Durban, South Africa – JSE Limited listed Aspen Pharmacare Holdings Limited (APN), a global multinational specialty pharmaceutical company, is pleased to announce that one of its wholly-owned South African subsidiaries, Aspen SA Operations (Pty) Limited (“Aspen SA Operations”), has concluded a ten-year agreement (“the Agreement”) with Serum Institute of India Pvt Ltd (“the Serum Institute”), the world’s largest vaccine producer, for Aspen SA Operations to manufacture, market and distribute four Aspen-branded routine vaccines in Africa, excluding certain markets due to the Serum Institute having grated prior rights to third parties.
The terms of Agreement for the vaccines, namely Pneumococcal Vaccine, Rotavirus Vaccine, Poly valent Meningococcal Vaccine and Hexavalent Vaccine (“the Products”), include a technical transfer and formulation, fill and finish arrangement which grants Aspen SA Operations the rights to:
(i) manufacture the Products from bulk drug substance supplied by the Serum Institute; and
(ii) make available the Products to markets in Africa by means of transactions with designated multilateral organisations, national governments of member states of the African Union (“AU”), and other public and private market customers.
Under the Agreement, Aspen SA Operations has secured a license to the enabling know how from the Serum Institute and there is a good faith undertaking between the Parties to discuss the expansion of the Agreement to include new products or new versions of the Products.
In addition to the Agreement, Aspen also anticipates receiving grant funding from the Bill & Melinda Gates Foundation (”the Gates Foundation”) and the Coalition for Epidemic Preparedness Innovations (“CEPI”) to support African regional manufacturing capacity for the affordable supply of vaccines to, among others, African countries and Gavi / UNICEF, as well as contributing to pandemic preparedness through rights to a share of Aspen’s vaccine manufacturing capacity over a period of ten years.
According to Africa Centre for Disease Control and Prevention (“CDC”), currently less than 1% of vaccines used on the continent contain any local manufacture, yet through GAVI, UNICEF, COVAX and the Africa Vaccine Acquisition Task Team (“AVATT”), hundreds of millions of doses of vaccine are supplied to African countries to support both the Expanded Programme on Immunization (“EPI”), protecting children from a range of vaccine preventable diseases, as well as the provision of COVID-19 vaccines for the general population.
Stephen Saad, Aspen Group Chief Executive said, “Africa has learnt from the experience of previous pandemics including HIV and now COVID, that regional capacities are fundamental to solving regional health challenges. The agreement concluded with the Serum Institute, and the anticipated grant funding from the Gates Foundation and CEPI, complement our previously stated commitment to expand sustainable and durable vaccine manufacturing on the continent to reduce Africa’s global vaccine dependency. We look forward to partnering with Adar and the Serum Institute. They are the largest manufacturers of vaccines globally and have a proven record of supporting universal healthcare. Aspen is now well-positioned as a first mover to contribute to Continental and, by implication, global health security through the provision of world-class, competitive and proven vaccine manufacturing capability and capacity.”
The Products will be produced at Aspen’s manufacturing facility in Gqeberha which has accreditation from a range of stringent international regulatory authorities and provides medicines and vaccines to improve the health and quality of life of patients in both the domestic and international markets.
Adar Poonawalla, The Serum Institute CEO, said “We are pleased to be partnering with Aspen and to support them in fulfilling their vaccine ambitions for Africa. We endorse their efforts to contribute towards reducing the Continent’s global vaccine dependency and we are confident that the Products will provide enhanced opportunities of wellbeing for all patients in Africa.”
Mark Suzman, Chief Executive Officer, Gates Foundation, said, “Despite significant successes in expanding access to vaccines and reducing child mortality, the recent inequities exposed by the COVID pandemic have clearly highlighted the need to strengthen Africa’s capacity to manufacture its own life-saving vaccines. As a critical step to closing this gap we are proud to be able to provide financial and technical support to this new partnership between the Serum Institute of India and Aspen and look forward to working closely with them and other regional partners to expand the supply and sources of vaccines for African and global markets going forward. This is in line with our work over two decades with a range of partners, including GAVI and Serum, to help build a diversified ecosystem to develop, manufacture and distribute high-quality, low-cost vaccines for low- and middle-income countries.”
Dr Richard Hatchett, CEPI Chief Executive Officer, added “CEPI’s partnership with Aspen, SII, and BMGF is an exciting step towards expanding vaccine manufacturing capacity in Africa, for Africa. This partnership will enhance the region’s health security and represents an important step towards preventing the kind of gross inequities of access to lifesaving vaccines that emerged during the pandemic.
