J&J says it is 5 months away from human trials on a Vaccine; Researchers Float License-Free COVID-19 Pledge

Johnson & Johnson, the pharmaceutical giant, said yesterday it is five months away from starting human trials on a COVID-19 vaccine that would be offered on a non-profit basis in the U.S.  This came amid an announcement on the same day about an “Open COVID-19 Pledge,” designed to ensure developments related to fighting the pandemic are not hindered by having to navigate a sea of related IP rights.

Safe Vaccine

“We have very good early indicators that not only can we depend on this to be a safe vaccine base but also one that will ultimately be effective, based on all the early testing and modeling we’ve been doing,” J&J Chairman and CEO, Alex Gorsky, said on CNBC Monday.

The firm began working on a vaccine in January, Gorsky, New York Magazine reported, and has partnered with the federal government’s Biomedical Advanced Research and Development Authority (BARDA) to speed the vaccine though testing and approval. “This is a bit of a moon shot for J&J going forward, but it’s one we feel is very, very important for us to be doing at this period in time,” he said.

Clinical data would be available by the end of the year, leaving open the possibility of emergency-use authorization by early next year.

Patent-Sharing

Meanwhile, Jose Contreras, a lawyer and professor associated with the “Open COVID Pledge,” told IAM about the motivation of the organizers, which includes CRISPER pioneer Jennifer Doudna and Mark Lemley: “They genuinely felt that there were enough patents floating around in the spaces where they needed to work that getting formal licenses would slow things down too much.”

The “Open COVID Pledge” invites universities, companies and other owners of intellectual property to grant free but temporary licenses to use their patented and copyrighted technologies in the fight against COVID-19 without fear of legal ramifications.

It will be interesting to measure the impact of the pledge and if it influences future research in diseases like cancer and Alzheimer’s, where collaboration is crucial and research dollars necessary. Striking a balance between sharing discoveries and proprietary research protected under patent law has been a continuing challenge in the bio-pharma industry.

To give those making the pledge some flexibility the Q&A section reveals that it can be tweaked if an entity needs to conform to specific rules and regulations.

For more information about the Pledge, or to make it, visit https://opencovidpledge.org/

Not-for-Profit in the U.S.

Gorsky of J&J said the plan is to distribute the vaccine on a “not-for-profit basis here in the United States.” The research, development, and testing of the vaccine is being co-funded by a $1 billion investment from Johnson & Johnson and BARDA, an arm of the Department of Health and Human Services (DHHS).

 

New Jersey-based Johnson & Johnson, whose shares rose 8% on the news (NYSE: JNJ), is one of a handful of companies in the COVID-19 vaccine arms race. The Massachusetts biotech company Moderna Inc. began human trials of its experimental vaccine this month in Seattle. Moderna’s CEO was reported as saying that under emergency use, a vaccine could be available to some people, possibly including health-care professionals, this year.

Late last week, Dr. Anthony Fauci told Americans to remain realistic about how quickly a vaccine can help. “Certainly, for sure, a vaccine is not going to help us now, next month, the month after,” he said.

Tracking COVID-19 Trends

Worldometer, is an excellent repository of well-sourced up-to-the minute data and trends about the coronavirus. The website is run by an international team of developers, researchers, and volunteers “with the goal of making world statistics available in a thought-provoking and time relevant format to a wide audience around the world.” It is published an independent digital media company that says it has no political, governmental, or corporate affiliation.

Worldmeter COVID-19 data is used by Johns Hopkins CSSE, Financial Times, The New York Times, Business Insider, among others.

For real-time facts and data on the COVID-19 crisis, The John Hopkins Coronavirus Resource Center provides a series of excellent global, national and local interactive maps.

Image source: CNBC; epmmagazine.com

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