J&J's COVID-19 Vaccine Clinical Trials To Begin Soon In US, Belgium

Johnson & Johnson (J&J) is planning to execute the human trials for its COVID-19 vaccine in the second half of July, according to a statement released by the company on Wednesday, June 10.

During the human trial involving an experimental COVID-19 vaccine, the company plans to test the shot’s safety and immune response (efficacy) in about 1,045 healthy volunteers aged between 18 and 55 years.

The trial, which will be conducted in the U.S. and Belgium, also plans to involve a few people aged 65 and above.

J&J is among the list of several such drugmakers who are in the race to find the right vaccine candidate against novel coronavirus, which has proved to be a contagious respiratory disease. So far, none of the coronavirus vaccine candidates has been approved.

The company has already signed a deal and reached a settlement with the U.S. government for the production of one billion COVID-19 vaccine shots through 2021, even before there is any clinical data available proving its safety and efficacy in humans.

J&J’s study plans to check the safety and efficacy of its coronavirus vaccine against a placebo in healthy volunteers. The company has accelerated its timeline for clinical testing in humans by almost two months.

"Based on the strength of the preclinical data we have seen so far and interactions with the regulatory authorities, we have been able to further accelerate the clinical development," said J&J's Chief Scientific Officer Paul Stoffels in the official statement.

The company is also believed to be in contact with the National Institutes of Allergy and Infectious Diseases to initiate an early late-stage trial for the COVID-19 vaccine. However, its timeline and a go-ahead for a late-stage trial ahead of its original schedule will depend on the regulatory approvals and early results from the ongoing study.

There are about 10 coronavirus vaccines already in human trials across the world, including Moderna Inc’s highly anticipated mRNA vaccine. This is one of its kind of vaccine that uses technology that has not been approved so far for any medicine.

On the other hand, J&J’s coronavirus vaccine uses the same technology that the company used to produce its Ebola shot during the epidemic.