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Johnson & Johnson begins human safety experiments for its Covid-19 vaccine

Six weeks later, all the animals had been uncovered to the SARS-CoV-2 virus. All 20 animals that obtained the placebo developed excessive ranges of virus of their lungs and nasal swabs. (Representational Image)

Johnson & Johnson on Thursday kicked off U.S. human security trials for its COVID-19 vaccine after releasing particulars of a research in monkeys that confirmed its best-performing vaccine candidate supplied sturdy safety in a single dose.

When uncovered to the virus, six out of six animals who bought the vaccine candidate had been utterly shielded from lung illness and 5 out of six had been shielded from an infection as measured by the presence of virus in nasal swabs, in line with the research revealed within the journal Nature.

“This gives us confidence that we can test a single-shot vaccine in this epidemic and learn whether it has a protective effect in humans,” Dr. Paul Stoffels, J&J’s chief scientific officer, advised Reuters in a phone interview.

The drugmaker mentioned it had began early-stage human trials within the United States and Belgium and would check its vaccine candidate in over 1,000 wholesome adults aged 18 to 55 years, in addition to adults aged 65 years and older.

The U.S. authorities is backing J&J’s vaccine effort with $456 million in funding as a part of a spending spree geared toward dashing manufacturing of a vaccine to finish the pandemic, which has contaminated thousands and thousands and killed greater than 660,000 folks.

Stoffels mentioned prior checks of this kind of vaccine in different ailments discovered {that a} second shot considerably will increase safety. But in a pandemic a single-shot vaccine has a major benefit, sidestepping lots of the logistical points concerned in getting folks to come back again for his or her second dose.

The firm plans to take up the query of 1 or two doses in its section 1 trial.

Depending on these outcomes, J&J plans to begin large-scale, section three testing with a single-shot routine within the second half of September. Around the identical time, the corporate will begin a parallel section three research testing a two-shot routine of the vaccine, Stoffels mentioned.

J&J’s vaccine makes use of a standard chilly virus often known as adenovirus sort 26 or Advert26 to ferry coronavirus proteins into cells within the physique, inflicting the physique to mount an immune protection towards the virus.

In the monkey research, scientists from J&J and Harvard’s Beth Israel Deaconess Medical Center studied seven totally different potential vaccines in 32 animals and in contrast the outcomes to 20 management animals who bought placebo pictures.

Six weeks later, all the animals had been uncovered to the SARS-CoV-2 virus. All 20 animals that obtained the placebo developed excessive ranges of virus of their lungs and nasal swabs.

In the best-performing candidate, which J&J chosen for human testing, not one of the animals had virus of their lungs and just one confirmed low ranges of virus in nasal swabs. Lab checks confirmed all of them had developed antibodies able to neutralizing the virus after a single shot.

“This study shows that even just a single immunization with the Ad26 vaccine leads to neutralizing antibody responses and robust protection of monkeys against COVID-19,” mentioned Dr. Dan Barouch, a vaccine researcher at Beth Israel Deaconness who led the analysis in collaboration with J&J.

J&J shares had been up practically 2% at $149.72 earlier than the bell on Thursday.

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