[Ip-health] Politico: Africa wants to produce a coronavirus vaccine — and Big Pharma’s not happy

Thiru Balasubramaniam thiru at keionline.org
Tue Jul 27 01:41:12 PDT 2021


https://www.politico.eu/article/as-africa-tries-to-tap-promise-of-mrna-vaccines-coronavirus-covid19-pharma-pushes-back/

Africa wants to produce a coronavirus vaccine — and Big Pharma’s not happy

A proposed mRNA tech transfer hub would let multiple manufacturers learn
how to produce vaccines.

BY ASHLEIGH FURLONG
July 26, 2021 4:31 pm

Africa is poised to make a bold move that could turn around its fortunes in
coronavirus vaccine manufacturing — taking the continent from import
dependence to self-sufficient production of life-saving jabs for
coronavirus, TB and maybe even one day for HIV.

Two manufacturers are establishing an mRNA vaccine technology-transfer hub
at the tip of the continent that could let it produce its own vaccines, on
its own terms. It's a way to address just how exposed countries are if they
don’t have their own vaccine manufacturing capacity. Africa imports about
99 percent of routine immunizations — and is the least vaccinated against
coronavirus in the world.

One counter-measure to address this dearth of vaccines kicked off in
October 2020, when South Africa and India, scrambling for options, proposed
an intellectual property waiver at the World Trade Organization. The move
would allow lower-income countries to produce coronavirus vaccines without
fear of infringing on patents.

The proposal has remained deadlocked, with the EU being the major blocker.
But even if the proposal were accepted, it wouldn't address one important
problem — how to actually produce the vaccines.

That’s how another idea took off: The World Health Organization pitched an
mRNA tech-transfer hub that would let multiple companies share the
knowledge of how to produce vaccines from start to finish. Even French
President Emmanuel Macron gave his stamp of approval.

Two South African companies have been chosen as the initial partners for
the first hub — Afrigen Biologics and Vaccines and Biovac. Afrigen will
take the role of trainer in chief and transfer the technology for the mRNA
vaccines to other sites, the first being Biovac.

The choice of mRNA technology was also no coincidence.

Before the pandemic, no vaccine or therapy produced using mRNA technology
had ever been approved. But the runaway success of the BioNTech/Pfizer and
Moderna vaccines convinced the EU to completely pivot to mRNA for future
supplies.

Its promise goes beyond coronavirus and holds the potential for
applications related to cancer, Ebola or HIV. But it’s exactly this
potential that makes pharmaceutical companies all the more keen to cling to
their newly minted technology even more tightly.

And therein lies the rub: To get the hub up and running in a year — when it
could still help end the pandemic — its partners need Big Pharma’s help.
And Big Pharma isn’t keen: Neither Moderna nor Pfizer has signaled interest
in working with the facility.

The two drugmakers also declined to comment to POLITICO on their potential
involvement.

Pharma is playing “a really dangerous game,” warned Jaume Vidal, senior
policy advisor for European projects at Health Action International. He
believes that its actions are, in effect, “condemning thousands.”

>From theory to practice

Through the hub, the WHO aims to bring together companies with knowledge of
how to produce mRNA vaccines — ideally a drugmaker that has one already
approved — with manufacturers that can be trained to produce the vaccine.
In this instance, Afrigen would be in the middle, helping to transfer the
technology from an mRNA vaccine developer to other manufacturers, with the
support of a network of universities and the Africa Centres for Disease
Control and Prevention (CDC).

It's not the first time the WHO has done this. A similar
technology-transfer program for influenza vaccines has led to hundreds of
millions of extra flu jabs since 2007.

Under the terms set out by the WHO, there are two ways the hub can use the
technology: It either needs to be free of intellectual property constraints
in low- and middle-income countries, or it can make such rights available
to recipients through non-exclusive licenses to produce, export and
distribute the COVID-19 vaccine in these countries.

Marie-Paule Kieny, director of research at Inserm and chair of the
U.N.-backed Medicines Patent Pool — a hub partner — argues it isn’t going
to run roughshod over existing licensing agreements.

Pointing to other partnerships done by the Medicines Patent Pool — whose
work includes signing agreements with patent holders for 13 HIV
antiretrovirals — Kieny said it's aware of Pharma's concerns about
competition, and that most of the time, a license is limited to a certain
territory. This means, for example, that an mRNA vaccine produced in South
Africa wouldn't be marketed or imported to the U.K.

Petro Terblanche, managing director of Afrigen, also sees the terms being
decided on a “case by case basis,” adding: “It’s in none of our interests
to infringe. This will be done in agreement.”

The choice of South Africa was also deliberate. “The due diligence, which
was conducted by both by the Medicines Patent Pool and by WHO, indicates at
this moment that there is no IP barrier in South Africa for the production
of mRNA vaccines,” Kieny said. That means that there is currently no patent
application for an mRNA vaccine in the country, even though a patent
application could still emerge, she added.

This distinction is important: While the hub could potentially go hand in
hand with the waiver, it’s not predicated on it. If implemented, the waiver
would simply allow time for production to go on. But because a waiver is
time-limited for the pandemic, it wouldn't override the eventual need for a
voluntary or compulsory licensing.

Losing control

Aside from the legal fine print, there's a bigger problem. Big Pharma isn't
convinced that companies would accept the terms of the hub.

