SA to begin Covid-19 vaccine production later this year as first clinical trial also set to start in 2022
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Johannesburg - South Africa will start production of a Covid-19 vaccine in the third quarter of this year, and the first clinical trial is set to start in November. This is the news from the Biovac Institute and its partners, which said they would immediately commence technical transfer activities, that includes on-site development and equipment installation activities.
Biovac CEO Dr Morena Makhoana said the company would obtain drug substances from facilities in Europe, and manufacturing of finished doses will commence in 2022. At full operational capacity, the annual Covid-19 vaccine production will exceed 100 million finished doses annually. All doses will exclusively be distributed within the 55 member states that make up the African Union.
“We are thrilled to collaborate with Pfizer and BioNTech to produce and distribute the Pfizer-BioNTech Covid-19 Vaccine within Africa. This is testament of the long-standing relationship we have had with Pfizer through the Pneumo-conjugate vaccine,” said Makhoana.
Managing Director at Afrigen Biologics and Vaccines, professor Petro Terblanche said the objective is to produce the first-ever end-to-end Covid-19 vaccine constructed from the same sequence as the Moderna vaccine 1273 in Africa and low, and low middle-income countries (LMIC). This technology will then be transferred to multiple spokes based in LMICs as part of a sustainable manufacturing capacity creation and supply of vaccines.
“The Hub and our core partner, Wits University, have made at lab scale the drug substance and formulated using selected lipid nanoparticles. We are still busy with analytics to complete the process and to enable us to confirm the qualities and composition. We will make multiple batches before starting the scale-up and GMP production. The target date for Phase 1 clinical trial to start is Nov 2022,” she said.
Chairperson and Pfizer CEO Albert Bourla said: “From day one, our goal has been to provide fair and equitable access of the Pfizer-BioNTech Covid-19 Vaccine to everyone, everywhere. Our latest collaboration with Biovac is a shining example of the tireless work being done, in this instance, to benefit Africa. We will continue to explore and pursue opportunities to bring new partners into our supply chain network, including in Latin America, to further accelerate access of Covid-19 vaccines.”
CEO and Co-founder of BioNTech, Dr Ugur Sahin, added: “We aim to enable people on all continents to manufacture and distribute our vaccine while ensuring the quality of the manufacturing process and the doses. We believe that our mRNA technology can be used to develop vaccine candidates addressing other diseases as well. This is why we will continue to evaluate sustainable approaches that will support the development and production of mRNA vaccines on the African continent.”
Director:Health Innovation at the Department of Science and Technology, Glaudina Loots said Aspen is already doing the fill/finishing of the J&J Ad26 vaccine and also announced that it would be re-branded to Aspenovax.
CEO of the Innovative Pharmaceutical Association of South Africa (IPASA) Bada Pharasi said as a voluntary association that represents the companies responsible for the supply of innovative medicines, medical devices, and vaccines in South Africa, IPASA and its member companies share a vested interest in the future prosperity of the country.
“Since 2016, innovative multinational pharmaceutical companies (IMNPCs) invested close to R3bn in research and developmental activities in the country, sponsoring and facilitating at least 382 clinical trials that have positively impacted the more than 100 000 patients who participated in them. IPASA continues to support numerous product development partnerships, which are an effective vehicle to ensure that people in lower and middle-income countries have access to essential medicines. In fact, Sub-Saharan Africa leads the world in innovative public-private partnerships,” he said.
President Ramaphosa described the landmark collaboration as “a breakthrough in our efforts to overcome global vaccine inequity, demonstrating what we can achieve when the state sector and the private sector craft a shared vision and pool resources for the greater good of society”.
IPASA research found that over 90% of multinational pharmaceutical companies list South Africa as their regional headquarters, with as many as 50% indicating that their operations in other markets across the continent are managed from South Africa. The advantages of being the preferred regional location for a high-value-adding sector such as Big Pharma is considerable, and the socio-economic benefits of this cannot be overstated,” he said.
Pharasi said IPASA is not privy to the finer details of the agreements, including the costs involved, but typically, there would be contractual arrangements between the two parties which would, no doubt, include confidentiality on certain aspects of the agreement.
“It should be noted that any company that positions itself to produce vaccines would have to take into account the cost of the technology transfer involved, on-site development of the facility, equipment installation, and the training of highly qualified staff to manage the production facility. It can be expected that the owner of the technology, which transfers the license, would bear some of the costs, as seen in the example of MSD in the article, but the bulk of the costs would be for the account of the recipient company,” he concluded.