The US is rolling out millions of doses of COVID-19 vaccines for children under 12 after the FDA authorized the Pfizer vaccine for kids and the CDC supported that decision.
The FDA authorization on Friday and the CDC advisory committee’s unanimous decision to recommend the vaccines on Tuesday now means that you can get your kids under 12 vaccinated. (Children 12 and older are already eligible to get a Pfizer vaccine, and the CDC recommends that they do so.)
CDC chief Rochelle Walensky endorsed the recommendation, clearing the last major hurdle to the decision. US states also have to OK the shots.
In anticipation of the decision, the Biden administration announced last week that it had already procured enough doses of the Pfizer vaccine to vaccinate the country’s 28 million children in this age range.
“On Friday, within minutes of FDA’s authorization, we began the process of moving 15 million doses from Pfizer’s freezers and facilities to distribution centers,” Jeff Zients, the White House’s COVID-19 response coordinator, said at a press briefing on Monday.
The program will be ramping up to its full strength this week with millions of doses being packed, shipped, and delivered to offices of pediatricians and family doctors, pharmacies, children’s hospitals, community health centers, rural health clinics, and other locations, he said.
“Starting the week of Nov. 8, our vaccination program for kids ages 5 to 11 will be running at full strength,” Zients said.
Parents and caregivers can check vaccines.gov to find out where vaccines for kids are available.
“We have many parents clamoring who really want a vaccine for their children,” said CDC panel member Beth Bell of the University of Washington, Seattle. “If I had a grandchild, I’d want to get them vaccinated as soon as possible.”
“We are parents and we have given this to our children,” said panelist Helen Talbot of Vanderbilt University.
Following a contentious daylong discussion last week, a panel of outside advisers to the FDA voted 17–0 (with one abstention) to recommend authorizing the two-dose vaccine for kids ages 5 to 11. The group decided that the vaccine’s benefits outweigh the risks and that it is safe and effective for preventing infections.
The approval was based on a study that looked at two 10-microgram doses of the vaccine, one-third the dose given to adults, given three weeks apart. It was more than 90% effective at preventing symptomatic COVID-19 in the clinical trial of 2,268 children. A second study of an additional 2,379 children looked at vaccine safety.
A few questions remain over the shots, as some FDA advisory panel members voiced concerns over the lack of data on whether one dose, rather than two, might be sufficient, whether it was appropriate to recommend approving the vaccine only for children at high risk of getting severely ill from COVID, or if the decision would be used to justify vaccine mandates.
About 12% of children in the study had obesity and 8% had asthma, which are considered high-risk conditions. However, children who had immune system problems or other health conditions were excluded from the study.
Immunocompromised children who get shots will be added to an ongoing safety study conducted by Pfizer that already includes all adults who got the Pfizer vaccine, according to the FDA.
While some governors have indicated that they will mandate vaccinations for kids 5 and up who attend school, such moves are sure to be contentious.
The vote comes as cases and hospitalizations have been steadily declining in the US. But kids now make up a bigger share of cases and hospitalizations, coinciding with the surge of the highly contagious Delta variant and the beginning of the school year.
On Sunday, Moderna announced it would delay filing with the FDA for authorization of its shots for 6- to 11-year-olds. That followed the agency saying it needs more time to review Moderna’s safety data regarding myocarditis among teens who have received the firm’s shots.
How are the kids’ vaccines different from the shots for adults?
The Pfizer vaccine for kids is not only a lower dose of the version that adults and adolescents get — 10 micrograms versus 30 micrograms — it’s a different formulation that is easier to store in a refrigerator.
The kids’ version can be stored for up to 10 weeks in a refrigerator, compared with the adult version, which can only be stored in a regular freezer for up to two weeks prior to use. Both versions are stored in an ultracold freezer (-80 degrees Celsius) until they are distributed or reach the expiration date.
The vaccines for young children will also have orange caps to differentiate them from the purple-capped vaccines for people 12 or older. This will help ensure that every kid who gets Pfizer’s COVID-19 vaccine gets the intended dose.
How dangerous is COVID-19 for kids?
Children are thought to be just as likely as adults to be infected with the SARS-CoV-2 virus but less likely to become very sick or need to be hospitalized. However, due to rising cases, the infection was the eighth leading cause of death in children ages 5 to 11 in the last 12 months, according to CDC data.
