Johnson & Johnson is pleased to reach an advanced stage in its discussions for a potential licensing agreement for its COVID-19 vaccine with Aspen SA Operations (Pty) Ltd, which is based in South Africa. The parties will continue to work toward a definitive agreement that builds on their existing manufacturing collaboration and would enable the first COVID-19 vaccine to be manufactured and sold by an African company, in Africa and for people living in Africa. Currently, COVID-19 vaccination rates are significantly lower across Africa compared to those seen in high-income countries.

“Since the earliest days of the pandemic we have been committed to supporting Africa’s response to COVID-19 through our vaccine clinical development program, large-scale implementation studies, first-of-their-kind purchase agreements and COVID-19 vaccine manufacturing at Aspen,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer. “Everyone at Johnson & Johnson is very proud of our ongoing collaboration with Aspen, which unites global and national expertise in the effort to support the vaccination of populations who are most in need at this critical stage of the pandemic.”

The timing of the signing of a final agreement is dependant on a number of factors. The license under discussion would enable Aspen, using COVID-19 vaccine drug substance supplied by Johnson & Johnson, to produce Aspen-branded finished vaccine for sale to public sector markets in Africa through transactions with national governments of African Union member states and certain multilateral entities serving Africa including the African Vaccine Acquisition Trust (AVAT), Gavi/COVAX and UNICEF.

“This is an important step toward COVID-19 vaccine manufacturing in Africa, for Africa, but a lot more needs to be done,” added Dr. Stoffels. “Most critically, the global community should prioritize a clear plan to scale up investment across the African continent in the specialized vaccines manufacturing infrastructure – and skilled local workforce – that will be needed to really rise to this challenge.”

The potential license would be the latest example of Johnson & Johnson sharing its intellectual property (IP) and manufacturing know-how to reliable and proven manufacturers that are well equipped to uphold the highest standards of product quality and safety.

Johnson & Johnson is delivering on its commitment to make available up to 900 million doses of its COVID-19 vaccine to the African Union (via AVAT) and the COVAX Facility, combined, through 2022. The Company is also a proud collaborator with the South African Medical Research Council (SAMRC) and others on a Phase 3b clinical study, ‘Sisonke Boost,’ to evaluate the safety and efficacy of booster doses (second-dose) of the Johnson & Johnson COVID-19 vaccine in South African healthcare workers.