UPDATE (September 23, 2020): At the end of March, as the severity of the coronavirus pandemic and COVID-19 were becoming increasingly apparent, Johnson & Johnson announced that it expected to be able to test its candidate vaccine on people by September 2020. The pharmaceutical company met that goal with July's Phase 1/2a first-in-human clinical study, and it has now announced that its Phase 3 clinical trial has launched.
The Phase 3 trial, called ENSEMBLE, is beginning after Phase 1/2a's interim results showed that its "safety profile and immunogenicity after a single vaccination were supportive of further development," according to a September 23 press release from Johnson & Johnson. "[ENSEMBLE] is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the safety and efficacy of a single vaccine dose versus placebo in up to 60,000 adults 18 years old and older, including significant representation from those that are over age 60. The trial will include those both with and without comorbidities associated with an increased risk for progression to severe COVID-19, and will aim to enroll participants in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa, and the United States."
Pending the outcome of ENSEMBLE, and in line with the company's initial expectations of the vaccine timeline, Johnson & Johnson says it still anticipates the first batches of its COVID-19 vaccine to be available for emergency use authorization in early 2021, if proven to be safe and effective.
"With our vaccine candidate now in our global Phase 3 trial, we are one step closer to finding a solution for COVID-19," Mathai Mammen, Johnson & Johnson's global head of Janssen Research & Development, LLC, said in the new statement, "We used a highly scientific and evidence-based approach to select this vaccine candidate. We are extremely grateful for the tireless efforts of our researchers and for the vital contributions of those participants who have volunteered to take part in our studies. Together, we are working to help combat this pandemic."
This post originally appeared on March 31, 2020:
We've heard amazing stories of companies shifting their focus to help out during the COVID-19 pandemic. So many cosmetics companies are switching their production lines to make hand sanitizer, and fashion designers are making protective masks for medical workers. But the companies we've been most eager to hear from are those in the pharmaceutical industry as its brilliant scientific minds work on ways to stop the spread of the novel coronavirus. And today, Jonhson & Johnson has announced hopeful news about research into a possible vaccine.
According to a March 30 press release from the company, Johnson & Johnson has been working with the Biomedical Advanced Research and Development Authority (BARDA) to develop a vaccine for COVID-19 since the novel coronavirus sequence became available. And now Johnson & Johnson is able to say that this "lead vaccine candidate" will begin to be tested on people in clinical studies by September, and if clinical data shows safety and efficacy by the end of 2020, it could become available in less than a year.
"The company expects to initiate human clinical studies of its lead vaccine candidate at the latest by September 2020 and anticipates the first batches of a COVID-19 vaccine could be available for emergency use authorization in early 2021, a substantially accelerated timeframe in comparison to the typical vaccine development process," the statement reads. According to the statement, the typical development process can last five to seven years before a potential vaccine is considered for approval.
Additionally, Johnson & Johnson is working on ensuring the availability of the vaccine by expanding its manufacturing capacity in the U.S. and other countries. "The additional capacity will assist in the rapid production of a vaccine and will enable the supply of more than one billion doses of a safe and effective vaccine globally," the statement reads. "The company plans to begin production at risk imminently and is committed to bringing an affordable vaccine to the public on a not-for-profit basis for emergency pandemic use."
In addition to its vaccine news, Johnson & Johnson also shared that, following the January announcement of a $250 million commitment over ten years to support front line health care workers, the company will also be committing another $50 million — for "immediate COVID-19" response, primarily for those workers.
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Originally Appeared on Allure