As of Oct. 16, there have been 94 COVID-related deaths in children aged 5 to 11, making up about 1.7% of all deaths in that age group.
“Far from being spared from this harm of COVID-19, in the 5- to 11-year-old age range there have been over 1.9 million infections, over 8,300 hospitalizations (about a third of which required intensive care unit stays), and over 2,500 cases of multisystem inflammatory syndrome (MIS-C) from COVID-19,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
MIS-C is a rare and serious COVID-19 complication that causes fever, rash, swelling, and heart complications in children. More than 5,000 kids and teens have developed MIS-C, and half of them are aged 5 to 13.
Although children with diabetes, asthma, obesity, or other health issues are at higher risk of getting severely ill from COVID, about one-third of children who have been hospitalized for COVID did not have an underlying health condition. COVID hospitalization rates are more than three times higher for Black, Latinx, or Native American children compared with those of white or Asian children ages 5 to 11.
With the rise of the highly contagious Delta variant, children are making up a greater proportion of people who get sick. Kids ages 5 to 11 made up nearly 11% of cases reported to the CDC the week of Oct. 10, although they make up only 8.7% of the US population.
COVID-19 is often compared to the flu. Fiona Havers, the medical officer for the Division of Viral Diseases at the National Center for Immunization and Respiratory Diseases, said school closures and mask-wearing drove flu rates down last season; only nine children were hospitalized for flu in the 2020–2021 season, while COVID hospitalizations in that time were similar to those for the flu in previous years. (More than 39,000 children were hospitalized in the 2018–2019 flu season.)
“This suggests that the annual rate of COVID-19 hospitalizations would have been much higher than those for influenza during typical influenza season had these mitigation measures not been in place,” Havers said.
Observed cases of people experiencing long-term COVID symptoms, or “long COVID,” are much higher in adults than kids. Fewer than 1 in 20 children diagnosed with COVID-19 have symptoms lasting longer than four weeks, according to a study from the UK, and only 1 in 50 still have symptoms after eight weeks.
What are the risks and benefits of the COVID vaccines for kids?
The side effects of the Pfizer vaccine in the kids studied were usually mild and occurred in the first day or two after the injection. The most common side effects were pain at the injection site, fatigue, headache, and muscle pain.
Fever was relatively uncommon, occurring in only 6.5% of kids after the second dose of the vaccine.
The study reported no cases of myocarditis, a type of heart muscle inflammation, in three months, although the clinical trial for children ages 5 to 11 was likely too small to pick up on such an uncommon problem. Myocarditis is a rare side effect mostly seen in teens or young men in their 20s given the Pfizer vaccine. It occurs in about 2 in 100,000 cases after a shot, according to a recent study from Israel.
Myocarditis can also be caused by COVID itself and is 16 times more common in people with COVID than those who have not been infected. Heart inflammation caused by the virus is typically more severe than vaccination-associated cases, which usually respond well to medicine and rest, according to the CDC.
At the FDA advisory panel meeting last week, the health experts weighed this risk against the possibility of a continuing increase in cases. If there is a winter surge or case numbers remain at current levels, the number of children's cases, hospitalizations, and deaths that would be prevented by vaccination clearly exceeded the risk of myocarditis, the analysis found. Vaccinating kids would also help prevent cases in older adults and those at higher risk of getting infected.
Walensky suggested that the CDC panel consider the risks and benefits of the vaccine in context with other vaccine-preventable diseases, like chickenpox. Chickenpox killed 16 children aged 5 to 9 in the five years before its vaccine was approved. In comparison, there have been 745 COVID deaths in children under 18 since the pandemic started, and 94 of those deaths were in kids ages 5 to 11.
In the end, the FDA vote came down to assuring that vulnerable children get the option of being vaccinated, said Amanda Cohn, an FDA panel member and chief medical officer for the CDC’s Vaccine Task Force, given the current high COVID rates nationwide and given the potential for another winter surge.
“We do not want children dying of COVID,” she said. “At this moment, the benefits do outweigh the risks.”
"Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy,” acting FDA Commissioner Janet Woodcock said in a statement.