NAIJA BIZ

COVID-19: J&J starts vaccine trials on humans after success on monkeys

American Pharmaceutical giant, Johnson & Johnson (J&J), announced yesterday that it was starting safe human trials with its COVID-19 vaccine after its study on monkeys showed that its best-performing vaccine candidate offered strong protection in a single dose.

A published study in the journal, Nature, stated that during the conduct of the trials, when exposed to the virus, 6 out of 6 animals who were given the experimental vaccine were completely protected from lung disease. Also, 5 out of the 6 animals were protected from infection as measured by the presence of the virus in nasal swaps.

The Chief Scientific Officer of J&J, Dr. Paul Stoffels, in a telephone conversation with Reuters 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.”

J&J said that it had started early-stage human trials in the United States and Belgium and would test the experimental vaccine on more than 1,000 healthy adults that are aged between 18 to 55 years, as well as adults who are 65 years and above.

It was also revealed that the United States Government is supporting J&J’s vaccine development with $456 million in funding as part of its massive financial commitment to help intensify development and production of a vaccine to stop the pandemic, which has infected over 16.7 million people and killed more than 660,000 people.

Stoffels said that initial tests of this vaccine on other diseases discovered 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.

He said that data shows that the Coronavirus experimental vaccine generated a strong antibody response and provided protection with only a single dose.

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

Stoffels pointed out that depending on the result that is gotten, J&J plans to start large scale phase 3 testing with a single dose regimen in the second half of September. The company hopes to start a parallel phase 3 study testing of a 2 dose regimen of the vaccine around the same time.

The white house coronavirus task force coordinator, Deborah Birx, during an interview with Fox News said, “The Johnson & Johnson vaccine is exciting because it’s a single dose. Having one dose show protection in monkeys like the other vaccines have shown with two doses does shorten the time period for development because your readout becomes 30 days quicker.”

J&J’s technology is really based on the human adenovirus, a type of common cold virus, it’s an approach that is perhaps best known for its use in an Ebola vaccine.

In the monkey study, scientists from J&J and Harvard’s Beth Israel Deaconess Medical Center studied seven different potential vaccines in 32 animals and compared the results to 20 control animals who got placebo shots.

All of the animals were exposed to the SARS-CoV-2 virus 6 weeks later and the 20 animals that received the placebo developed high levels of virus in their lungs and nasal swabs.

In the best-performing candidate, which J&J selected for human testing, none of the animals had the 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.

Recall that Nairametrics had earlier reported that another American biotech firm, Moderna’s experimental vaccine showed positive outcomes in animals as it induced a robust response and protected against infection in a study on monkeys. This has been followed up with experimental trials on humans.

Although other COVID-19 vaccine developers appear ahead, with AstraZeneca having already administered its experimental vaccine to almost 10,000 people in the UK, gaining protection with a single dose could prove an advantage in the logistical challenge of rolling out massive vaccination programmes globally.

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