Johnson & Johnson ramps up affordable COVID vaccine production, human trials soon

KOLKATA: Johnson & Johnson is preparing the ground for the entry of a vaccine against COVID-19 and is expanding its manufacturing capacity to supply more than one billion doses through 2021 in a not-for-profit project aimed at the common person, says its top scientist.

The US-based pharma giant, which has already advanced its schedule of starting human trials of its candidate vaccine to the second half of July from September, is working on the twin fronts of expanding existing manufacturing capacity and establishing new units, Chief Scientific Officer Paul Stoffels told PTI.

"We plan to begin production at risk and are committed to bringing an affordable vaccine to the public on a not-for-profit basis for emergency pandemic use. We are expanding our global manufacturing capacity, including establishing new vaccine manufacturing capabilities," Stoffels said in an email interview from Belgium.

"We are also scaling up capacities in other countries to further our goal to supply more than one billion doses of the vaccine globally through the course of 2021, provided the vaccine is safe and effective," he added.

J&J has joined hands with the US government for a $1 billion investment to speed up development and production of its vaccine.

The company's efforts, part of the global race to develop a vaccine against COVID-19, comes as the pandemic continues its spread with more than 10 million cases and over 5,05,000 fatalities across the world.

Explaining why the firm advanced its clinical trials by two months, Stoffels said, "Based on the strength of the preclinical data we have seen so far and after interacting with the regulatory authorities, we are able to accelerate the clinical development of our investigational SARS-CoV-2 vaccine candidate."

The trials, which will begin in a fortnight, will be conducted in the US and Belgium on 1,045 healthy adults between the ages of 18 and 55 and adults who are 65 years and older.

"From July 2020, the safety of the vaccine will be extensively tested in a small cohort of human volunteers. After the initial cohort it will be expanded to larger cohorts in a step-wise approach," Stoffels said.

The company is in discussion with the National Institutes of Allergy and Infectious Diseases with an objective to start the Phase 3 clinical trial ahead of its original schedule, pending outcome of Phase 1/2a studies and approval of regulators, the Belgium-based scientist added.

Stoffels, who is also vice chairperson of the executive committee of J&J, said the lead vaccine candidate is a non-replicating viral-vector vaccine that contains a piece of DNA that codes for the coronavirus 'spike'' protein.