By Julie Steenhuysen
CHICAGO, July 30 (Reuters) – Johnson & & Johnson on Thursday started U.S. human safety trials for its COVID-19 vaccine after launching details of a study in monkeys that showed its best-performing vaccine candidate provided strong security in a single dose.
When exposed to the virus, six out of 6 animals who got the prospect vaccine were completely secured from lung illness and 5 out of 6 were safeguarded from infection as determined by the existence of virus in nasal swabs, according to the study released in the journal Nature.
” This gives us self-confidence that we can evaluate a single-shot vaccine in this epidemic and discover whether it has a protective impact in people,” Dr. Paul Stoffels, J&Js primary clinical officer, informed Reuters in a telephone interview.
The U.S. government is backing J&Js vaccine effort with $456 million in financing as part of a spending spree focused on speeding production of a vaccine to end the pandemic, which has actually infected millions and killed more than 660,000 individuals.
Stoffels stated prior tests of this type of vaccine in other diseases found that a second shot considerably increases security. However in a pandemic a single-shot vaccine has a substantial advantage, avoiding a lot of the logistical concerns associated with getting people to come back for their 2nd dose.
The company plans to take up the question of one or 2 dosages in its stage 1 trial, which began today in the United States.
Depending on those outcomes, J&J prepares to start massive, phase 3 testing with a single-shot regimen in the 2nd half of September. Around the very same time, the business will start a parallel stage 3 research study screening a two-shot program of the vaccine, Stoffels stated.
J&Js vaccine utilizes a common cold virus called adnovirus type 26 or Ad26 to shuttle coronavirus proteins into cells in the body, causing the body to install an immune defense versus the infection.
In the monkey research study, researchers from J&J and Harvards Beth Israel Deaconess Medical Center studied seven different prospective vaccines in 32 animals and compared the outcomes to 20 control animals who got placebo shots.
6 weeks later, all of the animals were exposed to the SARS-CoV-2 infection. All 20 animals that got the placebo established high levels of virus in their lungs and nasal swabs.
In the best-performing candidate, which J&J picked for human testing, none of the animals had virus in their lungs and only one revealed low levels of virus in nasal swabs. Laboratory tests revealed they all had established antibodies capapable of reducing the effects of the infection after a single shot.
” This research study shows that even simply a single immunization with the Ad26 vaccine causes reducing the effects of antibody actions and robust security of monkeys against COVID-19,” said Dr. Dan Barouch, a vaccine scientist at Beth Isreal Deaconness who led the research study in partnership with J&J.
( Reporting by Julie Steenhuysen; editing by Richard Pullin).