This article will be updated regularly through October 31.
The White House said on Wednesday that it has acquired enough Pfizer-BioNTech coronavirus vaccine to supply more than 25,000 pediatric and primary care providers, in anticipation of the Food and Drug Administration meeting next week to consider an emergency authorization of a low-dose vaccine for children 5 to 11 years old. Children would receive a smaller dose of the Pfizer-BioNTech vaccine.
That smaller vaccine dose for this age group is 90.7% effective at preventing symptomatic COVID-19 infections, the companies said in trial data submitted to the Food and Drug Administration on Friday, ahead of the agency’s meeting next week and its review of the companies’ data. Kids in the trial also contracted the coronavirus as the highly transmissible Delta variant was spreading through the country from July to September, Pfizer and BioNTech said. No cases of severe illness were reported in the trial.
The Pfizer-BioNTech vaccine already has emergency use authorization for children ages 12 to 15.
Many parents have been waiting for their younger kids to be able to get vaccinated after the Food and Drug Administration gave full approval for those 16 and older in August — and as cases of COVID-19 in children have steadily risen since the start of the school year. The peak of child COVID-19 cases in the U.S. was seen in early September, per the American Academy of Pediatrics, and has remained at a high level.
Although children experiencing severe illness from COVID-19 is uncommon, the need to protect children is still high. Hospital pediatric units met capacity this fall across the country and in cities like Pittsburgh and Fort Worth, Texas, as the new school year kicked off.
The responsibility of deciding how and whether children obtain COVID-19 vaccinations may largely fall to mothers: They usually make the health decisions about children, per Kaiser Family Foundation (KFF) polling from this spring.
Furthermore, outbreaks in schools have led to classroom quarantines and, in some cases, a return to remote learning, further disrupting life not just for students but also for parents — often mothers, who have shouldered so much of the child care throughout the pandemic.
The 19th spoke with public health experts (who are also moms) about what parents should know as Pfizer and BioNTech seek emergency FDA authorization for young children.
What happens next?
A COVID-19 vaccine could be available for 5- to 11-year-olds within the next month or two, after the FDA, the Centers for Disease Control and Prevention, and regulators examine and verify Pfizer and BioNTech’s trial data.
A hearing on Pfizer-BioNTech’s application will take place on October 26. Parents of children who are younger — those from 2 to 5 years old and infants as young as 6 months old — will have to wait longer. Trial data on these groups is not expected to be released until later this year, Pfizer said in September.
For parents wanting more advice on getting their kids vaccinated, “This is a great time for people to start talking to their pediatrician,” said Margaret Aldrich, director of pediatric infection control at the Children’s Hospital at Montefiore in the Bronx.
The White House said that it will work to set up vaccination sites in November and through the end of 2021, in partnership with children’s hospitals across the country.
Natasha Burgert, a general pediatrician in Overland Park, Kansas, told The 19th she is encouraging vaccine-hesitant parents to talk to their pediatricians and other trusted sources to make decisions for their family, especially as misinformation spreads online.
Burgert stressed that Pfizer’s data still needs to be made public and reviewed by the FDA and CDC — all part of a process that parents should trust. She is not recommending that parents get their 5- to 11-year-olds vaccinated until she can review Pifzer’s data herself and the vaccine receives an emergency use authorization.
“That’s LOTS of critical eyes on the data set to make sure the science is sound,” she wrote in a newsletter to parents on Monday. “There’s nobody out there that’s trying to make or push this vaccine, especially onto children, without due diligence,” she told The 19th.
Lisa Black, a spokesperson for the American Academy of Pediatrics, said over email that the association looked forward to Pfizer’s data being reviewed by the FDA. Pfizer is the first of the three FDA-approved COVID-19 vaccine manufacturers to share trial results for kids ages 5 to 11.
Do kids of different ages get different doses?
Yes. The Pfizer-BioNTech COVID-19 vaccine being given to kids over 12 uses a 30-microgram dose, while doses of only 10 micrograms, administered 21 days apart, are effective (and create a robust antibody response) for children 5 to 11, the companies said Monday.
Aren’t children less likely to get COVID-19?