Thomas Cueni, director general of international pharma lobby IFPMA, said
the debate needs to “be honest in expectation management.” While he said
industry shares the objective of ensuring global equitable access, "you
need to be pragmatic in terms of accepting that companies are not going for
total sellout" and engage in tech transfer and voluntary licensing.

Drugmakers need to have high trust that "the recipient of the tech
transfer, the licensing, has the skilled workforce, skilled people, and
they can be trusted to stick to the agreements," he explained.

The WHO also could have done a better job, he added, noting he only heard
about the hub when the press release promoting it landed in his inbox.

To Alain Alsalhani, a pharmacist for Doctors Without Borders for nine
years, the basic fact remains that Big Pharma won't do anything without
direct benefit. So if drugmakers want to share their technology with a
manufacturer in Africa as a form of “social responsibility” or a way to
improve their public image, “they can do it bilaterally,” he said.

“They get the good press ... but they also hold complete control over
everything,” he added. "What they see in the hub is clearly a way for them
to lose control over [their] technology."

He made those comments to POLITICO in early July. Just two weeks later, his
prediction came true. On July 21, Pfizer and BioNTech announced their
bilateral plans for expansion in Africa, with Biovac set to complete the
final stage of production — or “fill and finish” — of the BioNTech/Pfizer
vaccine in 2022.

While the initiative was welcomed, many access groups pointed out that fill
and finish operations alone keep Africa reliant on Europe for the actual
drug substance.

Future proof

Even the hub's advocates concede they have to play the long game. Tech
transfer is slow, and neither Afrigen nor Biovac has experience in mRNA
technology. It's likely to take a year for the first vaccines to be
produced if an existing technology is provided by manufacturers, and 18
months if the hub needs to use an mRNA vaccine still in development.

Is it even worth it, then, if the earliest of these jabs trickle in is
mid-2022?

Kieny says it definitely is, pointing out that mRNA coronavirus vaccines
may well be needed for booster doses or periodic vaccination.

And to Terblanche, it's about more than this pandemic — the ambition in
choosing mRNA as the platform is to go for a “next-generation, future
relevant technology.”

The involvement of Big Pharma would be welcome, but the hub will go ahead
without them if need be — and the platform needs to survive post-pandemic.
“It has to be a multipurpose and a multi-product platform,” she said,
indicating that flu, TB, HIV and Ebola were all areas that would be
explored.

“It's going to take time; this is not a sprint,” she said.

Terblanche spoke to POLITICO before BioNTech's announcement on Monday that
it plans to work with the hub — or its future iterations — for its mRNA
malaria vaccine that's still in development. BioNTech will assess multiple
vaccine candidates, with the most promising being selected. It’s hoped that
the first candidate would go to clinical trials at the end of 2022.

This is why activists like Vidal are excited about the hub's potential — it
could mean that in the future, there might be African manufacturers of mRNA
vaccines for TB or malaria. “That's why it's so important that this hub is
successful,” he said.

And for all the mystique around mRNA vaccines, the technology is actually
fairly simple to use, said Kieny. Crucially, it can also be harnessed by
manufacturers of drugs, not just those with experience in biologicals.
Scaling up production using the technology is also less complex, as
Pfizer's dramatic ramp-up of production in Europe this past spring showed.

Playing politics?

The hub hasn’t only been hounded by questions of whether a pharma company
will join, but whether it has the necessary expertise to succeed. IFPMA’s
Cueni, for one, is doubtful of the WHO’s ability to run it.

While the Medicines Patent Pool has been successful in building up trust
around licensing agreements, he thinks the WHO “has a long way to go to
gain that trust.”

“They're playing too much politics and their operational track record is
not too impressive in the field,” he said.

Cueni was similarly scathing of the process by which the WHO created the
hub, saying that it was created “unilaterally without any consultation.” He
views it as almost the same as C-TAP, a technology-transfer initiative
launched by the WHO in May 2020, that no pharmaceutical company has signed
up to.

“What is their strategy? Are they floating these ideas in the hope that
companies will sign up? In which case they will be the heroes [because]
they announced it? Or if it fails, they can make us the villains because we
didn't do so?” he asked.

A WHO spokesperson declined to address Cueni's assertions directly. But he
noted the WHO will “continue to urge all pharmaceutical groups to do more
to break the inequity, which means sharing licenses, technology and
know-how, and waiving intellectual property temporarily.”

HAI’s Vidal, meanwhile, agrees with Cueni on one point — that the work of
the hub and C-TAP not only overlap, but could contradict each other.
“That's something that should be avoided at all costs,” he said.

However, those involved in the hub argue that while C-TAP's main focus was
on patents, the hub is about sharing technology and training others to use
it.

As for questions about whether two small South African companies have the
expertise, Terblanche is undaunted by the monumental challenge ahead. "I
think it's fair for the critics to say 'wow, so how are these guys going to
do it?'" she said.

“We don't underestimate the challenge and we know the ambition is massive,”
said Terblanche.

But she says that people do underrate the knowledge base in South Africa.
Just in her small team of about 15, there are over 60 academic degrees
between them.

They’re running at high energy at the moment, she said with a laugh: “We're
going to crash sometime down the line, but not before this hub is done.”

Update: This article has been updated with the announcement of BioNTech’s
plans for an mRNA malaria vaccine.


-- 
Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International
41 22 791 6727
thiru at keionline.org


More information about the Ip-health mailing list