Initially planned for September, the trial for SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant, is expected to start in the second half of July
Johnson & Johnson's first human study will evaluate the safety, reactogenicity and immunogenicity of the vaccine
So far, at least 412,926 people in the world have lost their lives to COVID-19
New York: As vaccine makers race against time to develop a safe vaccine against the novel coronavirus, Johnson & Johnson announced on Wednesday that it has fast-tracked the initiation of the Phase 1/2a first-in-human clinical trial of its experimental COVID-19 vaccine by two months through its Janssen Pharmaceutical Companies (Janssen). The trial for SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant, has been moved from September to the second half of July.
Earlier in March, the company announced it had identified a lead vaccine candidate for COVID-19, adding that the technology they’re using to develop the jab was also used to develop their investigational Ebola vaccine, as well as vaccine candidates for the Zika virus, RSV and HIV.
J&J's randomised, double-blind, placebo-controlled Phase 1/2a study will evaluate the safety, reactogenicity (response to vaccination), and immunogenicity (immune response) of the vaccine. The trial, which will take place in the US and Belgium, will enroll a total of 1,045 healthy adults between 18 and 55 years old and older than 65.
“Based on the strength of the preclinical data we have seen so far and interactions with the regulatory authorities, we have been able to further accelerate the clinical development of our investigational SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant,” Paul Stoffels, Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson, said.
He added that simultaneously, they are continuing their efforts to build important global partnerships and invest in their vaccine production technology and manufacturing capabilities.
The company said their goal is to manufacture over 1 billion doses of the potential preventive vaccine by the end of 2021.
“Our goal is to ensure we can deliver a vaccine to the world and protect people everywhere from this pandemic,” said the company.
The company is in discussions with the National Institutes of Allergy and Infectious Diseases with the objective to start the Phase 3 vaccine clinical trial ahead of its original schedule, pending outcome of Phase 1 studies and approval of regulators.
In March, the company received $456 million from the Biomedical Advanced Research and Development Authority to develop its vaccine and is one of several being evaluated under Operation Warp Speed, a public-private partnership to facilitate, at an unprecedented pace, the development, manufacturing, and distribution of COVID-19 countermeasures.
According to the World Health Organization (WHO), more than 120 vaccine candidates are under various stages of trial even as scientists believe that it make take 12-18 months before a successful one is achieved.
Worldwide, at least 412,926 people have now lost their lives to COVID-19, whereas as many as 7,294,130 cases have been confirmed in 196 countries and territories.