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Based on safety and other things, the company intends to check in even younger children afterwards, said Sadoff, a vaccine research scientist in J&J’s Janssen unit, without giving a timeline.
J&J said in a statement it is currently in discussions with partners and regulators concerning the addition of the pediatric population in its trials.
The U.S. Food and Drug Administration has stated it’s important for drugmakers to test their vaccines in children. Some doctors have raised concerns that the vaccines themselves may trigger a rare, life-threatening condition called Multisystem Inflammatory Syndrome in some children.
Rival drugmaker Pfizer Inc has already begun testing the COVID-19 vaccine it’s developing with Germany’s BioNTech in kids as young as 12. Their vaccine employs messenger RNA (mRNA), a new technology which has yet to create an approved vaccine.
J&J’s uses a cold virus to deliver coronavirus genetic material in order to spur an immune response. The platform – known as AdVac – is used in a vaccine for Ebola that was approved in Europe earlier this year and used on more than 100,000 people, including infants, children, and pregnant women.
The technology’s history of security ought to be important to regulators, said Dr. Paul Spearman, director of the infectious diseases division of Cincinnati Children’s Hospital.
“Most of these toxicities are going to come from the platform rather than from putting a different insert to the platform, Spearman said. So replacing the Ebola genetic material with this novel coronavirus”is not likely to give you major problems,” he added.
It had to pause the trial earlier this month due to a serious medical event in one participant. The analysis resumed last week
