Covid-19 vaccine: Johnson & Johnson begins Phase-3 trial with 60k people

According to Johnson & Johnson on Wednesday, it was entering the final Phase 3 stage of its Covid-19 vaccine clinical trial after positive results in earlier stages.

The company, and the US National Institutes for Health (NIH), which is providing funding, said, the trial will seek to enroll up to 60,000 volunteers across more than 200 sites in the US and around the world.

With the move, J&J becomes the tenth maker globally to conduct a Phase 3 trial against Covid-19, and the fourth in the US. The company, which is developing the vaccine on a not-for-profit basis through its subsidiary Janssen, said it anticipated the drug would be ready for emergency approval by early 2021 if proven effective.

Alex Gorsky, the company’s chairman, and CEO stated, “As Covid-19 continues to impact the daily lives of people around the world, our goal remains the same - hold the global reach and scientific innovation of our company to help bring an end to this pandemic."

Anthony Fauci, director of the NIH’s National Institute of Allergy and Infectious Diseases, said that four Covid-19 vaccine candidates are in Phase 3 clinical testing in the US just over eight months after Sars-CoV-2 was identified. This is an uncommon feat for the scientific community made possible by decades of progress in vaccine technology.

The US has given J&J about $1.45bn in funding under Operation Warp Speed. The vaccine is based on a single dose of a cold-causing adenovirus, combined with a part of the new coronavirus called the spike protein that it uses to invade human cells.

J&J used the same technology in its Ebola vaccine which received marketing approval from the European Commission in July.

The company said it was poised to imminently publish the results from an earlier stage of the trial on a medical preprint site.