Delivery of the doses, destined for the African Union’s 55 member states, will begin in the third quarter of 2021.
The availability of the vaccine will be subject to approval or authorization by national regulatory authorities of African Union member states. Earlier this month, the World Health Organization listed the vaccine for emergency use
Doses to be produced by Aspen Pharmacare in South Africa
Johnson & Johnson says it is committed to ensuring equitable global access to its COVID-19 vaccine on a not-for-profit basis for emergency pandemic use. The vaccine has several advantages for use in Africa: it can be stored and distributed in standard vaccine facilities; only requires a single-shot; and has been proven to be efficacious against the South African virus variant.
Phase 3 trials showed the vaccine was 66% effective at preventing moderate to severe COVID-19, but also showed efficacy of 57% in its South African trial where almost all the cases came from the B.1.351 variant. The data also demonstrated the vaccine was 85% effective in preventing severe disease across all regions studied and showed protection against COVID-19 related hospitalization and death across countries with different variants, beginning 28 days after vaccination.
The vaccine is compatible with standard vaccine distribution channels, enabling delivery to remote area. The vaccine is estimated to remain stable for two years at -25 to -15°C, a maximum of three months of which can be at routine refrigeration at temperatures of 2°-8°C. The company will ship the vaccine using the same cold chain technologies it uses today to transport other medicines.
South Africa’s Aspen Pharmacare is currently the sole manufacturer on the African continent to compound, fill, finish and package the J&J vaccine. Thanks to a R3bn investment – the single largest investment in the pharmaceutical industry in South Africa - the Gqeberha sterile manufacturing site will compound, fill, finish and package the vaccine.
The site has the capacity to produce more than 300 million doses per annum.
“We are particularly proud that this vaccine manufacture is taking place in Africa,” said Stephen Saad, Aspen Group Chief Executive, as South Africa's president Cyril Ramaphosa and an accompanying government delegation visited the site today.
“We hope that our success will inspire and give confidence to others to further invest in our continent. We have set ourselves a further target to become the pandemic solution for Africa. Security of supply for Africans is best achieved through African facilities. Aspen intends to assist with this goal by targeting further enhancement of capacities on the existing sterile footprint to ensure that we have the capabilities to give one liquid dose of vaccine per African person.”
Through the collaboration announced between Aspen and Johnson & Johnson, Aspen is the only manufacturing site on the African continent and in the southern hemisphere selected by J&J to compound, fill, finish and package the COVID-19 vaccine.#AspenWeCare#WeAreVaccinationpic.twitter.com/j5FoWJ41Vy— Aspen Pharma (@aspenpharma) March 29, 2021