Botswana News

High hopes for deal to unlock local Covid-19 vaccine manufacturing

On Monday President Cyril Ramaphosa
announced that South Africa will host the first World Health
Organization-backed Covid-19 mRNA vaccine Technology Transfer Hub – an
initiative designed to get the production of mRNA vaccines off the ground in
Africa.

One crucial element to the success of such an initiative is getting
companies with existing mRNA vaccine manufacturing know-how to enter into
technology transfer agreements that would see them share their know-how with
the hub.

The WHO is currently negotiating
such technology transfer agreements with leading mRNA vaccine producers,
Moderna and Pfizer/BioNTech, with deals possibly being announced as soon as
next week.

This is according to Professor Petro Terblanche, Managing Director
of Cape Town-based Afrigen Biologics and Vaccines, a company that forms part of
the consortium that makes up the local technology transfer Hub.

If concluded, such deals are
anticipated to enable a local Covid-19 vaccine to be developed for safety and
efficacy testing and production within 12 months – less than half the time it
would take was the consortium to collaborate with a company without an approved
mRNA vaccine already on the market.

The only two mRNA vaccines so far approved
by stringent medicines regulators such as the United States Food and Drug
Administration are those made by Pfizer/BioNTech and Moderna. The only mRNA
vaccine in use in South Africa is that made by Pfizer/BioNTech.

Hopes for a flying start

“We’re hoping to get feedback on
Monday from the WHO and the Medicines Patent Pool, (MPP), who are currently
negotiating with Moderna, BioNTech, and Pfizer. If talks succeed, we’ll be off
to a flying start and it will accelerate everything,” Terblanche told
Spotlight.

The MPP is a United Nations-backed body that negotiates voluntary
licenses with pharmaceutical companies to increase access to patented
life-saving medicines for low-and-middle-income countries.

MPP-negotiated
licenses have, for example, played a critical role in ensuring access to the
antiretroviral medicine dolutegravir, which is part of standard first-line HIV
treatment in South Africa.

Terblanche said if no deal could be
agreed with Moderna or Pfizer/BioNTech, and the companies supplying know-how
and technology to the new technology transfer hub were still in their clinical
trial phases, “that timeline would be impossible – it would take another year
or two”.

“The key thing here is the
technology provided. Once that agreement is in place, we can plan and
initialise the road map and absolute detail required to make this hub a
sustainable initiative,” she said.

African vaccine independence

The Covid-19 pandemic has focussed
the world’s attention on glaring inequities in vaccine access between
high-income countries and low-and-middle-income ones, (LMIC’s).

According to Dr Stavros Nicolaou,
Chair of Business For South Africa’s Covid-19 initiative, just 30 million Covid vaccine doses out of 2.3 billion produced worldwide have found their way into
arms in Africa. That amounts to about 0.2%.

“That’s an astonishing statistic.
The only way to sort this out, for this and any future pandemic of any kind, is
to build regional capacity. It’s the only way we can ensure global health
security.

“I understand why every country wants to look after its own – we’d
probably do the same if we could – but this virus has been demonstrated to be
mutagenic, and because of that, you’ll be chasing variants forever unless
there’s vaccine intervention.

“Access to technology and skills to create local
capacity is vital and the funding must follow,” he said.

Pipeline to other vaccines

Terblanche said her company would
respect the rights granted and conditions imposed by any mRNA Covid vaccine
producer while at the same time hoping they would never stand in the way of
social good.

“Once we have the technology and
skills transfer in place, we’ll use South Africa’s superb scientific and
sequencing capability to develop our own intellectual property for Covid and
other disease vaccines.

“Covid is our first goal but a pipeline to other
vaccines will then develop, and we can set up other African tech hubs and
distribute across the continent – ours is basically an innovation platform,”
she said.

Morena Makoana, CEO of Biovac,
another partner in the consortium and the company that will manufacture any
vaccine produced by Afrigen, said Biovac would hopefully be the first of many
companies across the continent churning out vaccines.

Biovac claims to have the
capacity to produce a minimum of up to 30 million Covid-19 doses in the first
year of scale-up.

“Afrigen will develop the product
and then they’ll need commercial managers to receive it and take it forward.
It’s not limited to Biovac. It’s a hub and spoke arrangement. We’re just lucky
to be the first in Africa included in this technology transfer project,”
Makoana said.

The South Africa-based initiative is
the first in a series of Covid mRNA vaccine technology transfer hubs that the
WHO is launching around the world to boost Covid-19 vaccine supplies. The hub
includes the South African Medical Research Council, Biovac, Afrigen, and five
top universities.

