Durban, South Africa – JSE Limited listed Aspen Pharmacare Holdings Limited (APN), a global multinational specialty pharmaceutical company, is pleased to confirm that one of its wholly-owned South African subsidiaries, Aspen SA Operations (Pty) Limited (“Aspen SA Operations”), has concluded an agreement (“Agreement”) with Janssen Pharmaceuticals, Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson (“Johnson & Johnson”), to manufacture and make available an Aspen-branded COVID-19 vaccine, “Aspenovax”[1], throughout Africa.
This follows the announcement of 30 November 2021 regarding the conclusion of a non-binding term sheet between Aspen and Johnson & Johnson (together the “Parties”) bearing reference to the subject of the Agreement.
The terms of the Agreement expand the existing technical transfer and manufacturing agreements between the Parties to grant Aspen SA Operations the rights to:
- manufacture finished Aspenovax product from drug substance supplied by Johnson & Johnson; and
- make available Aspenovax to markets in Africa through transactions with designated multilateral organisations and with national governments of member states of the African Union (“AU”).
Under the Agreement, Aspen has secured the enabling intellectual property from Johnson & Johnson and there is a good faith undertaking between the Parties to discuss the expansion of the Agreement to include any new versions of the drug substance, such as those developed for new variants or a different formulation for administration as a booster, and the applicable terms thereof.
The Agreement endures until 31 December 2026.
Stephen Saad, Aspen Group Chief Executive said, “With the conclusion of this agreement, our vision for Aspenovax, Africa’s own vaccine, has become a reality! This has been achieved through tremendous teamwork and collaboration between Johnson & Johnson and Aspen. Through this agreement and their earlier actions, Johnson & Johnson has demonstrated its commitment to our continent. Initially by choosing Aspen, located in Africa, as a core manufacturing partner, and then by showing resolve and dedication to a technical transfer process during the most stringent lockdown periods of the COVID outbreak. Even with all the support in the world, none of this would be possible without the competence of our teams at Gqeberha. They knew the weight of a continent’s ambitions rested on their shoulders. They persevered and succeeded in becoming a significant supplier within the Johnson & Johnson network. Aspenovax has become a reality due to the confidence placed in their abilities. They are our African heroes. We also need to acknowledge fellow committed Africans, including Africa Vaccine Acquisition Trust (“AVAT”), the AU, Africa Centres for Disease Control and Peventio (“Africa CDC”) and AVDA, who, through their individual and collective efforts, including their unwavering support, galvanised us along the way. Africa has a vaccination rate of just 12%, so we have much work still to do, if we are to truly embrace the global commitment that we are not safe until we are all safe. With Aspenovax, it is our intention to build off the base we have already founded and contribute to providing equitable access to the COVID vaccine on our continent.”
Dr Matshidiso Moeti, World Health Organization Regional Director for Africa said,” This important agreement on sharing know-how and technologies for the production of COVID-19 vaccines is a huge leap forward towards realising our shared vision for medicines and vaccines to be manufactured on the African soil for the African people. Vaccines are our best way out of this pandemic and local production is an essential recipe for our success.”
Dr John Nkengasong, Director of the Africa Centres for Disease Control and Prevention (Africa CDC), said “The COVID pandemic has significantly highlighted the inequality that exists in the manufacture and supply of vaccines. The African Union and Africa CDC have committed to promoting and advancing vaccine capacity and capability on the continent, not only to address the present situation but equally to reduce the continent’s dependence on imported vaccines and to prepare for any future pandemics. To this end, today’s announcement between Aspen and Johnson & Johnson is a momentous one for the continent as it enables our continent to own, manufacture and distribute the first COVID vaccine that will cover all 55 African Union states, thereby improving access to COVID-19 vaccines on the continent. Africa CDC continues to be committed to ensuring sustainable vaccine manufacture on the continent”
Strive Masiyiwa, African Union special envoy on COVID and Head of the AVAT Trust, said, “This agreement is the single biggest win for the African continent in the fight against covid and future pandemics. It is a timely milestone and an important step in making sure that the gross vaccine inequality we witnessed in the early part of the pandemic is not repeated.”
Dr Seth Berkley, the CEO of Gavi, the Vaccine Alliance, said “This is welcome news, and an important milestone in the effort to build sustainable vaccine manufacturing capacity on the African continent. As an Alliance that helps vaccinate half the world’s children against some of the world’s deadliest diseases, Gavi has been a strong supporter and driver of supplier diversification – steadily expanding our supplier base from five manufacturers in 2004 to 17 vaccine manufacturers today – of which 11 are based in Africa, Asia and Latin America. As a co-lead of COVAX, we proactively support the expansion of regional manufacturing efforts as a fundamental cornerstone of future pandemic preparedness.”
Dr Richard Hatchett of the Coalition for Epidemic Preparedness Innovations or CEPI said, “Today’s announcement is a true landmark and will lead, for the first time, to the production of a COVID-19 vaccine on the African continent. CEPI and I congratulate Aspen and Johnson & Johnson on this momentous agreement and important step towards Africa’s goal of vaccine self-sufficiency. We are committed to supporting both partners and the Republic of South Africa in this critical endeavour.”
Professor Benedict Oramah, the President of Afreximbank, said, “We are witnessing a remarkable event for Africa. After months of Africa’s relentless struggle against global COVID-19 vaccine inequity, we are elated that finally Africa can produce its own branded COVID-19 vaccine. Aspen gave Africa the window of access to COVID-19 vaccines when they were most needed. Now, it is setting the pace in on-shoring its production in Africa. Afreximbank is pleased to be a major partner and supporter of Aspen. We have financed and structured the commercial aspects of the Africa Vaccine Acquisition Trust (AVAT) order of 400 million doses of the COVID-19 vaccine being delivered to African Union member states.”
Dr Ayoade Alakija, Co-Chair of the Africa Union Africa Vaccine Delivery Alliance for COVID-19 (AVDA), said, “This agreement is a significant stepping stone on the path to securing African self-sufficiency. However, while this is certainly a step, or perhaps leap, in the right direction, there is still a need to ensure sustainability by strengthening workforce development and building African human capacity. It is past time that African manufacturers step into center stage to ensure our continent’s health security.
Johnson & Johnson released their own press release to announce the conclusion of this agreement and is available here.
[1] Aspen SA Operations has undertaken the required process to assess the acceptability of the Aspenovax name with the South African Health Products Regulatory Authority.
Supporting visual and supplementary material can be accessed here.
Aspen’s manufacturing capabilities
