is first and foremost concerned with the safety of anything submitted for emergency use authorization or full regulatory approval. That means asking not only whether the drug itself is safe, but also inspecting manufacturing facilities and practices while the drug in question is licensed. Meanwhile, the CDC’s concerns are geared more toward how the drug should be administered and to whom, in addition to its safety and efficacy.
As the White House waits for authorization, President Joe Biden announced a plan earlier this week to distribute pediatric vaccines in 25,000 pediatrician’s and primary care offices, as well as in children’s hospitals and school- and community-based clinics. The administration has already purchased enough doses to inoculate all children in this age group; the shots come in reconfigured packaging, with smaller needles for smaller arms.
“Kids have different needs than adults and our operational planning is geared to meet those specific needs, including by offering vaccinations in settings that parents and kids are familiar with and trust,” Jeff Zients, the White House’s Covid-19 response coordinator, told reporters on Wednesday.
The plan aims to avoid the bumpy, chaotic rollout adults faced earlier this year, as well as to build trust with families who may be hesitant to vaccinate their children by relying heavily on trusted sites like pediatricians’ offices, and messaging through schools.
Children aren’t as vulnerable to Covid-19 as adults, but they’re still testing positive
The likely authorization of a vaccine for younger stands to make schools a much safer place as Covid-19 continues to spread in the US.
Though children don’t often experience symptoms from Covid-19, as Vox’s German Lopez explained earlier this month, the combination of the delta variant and a return to classrooms last month resulted in a sharp rise in pediatric Covid-19 cases relative to earlier in the pandemic.
According to the American Academy of Pediatrics, almost 6.2 million children have tested positive for Covid-19 since the pandemic began. In just the six weeks prior to October 14, 1.1 million children tested positive.
About 280 children under the age of 18 died of Covid-19 between January and September this year, according to CDC data.
“In this latest wave of Covid-19, particularly down south, there have been thousands of children hospitalized. And, frankly, it’s an embarrassment in a developed country to have even 100 children, like we’ve had, die of infectious disease that’s preventable,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said at a town hall earlier this month.
Since US school districts have implemented a patchwork quilt of vaccine and mask recommendations — with some states like Texas and Florida ignoring scientific evidence on the efficacy of masking, and banning mask and vaccine mandates in school systems — both students and teachers are vulnerable to the illness.
And despite the eagerness of many children, teachers, and parents to get students back in the classroom, high infection rates across the US mean there have been some stops and starts, from quarantining exposed students to shutting down whole campuses after an outbreak. Vaccinating school children would help reduce the virus’s spread — not to mention reduce the number of disruptions to the school year.
Despite the upsides, some parents say they are still wary of vaccinating their children, or will opt not to do so. According to a September study by the Kaiser Family Foundation, only about a third of parents surveyed — 34 percent — said they would vaccinate their 5- to 11-year-olds as soon as that age group becomes eligible. Thirty-two percent said they would “wait and see” how well the vaccine works before having their child get the shot, and 24 percent said they wouldn’t have their children vaccinated at all.
More vaccines for more children are likely coming soon
The authorization of a Covid-19 vaccine for children ages 5 through 11 would mean that nearly everyone in the US is eligible for a vaccine, and drug companies are already making headway on shots for even younger children.
Pfizer, which along with BioNTech manufactures the only vaccine authorized for use in children under 18, is also performing clinical trials on children ages 2 to 5, and separate trials for children as young as six months.
Data from those trials is expected before the end of the year, according to Pfizer.
Moderna, which manufactures the other mRNA vaccine authorized for US adults, is also recruiting for its pediatric clinical trials on children ages 6 months to 11 years. The company submitted its clinical trial data on the vaccine’s effectiveness in teenagers ages 12 to 18 in June, but the FDA has paused before authorizing it due to a possible elevated risk of myocarditis in young men. Health authorities in Sweden and Denmark have stopped administering Moderna vaccines to people under 18 in those countries due to this possible elevated risk.
With more authorizations on the horizon, many parents will likely be relieved to add Covid-19 shots to their kids’ vaccination schedules: As Friday’s FDA review confirmed, the vaccine is safe and effective for young children, and the Biden administration plans to make it widely available as soon as it’s authorized. And if Covid-19 is something we’ll have to live with as a society, as experts increasingly believe, then getting one step closer to making the Covid-19 vaccine routine for young kids is good news indeed.