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SOUTHNEWS

 
No. 363, 1 April 2021

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South Centre series on manufacturing capacity for COVID-19 kicks off with Brazil’s Butantan Institute’s experience with Sinovac
 

Despite successful vaccines against the COVID-19 pandemic – most largely financed by public funds –, the global allocation of vaccines has been profoundly unequal. Most developing countries, despite initiatives such as the COVAX Facility, are expected to vaccinate their populations widely only in 2023 or later. The current manufacturing of vaccines is insufficient to respond to the global demand and efforts at the multilateral level to enhance technology transfer and manufacturing have been unsuccessful. Multiple facilities around the world, including in developing countries, suitable for manufacturing COVID-19 vaccines are currently unused for this purpose. Many could be repurposed or scaled-up to produce them, but the reluctance of most pharmaceutical companies to engage in technology transfer puts a limit to the potential expansion of production. Yet, various positive experiences involving institutions of the global South have taken place, which could provide the basis for increased local production and South-South Cooperation.

In this context, the South Centre has launched a series of webinars aimed at sharing information about the capacities for COVID-19 vaccines manufacturing in developing countries, understanding how these are built and could be expanded, facilitating the exchange on concrete experiences in addressing issues of technology transfer, know-how and intellectual property in contractual agreements, and advancing ideas on how the multiple challenges that arise could be addressed.
[1]
 

The first session took place on 23 March 2021 with Butantan Institute (São Paulo, Brazil), to discuss its partnership with Sinovac Life Sciences (Beijing), including clinical trials, technology transfer and local manufacturing of the Coronavac vaccine in Brazil. Dr. Ricardo Palacios, Director of Medical Research, and Mr. Tiago Rocca, Strategic Partnerships and Business Development Manager, shared the Institute’s experiences. It was moderated by Dr. Viviana Muñoz, Coordinator, Health, Intellectual Property and Biodiversity (HIPB) Programme, South Centre, and opening remarks were made by Dr. Carlos Correa, Executive Director, South Centre.

Butantan Institute, a leading public health institute in Brazil and the largest producer of immunobiologicals and biopharmaceuticals in Latin America, with a vast experience in tropical diseases, has been able to bring together the industrial manufacturing and the public health dimensions. The prior experience in vaccines’ manufacturing, including a previous technology transfer partnership with Sanofi-Pasteur for influenza,  and in regulatory procedures have been key in implementing the partnership. A key element has been the scientific capacity of the Institute and the existence of a supportive ecosystem composed of universities, laboratories, suppliers, manufacturers, government institutions, etc. The converging needs of both parties (Sinovac needed a partner for clinical trials outside of China, where COVID-19 cases were not widespread enough, while Brazil needed access to vaccines), the regulatory landscape in Brazil, the scientific and industrial capabilities for absorption of technology, the availability of financial support for the required investments, were among the factors that allowed the partnership to materialize.  While this experience may not be fully reproduced in other contexts, the webinar provided valuable insights as to how to shape other possible partnerships in the global South. A summary of the presentations follows below.
 
Dr. Carlos Correa, Executive Director, South Centre, made remarks on the status of manufacturing capacity globally. He noted that manufacturing of vaccines had been dominated by a few companies, and there has been little financial incentive for investments due to limited profitability compared to other pharmaceuticals. The situation has however dramatically changed with COVID-19, with a huge global demand that led to multiple vaccine candidates and the competition among governments and even the COVAX Facility to purchase existing production. Given the shortage in the supply, the expansion of manufacturing capacity is a must. The proposal to establish a technology pool, the COVID-19 Technology Access Pool (C-TAP), has not led to access to the needed technologies, and is now being substituted by proposals for bilateral voluntary licenses. The Coalition for Epidemic Preparedness Innovations (CEPI) mapped 250 companies or entities that could help to expand the global vaccines’ manufacturing capacity, but so far voluntary licenses have not been granted even to companies in Canada, Pakistan and Bangladesh who sought them. The experience of Butantan with Sinovac is one important example that deserves attention.
 
