[Vaccine-manufacturing] Nature: How COVID spurred Africa to plot a vaccines revolution

Thiru Balasubramaniam thiru at keionline.org
Wed Apr 21 19:13:15 PDT 2021


https://www.nature.com/articles/d41586-021-01048-1


NEWS EXPLAINER  21 APRIL 2021

How COVID spurred Africa to plot a vaccines revolution

For decades, Africa has imported 99% of its vaccines. Now the continent’s
leaders want to bring manufacturing home.

Aisling Irwin


Prompted by the pandemic, Africa’s leaders are on a path to ramp up
capacity in vaccine manufacturing and boost the continent’s regulatory
bodies for medicines. On 13 April, they pledged to increase the share of
vaccines manufactured in Africa from 1% to 60% by 2040. This includes
building factories and bolstering capacity in research and development.

The COVID-19 pandemic has left Africa woefully short of vaccines, according
to John Nkengasong, director of the Africa Centres for Disease Control and
Prevention (Africa CDC), based in Addis Ababa. The ambitious move
represents an important step in boosting Africa’s capacity in public
health, he added.

Africa’s vaccines revolution must have research at its core

Nkengasong was speaking at a 2-day vaccines summit on 12 and 13 April,
co-organized by Africa CDC and the African Union, and attended by 40,000
delegates. Also taking part were heads of state and leaders from research,
business, civil society and finance.

“We have been humbled, all of us, by this pandemic,” said Abdoulaye Diouf
Sarr, Senegal’s minister of health and welfare. The 1% figure “boggles the
mind”, added virologist Salim Abdool Karim, formerly a science adviser to
South Africa’s government.

Nature examines the opportunities and challenges that Africa’s plans
present.

How can Africa manufacture more vaccines?

Africa, a continent of 54 countries and 1.2 billion people, produces only
1% of the vaccines it administers. The remaining 99% are imported. Most
come from international procurement mechanisms, such as one organized
through the United Nations children’s charity UNICEF. As high-income
nations rush to vaccinate their populations against COVID-19, Africa has
found itself at the back of the queue. According to Andrea Taylor, a
researcher at Duke University in Durham, North Carolina, people in the
poorest countries will need to wait until the end of 2022 before everyone
is protected.

Kick-starting successful vaccine manufacturing needs at least four key
ingredients: financing amounting to hundreds of millions of dollars;
expanded research capacity; a commitment from governments to purchase
vaccines; and regulatory bodies that meet international standards. Compared
with other regions, African countries are lacking in all four.

COVID vaccination logistics: five steps to take now

The entire continent has around ten vaccine manufacturers, according to
'Vaccine manufacturing in Africa', a report on vaccine investment
opportunities funded by the UK government. Four manufacturers — the Pasteur
Institute of Dakar in Senegal, the Pasteur Institute of Tunis in Tunisia,
Biovac in Cape Town, and the Pasteur Institute of Algeria in Algiers — have
the capacity to manufacture the substance that a vaccine is made of. Two
others — Ethiopia Public Health Institute in Addis Ababa and Biovaccines in
Lagos, Nigeria — have announced plans to reach that point. Two
manufacturers are or plan to be involved only in ‘fill and finish’
processes or packaging and labelling.

Historically, international donors have been significant funders of African
vaccine capacity, including research and development, such as France’s
Pasteur Institute, whose research institutes are in Algeria, Morocco,
Tunisia and Senegal. Imported vaccines are also funded in large part
through international aid. Gavi, a partnership representing international
donors and pharmaceutical companies, buys vaccines at low prices from
pharmaceutical companies, and UNICEF has established a vast network to
distribute them across low- and middle-income countries.

Is manufacturing already ramping up?

Until the pandemic, progress was slow. There was not enough demand for
vaccines made in Africa to make manufacturing profitable, according to the
UK government’s analysis. Companies, moreover, say that selling vaccines
across Africa is expensive. But the African Union's free-trade area, which
began operating from January of this year, will benefit companies that sell
to different countries as they will pay fewer additional costs in the form
of taxes and tariffs.

What it will take to vaccinate the world against COVID-19

International donors are also stepping up. The Africa CDC plans to
establish five new vaccine-manufacturing centres across the continent. The
ambition is for Africa to manufacture 60% of its required vaccines within
20 years, according to John Nkengasong, director of the Africa CDC.

