[Ip-health] Stat: Pfizer looks to widen access to Covid-19 vaccine in Africa, but advocates say it doesn’t go far enough

Thiru Balasubramaniam thiru at keionline.org
Thu Jul 22 04:34:37 PDT 2021


https://www.statnews.com/pharmalot/2021/07/21/pfizer-biontech-covid19-vaccine-africa-pandemic/

PHARMALOT
STAT+

Pfizer looks to widen access to Covid-19 vaccine in Africa, but advocates
say it doesn’t go far enough

By Ed Silverman  July 21, 2021

Pfizer (PFE) and BioNTech (BNTX) moved Wednesday to widen access to
Covid-19 vaccines by striking a production deal with a South African
company, but the effort was quickly panned by patient advocates who argued
the arrangement doesn’t go far enough.

In a ballyhooed announcement, the drug makers said they contracted with The
Biovac Institute, a vaccine maker backed in part by the South African
government, to assemble the final stages of their Covid-19 vaccine, a
process known in the pharmaceutical industry as “fill-and-finish.” From
there, more than 100 million finished doses will be supplied exclusively to
all 55 African Union countries annually.

“This collaboration is another example of our commitment, from day one, to
provide fair and equitable access to the Pfizer-BioNTech Covid-19 vaccine
to everyone, everywhere. This commitment has been our North Star, and this
agreement is just one example of the tireless work being done to expand
access,” Pfizer chief executive officer Albert Bourla said at a Wednesday
meeting about Covid-19 vaccine access that was sponsored by the World Trade
Organization and the World Health Organization.

The deal was praised by South African President Cyril Ramaphosa, who in
statement called it “a breakthrough in our effort to overcome global
vaccine inequity.”

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as expiration dates approach
Yet critics complained the arrangement will not make it possible for Biovac
or other companies located in low and middle-income countries to gain the
expertise to more quickly produce enough Covid-19 shots to combat the
fast-moving coronavirus variants.

“This won’t help to end the dependency of African countries on the global
north,” said Lara Dovifat, a manager in the international access to
medicines campaign at Doctors Without Borders. “If really want to end that
dependency, we should have full tech transfer right now.”

The announcement comes after sustained criticism that Pfizer and other
Covid-19 developers have failed to ensure that supplies are available to
low and middle-income countries.  Concern mounted last year after wealthy
nations quickly signed supply deals and, to date, have contracted for 40%
of approximately 15 billion doses, according to the Duke Global Health
Innovation Center.

In response, the WHO last year created a program called COVAX in an attempt
to close the gap. So far, the program has contracted to supply roughly 3.7
billion doses to dozens of low and middle-income countries. But as variants
of the coronavirus take hold, public health experts say wider and faster
vaccine distribution is needed everywhere in order to contain the pandemic.

This is why patient advocates, who are urging the WTO to back a temporary
waiver of patent rights for Covid-19 vaccines, complain the deal reached
with Biovac is insufficient.

On one hand, the organizations acknowledged the licensing arrangement is
good news, because Africa has largely been neglected in the race to supply
vaccines, therefore, and any move to jumpstart production and distribution
on the continent can start to make a difference. But at the same time, the
patient advocates say Pfizer and BioNtech could – and should – do much more.

For one thing, the companies avoided participating in a new technology
transfer hub announced last month by the WHO for widening production of
vaccines using what is known as mRNA technology. This is the same
technology that Pfizer and BioNtech — as well as Moderna — have used to
develop their Covid-19 vaccines and is seen as particularly useful for
developing salves to combat other maladies.

The hubs are envisioned as training facilities for scaling up technology
and conducting clinical development work. Drug makers can offer production
know-how and licenses to facilitate technology transfers, while
manufacturers from low- and middle-income countries can receive training
and any needed licenses. The first hub involves a consortium of South
African companies, including Biovac.

Instead, Pfizer and BioNTech reached what is, essentially, a contract
manufacturing agreement with Biovac, since there is no indication that
either company is transferring technology to allow Biovac to eventually
manufacture a vaccine from start to finish.

Related: Pfizer to seek FDA authorization for third, booster dose of its
Covid-19 vaccine
“Biovac will not be given the ability to further develop its own internal
technical capacity and expertise that might allow it to manufacture other
mRNA vaccines and therapeutics in the future,” Brook Baker, a Northeastern
University professor who specializes in access to medicines and
intellectual property and a senior policy analyst for Health GAP, wrote us.

“It is more about keeping control than about sharing intellectual property
and technology,” said Ellen ‘t Hoen, a senior researcher in the global
health unit at the University of Groningen in the Netherlands and a former
executive director of the Medicines Patent Pool, which works with drug
makers to license medicines in low-income countries. She also spoke at the
WTO Summit, where she called out the “hoarding of knowledge required” to
produce Covid-19 vaccines.

A Pfizer spokesman sent us this: “Vaccine manufacturing is a biological
production. It is extraordinarily complex under any circumstances, and even
more so during a pandemic. To accelerate scale up of manufacturing, we are
primarily focusing on multiple existing sites, looking to external contract
manufacturers to support the important fill and finish and distribution
steps. We have explored innovative ways to increase the number of doses
we’re able to supply this year, and we now expect to manufacture
approximately 3 billion doses by the end of 2021.”

A Biovac spokesperson wrote us that “from our understanding of the mRNA
technology, we are of the opinion that we can produce the drug substance,
given time.” But she was not specific. We also asked Biovac how long it
would take the company to ramp up full production of the vaccine if it were
given the know-how and technology was transferred. We will pass along any
reply.

Another concern expressed is pricing, since the terms of the licensing
agreement with Biovac have not been disclosed. As a result, it remains
unclear what the vaccines will cost in Africa.

“There is no transparency,” argued Rohit Malpani, a board member at
UNITAID, which backs the Medicines Patent Pool.


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


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