Mr. Tiago Rocca, Strategic Partnerships and Business Development Manager, Butantan Institute, noted that Butantan is a public health institute in São Paulo, Brazil, with 120 years. Prior to this pandemic, Butantan had completed a technology transfer agreement with Sanofi-Pasteur for Influenza vaccines, obtained World Health Organization (WHO) prequalification and sought different forms of public-private partnerships under a Ministry of Health project, which expanded its clinical development capacity, he described. The strengthening of the regulatory capacity of Brazilian Health Regulatory Agency (ANVISA) also supported this expansion. Butantan has capacity for testing, cold chains, broader industrial capabilities to absorb technology and experience with vaccines production. When COVID-19 hit, Butantan conducted a prospection of potential partners. Mr. Rocca noted that vaccine producers had different reactions to being approached by Butantan: some did not want to conduct technology transfer, some only wanted to sell products in Brazil. The more suitable collaboration was with Sinovac, which needed a partner to conduct clinical trials outside of China -as few cases were reported there- and was willing to collaborate more deeply with Butantan. Mr. Rocca also highlighted that Butantan’s partnership with Sinovac includes analytical transfer, a less often referred to element of tech transfer. For the time being, Butantan does fill and finish for vaccines coming from China, but expects to fully produce locally in the future. A new biosafety level 3 manufacturing facility is being constructed that will allow complete manufacturing in Brazil by September 2021, based on existing premises.

In his remarks, Dr. Ricardo Palacios, Director of Medical Research, Butantan Institute, noted that Sinovac, unlike larger pharma companies such as Merck or Sanofi, could not conduct clinical trials on its own, which favored the partnership. Butantan benefited from the fact it had expertise in manufacturing as well as clinical trials. For countries that negotiate only the trials without the industrial capabilities, the risk is that citizens of the country will help to test the safety and efficacy of vaccines without actually receiving them. He stated that tying the clinical and the industrial sides together allowed for deeper collaboration in the case of Butantan. He suggested that local researchers should not be left to negotiate with the vaccine manufacturer without support from government and without local industrial capabilities. Dr. Palacios also made the case for continuing to advance work with older technologies, while newer technologies are adopted or developed. He recalled that CEPI and COVAX funded largely newer vaccine technologies and had the tendency to disregard older technologies such as inactivated viruses (case of Sinovac’s vaccine), which are effective, cost less and are able to be produced more broadly and timely particularly in developing countries. Both new and older technologies are important, yet more attention to existing technologies would have been helpful to speed up vaccine scale up. International support by donors such as PATH have also been instrumental to Butantan and Sinovac. Finally, the strengthening of local interlocutors is crucial for successful partnerships.

In Q&A, Mr. Rocca reiterated that collaboration between Butantan and the Ministry of Health has been technical and smooth for decades. He also highlighted the importance of a broader supportive ecosystem (producers, laboratories, universities, etc.), and that there are some technological gaps that make building other collaborations more difficult. For example, there is no know-how for mRNA vaccines and this would be much harder to implement. This is an area that requires investments with a forward-thinking approach. For the time being, priorities need to be set and production of other vaccines cannot be stopped due to the new demand for COVID-19 vaccines.

Dr. Palacios also added that investing in other platforms/vaccines at this point could impede the production of the already successful Coronavac. Butantan is expected to produce 130 million doses until the end of 2021, at least 100 million for Brazil but with expectation to export to the region afterwards. Dr. Palacios also responded to questions on the reasons for other companies not to have engaged with Butantan. These include interest to keep co-development of vaccine under control of the company, market and territory strategies, and non-technical match with existing capabilities for technology transfer.

The date of the next webinar of the South Centre Series on Manufacturing Capacity in Developing Countries will soon be announced on the South Centre’s  “A Public Health Approach to Intellectual Property Rights” website, https://ipaccessmeds.southcentre.int/.  

 

[1] See concept note, additional information and full recording of the event at the following link: https://ipaccessmeds.southcentre.int/event/manufacturing-capacity-for-covid-19-vaccines-the-experience-of-butantan-sinovac/

Author: Vitor Ido is Programme Officer of the Health, Intellectual Property and Biodiversity Programme (HIPB) of the South Centre. 
 
SOUTHNEWS is an e-newsletter service of the South Centre providing information and news on topical issues from a South perspective.

To view other articles in SouthNews, please click here.

For more information, please contact Anna Bernardo of the South Centre: Email bernardo@southcentre.int, or telephone +41 22 791 80 50.
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