New York: Johnson & Johnson plans to start testing its experimental COVID-19 vaccine in youths aged 12 to 18 as soon as possible.
“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, Economic Times (ET) reported quoting Reuters.
Later, the company plans to test it in even younger children taking into consideration the safety aspect, Sadoff, a vaccine research scientist at J&J’s Janssen unit was quoted as saying by Reuters.
J&J said in a statement that it is currently in discussions with regulators and partners regarding the inclusion of the pediatric population in its trials, the report added.
The U.S. Food and Drug Administration has said it is important for drugmakers to test their vaccines in children even though some doctors have raised concerns that the vaccines themselves could trigger a rare, life-threatening condition called Multisystem Inflammatory Syndrome in some children.
However, where J&J is concerned, the history of safety of its technology should be important to regulators, Dr. Paul Spearman, director of the infectious diseases division of Cincinnati Children’s Hospital, was quoted as saying.
J&J’s uses 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 used on more than 100,000 people, including infants, children, and pregnant women.
J&J started testing the vaccine in adults in a 60,000-volunteer Phase III study in late September. It had to pause the trial earlier this month because of a serious medical event in one participant. The study resumed last week, ET reported.
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