Confronted by the challenge of COVID-19, everybody and his uncle got together to fight back. In the field of vaccines and therapeutics this often meant a private-public partnership with governments in the Western world, particularly the US, doling out astronomical sums of money as advance payments for vaccines still under development. Not only did this help fund vaccine development, but there have been instances in which public research institutions worked together with private pharma companies to actually develop vaccines. Now in the relative lull with large numbers in the Western world having been vaccinated and governments pushing for booster doses, things have begun to unravel, the public-private honeymoon has transformed into a seven-year itch and nowhere more than in the home of private enterprise, the US of A!
Moderna and the National Institutes of Health (NIH) are in a bitter dispute over who deserves credit for inventing the central component of the company’s powerful coronavirus vaccine, a conflict that has broad implications for the vaccine’s long-term distribution and billions of dollars in future profits, the New York Times reports (www.nytimes.com/2021/11/09/us/moderna-vaccine-patent.html?)
The vaccine grew out of a four-year collaboration between Moderna and the N.I.H., the US government’s biomedical research agency — a partnership that was widely hailed when the shot was found to be highly effective. A year ago this month, the US government called it the “N.I.H.-Moderna Covid-19 vaccine.”
The agency says three scientists at its Vaccine Research Center — Dr John R. Mascola, the Center’s director; Dr Barney S. Graham, who recently retired; and Dr Kizzmekia S. Corbett, who is now at Harvard — worked with Moderna scientists to design the genetic sequence that prompts the vaccine to produce an immune response, and should be named on the “principal patent application.”
Moderna disagrees. In a July filing with the United States Patent and Trademark Office, the company said it had “reached the good-faith determination that these individuals did not co-invent” the component in question. Its application for the patent, which has not yet been issued, names several of its own employees as the sole inventors.
The N.I.H. had been in talks with Moderna for more than a year to try to resolve the dispute; the company’s July filing caught the agency by surprise, according to a government official familiar with the matter. It is unclear when the patent office will act, but its role is simply to determine whether a patent is warranted. If the two sides do not come to terms by the time a patent is issued, the government will have to decide whether to go to court — a battle that could be costly and messy.
The dispute is about much more than scientific accolades or ego. If the three agency scientists are named on the patent along with the Moderna employees, the federal government could have more of a say in which companies manufacture the vaccine, which, in turn, could influence which countries get access. It would also secure a nearly unfettered right to license the technology, which could bring millions into the federal treasury.
The fight comes amid mounting frustration in the U.S. government and elsewhere with Moderna’s limited efforts to get its vaccine to poorer countries. The company, which has not previously brought a product to market, received nearly $10 billion in taxpayer funding to develop the vaccine, test it and provide doses to the federal government. It has already lined up supply deals worth about $35 billion through the end of 2022.
Experts said the disputed patent was the most important one in Moderna’s growing intellectual property portfolio. It seeks to patent the genetic sequence that instructs the body’s cells to make a harmless version of the spike proteins that stud the surface of the coronavirus, which triggers an immune response.
While it has not publicly acknowledged the rift until now, the Biden administration has expressed frustration that Moderna has not done more to provide its vaccine to poorer nations even as it racks up huge profits.
If the N.I.H. scientists were named as co-inventors on the patent, the agency would generally not need Moderna’s permission to license it to other companies or organizations, patent law experts said. In theory, that could help expand the supply of the Moderna vaccine.
Moderna has pledged not to enforce its Covid vaccine patents during the pandemic. But a licence from the government would provide additional legal reassurance to manufacturers and allow them to keep producing the vaccine after the pandemic, experts said.
The story of the public-private collaboration has been one of the few bright spots of the pandemic. The three government scientists — especially Dr. Corbett, who emerged as a role model for young Black women in science and has worked to address vaccine hesitancy in minority communities — have been hailed as heroes.
Dr. Anthony S. Fauci, who oversaw the research in his role as director of the allergy and infectious diseases institute, said that the “vaccine was actually developed in my institute’s vaccine research center by a team of scientists led by Dr. Barney Graham and his close colleague, Dr. Kizzmekia Corbett.”
