The NIH claims joint ownership of Moderna’s coronavirus vaccine

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The Muslim Times has the best collection of articles for the war against Covid 19, especially the vaccines.

Source: Axios

By Bob Herman

The National Institutes of Health may own intellectual property that undergirds a leading coronavirus vaccine being developed by Moderna, according to documents obtained by Axios and an analysis from Public Citizen.

Why it matters: Because the federal government has an actual stake in this vaccine, it could try to make the vaccine a free or low-cost public good with wide distribution, if the product turns out to be safe and effective.

The big picture: The NIH mostly funds outside research, but it also often invents basic scientific technologies that are later licensed out and incorporated into drugs that are sold at massive profits. The agency rarely claims ownership stakes or pursues patent rights, but that appears to be different with this coronavirus vaccine.

  • “We do have some particular stake in the intellectual property” behind Moderna’s coronavirus vaccine, NIH Director Francis Collins said during an Economic Club interview in May.

Driving the news: New evidence shines light on the extent of NIH’s involvement.

  • NIH and Moderna have researched coronaviruses, like MERS, for several years, and signed a contract this past December that stated “mRNA coronavirus vaccine candidates [are] developed and jointly owned” by the two parties. The contract was not specific to the novel coronavirus, and it was signed before the new virus had been sequenced.
  • Separately, four NIH scientists have filed for a provisional patent application entitled “2019-nCoV vaccine,” according to disclosures in a pending scientific paper. Moderna scientists co-authored that paper, but none are listed as vaccine co-inventors.
  • That makes it clear “the government and the public have a stake” in the coronavirus vaccine, said Zain Rizvi, a health law and policy researcher at Public Citizen. “The vaccine would not exist without the intellectual contributions of federal scientists.”

What they’re saying: NIH said in a statement that its scientists created the “stabilized coronavirus spike proteins for the development of vaccines against coronaviruses, including SARS-CoV-2,” and the government consequently has “sought patents to preserve the government’s rights to these inventions.”

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In this day and age, understanding bacteria and viruses and developing vaccines are national security issues. In my view sizable part of every country’s defense budget should be spent in these pursuits rather than making tanks and other weapons.

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2 replies

  1. At the year’s start, few outside the world of biotech had heard of a Boston-area company with a New Age name and unproven approach to drugmaking. Most in the industry who did know Moderna Inc. doubted its prospects. Investors barely had interest in the company, which had yet to produce a medicine.

    Moderna and its staffers were dealing with other pressures. For nine years, chief executive officer Stéphane Bancel nurtured a high-stress environment at the Cambridge, Mass., company, characterized by high expectations, sharp critiques of workers and heavy employee turnover, according to current and former staffers. Mr. Bancel’s admonitions of some underlings in group meetings motivated some to do better, and others to leave.

    Today, Moderna represents one of the world’s best shots at stemming a historic pandemic. It’s a front-runner in the hunt for a coronavirus vaccine, vying against industry heavyweights with proven track records. The question is whether Moderna’s vanguard science and tough management style is the right recipe for a vaccine breakthrough.

    This summer, the U.S. government plans to fund and conduct decisive studies of three experimental coronavirus vaccines. Moderna’s will be first, starting later this month. Its lead status in the vaccine hunt is the reason the company’s shares have soared more than 200% this year.

    “I think the world is going to change tremendously,” says Mr. Bancel, referring to the company’s coronavirus vaccine as well as the experimental drugmaking technology being used to develop it.

    A 47-year-old native of France, Mr. Bancel says Moderna’s vaccine could be available for emergency use in health-care workers as soon as the fall with a full rollout next year. Eventually, he adds, the company could produce dozens of drugs and vaccines “for diseases for which there is no solution.”

    The bold promises of Mr. Bancel and his colleagues have long struck some in the pharmaceutical industry and on Wall Street as hubris. No company using the same experimental approach has managed to pull off a successful drug. Moderna has more than 20 experimental drugs and vaccines for cancer, infectious diseases and other conditions in development, but none are close to being commercially available to patients.

    https://www.wsj.com/articles/inside-moderna-the-covid-vaccine-front-runner-with-no-track-record-and-an-unsparing-ceo-11593615205?mod=hp_lead_pos6

  2. Moderna is a clinical-stage company, meaning it doesn’t yet have products on the market. The biotech company has about 20 candidates in the pipeline for indications including autoimmune disorders, cancer, and infectious diseases. A lot is riding on a possible COVID-19 vaccine approval because it would give Moderna a commercialized product.

    And one more important point: Moderna’s entire pipeline — including this vaccine — is based on the same technology, so positive data here may boost investor confidence in the rest of the company’s work. Moderna uses messenger RNA (mRNA) to deliver instructions to the body’s cells. These instructions tell the body to make certain proteins that can prevent or treat disease.

    Encouraging interim data
    So far, Moderna’s news has been positive. The company reported encouraging interim data from phase 1, with trial participants showing levels of binding antibodies and neutralizing antibodies at the same levels as or above those of recovered COVID-19 patients. Binding antibodies are those that alert the body to the presence of a pathogen, but more importantly, neutralizing antibodies actually block infection.

    Though Moderna is moving in the right direction, the vaccine must prove itself in a few areas. In the interim report, data on neutralizing antibodies was only available for eight trial participants. We must see this trend in many more before declaring victory.

    Another missing piece has to do with the age of trial participants. The interim data concerned volunteers age 18 to 55. Moderna currently is treating older groups in phase 2. This age group is extremely important for any successful vaccine because elderly patients have been among the most vulnerable during the COVID-19 pandemic. It’s essential that a vaccine works for them.

    https://www.fool.com/investing/2020/07/05/could-moderna-be-a-millionaire-maker-stock.aspx

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