- Researchers will need to examine the dosages, interval between doses, and the number of doses that work best in children.
- This process could take several months, according to pediatric infectious disease experts.
- Kids may not have an approved vaccine until middle or late 2021.
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Though adults may begin getting vaccinated against COVID-19 within a few weeks, it’ll likely be several months before a vaccine is approved and available for kids.
The clinical trials conducted this year tested the vaccine’s safety and efficacy in adults, and researchers will need to conduct additional studies on how the vaccine affects younger children.
Researchers will need to examine the dosages, interval between doses, and the number of doses that work best in children.
This process could take several months, according to pediatric infectious disease experts. Kids might not see a vaccine until the summer or fall of 2021.
In November, the American Academy of Pediatrics (AAP) published a statement calling for drug manufacturers to include children in their trials soon.
Already, more than 1 million kids in the United States have developed COVID-19, and pushing back clinical trials could delay their access to a vaccine and further impact their overall health and development.
“People are now feeling more comfortable than they were at the beginning of the summer around vaccinating children. Given all the data that’s been generated in tens of thousands of adults, the idea is that we should be considering vaccinating children in studies at this point because it’s going to take some time,” Dr. Yvonne Maldonado, a pediatric infectious disease specialist with Stanford Medicine, told Healthline.
According to Maldonado, vaccines are typically first tested in adults before they’re evaluated in children.
“Generally, at some point during that process, they start getting tested in children,” Maldonado said.
The clinical trials conducted on adults this year included tens of thousands of participants. In initial data, the trials found that the vaccines appear to be effective and safe, although more research will be done even after they’re released.
The vaccines appear to give an effective immune response and do not facilitate an intense inflammatory immune response, which some people had been concerned about.
“That is the usual safety maneuver. We test things in adults first and make sure that it’s safe and immunogenic, then move to children,” said Dr. Beth Thielen, an assistant professor of pediatrics at the University of Minnesota Medical School, noting that this process can vary depending on the disease.
Drugs are usually first examined in older kids before being tested in younger children, she explained.
Pfizer, for example, recently began testing its vaccine in kids ages 12 and older. The other leading manufacturers, AstraZeneca and Moderna, have not yet started testing their vaccines in children.
The studies will likely need to look at the dosage, the number of doses, and the interval between the doses to determine if these elements need to be adjusted for kids.
Once vaccine safety is displayed in older kids, the trials could slowly and carefully incorporate younger children.
Maldonado said she expects the trials involving children to be much smaller than some of the trials conducted on adults, which could help speed up the process.
Because the safety of the vaccines have shown promise in adults, the trials with children may need to only include several hundred to a few thousand kids to look at efficacy.
“If you can look at these large clinical trials in adults for safety, and you can demonstrate that these vaccines see generally safe in humans, I think the FDA [Food and Drug Administration] and most others would be convinced you would not need to do studies in tens of thousands of children,” Maldonado explained.
The trials will likely look at whether vaccinated children contract the virus and if their antibody response is similar to what adults produce to protect them against severe disease.
If the antibody response in children is sufficient, the FDA may approve the vaccine under an Emergency Use Authorization (EUA) for kids.
Maldonado said this process has occurred with other vaccines. The researchers will also likely continue to look at the children over time to understand the durability of the vaccine.
There may be larger trials looking at safety and efficacy, which could be lengthier.
Maldonado said she hopes the trials begin soon, as it does take time to conduct the trials and extrapolate results about the outcomes.
“We want to be able to have a vaccine sometime in 2021 for children, as well as adults,” Maldonado said, adding that she expects to see a vaccine for kids in either the summer or fall of 2021.
It will also take time for distribution to ramp up, noted Thielen, which makes a target date of late 2021 all the more likely.
In general, kids have a lower risk of getting severely sick with COVID-19 compared with older adults.
On rare occasions, some children have developed a condition called multisystem inflammatory syndrome in children, or
Kids also tend to silently pass on the virus, as many who contract it develop mild symptoms or no symptoms at all.
The vaccine is meant to prevent severe disease, and it’s unclear if the vaccine could also prevent infection altogether in some people, or if it could lower viral shedding, or transmission.
That’ll be an important factor to look at, especially with children, as it could help get a handle on asymptomatic shedding, Thielen explained.
Vaccines have long been a way to lower transmission in communities. For example,
“It’s not just about your child, but what if they’re spending time with their grandparents or other older adults? It’s not just thinking about what’s going to happen to them, but could they transmit the virus to other people?” Thielen said.
Though the vaccine may be distributed to certain adults within a few weeks, kids likely won’t have access to a vaccine until late 2021.
The clinical trials conducted so far have focused on the vaccines’ safety and effectiveness in adults.
Pediatric infectious disease doctors hope to see younger children included in clinical trials soon to help speed up the process and get kids vaccinated sooner.