American pharmaceutical and medical device company Johnson & Johnson plans to begin its experimental COVID-19 vaccine in children and teens ages 12-18 as soon as possible.
The news comes as countries worldwide are experiencing a surge in their daily coronavirus (COVID-19) cases as the winter season looms. In the United States alone, on Friday, it recorded 99,321 new COVID-19 cases, the most single-day daily tall of any country. As of Saturday night, the U.S. recorded another 71,931 new cases, according to data from the Johns Hookins University of Medicine.
During a virtual meeting with officials at the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices on Friday, J&J’s Dr. Jerry Sadoff said the company plans to test its COVID-19 vaccine into children “as soon as we possibly can, but very carefully in terms of safety.”
Sadoff, a vaccine research scientist at J&J’s Janssen unit, said the company even mulls to test in even younger children afterward, depending on safety and other factors.
The company reportedly stated that it is currently in talks with regulators and partners regarding the inclusion of the pediatric population in its vaccine trials.
J&J’s previous experience with the same technology in a vaccine successfully used in children is seen to give a boost with regulators, according to a recent Reuters report.
COVID-19 Vaccines could cause a life-threatening condition in children
It is crucial for drugmakers to test their COVID-19 vaccines in children, the U.S. Food and Drug Administration (FDA) asserted.
Experts in the medical community raised concerns that the vaccines themselves could cause a life-threatening condition called Multisystem Inflammatory Syndrome in children (MIS-C).
“MIS-C is a condition where different body parts can become inflamed, including the heart, lungs, kidneys, brain, skin, eyes, or gastrointestinal organs. Children with MIS-C may have a fever and various symptoms, including abdominal (gut) pain, vomiting, diarrhea, neck pain, rash, bloodshot eyes, or feeling extra tired. We do not yet know what causes MIS-C. However, many children with MIS-C had the virus that causes COVID-19, or had been around someone” infected by the disease, according to CDC.
In order to spur an immune response, J&J reportedly uses a cold virus to deliver coronavirus genetic material. 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.
J&J earlier paused its trials after a volunteer fell ill
Earlier this month, J&J’s paused the clinical trials of its COVID-19 vaccine candidate after an “unexplained illness” in a volunteer. The company is conducting Phase III trials of its coronavirus vaccine candidate.
“We have temporarily paused further dosing in all our Covid-19 vaccine candidate clinical trials, including the Phase 3 ENSEMBLE trial, due to an unexplained illness in a study participant,” J&J said in a statement.
The company added, “Following our guidelines, the participant’s illness is being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board (DSMB) as well as our internal clinical and safety physicians.”
Last week, the company announced that it is preparing to resume the Phase 3 ENSEMBLe trial of its COVID-19 vaccine candidate.
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