Johnson & Johnson is going to start its testing experimental COVID-19 vaccine in youths aged 12 to 18 as soon as possible. The company’s earlier experience with an similar technology in a vaccine successfully utilized in children could provide it a leg up with regulators.
“We plan to go into children as soon as we possibly can, but very carefully in terms of safety,” J&J’s Dr. Jerry Sadoff told at a virtual meeting of the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices on Friday.
Sadoff, a vaccine research scientist at J&J’s Janssen unit said, “Depending on safety and other factors, the company has planned to test in even younger children afterwards.”
J&J is currently in discussions with regulators and partners regarding the inclusion of the pediatric population in its trials, they mentioned in a statement.
The U.S. Food and Drug Administration have said it’s important for drugmakers to check their vaccines in children. While some doctors have raised concerns that the vaccines themselves could trigger a rare, life-threatening condition called Multisystem Inflammatory Syndrome in some children.
On the other hand, Pfizer Inc has already begun testing the COVID-19 vaccine, which it’s developing with Germany’s BioNTech in children as young as 12. They have used a messenger RNA (mRNA) that is a new technology that has yet to produce an approved vaccine.
J&J’s has used a cold virus to deliver coronavirus genetic material in order to spur an immune response. The platform – called AdVac -is used in a vaccine for Ebola that was approved in Europe earlier this year and was used on 100,000 people, including infants, children, and pregnant women.
Dr. Paul Spearman, director of the infectious diseases division of Cincinnati Children’s Hospital said, the technology’s history of safety should be important to regulators.
“Most of the toxicities are getting to come from the platform and not from putting a special insert into the platform, Spearman said. So replacing the Ebola genetic material thereupon of the novel coronavirus “is unlikely to offer you major issues,” he added.
In late September, J&J started testing the vaccine in adults with 60,000-volunteer in Phase III of the study. But, they had to pause the trial earlier this month due to a severe medical event in one participant. The study resumed last week.