J&J Considers Licensing COVID-19 Vaccine to South African Company

Johnson & Johnson recently announced a potential licensing agreement for its COVID-19 vaccine with Aspen SA Operations (Pty) Ltd, based in South Africa. 

The companies will work towards a definitive agreement that builds on their existing manufacturing collaboration. The agreement would allow for the first manufacturing and distribution of a COVID-19 vaccine sold by an African company for people living in Africa. 

Currently, coronavirus vaccination rates are notably lower across Africa compared to those 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,” Paul Stoffels, MD, vice chairman of the executive committee and chief scientific officer, said in the announcement. 

“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,” Stoffels continued. 

The license agreement would enable Aspen to produce an Aspen-branded finished vaccine for sale to public sector markets in Africa by using Johnson & Johnson’s COVID-19 vaccine drug substance.

The sale to public markets would be made through transactions with national governments of African Union member states and certain multilateral entities serving Africa, including the African Vaccination Acquisition Trust (AVAT), Gavi/COVAX, and UNICEF. 

Johnson & Johnson will make about 900 million doses of its COVID-19 vaccine available to the African Union (via AVAT) and the COVAX Facility, combined, through 2022. 

In July, Johnson & Johnson announced that a single shot of its vaccine generated robust and persistent activity against the SARS-CoV-2 Delta variant and other prevalent viral variants.

For example, an analysis studied blood samples from participants in the company’s Phase 3 ENSEMBLE trial and found that the vaccine was consistently effective across all regions studied globally, including South Africa and Brazil.

And just last week, the World Health Organization (WHO) deemed the recently discovered Omicron variant, found in South Africa, a variant of concern based on the evidence that Omicron has several mutations that may impact how it behaves.