“Cases of COVID in children have risen over 200 percent in the last two months, since July,” Aldrich said in September, citing CDC data. Although children are less likely to experience severe illness or die after contracting COVID, and many may not display symptoms, pediatric hospitalizations caused by the virus have increased sharply as the Delta variant spreads.
“Once you have a large number of kids … getting COVID, it’s a numbers game. Some of those kids are going to run into trouble. Kids have needed ICU-level care,” Aldrich told The 19th. “Kids have had complications related to COVID over the past many months now.”
A KFF survey in August found that 4 in 10 parents of children under 12 wanted to “wait and see” before getting their child vaccinated against the virus, after a COVID-19 vaccine is authorized and available for their kids. A majority of those parents said they were most concerned about their children experiencing serious side effects from the vaccine and that there is not enough information about long-term effects.
“The risk of death for COVID far outweighs the risks associated with this vaccine, as was shown for the adult clinical trials,” said Aldrich, who is a mother of three daughters. Her oldest is currently vaccinated, and she plans to have her other children inoculated as soon as it’s available for them.
Burgert said she’s looking forward to when her unvaccinated 11-year-old son can be protected against the virus, as her 14-year-old daughter is already vaccinated.
A statistically insignificant number of cases of myocarditis, an inflammatory heart condition, have been seen so far in clinical trials of the COVID vaccine in kids, The 19th reported last month. In most cases, this very rare side effect began within a few days after receiving a second Pfizer dose. This follows a greater history of delayed vaccine side effects, which tend to happen within two months of vaccination.
“The process that this vaccine has gone through really has been consistent with the process that any vaccine would go through,” Aldrich said.
“This is going to seem fast, but it’s really not,” Burgert wrote in her Monday newsletter. “We are in a global pandemic. As such, we have the luxury of nearly unlimited cash AND the full attention of an international collection of brilliant minds.”
Although the risk for children getting seriously ill from the virus is lower than for older Americans, Aldrich stressed that “if you are the one person who’s child ends up in the ICU, that’s 100 percent of your experience. If you can prevent that from happening, why wouldn’t you do that?”
I’m a working parent. How can I make time to get my kid vaccinated?
The Pfizer vaccine still requires two shots — and if children experience mild side effects like chills or fever, they could have to miss school and need care at home. Employed parents may have to take time off from work to care for their children — a responsibility that 61 percent of employed mothers told KFF this spring usually falls to them.
Few working parents told KFF in August that their employer would offer paid time off to get their children vaccinated, or paid time off to care for them if they experience short-term side effects.
If time off isn’t possible, there are other options — like relying on a family member or trusted guardian to go with your child to the vaccination appointment.
“Most pediatricians and public health places will accept a nanny or a babysitter or a grandparent to bring them to the clinic with an authorized letter that says that they are authorized to be able to sign on behalf of that patient,” Burgert said.
Will my school mandate COVID-19 vaccines?
It depends on where you live. In California, Gov. Gavin Newsom has said that eligible California students must get vaccinated against the coronavirus in order to take classes in-person, pending full FDA approval of shots for students’ age groups. The governor’s office reportedly said that they don’t expect the mandate to take affect until at least the next school year.
Jeffrey Zients, the White House coronavirus response coordinator, also stressed on October 20 that vaccine mandates for children depend on local school district and state decisions, although the Biden administration supports such vaccine requirements.
“School vaccination requirements have been around for decades, and those decisions should be made at the state and local level,” Zients said. “We know that in general, requirements work, and we support states and school districts taking actions to ensure that everyone who’s eligible get vaccinated.”
How can I protect my child now?
The most important thing that parents can do to protect their children is to get vaccinated themselves. Taking precautions against the virus is also a “multi-step process for protection,” Aldrich noted — wearing masks indoors and inside schools is equally important, as mask-wearing reduces the risk of spreading the virus.
Social distancing and handwashing are still effective ways to protect your family as part of that multi-step protection plan, in addition to getting vaccinated.
Burgert stressed that parents and kids should also get a flu shot to protect them against illness. There’s no reason to wait to get your flu shot before getting a COVID-19 vaccine, she added.
Parents should still wait for EUA authorization for a vaccine for children under 12, Aldrich said, after the White House’s COVID-19 Response Team previously cautioned parents against asking their pediatrician for off-label usage of the full authorization adult version of the vaccine.