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J&J Starts Human Study of COVID-19 Vaccine after Promising Data

J&J kicked off human safety trials for its COVID-19 vaccine after a study in monkeys showed its best-performing vaccine candidate offered strong protection in a single dose.

In a journal published in the journal Nature, when exposed to the virus, six out of six animals who got the vaccine candidate were completely protected from lung disease and five of six were protected from infection as measured by the presence of the virus in nasal swabs.

Dr. Paul Stoffels, J&J’s Chief Scientific Officer told Reuters in a telephone interview, “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.”

The drugmaker said it had started early-stage human trials in the United States and Belgium and would test its vaccine candidate in more than 1,000 healthy adults aged 18 to 55 years, as well as adults aged 65 years and older.

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

“Prior tests of this type of vaccine in other diseases found that a second shot significantly increases protection. But in a pandemic a single-shot vaccine has a significant advantage, sidestepping a lot of the logistical issues involved in getting people to come back for their second dose,” Stoffels said.

The company plans to take up the question of one or two doses in its phase 1 trial.

Depending on those results, J&J plans to start large-scale, phase 3 testing with a single-shot regimen in the second half of September. Around the same time, J&J will start a parallel phase 3 study testing a two-shot regimen of the vaccine.