Aspen Pharmacare, SAʼs biggest pharmaceutical manufacturer, has announced a groundbreaking and non-binding agreement with Johnson & Johnson to produce its COVID-19 vaccines under licence and under its own branded name, Aspenovax.
The agreement, reports BusinessLIVE, gives Aspen greater control over which customers to supply and paves the way for a further licensing deal for manufacturing the active pharmaceutical ingredients used in the jab, boosting Africaʼs security of supply.
The agreement means that Aspen can sell Aspenovax to African Union members and multinational organisations like the international vaccine-sharing vehicle Covax.
African nations import 99% of the vaccines they administer, meaning they were at the back of the queue when the coronavirus crisis struck in 2020. As a result, Africa is way behind the rest of the world, with only 7% of its population vaccinated against the disease.
Aspen has the capacity to bottle 300m doses of J&Jʼs vaccine at its Gqeberha plant, but plans to increase this to 450m a year by February, and 700m by January 2023. It eventually aims to expand vaccine production into shots against other diseases and make as many as 1,3bn vaccine doses a year, said Aspen CEO Stephen Saad.
Aspen was contracted by J&J in November 2020 to formulate, fill and package vials of its COVID-19 shot, but until now it has been J&J that determines which countries can buy the product. While most of the doses Aspen helps produce have been shipped to Africa, J&J initially sent some to Europe, triggering international criticism.
The deal comes as the emergence of the Omicron variant of the coronavirus has highlighted the need for greater vaccine equity, said Saad. “Africa remains vaccine constrained, preventing an effective response to the need to protect Africans against the virus,” he said. “The solution has to be regional capacitation. We have dispelled any myths that Africa cannot be home to vaccine capacity. Aspen has made more than 120m [J&J] doses to date, almost all going to Africa.”
Daily Maverick writes that when Strive Masiyiwa, African Union special envoy on COVID-19 and head of the African Vaccine Acquisition Task Team, heard that an existing facility in Africa could produce 250m annual doses of the J&J COVID-19 vaccination, he thought it was a hoax.
Masiyiwa and his team had been delegated to procure vaccines for 50% of Africa’s population, about 450m people, and had quickly learnt that Africa was last on the list when it came to procuring vaccines from global suppliers.
At that stage, Aspen had just finalised the deal to “fill and finish” J&J’s vaccine at its Gqeberha plant, most of which were already designated for markets in Europe. Some negotiations between the J&J management team, President Cyril Ramaphosa, and Afreximbank, a pan-African multilateral trade finance institution that paid for the vaccines up front, saw most of these vaccines diverted to African markets. This was after the Africa Vaccine Acquisition Trust (Avat) and the African Union signed a contract with J&J for 400m doses for the continent, most of which were produced by Aspen.
Aspen’s Saad took the relationship with J&J a step further, and in this he had some powerful backers, including the World Health Organization, Ramaphosa, Avat and Afreximbank.
After months of negotiations, writes Daily Maverick, Aspen confirmed the groundbreaking agreement with J&J this week. The parties have committed to finding a formal agreement that will see J&J license its COVID-19 technology to Aspen, which will manufacture the vaccine in Gqeberha, using the drug substance supplied by J&J. Aspen will sell the finished-form vaccine under the Aspenovax label to public sector markets in Africa.
This is uncharted territory for J&J, which typically does not license its intellectual property to third parties.
Aspen, however, is no stranger to these types of groundbreaking agreements. More than a decade ago the company signed voluntary licence agreements for the production of antiretrovirals that paved the way to affordable treatments for people with HIV/Aids.
“As with the solution found back then, resulting in voluntary licences for antiretrovirals used in treating HIV/Aids, we hope that this vaccine licence and related technical transfers may serve as a blueprint to assist in capacitating Africa and other developing markets,” Saad said.
He declined to comment on the price of Aspenovax, saying only that it would be competitively priced.
“We hope this licence agreement is a step towards a more diverse local manufacturing base for vaccines in Africa,” said Dr Ngozi Okonjo-Iweala, director-general of the World Trade Organization. “This shows that collaboration is possible, that we can resolve difficult issues and that voluntary licensing can solve technology transfer problems.”
Describing the deal as a “milestone agreement”, the World Health Organizationʼs regional head for Africa Matshidiso Moeti said it marked an important step towards teh continent's ambitions to manufacture its own vaccines. “We see this as being absolutely essential to ensure health security and access to safe, effective and quality products in Africa,” she said.
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