Johnson & Johnson begins human study of COVID-19 vaccine after promising data on monkeys

(Reuters) – Johnson & Johnson began human safety trials in the US on Thursday for its COVID-19 vaccine after publishing details of a study in monkeys that showed its best-performing candidate vaccine offered strong protection in a single dose.

When exposed to the virus, six out of six animals that received the vaccine candidate were fully protected from lung disease and five out of six were protected from 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 know if it has a protective effect on humans,” Dr. Paul Stoffels, chief scientific officer at J&J, told Reuters in a telephone interview.

The drug maker said it had begun early-stage human trials in the United States and Belgium and that it would evaluate its vaccine candidate in more than 1,000 healthy adults ages 18 to 55, as well as adults older than 65.

The US government is backing J & J’s vaccine effort with $ 456 million in funding as part of a wave of spending aimed at speeding up production of a vaccine to end the pandemic, which has infected millions and killed more than 660,000 people.

Stoffels said previous tests of this type of vaccine on other diseases found that a second injection significantly increases protection. But in a pandemic, a single shot vaccine has a significant advantage, bypassing many of the logistical problems involved in getting people back for their second dose.

The company plans to address the issue of one or two doses in its phase 1 trial.

Depending on those results, J&J plans to begin large-scale phase 3 testing with a one-shot regimen in the second half of September. At about the same time, the company will begin a phase 3 parallel study to test a two-injection regimen of the vaccine, Stoffels said.

“The Johnson & Johnson vaccine is exciting because it is a single dose,” said Deborah Birx, Coordinator of the White House Coronavirus Task Force, in an interview with Fox News.

Having one dose “shows protection in monkeys as the other vaccines have shown with two doses shortening the time period for development because their reading becomes 30 days faster,” he said.

The J&J vaccine uses a common cold virus known as adenovirus type 26, or Ad26, to transport the coronavirus proteins to the body’s cells, causing the body to mount an immune defense against the virus.

In the monkey study, scientists at J&J and Harvard’s Beth Israel Deaconess Medical Center studied seven different potential vaccines in 32 animals and compared the results with 20 control animals that received placebo injections.

Six weeks later, all animals were exposed to the SARS-CoV-2 virus. The 20 animals that received the placebo developed high levels of the virus in their lungs and nasal samples.

In the best-performing candidate, which J&J selected for the human test, none of the animals had viruses in the lungs and only one showed low levels of virus in the nasal swabs. Laboratory tests showed that everyone had 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 led the research. in collaboration with J&J.

J&J shares rose nearly 2% to $ 149.93 before the market opened Thursday.