<html><head><meta http-equiv="Content-Type" content="text/html; charset=utf-8"></head><body style="word-wrap: break-word; -webkit-nbsp-mode: space; line-break: after-white-space;" class=""><div class=""><a href="https://www.npr.org/sections/goatsandsoda/2021/10/19/1047411856/the-great-vaccine-bake-off-has-begun" class="">https://www.npr.org/sections/goatsandsoda/2021/10/19/1047411856/the-great-vaccine-bake-off-has-begun</a> </div><div class=""><br class=""></div><div class=""><h1 style="box-sizing: border-box; margin: 0px 0px 15px; padding: 0px; border: 0px; font-family: "Gotham SSm", Helvetica, Arial, sans-serif; font-size: 2.06em; font-weight: normal; font-stretch: inherit; line-height: 1.2; vertical-align: baseline; -webkit-font-smoothing: antialiased; color: rgb(51, 51, 51); letter-spacing: -0.00625em;" class="">Moderna won't share its vaccine recipe. WHO has hired an African startup to crack it</h1><div class=""><div class="dateblock" style="box-sizing: border-box; margin: 0px 0px 8px; padding: 0px; border: 0px; font-family: "Gotham SSm", Helvetica, Arial, sans-serif; font-stretch: inherit; line-height: inherit; vertical-align: baseline; caret-color: rgb(118, 118, 118); color: rgb(118, 118, 118);"><time datetime="2021-10-19T18:27:06-04:00" style="box-sizing: border-box; margin: 0px; padding: 0px; border: 0px; font-family: inherit; font-size: inherit; font-style: inherit; font-variant-caps: inherit; font-stretch: inherit; line-height: inherit; vertical-align: baseline;" class=""><span class="date" style="box-sizing: border-box; margin: 0px; padding: 0px; border: 0px; font-family: inherit; font-size: inherit; font-style: inherit; font-variant-caps: inherit; font-stretch: inherit; line-height: inherit; vertical-align: baseline;">October 19, 2021</span><span class="time" style="box-sizing: border-box; margin: 0px; padding: 0px; border: 0px; font-family: inherit; font-size: inherit; font-style: inherit; font-variant-caps: inherit; font-stretch: inherit; line-height: inherit; vertical-align: baseline;">6:27 PM ET</span></time></div><div class="program-block" style="box-sizing: border-box; margin: 0px; padding: 0px; border: 0px; font-family: "Gotham SSm", Helvetica, Arial, sans-serif; font-stretch: inherit; line-height: inherit; vertical-align: baseline; caret-color: rgb(118, 118, 118); color: rgb(118, 118, 118);">Heard on <a href="https://www.npr.org/programs/all-things-considered/2021/10/19/1047241691" style="box-sizing: border-box; margin: 0px; padding: 0px; border: 0px; font-family: inherit; font-size: inherit; font-style: inherit; font-variant-caps: inherit; font-stretch: inherit; line-height: inherit; vertical-align: baseline; color: rgb(80, 118, 184); text-decoration: none;" class="">All Things Considered</a></div></div></div><div class=""><br class=""></div><div class=""><p class="">Fans of the television series <em class="">The Great British Bake Off</em>
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.</p><p class="">The World Health Organization has hired the company, called <a href="https://www.afrigen.co.za/" class="">Afrigen Biologics and Vaccines</a>,
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.</p><p class="">Until recently, Afrigen specialized in
developing veterinary vaccines using fairly traditional methods. Now,
says Afrigen's managing director, <a href="https://www.linkedin.com/in/petro-terblanche-a21267145/" class="">Petro Treblanche</a>, the company's labs are a hive of research into the cutting-edge technology behind mRNA vaccines.</p><p class="">"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."</p></div><div class=""><h3 class="edTag">First crack the code; then teach others</h3></div><div class=""><p class="">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.</p><p class="">"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."</p><p class="">Specifically manufacturers in low- and middle-income countries. Friede says the pandemic has shown they're sorely needed.</p><p class="">"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.</p><p class="">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.</p> <aside id="ad-secondary-wrap" aria-label="advertisement" class="">
</aside> <h3 class="edTag">There's a reason WHO chose to copy Moderna</h3><p class="">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.</p><p class="">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.</p><p class="">"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.</p><p class="">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.</p> <h3 class="edTag">The Moderna patent doesn't disclose everything deliberately</h3><p class="">But Afrigen's Petro Treblanche says there are still a lot of unknowns. Take Moderna's patent.</p><p class="">"It's written very carefully and cleverly to not disclose absolutely everything," says Treblanche.</p><p class="">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."</p></div><div class=""><p class="">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."</p><p class="">"We
understand other encapsulations," says Treblanche. But for all the
expertise at Afrigen, "my team has never formulated a liquid
nanoparticle."</p> <h3 class="edTag">The drug company is facing pressure to be more forthcoming</h3><p class="">Moderna
is facing growing pressure to share this type of know-how. Last week
several U.S. Democractic senators and congress members released a <a href="https://www.warren.senate.gov/imo/media/doc/2021.10.12%20Letter%20to%20WH%20and%20BARDA%20on%20Moderna%20Contract.pdf" class="">letter </a>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.</p><p class="">When asked for comment, Moderna referred NPR to a <a href="https://www.modernatx.com/moderna-blog/our-global-commitment-to-vaccine-access" class="">statement on its website</a>
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.</p> <h3 class="edTag">The WHO feels Moderna will ultimately cooperate </h3><p class="">The
WHO's Friede says this type of plant – run by a company like Moderna or
Pfizer — would have limited impact because it won't be a 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.</p><p class="">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.</p><p class="">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.</p><p class="">But even that could be too late, says Ramsus Bech Hansen, CEO of <a href="https://www.airfinity.com/" class="">Airfinity</a>, an independent London-based analytics company.</p><p class="">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.</p><p class="">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."</p> <h3 class="edTag">The end goal is even more ambitious </h3><p class="">WHO's Friede is less convinced that there will soon be sufficient COVID vaccine supply.</p><p class="">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.</p></div><div class=""><p class="">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.</p><p class="">"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.</p><p class="">"Moderna is the blueprint," says Treblanche. But in the long term, "this is about trying to make a vaccine that's even better."</p></div><br class=""><div class="">
Arthur Stamoulis<br class="">Citizens Trade Campaign<br class="">(202) 494-8826<br class=""><br class=""><br class=""><br class="">
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