The African Development Bank, moreover, says it aims to help finance at
least two technology platforms for vaccine production, which will be
capable of producing at least 300 million doses per year. These platforms
will need investments of up to US$400 million.

What is the role of medicines regulation?

All vaccines need approval from their national regulatory authorities. But,
across Africa, these authorities range in quality from “robust and
functional” to offering regulation that is “virtually non-existent”,
according to a study published last month1 by researchers at the School of
Pharmacy at the University of the Western Cape in South Africa.

The pandemic has prompted calls to accelerate efforts to establish an
African Medicines Agency (AMA) — similar to the European Medicines Agency
(EMA) — which would provide national African regulators with regulatory
guidance on new medicines as the EMA does in Europe. The project is being
led by the African Union and the Africa CDC. The AMA will cost $100 million
to establish.

As of February 2021, only eight countries had ratified an international
treaty that would bring the AMA into existence1. Fifteen countries will
need to ratify it to bring it into existence; Tedros Adhanom Ghebreyesus,
director-general of the World Health Organization, urged countries to
quickly relevant laws in their national parliaments.

Can Africa learn from other countries?

Companies in other low- and middle-income countries have become hubs for
vaccine manufacturing. The roots of vaccine manufacturing in India, which
supplies around 70% of Africa’s vaccines, lie in a desire among
policymakers for national self-reliance in vaccines and therapeutics dating
from the 1950s and 1960s — shortly after the country attained independence
from the United Kingdom. Indian companies such as the Serum Institute in
Pune and Bharat Biotech, which have risen to prominence during the
pandemic, did not suddenly emerge overnight, Rajinder Sur, Bharat Biotech’s
chief executive told the AU meeting.

Why a pioneering plan to distribute COVID vaccines equitably must succeed

The Serum Institute, now the world’s biggest vaccine manufacturer —
producing more than 1.5 billion doses a year — was founded in 1966. Its
owner, race-horse breeder Cyrus Poonawalla, began cultivating therapeutic
anti-tetanus serum from the serum of retired horses, and, within two years,
expanded into tetanus-vaccine manufacturing — and then gradually into
production of multiple vaccines. A pivotal moment came in 1994 when the
institute achieved accreditation from the WHO and began to export its
vaccines and selling to agencies such as UNICEF.

Other lower-income countries now producing COVID-19 vaccines, including
Thailand and Vietnam, can do so at least in part because they benefited
from an influenza-technology transfer programme run by the WHO some 15
years ago, says Martin Friede, coordinator of the WHO’s Initiative for
Vaccine Research in Geneva.

The WHO established a training centre for 11 participating manufacturers to
learn how to make pandemic influenza vaccines. By 2009–10, six of the
countries were producing vaccines against avian influenza H1N1. The WHO is
now trying to replicate this facility with the COVID-19 Vaccines Global
Access (COVAX) manufacturing task force. At the same time, some countries
are actively looking to acquire technology for RNA-vaccine manufacturing.
As Nature reported last month, this is partly because the technology is
more straightforward to develop and less capital-intensive.

In the next pandemic, will Africa make its own vaccines?

The AU meeting ended on an upbeat note, with delegates talking of “tipping
points”, “now-or-never moments” and “global goodwill” to enable Africa to
finally create its own vaccines industry. Progress will need political
commitment, long-term finance and regional cooperation, said Patrick
Tippoo, executive director of the African Vaccine Manufacturers’
Initiative, a group of vaccine manufacturers and research institutes.

Why COVID vaccines are so difficult to compare

The foundational problem, Tippoo added, is that the continent’s leaders
have lacked the vision to recognize the centrality of local vaccine
manufacturing in health-care policy.

The lack of manufacturing and weak regulation will require long-term
governmental support if they are to be overcome, said Solomon Quaynor, a
vice-president at the African Development Bank Group. Without such support,
he warned the meeting’s delegates, “there will be no vaccine manufacturing
in Africa”.

But momentum is on the side of new beginnings. “In the final analysis, the
onus is on us as Africa. I do know we can do the job,” said Ngozi
Okonjo-Iweala, Nigeria's former finance minister and now director-general
of the World Trade Organization.

doi: https://doi.org/10.1038/d41586-021-01048-1

References

1. Ncube, B. M. et al. J. Pharm. Policy Pract. 14, 29 (2021).


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


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