[Ip-health] NPR: The great vaccine ... bake off ... has begun

Thiru Balasubramaniam thiru at keionline.org
Wed Oct 20 05:50:10 PDT 2021


The great vaccine ... bake off ... has begun

https://www.npr.org/sections/goatsandsoda/2021/10/19/1047411856/the-great-vaccine-bake-off-has-begun

October 19, 20216:27 PM ET


NURITH AIZENMAN


Fans of the television series The Great British Bake Off have long marveled
at the skill contestants show during the dreaded "technical challenge" —
for which they are given a basket with all the ingredients needed to make a
highly unusual dish but a set of instructions that are often as vague as,
"Bake until ready." Now a team of scientists at a pharmaceutical startup in
South Africa is essentially confronting the same type of test — except the
stakes are life and death.

The World Health Organization has hired the company, called Afrigen
Biologics and Vaccines, as part of a $100 million plan to figure out how to
make an mRNA vaccine against COVID that is as close as possible to the
version produced by Moderna.

Until recently, Afrigen specialized in developing veterinary vaccines using
fairly traditional methods. Now, says Afrigen's Managing Director, Petro
Treblanche, the company's labs are a hive of research into the cutting-edge
technology behind mRNA vaccines.

"You will see scientists in white coats and some with full personal
protective equipment [suits] operating a bioreactor to make the actual
DNA," says Treblanche. "You will see microbiology clean rooms where testing
is taking place. You will see stability chambers where some of the products
are put in to understand how stable they are in different environments of
humidity and temperature."

Petro Terblanche, managing director of Afrigen Biologics and Vaccines, says
that while Moderna's patent is helpful, "it's written very carefully and
cleverly to not disclose absolutely everything."

Tommy Trenchard for NPR

Once Afrigen has sorted out all the complicated steps to make Moderna's
shot on an industrial scale, WHO and other partners plan to pay Afrigen to
become a teaching center.

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"We call it a 'technology transfer hub,' " says Martin Friede, the WHO
official in charge of this effort. "Manufacturers from around the world
will be invited to come and learn the entire process. So this will
accelerate the availability of the technology, not to one manufacturer but
to many manufacturers."

Specifically manufacturers in low- and middle-income countries. Friede says
the pandemic has shown they're sorely needed.

"There are regions on earth — the whole of Africa, for example, the whole
of the Middle East — that really suffer because they've got no vaccine
production capacity," says Friede.

At best some countries have "fill and finish" plants that can complete the
final stages of packaging a vaccine. But Friede says the lack of
soup-to-nuts manufacturers is a major reason that low- and middle-income
countries have been all but boxed out of buying COVID vaccines. For
instance, just 5% of people in Africa have gotten a full dose even as
wealthy countries have vaccinated well above half of their populations.

Friede says it makes sense to set up more manufacturers of mRNA vaccines in
particular because the technology appears so effective against COVID — and
because it shows promise against other diseases including malaria and
tuberculosis.

As to why WHO has chosen to try to copy Moderna rather than the other mRNA
COVID vaccine, which is made by Pfizer BioNTech, Friede says the choice was
practical.

"Moderna has reiterated on several occasions that they will not enforce
their intellectual property during the pandemic," says Friede. In other
words, a manufacturer probably won't face a lawsuit for producing a vaccine
that's virtually identical to Moderna's.

Also, says Friede, compared to Pfizer's vaccine, there just happens to be a
lot more information in the public domain about how Moderna's vaccine is
made.

But Afrigen's Petro Treblanche says there are still a lot of unknowns. Take
Moderna's patent.

"It's written very carefully and cleverly to not disclose absolutely
everything," says Treblanche.

So while Afrigen has been able to determine most of the equipment and
specialized ingredients that are needed, "what we don't know is the exact
concentrations," says Treblanche. "And we don't know some of the mixing
times — some of the conditions of mixing and formulating."

The quality control department at Afrigen Biologics and Vaccines.

Tommy Trenchard for NPR

A particularly vexing question is how to replicate Moderna's "lipid
nano-particle" — a special casing around the mRNA strand at the heart of
the vaccine that keeps it stable as it travels through the body to, as
Treblanche puts it, "essential places like the spleen and lymph nodes."

"We understand other encapsulations," says Treblanche. But for all the
expertise at Afrigen, "my team has never formulated a liquid nanoparticle."

Moderna is facing growing pressure to share this type of know-how. Last
week several U.S. Democractic senators and congress members released a
letter pointing out that Moderna got a massive infusion of U.S. taxpayer
funds to help develop its vaccine. At least $1 billion was for the research
component alone. These officials contend that the Biden Adminstration can
and should use language in the government's contracts with Moderna to force
the company to divulge its process.

When asked for comment, Moderna referred NPR to a statement on its website
expressing that the company has a commitment to "protect as many people as
possible around the globe." It notes that, among other steps to expand
vaccine access to people in low income countries, Moderna has announced
plans to build its own plant in Africa. The company has said it will begin
searching for the location soon. Pfizer-BioNTech has made a similar
announcement.

The WHO's Friede says this type of plant would have limited impact because
it won't be teaching center. "But also — and this is very important," he
adds, "we need to make sure that it is owned by the Africans, and that the
Africans are empowered." Otherwise there's no guarantee that in the event
of another global supply crunch the doses wouldn't be shipped to the U.S.
or Europe.

Stil, Friede says Moderna is at least in talks with the WHO. And he remains
hopeful the company will ultimately agree to provide some kind of tech
transfer.

If so, Friede estimates it would cut the time it will take to get a
manufacturer pumping out doses of the Moderna copycat vaccine from three or
four years down to about two.

But even that could be too late, says Ramsus Bech Hansen, CEO of Airfinity,
an independent London-based analytics company.

Hansen says in recent months several of the existing manufacturers have
ramped production to an "extraordinary" level. And he projects that by next
year existing plants will already be providing more than enough COVID
vaccines for the world.

This doesn't mean the effort centered on Afrigen is pointless, says Hansen.
"But we should think about these regional initiatives more as preparation
for the next pandemic."

WHO's Friede is less convinced that there will soon be sufficient COVID
vaccine supply.

But even if that's the case, he says it will still be enormously valuable
to have cracked the code of mRNA production on behalf of low and middle
income producers.

Afrigen's mandate isn't just to figure out how to produce Moderna's
COVID-19 vaccine. The World Health Organization wants the company to become
a teaching center where manufacturers from around the world will come to
learn the process.

Tommy Trenchard for NPR

All the more so, since an additional goal of the effort is to devise a
COVID vaccine that can remain stable at much higher temperatures than the
ones made by Moderna and Pfizer.

"That's a tall order," concedes Afrigen's Treblanche. But she says it's
both do-able and vital given how much of an obstacle the extreme cold chain
required by the current mRNA vaccines pose in African countries with
limited infrastructure.

"Moderna is the blueprint," says Treblanche. But in the long term, "this is
about trying to make a vaccine that's even better."

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


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