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Wednesday, March 3rd, 2021

Johnson & Johnson expects human testing of COVID-19 vaccine by Sept under accelerated timeline

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Johnson & Johnson wants to begin human testing of a COVID-19 vaccine candidate by September as part of a $1 billion joint investment between the company and the U.S. Department of Health and Human Services (HHS).

The end goal is to create a billion vaccines for emergency pandemic use to be dispersed globally. As a result of the arrangement, Johnson & Johnson will create new vaccine manufacturing capabilities in the United States and simultaneously add production capacity outside the U.S. This, the company hopes, will also provide assurances to a taxed global vaccine supply.

“We are very pleased to have identified a lead vaccine candidate from the constructs we have been working on since January,” said Dr. Paul Stoffels, vice chairman of the Executive Committee and chief scientific officer at Johnson & Johnson. “We are moving on an accelerated timeline toward Phase 1 human clinical trials at the latest by September 2020 and, supported by the global production capability that we are scaling up in parallel to this testing, we expect a vaccine could be ready for emergency use in early 2021.”

COVID-19, the disease byproduct of SARS-CoV-2 that has swept across the globe in a matter of months, has to date infected more than 755,500 people, according to data from Johns Hopkins University. The United States is now the epicenter of the disease, with more than 148,000 cases, though its death rates have been lower than in other afflicted nations. Currently, there are no approved treatments or vaccines for the disease.

The arrangement for Johnson & Johnson’s new lead vaccine expands on an arrangement already in place between its Janssen Pharmaceutical Companies and the Biomedical Advanced Research and Development Authority (BARDA), which is part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at HHS. Despite the existing relationship, the timeframe proposed for the vaccine represents a major acceleration over the typical vaccine development process, if successful. Usually, the vaccine development process can take 5 to 7 years just to be considered for approval.

Regardless, the government and Johnson & Johnson will co-fund vaccine research, development and clinical testing. At the same time, they will also expand efforts to identify potential antiviral treatments for SARS-CoV-2. While this vaccine is Johnson & Johnson’s lead product, two back-ups are also in place if needed.

Johnson & Johnson has pledged to bring an affordable vaccine to the public on a not-for-profit basis for emergency use.