The Food and Drug Administration reviewed Pfizer-BioNTech and Moderna’s emergency use authorization applications for children in the youngest age group and found both vaccines to be safe and effective. On Wednesday, the agency’s outside advisory committee met to discuss the data. The panel of experts voted unanimously to recommend the use of both vaccines, finding that the benefits of the shots outweigh any risks for young children.
Now, the FDA and the Centers for Disease Control and Prevention will make an official call on whether to authorize the vaccines.
With the rollout finally on the horizon, parents of kids under 5 may have some vaccine-related questions and concerns. Experts address some of the most common ones below.
When will it be available?
If the FDA and then the CDC greenlight the vaccines for this age group, the shots could be available as soon as the week of June 20, said White House COVID-19 response coordinator Dr. Ashish Jha.
“Our expectation is that within weeks, every parent who wants their child to get vaccinated will be able to get an appointment,” Jha told reporters during a recent press briefing.
How many doses are needed to be fully vaccinated?
The Pfizer vaccine for kids ages 6 months to 4 years old consists of three doses: Each one is three micrograms, which is one-tenth of the dose for adults. The first two doses are spaced three weeks apart and the third one is given at least two months after the second.
The Moderna vaccine for kids 6 months to 5 years old is made up of two doses given four weeks apart. Each one is 25 micrograms, or one-quarter of the adult version.
How effective are these vaccines?
According to Pfizer, its three-dose vaccine was 80% effective against symptomatic COVID-19 during the time omicron was the dominant variant. However, this data was from a mid-trial analysis, so the final results may differ.
Moderna said its two-dose vaccine was 51% effective against symptomatic infection for children ages 6 months to under 2 years, and 37% effective for children ages 2 to 5. These numbers — which were based on data mostly collected during the omicron wave — are similar to the efficacy of the vaccine for this variant in older populations, the company said.
But these numbers don’t tell the whole story. While the shots may not do a great job at preventing infection altogether, “efficacy against severe disease in children is expected to be very, very high for both brands of shots, though neither clinical trial reported enough COVID hospitalizations to properly calculate those stats,” journalist Katherine J. Wu wrote for The Atlantic.
What are the side effects for this age group?
Children in this age group tolerated both vaccines well, and their reactions to the shots were generally quite mild. Common side effects included irritability, fatigue, loss of appetite, pain at the injection site and headaches.
CDC data published in December found that for the millions of vaccinated kids ages 5 to 11, side effects have been largely mild and short-lived. Common ones include pain at the injection site, headaches and fatigue.
The Pfizer vaccine is currently the only shot authorized for use in kids ages 5 to 17. Moderna requested authorization for its vaccine for kids ages 6 to 17 this week, which was unanimously endorsed by the FDA’s outside advisers on Tuesday.
If your child experiences symptoms after the vaccine, Dr. Ruth Kanthula —assistant professor of pediatric infectious diseases at MedStar Georgetown University Hospital — recommends contacting your pediatrician.
“Parents may consider giving over-the-counter fever- and pain-reducing medications as needed after their child receives the vaccine,” she told HuffPost.
However, giving your child acetaminophen or ibuprofen before the shot to prevent side effects is not recommended, as it could reduce the body’s immune response to the vaccine.
Why should I vaccinate my kid if they’re low risk?
It seems that many parents of kids under 5 have at least some hesitation about vaccinating their little ones. According to an April Kaiser Family Foundation survey, only 18% of parents with kids in this age group say they would get their child vaccinated as soon as health officials authorize the shot. Another 38% say they would take a “wait and see” approach; 27% say they will “definitely not” get their kid vaccinated. And 11% said they’d only do it if it was a requirement for school or day care.
It’s true that young kids are at low risk for serious illness from COVID-19. But that risk isn’t zero, said Kanthula, who strongly encourages parents to vaccinate their children against COVID-19.
“Children of all ages and especially children with other conditions — for example, children who are immunocompromised, are obese or have asthma —are at risk of developing severe disease,” she said. “Additionally, children are at risk of developing a post-COVID illness such as long COVID or multi-system inflammatory syndrome in children — or MIS-C.”
During the pandemic, more than 30,000 kids under the age of 5 have been hospitalized with COVID-19 and nearly 500 have died, according to Surgeon General Dr. Vivek Murthy.
These deaths “may have been preventable from a vaccine,” said Dr. Natasha Burgert, a pediatrician in Overland Park, Kansas.
A CDC study published in April found that hospitalization rates during the omicron surge were almost twice as high for unvaccinated 5-11-year-olds as for vaccinated kids in that age range. Around one-third of those hospitalized had no underlying medical conditions.
Not only does the vaccine protect kids from getting seriously ill, but it also reduces the risk for their families and communities. This is especially important for protecting older people, individuals with compromised immune systems and underlying conditions, as well as babies younger than 6 months.
“Getting young kids vaccinated will decrease symptomatic illness and spread of the virus to others,” Burgert said.
Consider, too, the ways vaccinating this age group will help stave off further disruptions to their lives.
“Countless children have, for two and a half years, had to endure a steady drumbeat of school closures, exposures, and the heartache of sick caregivers and friends — many of whom have died,” Wu wrote in her piece for The Atlantic.
Why was the vaccine authorization delayed for this age group?
Many parents and caregivers have expressed frustration about the lag in vaccine authorization for young children. Those feelings are understandable, Kanthula said.
But know that the delays shouldn’t be cause for concern. In fact, the additional time it’s taken should only bolster parents’ confidence in the process.
“Approval for drugs and vaccines for use in children typically lags [behind] approval for use of the same products in adults,” Kanthula explained. “A lot of work goes into ensuring drugs are safe and effective for children because children are considered a vulnerable population.”
“Children are not little adults, and researchers know vaccine doses cannot just be cut in half for children,” Kanthula continued. “Children of different ages have different physiology and physiological responses. The same is true with regards to immune systems of children.”
For example, the authorization of the Pfizer vaccine for kids under 5 was delayed because the original two-dose vaccine did not produce the desired immune response. It was safe — just not as effective as expected. That’s why the company decided to begin testing a three-dose series.
Burgert said the parents of young kids she sees in her practice have not expressed concerns about the delay.
“Families want to have confidence that the vaccine works and it is safe, and they are willing to wait until the data suggests both are true,” she said.
Experts are still learning about COVID-19. The information in this story is what was known or available as of publication, but guidance can change as scientists discover more about the virus. Please check the Centers for Disease Control and Prevention for the most updated recommendations.