When Pfizer’s pediatric COVID-19 vaccines received emergency approval from the Food and Drug Administration (FDA) in 2021, parents everywhere breathed a sigh of relief, knowing they finally had some concrete way to protect their children. Now it’s easy for kids 5 and up to get vaccinated by a health care professional or their nearest pharmacy (younger children might get approval in the coming weeks).
Still, although millions of children nationwide have rolled up their sleeves, many parents have lingering questions about the shots' safety. The Centers for Disease Control and Prevention (CDC) urges everyone to get vaccinated, but some moms and dads worry it's too soon, it's untested, it might be unsafe. They're concerned that the vaccines may contain a live virus (it doesn't), or that safety steps were skipped over (they weren't).
The truth is, the pediatric vaccines had to follow a typical, straightforward trajectory and undergo months of extensive clinical trials overseen by the FDA before they could win approval. The organization had already completed vaccine safety tests on tens of thousands of adults, and millions of vaccine doses have since been dispersed with no major adverse reactions. As a result, the pediatric trials could be designed to "bridge the vaccine in a safe way to younger groups," says Paul Spearman, M.D., the director of the Division of Infectious Diseases at Cincinnati Children's Hospital.
But the scientists had to start somewhere. In order for the first pediatric vaccines to win emergency use authorization, many brave children and teens needed to participate in clinical trials nationwide. One of them was Ty Dropic from northern Kentucky, who signed up for the Pfizer trial via Cincinnati Children’s Hospital. Here, he shares his experience with Parents. Reading it may offer insight into what the process was like, and help explain why experts say all kids should get vaccinated as soon as possible.
Signing Up for a COVID-19 Vaccine Clinical Trial
Ty decided to participate in the Pfizer clinical trial at the suggestion of his mother, pediatrician Amanda Dropic, M.D. "My mom came to me with the idea and said that it's been tested in adults, and it's been found safe in adults," the teen told Parents in 2021. "It would help the community a lot and there weren't really any downsides to it." After speaking to Amanda about potential side effects—like headaches or soreness at the injection site—Ty decided that the benefits of joining the trial outweighed the risks.
At the time, pediatric approval of a COVID-19 vaccine was seen as a major step toward ending the pandemic. For the most part, children and teens have been spared from the worst effects of COVID-19, but in rare cases, they still get serious symptoms that lead to hospitalization or death. Young people can also transmit the virus to others who may be more susceptible, notes Dr. Spearman. As of May 4, 2022, just over 1,000 children have died from the coronavirus in America, and thousands more have been diagnosed with a mysterious side effect called MIS-C, or multisystem inflammatory syndrome in children.
Kids who participated in the clinical trials hoped that vaccinating young people might allow them to return to “normal life” sooner—that it might mean the end of remote schooling, social distancing, mask wearing, and other precautions that frequently affected their mental health. Those things haven’t completely ceased yet, but kids like Ty have certainly helped.
Receiving the Vaccine
Ty was 13 years old when he enrolled in the clinical trial for the Pfizer vaccine. Before getting his jab, he needed to undergo a blood test and get tested for COVID-19. “The nasal swab tickled the back of my nose for a second—it doesn’t feel good, but it’s only for a second,” he told Parents. Then it was time for the vaccine, which Ty remembered as not being a big deal. “It pokes your arm but that’s really all.”
In the aftermath, Ty didn't know whether he received the actual vaccine or a placebo. (Placebos are necessary in clinical trials to provide a point of comparison). His family asked to be "unblinded," and learn which one he got, but they knew that information wouldn't be shared with them until after Pfizer's FDA approval. Ty decided that if he got the placebo, he would get the vaccine when it was available.
Waiting for Potential Side Effects
The next step in the pediatric clinical trials involved monitoring participants for side effects. For a week after he got the vaccine, Ty completed a daily electronic "vaccine diary" that asked him to report on his symptoms. He was also asked to complete the diary every week for the following two years. This real-life feedback helps scientists track the long-term effects of the vaccine in kids.
Ty’s three siblings under 18 were also enrolled in Pfizer pediatric trials. His mother said that if any of them were to come down with fever, cough, congestion, or other COVID-19 symptoms within two years of those trials, they would have to call it in. Then “we send in a swab and they do a visit,” she added.
For his part, Ty didn’t experience any side effects, and his siblings had only had minor symptoms. As we know now, that echoes the experience of adults who get the COVID-19 vaccine. “Many of those who received the vaccine appeared to tolerate it well,” explains Dr. Spearman. “Others got sore arms or a little bit of tiredness. Sometimes they have other systemic side effects like headaches. In general, though, there are very mild side effects.” Very few children experience major issues, the data shows.
Dealing with Vaccine Hesitancy
When he got the shot, Ty found that he wasn’t the only young person excited about the vaccine. In fact, he said that most teens in his community definitely wanted the vaccine, or were still deciding. “I haven’t had any people who have said, ‘No, I’m not gonna get the vaccine,'” he recalled.
Today, 28 percent of kids age 5 to 11 have been fully vaccinated, as have 59 percent of those age 12 to 17. Vaccine hesitancy is finally dropping and uptake is rising among those of all ages, possibly in response to concerns about new variants of the coronavirus. Dr. Spearman understands why parents worry about the vaccines, but he stresses there’s nothing to fear. “We hope parents look at all the safety data we have for these mRNA vaccines,” he says. “That includes looking at the data from the tens of millions of individuals who have received the vaccines in the adult age groups.”
Yes, the vaccines were developed in record time. But Dr. Spearman insists that those who ran the clinical trials didn't rush through the safety procedures. (Only administrative components were sped up.) "Even though the vaccine authorization and development process moved very quickly, it was done with a lot of care, and it's still being done that way," he insists. "Parents should be reassured by the high quality of the studies being done to establish the safety and immunogenicity of this vaccine."
Moving Forward
Both Pfizer and Moderna have been conducting clinical trials of their COVID-19 vaccines in children under the age of 5, and are expected to file requests for emergency use authorization to the FDA in late spring 2022, with a vaccine possibly available by summer, company officials say. Dr. Spearman hopes that soon even more parents will embrace the idea of vaccinating their children against the coronavirus. “It’s gonna be a great advantage for us in getting kids back to normal activities,” he says.
Here's what Ty wanted to let kids know back in 2021, when he stepped up to try out the Pfizer shot: "The vaccine is safe and it's effective. Once you get the vaccine, that's the start of where you can get your masks off, stopping temperature checks, and going back to in-person school. It's gonna be a big change back to normal." But like most young people in America, he was ready for it.
