Low cost and open source: vaccines in developing countries

In South Africa, a scientific knowledge transfer hub is working to create a Covid-19 vaccine based on the publicly available sequence of Moderna’s mRNA vaccine, without Moderna’s involvement but with its approval. In India, scientists are also testing a vaccine to fight SARS-CoV-2. These seem to be big steps for developing countries in order to be independent in the fight against today’s pandemic and those of the future.

The African continent remains the least vaccinated against Covid-19 globally. As of 30 June 2022, only 22.7% of the African region’s population had received at least one dose of any of the Covid-19 vaccines. In populous countries such as Nigeria and the Democratic Republic of Congo, not even 10% of the population has been vaccinated and only two small countries (Seychelles and Mauritius) have achieved the target of 70% of adults being fully vaccinated.

The June bulletin of the World Health Organization (WHO) is not reassuring. Most vaccines arrive through the COVAX programme and through international cooperation, but the number of these doses is not sufficient, and many have (nearly) expired by the time they arrive.

African response

A step towards more independence and more vaccines began in July 2021, in Cape Town, where an mRNA vaccine technology transfer hub was launched. Its researchers say they have completed the process of reproducing Moderna’s mRNA vaccine against Covid-19, and that the first batches have already been produced.

This is the first hub meant to build capacity for vaccine manufacturing in low- and middle-income countries, created following a call for expression of interest launched in April 2021 by the WHO. Besides producing mRNA Covid-19 vaccines, it also aims to transfer knowledge to other developing countries.

The initiative, funded by the WHO and Team Europe (the European Union, the EU Member States, the European Investment Bank and the European Bank for Reconstruction and Development) is run by the biotech company Afrigen alongside a consortium of South African companies and universities.

Petro Terblanche profile Professor Petro Terblanche, Afrigen’s Managing Director: “We made a choice to use the sequence of the Moderna vaccine that was made available in the public domain by Stanford scientists (who reverse-engineered the droplets left in used vials, Ed.). Based on this sequence, we designed a construct and produced the plasma DNA.”Read Petro Terblanche’s full interview

Lawyers and patents

The South African drug is openly based on public information related to the Moderna vaccine, for which various patents have been awarded. However, Afrigen’s Managing Director Petro Terblanche says, ‘there are no intellectual property rights infringements’. Although not actively collaborating with the South African consortium, Moderna declared in black and white terms in a statement that it will ‘never enforce its patents for Covid-19 against manufacturers in or for the 92 low- and middle-income countries in the Gavi COVAX Advance Market Commitment’, while reiterating in the same communiqué that it expects all others – the richest countries – to continue to respect intellectual property rights.

WHO Director-General Tedros Adhanom Ghebreyesus said he was proud of the South African mRNA Technology Transfer Hub’s achievements and grateful for the support it had received from Team Europe, Canada and Norway. ‘The mRNA technology will not just be for Covid. It will be for Malaria, TB and HIV – it will be a game changer’.

Meanwhile, the number of countries that are interested in receiving the hub’s know-how on producing mRNA vaccines is increasing. From Argentina to Vietnam to Ukraine, the list is continually growing. The WHO, with the support of an expert group, has been selecting beneficiaries to receive a technology transfer and specialised training on mRNA vaccines, with Ukraine being one of the most recent such countries.

Not only mRNA

Moving focus from South Africa to India reveals other positive developments. The American not-for-profit organisation Texas Children’s Hospital Center for Vaccine Development, along with the Baylor College of Medicine, successfully developed Corbevax, a low-cost, open-source and patent-free Covid-19 vaccine, which received emergency authorisation for use in India in January.

‘It is based on a well-known, decades-old technology: recombinant proteins, very similar to those used for vaccines against hepatitis B, pertussis, etc.’, explains Professor Maria Elena Bottazzi, a Honduran, Italian-born and American-naturalised microbiologist who, with her colleague Peter Hotez, developed the vaccine.

33 research centres with more than 3 000 participants between the ages of 18 and 80 conducted two Phase III clinical trials to gain approval in India. The tests determined that Corbevax was safe and well tolerated and, according to the organisation, more than 80% effective against Covid-19’s delta variant.

Calling it the ‘World’s Coronavirus Vaccine‘, Botatazzi said, ‘it is a much cheaper process than the messenger RNA technology that Pfizer or Moderna use. We chose the most scalable, reproducible and stable method with a yeast cell that ferments and coded it to produce these proteins’.

Elena Bottazzi profileMaria Elena Bottazzi, Co-Director Texas Children’s Hospital Center for Vaccine Development , Professor of Pediatrics and Molecular Virology and Microbiology: “The cost of these vaccines is two or three dollars per dose. They can be used simply, have robust stability and can be stored for long periods of time. […] We aim to use technology that is easy to access, cheap and produced locally, and we wanted to remove any barriers to access.”Read Maria Elena Bottazzi’s full interview

Similar to the South African hub, the underlying concept is the open transfer of knowledge, free of charge. ‘Those who want to produce our vaccine can read our research that is public and if you need, you can contact us to get support,’ said Professor Bottazzi. She and her colleague Peter Hotez were nominated for the Nobel Peace Prize, thanks to their work in India. ‘For 20 years we have been working on the idea of giving support to those in need and trying to revolutionise a pharmaceutical model. […] This is really a beautiful emotion’.

Related content:
A scientist’s opinion: interview with Petro Terblanche on the first African vaccine hub
A scientist’s opinion: interview with Maria Elena Bottazzi on vaccines in low- and middle-income countries

Leave a Reply