A year later, the collaboration is at the heart of a call by a group of public health advocates and academics who want the government to forcefully exert patent rights over the Moderna vaccine.
The advocates are asking NIH to negotiate aggressively with Moderna for patent licensing terms that would speed vaccinations to the developing world by requiring the company to cooperate in a plan to dramatically increase production and reduce the price.
When it comes to developing and patenting drugs, the U.S. government has almost never played hardball with its partners in the private sector. One exception came in 2019, when the Justice Department sued drugmaker Gilead for patent infringement over sales of its costly drug Truvada as a prevention for HIV, after an article in The Washington Post and a hearing in Congress. That lawsuit is pending.
Now nonprofit advocacy groups PrEP4All, Public Citizen and others contend that the pandemic has presented another moment requiring government action to ensure a key NIH invention is leveraged to stem infections around the world.
“It seems to me like a golden opportunity to do what’s right,” said Wafaa M. El-Sadr, a professor of epidemiology and medicine at Columbia University who leads an initiative to fight HIV, tuberculosis and other diseases overseas. “It’s within our hands collectively in the United States to move forward so this technology can enable others to be able to produce these vaccines at a rapid pace.”
The groups cite the danger of continued coronavirus outbreaks overseas, which probably will generate variants that could become resistant to vaccines everywhere, including in the United States.
“This really is an NIH/Moderna vaccine. For NIH to not have ensured global access is a dereliction of their duty to protect the public health of the United States,” said James Krellenstein, executive director and co-founder of PrEP4All, which advocates for broader access to HIV drugs. “These patents reflect one of the last opportunities NIH has to exert leverage.”
Moderna has said it will make 700 million to 1 billion vaccines this year and potentially 1.4 billion in 2022. Its pace for 2021 is half of what Pfizer has promised to make of its own mRNA vaccine. Moreover, while Pfizer has said it is selling vaccine at a discount directly to poorer countries, Moderna has announced few such deals, according to a Duke University vaccine tracking project.
Moderna also has been criticized for not yet signing up to supply Covax, a program designed by the World Health Organization to ensure more equitable distribution of coronavirus vaccines.
Moderna, which has predicted $18.5 billion in coronavirus vaccine sales in 2021, did not respond to a request for comment. The NIH arm that worked on the project, the National Institute of Allergy and Infectious Diseases, also did not respond to a request for comment. The groups sent their letter to Health and Human Services Secretary Xavier Becerra, as well as NIH Director Francis Collins and NIAID Director Anthony S. Fauci.
Last year in response to questions from The Post, NIAID said it took a nonexclusive approach to licensing its coronavirus spike protein to multiple companies. It said that licensing arrangements typically take the form of royalty payments to the government. The public has “little information” about such agreements because NIH releases only limited metrics about its licensing activities, the Government Accountability Office found in a report last year.
Vaccine companies have opted against technology-sharing programs hosted by the WHO and opposed waivers of international patent protections. The industry says proprietary know-how and intellectual property — which protect profitable monopolies on its products — are the backbone for innovation and production deals with preferred contract manufacturers.
But current estimates are that many countries in the developing world may not get substantial amounts of coronavirus vaccine until 2023.
The spike protein from NIH mimics the coronavirus in the human body, which teaches the immune system to attack the real virus. Other companies used NIH’s spike protein design in their coronavirus vaccines, including Pfizer and Johnson & Johnson.
The public interest groups said they singled out Moderna because the company has an extra degree of partnership with the NIAID, which had worked for several years with Moderna on vaccine development for Middle East respiratory syndrome (MERS). The NIAID also conducted the first clinical trials on Moderna’s vaccine.
When compared with the Johnson & Johnson and AstraZeneca vaccines, which are based on a more common viral vector technology, the mRNA vaccines have demonstrated greater effectiveness at preventing infection, although it is difficult to accurately compare performance because of different times and locations of clinical trials.
The mRNA system also can be more rapidly modified to fight variants, and production times are being driven down as manufacturers gain expertise. The mRNA vaccines could go further, faster, toward eliminating the coronavirus and preventing resistant variants from evolving and spreading.
They need to be kept frozen at minus-20 degrees Celsius (minus-4 Fahrenheit), which is in the range of a standard household freezer, while more traditional vaccines can be kept unfrozen in refrigerators for longer periods. That could make mRNA shots less practical to use in the harshest environments without modern infrastructure.
Another potential hurdle is shortages of raw materials, including lipids that are used to encase the mRNA instructions on how to make the coronavirus spike protein. The mRNA vaccines have never before been authorized or produced on industrial scale, so companies are racing to keep up with demand.
Advocacy groups say cold-chain supply and raw-materials shortages are surmountable problems. What they see as a bigger problem is a lack of market incentives. Moderna lacks sufficient financial motivation to quadruple production capacity to reach a global population, because the developing world can’t pay enough per shot to make the investment of billions in equipment and trained personnel worthwhile, Krellenstein said, especially when the success of the vaccine in two or three years’ time could eliminate the need for more shots.
That’s why an interventionist government role is required, to either directly produce vaccine or tap contract manufacturers, PrEP4All and the other groups said. PrEP4All has published recommendations for government intervention to manufacture more vaccine.
“Certainly there are things that the government can do, requiring technology sharing, using the WHO to work with other technology organizations in other countries, and it can be done in a regulated way,” said Kenneth Mayer, an infectious-disease and HIV specialist at Beth Israel Deaconess Medical Center in Boston and a professor at Harvard Medical School.