Johnson & Johnson’s decision to move forward to advanced stages in discussions about providing a licensing agreement to South African company Aspen Pharmacare to produce its COVID-19 vaccine is a “significant game changer for the continent,” according to Stavros Nicolaou, group senior executive of strategic trade development at Aspen. This would make it the first African company to have the right for distribution of a COVID-19 vaccine.
"We made the decision to progress now to putting together a commercial license for partners at Aspen," said Adrian Thomas, vice president of strategy and external affairs for Johnson & Johnson’s global public health work, during an Africa Centres for Disease Control and Prevention stakeholder meeting on vaccine manufacturing.
The companies announced nonbinding terms for a potential licensing agreement last week. Aspen has been producing the vaccine under contract, providing doses to the African Union for purchase by countries but with no control over where they are distributed. It has already produced 120 million doses. Under that contract arrangement, 10 million COVID-19 vaccine doses partially produced in South Africa were controversially sent to Europe.
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But under a licensing agreement, Aspen would have more autonomy — allowing it to determine the price and distribution of the vaccine. The agreement is for distribution on the African continent, where the vaccine will be marketed as Aspenovax.
“This now means that Africa has its first COVID vaccine. It means that we would now determine both the availability, allocation, and distribution of the vaccine,” Nicolaou said during the stakeholders meeting.
This would place Aspen in a role similar to that of Serum Institute of India, which has a licensing agreement to produce a COVID-19 vaccine developed by Oxford University and AstraZeneca.
The licensing deal is not a technology transfer. Aspen would still be dependent on other Johnson & Johnson manufacturing facilities for vaccine ingredients, and the company will continue to be involved in the final stage of the manufacturing process, known as “fill and finish.” The agreement would be valid through 2026.
While pharmaceutical companies have been criticized for not providing technology transfers to produce drug substances, Thomas defended the company’s decision during the stakeholders meeting.
“It is fill-and-finish. That is no simple task. It’s a very complex sterile manufacturing piece,” he said. “As we get the need and have the experience successfully of transferring drug product, then we’d look to the next step [of licensing the vaccine ingredients]. There is no magic formula for that, but it has to be built on successful experience.”
Thomas said that moving forward on the licensing agreement with Aspen needed to be done in a “very thoughtful way — step-by-step building on strength and experience.”
“We have had challenges in going from zero to 100% [manufacturing] in such a short period of time,” he said. “What we’ve learned is that we have to focus on the highest quality — no compromises on quality processes, stringent regulatory standards, and [being] able to meet global standards. And Aspen has done that, and we feel very confident now in the further investment.”
Update, Dec. 7, 2021: This article has been updated to clarify that Johnson & Johnson and Aspen Pharmacare are in advanced stages of discussing a licensing agreement.