By Economic Times – Human trials begin in fortnight, J&J works to ramp up production of affordable COVID vaccine: Top scientist 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.

“Our aim for the vaccine candidate is that when a person receives the vaccine, their cells will make the spike protein, which is recognised by the immune system as foreign, stimulating production of antibodies and additional immune responses to fight off the virus. The process creates an immune memory, which ultimately teaches the body to both recognise and attack the virus,” Stoffels elaborated.

The company, he added, is partnering with health authorities and the world’s best scientists to provide the safety and efficacy data necessary to support worldwide use of its SARS-CoV-2 vaccine candidate.

Giving details of the trial, he said,”The randomised, double-blind, placebo-controlled Phase 1/2a study will evaluate the safety, reactogenicity (adverse response to vaccination), and immunogenicity (beneficial immune response) of our investigational SARS-CoV-2 vaccine candidate.”

He described the pandemic as a challenge of global proportions requiring collaboration and support of governments around the world. Since January, J&J has been working directly with governments and health authorities to help end this fast-moving COVID-19 pandemic.

“J&J has a long-standing commitment to address global health crisis and will continue to work closely with partners worldwide to combat the current COVID-19 pandemic through a multi-pronged approach… We will continue to bring our full resources and best scientific minds to combat this pandemic,” Stoffels said.

Vaccine development is a lengthy process which often takes years and has many challenges, explains E. Sreekumar, chief scientific officer at the Rajiv Gandhi Centre for Biotechnology (RGCB)
in Kerala.

Vaccine testing typically begins with animal and lab testing before going on to different stages of
human testing.

The
human testing phase comprises many phases. Phase one
trials are small-scale, usually involving few participants, to assess whether the vaccine is safe for humans. Phase two
trials often involve several hundred subjects, and mainly evaluate the efficacy of the vaccine against the disease.

The final phase involves thousands of people to further assess the efficacy of the vaccine over a defined period of time, and can last several months, Sreekumar said.
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