Speaking at the virtual launch of
the tech transfer hub last Monday, (21 June), President Cyril Ramaphosa said,
“This landmark initiative is a major advance in the international effort to
build vaccine development and manufacturing capacity that will put Africa on a
path to self-determination.”

Ramaphosa stressed that although the
establishment of the technology transfer hub was a step in the right direction,
it did not detract from South Africa’s insistence on a waiver of aspects of the
WTO Trips agreement relating to the protection of intellectual property rights
on Covid-19-related products.

WHO Director-General Dr Tedros
Adhanom Ghebreyesus said Covid-19 had highlighted the importance of local
production to address health emergencies, strengthen regional health security
and expand sustainable access to health products.

Complex, but doable

Terblanche said Afrigen and Biovac
were talking to about five other less mature vaccine developers, the main
criteria being what formulation they can bring to the party.

“We want a thermo-stable vaccine
which we can distribute into other less resourced African countries, ideally
one that can be stored at 2-8 degrees Celsius, or even room temperature to
optimise access,” she said.

This would be a major step up on the current
Pfizer/BioNTech Covid-19 vaccine which needs to be stored at very low
temperatures and has relatively limited storage times.

“We want to vaccinate
1.2 billion people in Africa. That’s a lot of people to reach with a complex
cold chain, especially in rural areas,” Terblanche said.

Spotlight put it to her that
producing appropriate vaccines for Africa would require complementary
manufacturing capacities, alignment of the African Centre for Disease Control,
the African Union, the African Vaccine Manufacturing Initiative, plus other
stakeholders to steer different companies in different African countries.

Terblanche’s response was
phlegmatic.

“It is complex, yes. I’m also aware
that objectives may not always converge. That’s the nature of the beast. We
know exactly what we need to deliver. We’ll drive hard and build the consortium
around that. We can’t control others’ agendas and complex politics.”

She said what her small, agile
start-up company had control over was its mindset. “Critical things need to
happen. We have a softer, behavioural approach and mindset. These are major
tech challenges never tackled before in Africa.

“Everybody wishes for this
continent to have vaccine security. We’ve already built something out of
nothing (her facility). Our mindset is that it can be done.”

Will the funding be there?

On the challenge of funding in the
current Covid-ravaged economic climate, she said WHO member states,
philanthropic organisations, the French government, several SA-based
foundations, and President Ramaphosa had pledged their financial support.

“I don’t think it will be an issue.
We’re not talking billions of dollars here. It’s more like 30-40 million
dollars max, including clinical trials. If we have to do a bridging study for a
vaccine, those numbers are included.

“I’ve had a discussion with the Gates
Foundation, while the Elma Foundation here is very keen. I’m meeting with
another group of South African philanthropists today. There’s incredible social
capital available.”

She said the hub was building on
existing infrastructure at Afrigen and Biovac. “This is not a greenfield
project – a significant cost factor will be what regulatory trials will be
required for vaccine registration, driven by the technology and skills
acquired,” she said.

Addressing endemic corruption in
South Africa, she said her company had an exemplary record of governance and
full compliance with Level One BEE requirements. “We have to be trusted by the
donors to be responsible with their money and our record shows that,” she
added.

When asked to confirm whether the
negotiations are taking place, Pfizer referred us to the WHO. Pfizer did
however provide the following brief comment: “As we’ve stated publicly
before, from day one of our Covid-19 vaccine development program, we have been working
with countries of all income levels and supranational organisations to make
sure our Covid-19 vaccine is accessible to all.

“To date, Pfizer has concluded
agreements to supply 122 countries with doses of the Pfizer-BioNTech Covid-19
Vaccine in 2021 – and has supplied doses of the vaccine to multiple countries
in Africa, including, South Africa, Rwanda, Cape Verde, Tunisia, Angola,
Botswana, Ivory Coast, and Togo.

“We’ve committed to manufacture 3 billion doses
of the Pfizer-BioNTech Covid-19 Vaccine worldwide in 2021 – 1 billion of which
will be donated to low- and middle-income countries.”

Spotlight has also asked the World
Health Organization and Moderna for confirmation of the negotiations. We will
update this article if we receive any responses.

Note: The Bill and Melinda Gates Foundation is mentioned
in this article. Spotlight receives funding from the Bill and Melinda Gates
Foundation.

*This article
was produced by
Spotlight – health journalism in the public interest


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