[Ip-health] Buying Know-How to Scale Vaccine Manufacturing | by James Love | Mar, 2021 | Medium

James Love james.love at keionline.org
Sat Mar 20 10:35:28 PDT 2021


Simon Lester asked if we had something written up on buy-outs of know-how,
so I wrote this. Jamie

https://jamie-love.medium.com/buying-know-how-to-scale-vaccine-manufacturing-586bdb304a36

Buying Know-How to Scale Vaccine Manufacturing
March 20, 2021

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.

---quote--- The vaccine is inexpensive to replicate, elicits a high
antigen-specific antibody titer within the host, and provides protective
efficacy after a single dose. -----end quote

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

---quote--- These recombinant vaccines permit rapid development of high
levels of neutralizing antibodies to SARS-CoV-2 in experimental animals.
This vaccine is designed to improve the durability of the immune response
by inducing mucosal and systemic immunity. Further, this system should be
incredibly simple and efficient when producing vaccine at scale. ---end
quote

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 revise 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, make 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.


More information about the Ip-health mailing list