“Manufacturers need sustainable and resilient business models between outbreaks, so their facilities and workforce can be ready to spring into action when needed during an epidemic or pandemic, and public sector investment will be key to unlocking this sustainability in Africa. We are proud to be part of an effort that will secure critically needed vaccine manufacturing capacity in Africa, for Africa, so that it can be ready when it faces future epidemic or pandemic threats.”
On 10 May 2022, The AU called for agencies responsible for bulk purchasing of vaccines to offtake at least 30% of all vaccines produced by Africa for global consumption. In Africa, 99% of all vaccines administered are currently imported. Enhancing access to medicines is at the forefront on Aspen’s ESG strategy.
“Africa is a significant consumer of a range of vaccines and demand will grow further in the next decade, yet the vast bulk of those vaccines are sourced from outside the continent. The Covid pandemic laid bare Africa’s vulnerability when supplies are constrained globally. We therefore welcome the announcement of the partnership for the production of routine vaccines by Aspen,” said Mr Ebrahim Patel, South Africa’s Minister of Trade, Industry and Competition.
“The South African government has worked closely with the domestic pharma industry and other partners on the continent to strengthen vaccine supply security, reduce reliance on imports, improve access to vaccines and kickstart the biotechnology sector in SA and on the continent. This development is consistent with these ambitions and is a significant first step to the African Union achieving its stated objective of reducing vaccine imports from 99% to 40% by 2040. We look forward to global and continental procurement agencies shifting their sourcing to help achieve the 40% African production objective,” Minister Patel said.
Dr Ahmed Ogwell Ouma, Acting Director, Africa CDC said “We are very pleased to hear about the announcement by Aspen that it will Manufacture and make available four Routine Vaccine for Communicable diseases in Africa.
This is a very important step for African Vaccines Manufacture and is in line with three important aspects of Africa CDC’s Work. Firstly, it has responded to the AU Heads of State call for 30% of Vaccines for Africa are to be procured from African Producers. Secondly, it is in line with the goals and ambitions of an African Partnership on Vaccine Manufacture to expand access on the Continent. Lastly, it is in line with the African new order of strengthening local Manufacture of all health products including Vaccines. I Congratulate Aspen on this very important step and look forward to stimulating further Vaccine Manufacture on the African Continent.”
Dr Matshidiso Moeti, World Health Organisation Regional Director, said, “Unlike any other health emergency, the COVID-19 pandemic laid bare the dangers of the continent’s continuing dependency on health commodities produced elsewhere, and compelled the need for Africa to enhance its local manufacturing capacity. We welcome this initiative as it marks a critical milestone in the continent’s push for self-sufficiency in vaccines, diagnostic and therapeutic products.”
Strive Masiyiwa, Head of AVATT said, “During the height of the pandemic it became clear to myself and my AVATT colleagues set up by the AU Chair President Cyril Ramaphosa, that the only way to secure vaccines early was through production facilities on the African continent. This was because nations that had such production facilities were restricting exports until such time as they had met the needs of their own citizens. Aspen emerged at the time as the largest pharmaceutical company in Africa which had the full capability and capacity to respond to Africa’s desperate situation and began to produce the Johnson and Johnson vaccine on behalf of the continent. We at AVATT are so pleased with this latest development as it is yet another major milestone in ensuring that Africa has capacity on the ground to meet vaccine demand should another crisis emerge again.”
“The Secretariat of the AU COVID-19 Commission wishes to extend its congratulations to Aspen for this important development. The COVID-19 Commission set out to position Africa as a biotech investment destination and we are excited to see this manifesting as Aspen and the Serum Institute announce this ground breaking partnership. The COVID-19 Commission will continue to work together with the Partnership on Africa’s Vaccine Manufacturing (“PAVM”) and other partners towards the goal of producing 60% of Africa’s required vaccine on African soil by 2040,” said Dr Lwazi Manzi, Head of the AU COVID 19 Commission Secretariat
The ongoing COVID-19 pandemic and the recent World Health Organisation’s declaration of Monkeypox being a Public Health Emergency of International Concern, have underscored the need for continental vaccine research and development as well as manufacturing to be expanded and supported. As recognised by the Partnerships for African Vaccine Manufacturing (“PAVM”), a foundation of consistent, ongoing routine vaccination demand is required to manage the outbreak, epidemic and pandemic vaccine manufacturing capability and capacity needed to support regional and global health security.
Click here to access an announcement message from each of the following stakeholders:
Trevor Mundel, President of Global Health, Gates Foundation
Dr Ahmed Ogwell Ouma, Deputy Director of the Africa, CDC
Dr Richard Hatchett, Chief Executive Officer, CEPI