Buying Know-How to Scale Vaccine Manufacturing

The development of a number of COVID 19 vaccines has been an impressive achievement, one that can be attributed to a genuine sense that this was an emergency, and the fact that governments spent billions of dollars to subsidize or completely pay for research and development, and de-risking the scale up of products through massive advanced purchase contracts. What has been less impressive has been the effort to scale the manufacturing efforts to meet demand. One tool that has not been used, and should be mobilized, right now, is to spend money to make the know-how a global public good.

Buyouts of manufacturing know-how, access to cell lines, and rights in inventions and data, isn’t cheap, but it will be less expensive than trying to vaccinate the world without doing so.

Buying manufacturing know-how in 2021 wasn’t the best approach. When governments started throwing money at companies to develop vaccines, they could have acquired the rights to inventions, data, know-how, and biologic resources, then, and it would not have been expensive. That did not happen. Now, once these assets are largely privatized, on terms unfavorable to the public that paid for the R&D, it’s going to be more expensive.

The fact that there are now several vaccines in the market and more in development makes the task more manageable. If governments could collaborate to create a buyout fund, they can offer to pay for full technology transfer. This can be done with or without royalties from generic suppliers, although, to truly open source the know-how, and make it a global public good, royalties, if desired, can be replaced with payments from a fund to reward vaccines that become the most important in terms of their use and efficacy, such as was proposed by Barbados and Bolivia to the WHO in 2008. (see discussions here and here ) for a Priority Medicines and Vaccines Prize Fund (PMV/pf), as well as similar proposals (see discussions here and here)

There are a number of sources of manufacturing know-how that would not require particularly expensive buyouts or future payments based upon future uses of a vaccine. Small firms, technology transfer consultants, academics, former employees of vaccine manufacturers, companies that don’t have a candidate themselves, all may have useful contributions that could be shareable more widely if compensated to do so.

It’s not unusual for companies to buy know-how. Pfizer bought its vaccine know-how from BioNtech. The US government actually signed a contract with Pfizer in July 2020 that required Pfizer to acquire the manufacturing know-how from BioNtech in Europe and transfer the manufacturing to the United States, which Pfizer did. Likewise, AstraZeneca bought its vaccine technology from Oxford University, and the Canadian government is buying vaccine manufacturing know-how from Novavax. The U.S. Operation Warp Speed (OWS) contracts include a number of agreements to buy and share manufacturing know-how, although not necessarily to make it into a global public good.

Each technology platform has its own challenges as regards technology transfer. Among the most interesting platforms right now are mRNA (the shiny new thing, by Pfizer, Moderna, Curevax), viral vector (J&J, AstraZeneca, Sputnik, CanSino, etc) protein subunit (Novavax, instituto finlay de vacunas, etc), as well as several others. There are vaccines in development that can be self-administered with a nasal spray, including one promising candidate from the Cuban Center for Genetic Engineering and Biotechnology (CIGB), an institution that may be open to sharing the manufacturing know-how.

Governments don’t have to buy out everyone. Those who keep technology proprietary will be faced with competition from public domain alternatives that will eventually drive prices down. This downward pressure on prices makes the financing of know-how buyouts even more attractive, as should the recent announcements by companies like Pfizer, J&J and others that they plan to jack up prices in the not too distant future.

In addition to the vaccines now on the market or in late stage clinical trials, there are a number of new 2nd generation vaccines that look promising. Two from the NIH are particularly interesting.

A single dose VSV-EBOV-Based COVID-19 Vaccine is inexpensive and easy to replicate, and the NIH has the manufacturing know-how, which one NIH official said “a high school teacher” could do. The U.S. Federal Register notice for licensing this technology is here.

The NIH also has a license opportunity for “Replication-Competent Adenovirus Type 4 SARS-CoV-2 Vaccines,” which it describes as follows:

If the NIH does not bind these technologies to exclusive agreements with companies in the coming weeks, policy makers should ask, why not retain ownership of the vaccines, as opposed to paying for the trials but privatizing ownership, as was done in 2020?

A buyout of know-how will cost money, particularly if the know-how is put into the public domain as a global public good. The whole world will benefit, but not everyone will pay. Past efforts to have a global treaty or agreement on biomedical R&D have been met with stiff opposition from Bill Gates and large drug companies. But in this pandemic, with so much at stake, and a recognition that the failure to get vaccines to everyone is a “catastrophic moral failure,” it should be a manageable task. I would put the initial resources necessary to start the process fairly low, as little as $20 million, but aim for an initial $1 billion to start negotiations to see what can be bought. The more money the better, but if one starts with the notion than tens of billions are required, it just won’t get off the ground. (Even when governments are spending trillions on stimulus packages to address the economic harm from the pandemic.)

In the longer run, governments need to better collaborate on the terms to include in government funded R&D grants and contracts, and to create mechanisms that ensure important medicines and vaccines can be made available as global public goods. This could include embracing the call for the WTO to create an opt-in agreement on the supply of public goods, where members can making binding commitments, similar to GATS commitments, to fund or supply public goods. And the WHO should revisit the proposals to have a global treaty or agreement on biomedical R&D, and address a range of issues, including but not limited to funding of pandemic countermeasures.

To be sure, there is considerable opposition to any effort to delink R&D incentives from the grant of monopolies or to create global mechanisms to make drugs, vaccines or other biomedical inventions into global public goods.

Bill Gates intervened with Oxford to abandon a promise to openly license its vaccine in favor of an exclusive agreement with AstraZeneca, a company that made serious mistakes in the clinical trials and has experienced production problems, missed delivery deadlines, and price gouging of the technology in Africa. Gates pressured the World Health Organization in 2020 to block a proposal to include vaccines in the COVID Technology Access Pool, and has been making statements that vaccine manufacturing is too complex and difficult to have open licensing, and Gates funded organizations have been flooding social media and new stories with similar claims.

Big drug companies and their trade associations have also been actively bashing proposals for a WHO biomedical R&D agreement and the WHO C-TAP open licensing proposal. Companies have commercial reasons to hold manufacturing know-how close, particularly for new platforms like mRNA products.

This combination of big pharma and Bill Gates’ outsized presence in public health, as the largest or second largest donor to the WHO and the main or a major beneficiary of countless academic, journalism and non-government organizations working on global health, makes it difficult to do many of the things that are obviously needed right now.

The biggest obstacle to making vaccines global public goods, however, is not the opposition, but a lack of leadership from heads of states, particularly in high income countries. What we have seen in the past 14 months, is government after government protecting the commercial interests of vaccine manufacturers, instead of the public, and we are paying an enormous price for this policy failure.

Director, Knowledge Ecology International, an NGO working on knowledge governance

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