American healthcare company Johnson & Johnson (J&J) is planning to initiate vaccine trials for its COVID-19 vaccine candidate in youths aged between 12 to 18 as soon as possible.
As the group’s previous experience with the same technology in a vaccine used in children was a success, it is hoped to get a positive response from 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 a virtual meeting of the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices on Friday.
Dr. Sadoff further added that considering the safety and other factors, J&J is planning to start testing the vaccine in even younger children afterward, however, he didn’t give a timeline. The company in a recent statement said that it is holding discussions with the regulators and partners about expanding the trials into the pediatric group.
The U.S Food and Drug Administration has earlier mentioned that it is highly important for the drugmakers to test their vaccines in children. Some experts have expressed their concern that the vaccines could create a rare, life-threatening condition called Multisystem Inflammatory Syndrome in some children.
The American drugmakers Pfizer Inc has already started their COVID-19 vaccine trials in children as young as 12. Their vaccine uses messenger RNA (mRNA), a new technology that has yet to develop an approved vaccine.
J & J is using a cold virus to deliver coronavirus genetic material to stimulate an immune response. The platform called AdVac is used in a vaccine for Ebola that was approved in Europe earlier this year and tested in more than 100,000 people, including infants, children and pregnant women.
Dr. Paul Spearman, director of the infectious diseases division of Cincinnati Children’s Hospital says that the regulators will give prime importance to the safety of the technology.
“Most of the toxicities are going to come from the platform and not from putting a different insert into the platform. So replacing the Ebola genetic material with that of the novel coronavirus is unlikely to give you major issues,” Dr. Spearman added.
In late September, J&J had commenced its Phase 3 vaccine test in about 60,000 volunteers. But they had to suspend their trials earlier this month due to some critical medical conditions in one participant and restarted it last week.
