By Julie Steenhuysen
CHICAGO, July 30 (Reuters). Johnson & Johnson launched a safety study of COVID-19 in humans in the United States on Thursday after details of studies in monkeys showed that its vaccine candidate performed best in a single dose.
According to a study published in the journal, six of the six animals that received the vaccinated were completely protected against lung disease, and five of the six were protected against infection by measuring the presence of the virus in nasal swabs. Nature.
“This gives us confidence that we can investigate a single vaccine against the epidemic and see if it has a protective effect on humans,” Dr Dr said in a telephone interview with Reuters. Paul Stoffels, J&J Chief Scientific Officer.
The U.S. government is supporting J&J’s vaccination efforts with $ 456 million. USD funding as part of spending to accelerate vaccine production to prevent a pandemic that has infected millions and killed more than 660,000 people.
Stoffels said previous studies of this type of vaccine against other diseases have found that a second shot significantly increases protection. However, during a pandemic, a single vaccine has a significant advantage in eliminating many of the logistical issues associated with people returning to their second dose.
The company plans to take the one- or two-dose issue during a phase 1 study that began in the U.S. this week.
Based on those results, J&J plans to launch large-scale Phase 3 single-shot trials in the second half of September. Around the same time, the company will launch a parallel phase 3 study to test the two-generation vaccine regimen, Stoffels said.
The J&J vaccine uses a common cold virus known as adnovirus type 26 or Ad26 to deliver coronavirus proteins to the body’s cells, forcing the body to attach immune protection against the virus.
In a study of monkeys, researchers at J&J and Harvard Beth’s Israel Deaconry Medical Center examined seven different possible vaccines from 32 animals and compared the results with 20 control animals that received placebo.
Six weeks later, all animals were exposed to the SARS-CoV-2 virus. All 20 placebo-treated animals developed high levels of virus in the lungs and nasal swabs.
For the best-performing candidate selected by J&J for human testing, none of the animals had a virus in their lungs, and only one animal had a low level of virus in the nasal swabs. Laboratory tests have shown that they have all developed antibodies that can neutralize the virus after a single shot.
“This study shows that even a single vaccination with Ad26 neutralizes antibody responses and strong protection of monkeys against COVID-19,” said Dr. Dan Barouch, a Beth Isreal Diakonness vaccine researcher who led the study in collaboration with J&J.
(Report – Julie Steenhuysen; edited by Richard Pullin)