BE ties up with Janssen Pharmaceutica NV for coronavirus vaccine production

Mumbai|Hyderabad: US drug maker Johnson & Johnson (J&J) has transferred the technology and manufacturing rights of its SARS-Cov2 vaccine to India’s Biological E, a development that could result in the launch of J&J’s vaccine in India by mid 2021.

In an exclusive interview to ET, J&J chief scientific officer Paul Stoffels said both the companies would look at maximising the number of dosages and hope to produce up to 400-500 million vaccine doses each year for India.

“It’s a complex manufacturing process that needs to be transferred. We can only do a few of these tie-ups in the world. That’s why we have tied up with Biological E who have large capacity to manufacture vaccines,” said Stoffels.

The manufacturing, transfer of technology, validation of the vaccine have already started. The companies started working together several weeks before the deal was officially announced to learn how they could accelerate production. "In order to get the vaccine on time for the public, we need to start producing even before it works,” Stoffels said.

“Given the magnitude of the pandemic, our ability to mount an effective response will be predicated on the ability to supply the vaccine globally and in significant quantities. This is best achieved through collaboration,” said Mahima Datla, MD, Biological E. The company can manufacture 40-50 million doses per month in its Hyderabad facility.

J&J’s vaccine candidate for SARS-Cov2 works on a platform called the adenovirus platform, which was used to develop the vaccine for ebola and zika. The AdVac® and PER.C6® technology places a piece of SARS-Cov2 virus DNA — specifically, one that codes for the coronavirus ‘spike’ protein that latches on to human cells — inside a dead adenovirus.

The vaccine candidate hopes to trigger antibody response to the spike protein. The company will start its phase 3 trials in mid September.

Stoffels, who led the Ebola vaccine development for J&J, and Janssen, the research arm of J&J, have been working on this technology for over a decade. More than 80,000 people have been exposed to its vaccine vector which is the carrier that makes the vaccine work.

“We have seen a good safety and efficacy profile of our platform, so this gives us a good feeling that this will accelerate the development of the Covid 19 vaccine, but still we are going to do all the necessary work to prove its efficacy and safety,” Stoffels said.

In the next step, the company will start clinical trials across the world in more than 50,000 participants to study efficacy and safety.

It expects that even with accelerated development it will still take time till mid 2021 to immunise people in large parts of the world. “Realistically, we will have to wait till second quarter or even mid of next year to vaccinate a large number of people," he said.