The American multinational corporation better known for its consumer products, Johnson & Johnson (J&J) has begun its U.S. human safety trials for its COVID-19 vaccine.
J&J had released the specifics of a study it conducted on monkeys that showed its best-performing vaccine candidate gave strong protection with just a single dose.
Promising Results
As per the study published in the journal Nature, the drugmaker highlighted that when exposed to the virus, six out of six animals who got the vaccine candidate were completely protected from lung disease and five out of six were protected from infection as measured by the presence of the virus in nasal swabs.
Sharing his excitement on the revelation, Dr. Paul Stoffels, J&J’s chief scientific officer, said “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.”
Johnson & Johnson has started early-stage human trials in the United States and Belgium and is expected to test its vaccine candidate in over 1,000 healthy adults aged 18 to 55 years, as well as adults aged 65 years and older.
The U.S. government has already infused $456 million in funding to support J&J’s vaccine effort as part of a spending spree aimed at speeding the production of a vaccine to end the pandemic.
Dr. Stoffels said 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.
The company plans to take up the question of one or two doses in its phase 1 trial.
Depending on those results, J&J intends to start large-scale, phase 3 testing with a single-shot regimen in the second half of September along with a parallel phase 3 study testing a two-shot regimen of the vaccine.
The firm’s study results exhibit that none of the animals who were administered its best performing candidate had a virus in their lungs and only one showed low levels of virus in nasal swabs. Lab tests showed they all had developed antibodies capable of 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,” said Dr. Dan Barouch, a vaccine researcher at Beth Israel Deaconness who led the research in collaboration with J&J.
