- Researchers need to examine the dosage, the interval between doses, and the number of doses most suitable for children.
- This process can take several months, according to pediatric infectious disease experts.
- Children may not have an approved vaccine until mid or late 2021.
Although adults may start getting vaccinated against COVID-19 within a few weeks, it may take several months before a vaccine is approved and available for children.
Clinical trials conducted this year are testing the safety and efficacy of vaccines in adults, and researchers need to carry out additional studies into how vaccines affect younger children.
Researchers need to examine the dosage, the interval between doses, and the number of doses most suitable for children.
This process can take several months, according to pediatric infectious disease experts. Children may not get the vaccine until the summer or fall of 2021.
In November, the American Academy of Pediatrics (AAP) published a statement calling on drug manufacturers to promptly include children in their trials.
More than 1 million children in the United States have developed COVID-19, and refusing clinical trials could delay their access to vaccines and further impact their overall health and development.
“People now feel more comfortable than they did at the start of the summer about vaccinating children. Given all the data that has been generated on tens of thousands of adults, the idea is that we should consider vaccinating children in research at this point because it will take time, “Dr. Yvonne Maldonado, a pediatric infectious disease specialist at Stanford Medicine, said Healthline.
According to Maldonado, vaccines are usually first tested in adults before being evaluated in children.
“Generally, at some point during that process, they start being tested on children,” says Maldonado.
Clinical trials conducted on adults this year involved tens of thousands of participants. In preliminary data, trials find that the vaccine appears to be effective and safe, although more research will be conducted even after its release.
Vaccines appear to provide an effective immune response and do not facilitate the intense inflammatory immune response, which some people fear.
“That is the usual safety maneuver. We tested things in adults first and made sure they were safe and immunogenic, then moved on to children, ”said Dr. Beth Thielen, assistant professor of pediatrics at the University of Minnesota School of Medicine, notes that this process can vary depending on the disease. .
Medicines are usually first checked in older children before being tested in younger children, he explained.
Pfizer, for example, recently started testing its vaccine in children 12 years of age and older. Other leading manufacturers, AstraZeneca and Moderna, have not yet started testing their vaccines in children.
Studies likely need to look at dosages, dosage amounts, and the interval between doses to determine if these elements need to be adjusted for children.
Once the safety of the vaccine is shown in older children, trials can slowly and delicately involve younger children.
Maldonado said he expected 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 vaccine’s safety has shown promise in adults, trials with children may only need to involve a few hundred to several thousand children to see its efficacy.
“If you can look at this big clinical trial in adults for safety, and you can show that this vaccine is generally safe in humans, I think the FDA [Food and Drug Administration] and most other people will believe that you don’t need to study tens of thousands of children, ”Maldonado explained.
The trial will likely look at whether vaccinated children have contracted the virus and whether their antibody responses are similar to those produced by adults to protect them from severe disease.
If the antibody response in children is sufficient, the FDA may approve vaccines under the Emergency Use Authorization (EUA) for children.
Maldonado said this process has happened with other vaccines. Researchers are also likely to continue to observe the children over time to understand vaccine resistance.
There may be larger trials looking at safety and efficacy, which could take longer.
Maldonado said he hopes the trials begin soon, as it does take time to conduct trials and predict results about the results.
“We want to be able to have a vaccine by 2021 for children, as well as adults,” said Maldonado, adding that he expects to see vaccines for children in either the summer or fall of 2021.
It will also take time to improve distribution, said Thielen, making a target end date of 2021 more likely.
In general, children have a lower risk of getting COVID-19 compared to older adults.
Sometimes, some children develop a condition called multisystem inflammatory syndrome in children, or
Children also tend to transmit the virus secretly, as many who get it develop mild or no symptoms at all.
These vaccines are intended to prevent serious illness, and it’s not clear whether they can prevent infection in some people, or they can decrease viral shedding, or transmission.
That would be an important factor to watch out for, especially with children, as it can help treat asymptomatic discharge, explains Thielen.
Vaccines have long been a way to reduce transmission in the community. As an example,
“It’s not just about your child, but what if they spend time with grandparents or other adults? It’s not just thinking about what will happen to them, but can they pass the virus on to other people? “Said Thielen.
Although the vaccine can be distributed to select adults within a few weeks, children are unlikely to have access to the vaccine until the end of 2021.
The clinical trials conducted so far have focused on the safety and effectiveness of vaccines in adults.
Pediatric infectious disease doctors hope to see younger children included in clinical trials soon to help speed up the process and vaccinate children more quickly.