Johnson & Johnson Paves The Ground For The Entry Of A COVID-19 Vaccine And Expands Its Production Capacity To Deliver Over One Billion Doses Until 2021 In A Non-Profit Project For The Ordinary said its chief scientist.
The American pharmaceutical giant, which has already advanced its schedule for starting human trials of its candidate vaccine in the second half of July from September, is working on both fronts of the expansion of existing production capacity and creation new units, Chief Scientific Officer Paul Stoffels told PTI.
“We plan to start at-risk production and are committed to providing the public with an affordable, not-for-profit vaccine for use in an emergency pandemic. We are expanding our global manufacturing capacity, including by building new capacity manufacturing vaccine, “said Stoffels. in an email interview from Belgium.
“We are also expanding capacity in other countries to reach our goal of delivering more than a billion doses of vaccine worldwide by 2021, provided the vaccine is safe and effective,” he said. added.
J&J has partnered with the United States government for a billion dollar investment to accelerate the development and production of its vaccine.
The company’s efforts, part of the global race to develop a vaccine against COVID-19, come as the pandemic continues to spread with more than 10 million cases and more than 5.05,000 deaths. in the world.
Explaining why the company advanced its clinical trials by two months, Stoffels said: “Based on the preclinical data we have seen so far and after interacting with regulatory authorities, we are able to accelerate development clinical trial of our experimental SARS – Candidate for CoV-2 vaccine. “
The trials, which will begin in two weeks, will be conducted in the United States and Belgium on 1,045 healthy adults aged 18 to 55 and adults 65 and older.
“Starting in 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 extended to larger cohorts using a phased approach,” said Stoffels.
The company is in discussions with the National Institutes of Allergy and Infectious Diseases with the aim of starting the phase 3 clinical trial before its initial schedule, pending the results of phase 1 / 2a studies and the approval of regulatory authorities. , added the Belgian scientist.
Stoffels, who is also vice chairman of J&J’s executive committee, said the main vaccine candidate is a non-replicating viral vector vaccine that contains a piece of DNA that codes for the “ spike ” protein of the coronavirus.
“Our goal for the vaccine candidate is that when a person receives the vaccine, their cells produce the advanced protein, which is recognized by the immune system as foreign, stimulating the production of antibodies and additional immune responses to fight the virus. The process creates an immune memory, which ultimately teaches the body to both recognize and attack the virus, “said Stoffels.
The company, he added, is working in partnership with health authorities and the world‘s best scientists to provide the safety and efficacy data necessary to support the worldwide use of its SARS-CoV- vaccine candidate 2.
Giving details of the trial, he said, “The randomized, double-blind, placebo-controlled phase 1 / 2a study will assess safety, reactogenicity (adverse response to vaccination) and immunogenicity (response beneficial immune system) from our experimental SARS. CoV-2 candidate. “
He described the pandemic as a global challenge requiring the 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 rapid COVID-19 pandemic.
“J&J has a long-standing commitment to address the global health crisis and will continue to work closely with partners around the world to address the current COVID-19 pandemic through a multi-pronged approach. We will continue to bring all our resources and our best scientific minds to fight this pandemic, “said Mr. Stoffels.
Vaccine development is a long process that often takes years and comes with many challenges, says E. Sreekumar, scientific director of the Rajiv Gandhi Center for Biotechnology (RGCB) in Kerala.
Vaccination tests usually start with animal and laboratory tests before moving on to different stages of human tests.
The human test phase includes several phases. Phase one trials are small, usually involving few participants, to assess whether the vaccine is safe for humans. Phase two trials often involve several hundred subjects and primarily assess the effectiveness of the vaccine against the disease.
The final phase involves thousands of people to further assess the effectiveness of the vaccine over a defined period of time, and can last several months, said Sreekumar.
(With the exception of the title, this story was not edited by GalacticGaming staff and is published from a syndicated feed.)