SOURCE: Johnson & JohnsonSUMMARY:
A preclinical study just published in Nature shows that the company's investigational vaccine has shown positive early data for eliciting an immune response against SARS-CoV-2, the virus that causes COVID-19. We share more about the findings from the recent preclinical study, along with other up-to-date information about the potential vaccine candidate.DESCRIPTION:
In January 2020, just as SARS-CoV-2, which causes COVID-19, began to spread around the globe, the Janssen Pharmaceutical Companies of Johnson & Johnson started researching potential vaccine candidates.
Three months later, scientists at the company announced a lead vaccine candidate in development at Janssen and its plans to put it into a Phase 1/2a human clinical trial no later than September 2020—a timeline that, in June, the company announced it had accelerated.
Today, data published in Nature showed that Janssen's investigational vaccine elicited an immune response against SARS-CoV-2 in a preclinical, nonhuman study.
Based on the positive data from this preclinical study, which was conducted in collaboration with researchers from Beth Israel Deaconess Medical Center, first-in-human trials of the potential vaccine are now underway.*
"We are excited to see these preclinical data because they show our SARS-CoV-2 vaccine candidate generated a strong antibody response and provided protection with a single dose," says Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson. "The findings give us confidence as we progress our vaccine development and upscale manufacturing in parallel, having initiated a Phase 1/2a trial in July with the intention to move into a Phase 3 trial in September."
Johnson & Johnson is deploying the full strength of its science, scale and expertise to help fight the pandemic as COVID-19 continues to affect people and communities across the world—according to the World Health Organization, as of this month, global cases have now surpassed 16 million.
Read on to learn the latest facts about Janssen’s investigational COVID-19 vaccine.
The Company Has Launched Phase 1/2a First-in-Human Trials
On June 10, Johnson & Johnson announced it was accelerating the timeline to start early-stage testing of Janssen's vaccine candidate in humans in the second half of July.
Phase 1/2a trials aim to evaluate a few things: whether the vaccine candidate triggers an immune response, how safe it is, if there are any possible side effects and potential dosage amounts.
This phase of a clinical trial is randomized, double-blind and placebo-controlled, which means that neither participants nor investigators or study staff know who is getting a placebo and who is getting the vaccine candidate—an approach that is considered to be the gold standard of epidemiological studies.
1,045 People Will Participate in This Janssen Trial
Healthy participants in Belgium and the U.S. between the ages of 18 and 55, as well as those 65+, will receive inoculations to evaluate the vaccine candidate’s safety profile, common adverse reactions—such as arm soreness at the site of injection—and ability to invoke an immune response.
Johnson & Johnson has identified clinical study sites in cities that have underserved and underrepresented populations and is partnering with organizations to proactively identify and include diverse patient populations. The company is also working to mitigate hurdles to participation at various sites, such as transportation and childcare, to ensure a diverse group of study volunteers are recruited.
Plans are also underway for a Phase 1 study in Japan, as well as a Phase 2 study in the Netherlands, Spain and Germany. If these trials are successful, Johnson & Johnson plans to begin Phase 3 studies, in which even more volunteers will receive the investigational vaccine, in September.
Janssen Plans to Produce More than 1 Billion Doses of a Potential Vaccine
Provided that the investigational vaccine proves to be safe and effective, the company aims to manufacture over 1 billion doses to be distributed globally through 2021.
These efforts—along with research and development—are spurred by an expanded collaboration between Janssen and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health & Human Services.
Janssen is using the same technology that it has used in the development of its Ebola vaccine and investigational HIV, RSV and Zika vaccine candidates, which involves using an inactivated common cold virus that's not replicating.
The Company Is Also Scaling Up Manufacturing
The investigational vaccines will be produced at Janssen's facility in Leiden, the Netherlands. In April the company also announced manufacturing partnerships in the U.S., and, recently, one in Italy, with more plants to potentially be added in other countries.
This expanded production capability aims to enable the company to rapidly scale up to produce and provide more than 1 billion doses to people around the world.
The company’s potential vaccine would be able to be distributed through standard, reliable channels around the world, and it would not require special transport or infrastructure to reach populations in need.
*This project has been funded in whole or in part with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under Other Transaction Agreement HHSO100201700018C.
Tweet me: A preclinical study in @nature about an investigational #COVID19 vaccine shows that it provides robust protection against the coronavirus. Learn more as Lisa Ling talks to @JNJnews' Dr. Paul Stoffels and @harvardmed's Dr. Dan Barouch: https://bit.ly/3fhwaSa
KEYWORDS: NYSE:JNJ, johnson & johnson, COVID-19, vaccine