SOUTH AFRICA – Pharmaceutical company Aspen has entered into a COVID-19 vaccine licensing partnership deal with Johnson & Johnson (J&J) to develop African vaccine-manufacturing capacity.
As part of the partnership, Aspen will manufacture and distribute Africa’s first locally produced J&J’s COVID shot with the goal to boost COVID-19 vaccination rates across the continent.
The South Africa-based company will receive drug substances from J&J under the deal which it will use to produce finished Aspen-branded vaccines at scale and according to international standards for the African public sector.
Currently, Aspen is packaging J&J’s vaccine at its factory headquarters in South Africa which it plans to sell as a J&J’s single-dose shot named Aspenovax for the African continent.
Aspen will manufacture vaccines which will be available to all African Union member states along with multilateral organizations supporting Africa’s COVID-19 vaccination efforts such as the African Vaccine Acquisition Trust and the COVAX Facility.
Vaccines are significant in global vaccination efforts to control the COVID-19 pandemic and curbing the risk of new emerging variants hence the dire need to increase the capacity of all regions to manufacture the health products they need.
The Aspen-J&J partnership comes at the right time when African countries are working together to produce their own vaccines, medicines and diagnostics to address health emergencies and reach universal health coverage.
Aspen Pharmacare Group’s Senior Executive responsible for Strategic Trade Development Stavros Nicolaou affirmed that the anticipated licensing deal was crucial as it would ensure that Aspenovax would effectively provide Africa with its first COVID-19 vaccine.
“The strategic collaboration will go a long way toward building local vaccine manufacturing capacity on the continent and our vision for Africa’s own vaccine will become a reality with the conclusion of the pact,” the Aspen Executive maintained.
Additionally, Johnson & Johnson has reportedly shipped more than 200 million vaccine doses to Africa through a mix of purchase agreements including government donations while Moderna and BioNTech are planning to establish their own African vaccine manufacturing plants.
Moderna inked a strategic deal with Kenya to build a US$500 million mRNA vaccine manufacturing plant in Africa which is expected to produce up to 500 million vaccine doses a year.
Pfizer also entered into a partnership with BioNTech to set up modular factories housed in shipping containers dubbed BioNTainers to make the company’s COVID-19 vaccine from start to finish, save for the final fill-finish step.
SAHPRA highlights Pfizer vax safety issues
Meanwhile, the South Africa Health Products Regulatory Authority (SAHPRA) has highlighted the risks and benefits of the Pfizer Comirnaty COVID-19 vaccine which was authorized for use in adults and children aged 12 years and older.
Comirnaty is a vaccine indicated for active immunization to prevent COVID-19 which is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.
SAHPRA has evaluated all COVID-19 vaccines authorized for use in South Africa for quality, safety and efficacy to prevent serious disease and death from the COVID-19 disease.
The latest regular safety data reviewed by SAHPRA for Pfizer COVID-19 vaccines reports that the benefit-risk profile of the vaccine remains favorable and safe to be administered as per the roll-out schedule.
Consequently, safety reports are to be submitted to SAHPRA during the full cycle of the COVID-19 vaccine rollout process where vaccine safety issues are identified, monitored and assessed.
The authority has also directed vaccine manufacturers to provide risk management plans indicating how identified risks will be mitigated in case of adverse effects which are potentially linked to vaccination.
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