Saturday, July 13, 2024

Aspen-branded COVID-19 vaccine to be sold across Africa


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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”), has confirmed a non-binding term sheet with Janssen Pharmaceuticals, Inc., and Janssen Pharmaceutica NV, two of the Janssen Pharmaceutical Companies of Johnson & Johnson (“Johnson & Johnson”), that will form the basis for negotiation of a definitive agreement on the manufacture and sale of an Aspen-branded COVID-19 vaccine throughout Africa.

That agreement would expand the existing technical transfer and manufacturing agreements between the parties to grant Aspen SA the rights to:

  • manufacture finished SARS-CoV-2 COVID-19 vaccine product from COVID-19 drug substance supplied by Johnson & Johnson; and
  • sell the finished form vaccine, to be launched and branded as Aspenovax, to public sector markets in Africa through transactions with designated multilateral organisations and with national governments of member states of the African Union.

In addition, Johnson & Johnson would grant Aspen a license to the enabling intellectual property for this purpose.

The term of the grant of rights and supply of COVID-19 drug substance, subject to the signing of the definitive agreement, would be until 31 December 2026. The non-binding term sheet contemplates 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 as a different formulation for administration as a booster, and the applicable terms thereof.

Stephen Saad, Aspen Group Chief Executive said, “The COVID-19 pandemic has highlighted the inequitable access to vaccines globally. This is evident no more so than in Africa which has historically had no option but to import 99% of its vaccine requirements. Those regions with manufacturing capacity and capabilities have enjoyed ready access to COVID-vaccines, those without have not. Africa remains vaccine constrained, preventing an effective response to the need to protect Africans against the virus. We are most grateful to Johnson & Johnson for their confidence in collaborating with Aspen to address these challenges.”

“Through our contract manufacturing partnership with Johnson & Johnson, Aspen has been able to manufacture over 100 million doses of the Janssen COVID-vaccine to date, almost all of which have been supplied to Africa, and today, we are pleased to share the progress being made that would enable Aspen the rights to manufacture and sell Aspen’s own brand of the vaccine in Africa. This has the potential to represent a bold step forward in sustainably capacitating Africa with the ability to manufacture Aspenovax and release it exclusively for supply to African customers. A COVID-19 vaccine made in Africa for Africa.”

Stephen Saad added, “As with the solution found over a decade ago resulting in voluntary licenses for antiretrovirals used in treating HIV/AIDS, we hope that this potential license agreement and related technical transfers might serve as a blue-print to assist in capacitating Africa and other developing markets and in so doing ensure that we can truly live and give substance to our global commitment that we are not safe until we are all safe.”

President Cyril Ramaphosa, African Union COVID champion said,  “The effectiveness of our response as the African continent to the COVID-19 pandemic has been severely hampered by the grossly unequal distribution of COVID vaccines across the world. Today’s landmark announcement between Africa’s Aspen Pharmacare and Johnson & Johnson is the culmination of months of hard work with, among others, the African Union, Africa Centres for Disease Control and Prevention and the African Vaccine Acquisition Trust, in developing production capacity on the continent. This announcement has the potential to make an important contribution to addressing vaccine inequality and building Africa’s capacity to meet its own vaccine needs now and into the future.“

Strive Masiyiwa, African Union special envoy on COVID and Head of the AVAT Trust, said “The biggest and boldest step that Africa took through the Africa Vaccine Acquisition Trust and African Union, was signing a contract with Johnson & Johnson for 400 million doses for the continent, the majority to be produced by Aspen. Today’s announcement is an important milestone. It gets us one step closer to securing Africa’s future vaccine production and ensures that the gross vaccine inequality we witnessed in the early  part of the pandemic is not repeated.”

“We welcome this agreement. It is a major development which will help reduce the inequities Africa is facing in accessing COVID-19 vaccines. This cooperation and technology transfer arrangement is an important step forward towards increasing Africa’s manufacturing capacity and the push to ramp up access to vaccines and other key medical interventions,“ said Dr Matshidiso Moeti, World Health Organization Regional Director for Africa.

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