<p>Johnson & Johnson plans to start testing its experimental Covid-19 vaccine in youths aged 12 to 18 as soon as possible, and the company's previous experience with the same technology in a vaccine successfully used in children could give it a leg up with regulators.</p>.<p>"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 US Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices on Friday.</p>.<p>Depending on safety and other factors, the company plans to test in even younger children afterwards, said Sadoff, a vaccine research scientist at J&J's Janssen unit, without giving a timeline.</p>.<p>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.</p>.<p>The US Food and Drug Administration has said it is important for drugmakers to test their vaccines in children. Some doctors have raised concerns that the vaccines themselves could trigger a rare, life-threatening condition called Multisystem Inflammatory Syndrome in some children.</p>.<p><strong>Also read: <a href="https://www.deccanherald.com/international/world-news-politics/second-study-testing-covid-19-antibody-drug-has-a-setback-909323.html" target="_blank">Second study testing Covid-19 antibody drug has a setback</a></strong></p>.<p>Rival drugmaker Pfizer Inc has already begun testing the Covid-19 vaccine it is developing with Germany's BioNTech in children as young as 12. Their vaccine uses messenger RNA (mRNA), a new technology that has yet to produce an approved vaccine. 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.</p>.<p>The technology's history of safety should be important to regulators, said Dr. Paul Spearman, director of the infectious diseases division of Cincinnati Children's Hospital.</p>.<p>"Most of the toxicities are going to come from the platform and not from putting a different insert into the platform, Spearman said. So replacing the Ebola genetic material with that of the novel coronavirus "is unlikely to give you major issues," he added.</p>.<p>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.</p>
<p>Johnson & Johnson plans to start testing its experimental Covid-19 vaccine in youths aged 12 to 18 as soon as possible, and the company's previous experience with the same technology in a vaccine successfully used in children could give it a leg up with regulators.</p>.<p>"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 US Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices on Friday.</p>.<p>Depending on safety and other factors, the company plans to test in even younger children afterwards, said Sadoff, a vaccine research scientist at J&J's Janssen unit, without giving a timeline.</p>.<p>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.</p>.<p>The US Food and Drug Administration has said it is important for drugmakers to test their vaccines in children. Some doctors have raised concerns that the vaccines themselves could trigger a rare, life-threatening condition called Multisystem Inflammatory Syndrome in some children.</p>.<p><strong>Also read: <a href="https://www.deccanherald.com/international/world-news-politics/second-study-testing-covid-19-antibody-drug-has-a-setback-909323.html" target="_blank">Second study testing Covid-19 antibody drug has a setback</a></strong></p>.<p>Rival drugmaker Pfizer Inc has already begun testing the Covid-19 vaccine it is developing with Germany's BioNTech in children as young as 12. Their vaccine uses messenger RNA (mRNA), a new technology that has yet to produce an approved vaccine. 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.</p>.<p>The technology's history of safety should be important to regulators, said Dr. Paul Spearman, director of the infectious diseases division of Cincinnati Children's Hospital.</p>.<p>"Most of the toxicities are going to come from the platform and not from putting a different insert into the platform, Spearman said. So replacing the Ebola genetic material with that of the novel coronavirus "is unlikely to give you major issues," he added.</p>.<p>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.</p>