And the private sector has been at the centre of another problem confronting the US. However, US President Joe Biden appears to have sorted that out, nominating Dr Robert M. Califf, a former commissioner of the Food and Drug Administration (FDA), to lead the agency again, the New York Times reports (www.nytimes.com/2021/11/12/us/politics/robert-califf-fda.html?)
Biden’s decision ends nearly a year of political wrangling as the White House vetted then dropped several candidates after complaints that some were too close to the pharmaceutical industry.
Dr. Califf, 70, a respected academic and clinical trial researcher who ran the agency during the last year of the Obama administration, has long been a consultant to drug companies and ran a research centre at Duke University that received some funding from the drug industry.
The agency is sorely in need of permanent leadership. Since Margaret Hamburg, who served as commissioner for most of the Obama administration, left in 2015, the F.D.A. has had seven different commissioners — some acting, some permanent — including Dr. Califf, who served for just 11 months after Dr. Hamburg’s departure. And recently, its reputation for independence has come under attack.
The F.D.A. has been front and centre in the federal government’s response to the coronavirus pandemic. It has the authority to approve Covid vaccines, tests and treatments, as well as certain types of protective equipment. It was also widely criticized for allowing manufacturers to flood the market with inaccurate Covid tests early in the pandemic and for failing to stand up to Biden’s predecessor, Donald J. Trump, who at times promoted unproven and unsafe treatments.
“Dr. Califf is one of the most experienced clinical trialists in the country, and has the experience and expertise to lead the Food and Drug Administration during a critical time in our nation’s fight to put an end to the coronavirus pandemic,” Mr. Biden said in a statement. “As the F.D.A. considers many consequential decisions around vaccine approvals and more, it is mission critical that we have a steady, independent hand to guide the F.D.A. I am confident Dr. Califf will ensure that the F.D.A. continues its science and data driven decision-making.”
If Dr. Califf is confirmed by the Senate, he will again take the reins of an agency that is responsible for more than $2.8 trillion worth of food, medical products and tobacco. The F.D.A regulates products accounting for about 20 cents of every dollar spent by consumers in the US.
During the Trump administration, the agency granted an emergency- use authorization for hydroxychloroquine that it later withdrew, and revised its emergency authorization of convalescent plasma to restrict its use.
A report this week found that the COVID-19 pandemic has caused a 16% rise in deaths among the 38 member nations of the Organization for Economic Cooperation and Development. Life expectancy fell the most in Spain and the US, with the US losing 1.6 years of life per capita on average over the course of the pandemic.
In eastern Europe, countries where vaccination rates are poor are being hit by a wave of covid deaths. In the past few weeks the death rate from Covid has hit record highs in Bulgaria, Latvia and Romania. It is now also soaring in Croatia, Estonia, Lithuania, Slovenia and Ukraine.
The Biden administration announced a deal with Johnson & Johnson and COVAX, a global Covid-19 vaccination program, to distribute J&J’s Covid-19 vaccine to people in conflict zones and other difficult-to-reach settings. The company’s vaccine is preferred for this kind of work because it is more easily stored and transported, and it requires only one dose.
Covaxin, India’s indigenous COVID-19 vaccine, has got the Emergency Use Listing from the World Health Organisation. WHO has stated that it found Covaxin to have 78% efficacy against the virus and suitable for use in low- and middle-income countries.
The WHO’s EUL authorisation enables international organisations like UNICEF and GAVI COVAX to purchase Covaxin. It also helps other countries speed up their own authorisation procedures for the Covaxin, which, in turn, eases travel for Indians who got the Covaxin shots.
Covaxin is manufactured by Hyderabad-based Bharat Biotech and developed jointly with the Indian Council of Medical Research and the National Institute of Virology, Pune. It is one of the six vaccines that are authorised for use in India, and the second most widely available after the AstraZeneca-SII Covishield.
Lalita Panicker is Consulting Editor, Views, Hindustan Times, New Delhi