Johnson & Johnson has launched human safety trials in the United States for its COVID-19 vaccine.
Johnson & Johnson on Thursday kicked off human safety trials in the United States for its COVID-19 vaccine after releasing details of a study in monkeys that showed its top-performing vaccine candidate to offer strong protection in a single dose.
When exposed to the virus, six out of six animals that received the candidate vaccine were fully protected against lung disease and five out of six were protected against infection as measured by the presence of virus in nasal swabs, according to the study published in the journal. Nature.
“This gives us confidence that we can test a single injection vaccine in this epidemic and find out if it has a protective effect in humans,” Dr. Paul Stoffels, scientific director of J&J, told Reuters during a telephone interview.
The drugmaker said it has started early-stage human trials in the United States and Belgium and will test its vaccine candidate in more than 1,000 healthy adults between the ages of 18 and 55, as well as adults aged 65 and over.
The U.S. government is supporting J&J’s vaccination effort with $ 456 million in funding as part of a spending spree to speed up production of a vaccine to end the pandemic, which has infected million people and killed more than 660,000 people.
Stoffels said previous testing of this type of vaccine in other diseases found that a second injection greatly increases protection. But in a pandemic, a single-injection vaccine has a significant advantage, avoiding many of the logistical issues associated with returning people for their second dose.
The company plans to take up the issue of one or two doses in its Phase 1 trial.
Based on these results, J&J plans to begin large-scale Phase 3 testing with a single-dose regimen in the second half of September. At around the same time, the company will start a parallel Phase 3 study testing a two-dose regimen of the vaccine, Stoffels said.
J & J’s vaccine uses a cold virus known as adenovirus type 26 or Ad26 to transport the coronavirus proteins into the body’s cells, causing the body to build an immune defense against the virus. .
In the monkey study, scientists from J&J and Beth Israel Deaconess Medical Center at Harvard studied seven different potential vaccines in 32 animals and compared the results to 20 control animals that received placebo injections.
Six weeks later, all of the animals were exposed to the SARS-CoV-2 virus. All 20 animals that received the placebo developed high levels of the virus in their lungs and nasal swabs.
In the top-performing candidate, which J&J selected for human testing, none of the animals had viruses in the lungs and only one had low levels of virus in the nasal swabs. Laboratory tests showed that they had all developed antibodies capable of neutralizing the virus after a single injection.
“This study shows that even a single immunization with the Ad26 vaccine leads to neutralizing antibody responses and robust protection of monkeys against COVID-19,” said Dr. Dan Barouch, vaccine researcher at Beth Israel Deaconness who has led the research in collaboration with J&J.
J&J shares rose nearly 2% to $ 149.72 ahead of Thursday’s bell.
(Except for the title, this story was not edited by GalacticGaming staff and is posted from a syndicated feed.)
