Minister Naledi Pandor: Biovac-Pfizer vaccine manufacture agreement signing ceremony

Address by the Minister of Science and Technology, Naledi Pandor MP, at the Biovac-Pfizer vaccine manufacture agreement signing ceremony, Pinelands, Cape Town

Minister Motsoaledi
Biovac CEO
Pfizer SA representative
Ambassador Gaspard

We owe much to vaccines. Much of the public health improvement over the last two centuries has been vaccine related - across the world, in both rich and poor countries, developed and undeveloped, north and south. Reaching children has been the aim of most campaigns to spread the impact of vaccines in poor countries. The barriers to vaccinating children are well known - the high prices of new vaccines, weak public health systems. But there is another barrier - low profit margins for vaccines and high profit margins for drugs. This leads to less research into vaccines and more research into drugs.

Every year, across the world, according to Medicin sans Frontiers, 2.58 million episodes of severe pneumonia occur in children under the age of five, accounting for 18% of all episodes of severe pneumonia and 33% of all pneumonia-related deaths. Most of these children live in low- and middle-income countries. If children have HIV, they are far more likely to develop severe pneumonia than their HIV-negative friends.

It is now more expensive to vaccinate children against the twelve main diseases than it was ten years ago. Vaccine prices have skyrocketed. One vaccine dominates  - the pneumoniavaccine- and it gobbles up 40% of South Africa's budget for vaccines. The vaccine is owned by two big pharmaceutical companies, Pfizer and GSK. They reduced their prices marginally for this vaccine earlier this year in response to public campaigns and in the light of the more than $19 billion taken in sales of the pneumonia vaccine to date.

There is more that we can do to cut the costs of the vaccine. And that is to manufacture the vaccine here in Cape Town. And that is what we are here to announce.

Pfizer and the Biovac Institute of South Africa have reached an agreement for the transfer of technology that will enable the Biovac Institute to manufacture Pfizer's Prevenar 13 Vaccine at Biovac’s new commercial scale manufacturing plant here in Cape Town. As part of the agreement Pfizer will transfer ownership of equipment to Biovac and Pfizer will also implement a skills-transfer process so that South African employees of Biovac will be able to manufacture the vaccine after the technical transfer period. The agreement is designed to ensure that the Biovac Institute is able to supply Prevenar 13 on a sustainable basis in South Africa. Over the next five years the technology transfer will take place in three phases -Phase I : Packaging of labelled syringes, phase II: Labelling and Packaging of Bulk Unlabelled Syringes, phase III: Formulation (RDM), Filling, Labelling and Packaging - and local manufacture is scheduled to start in 2020.

The Biovac Institute (Biovac) was established in 2003 as a public private partnership between the Biovac Consortium and the South African Government (represented at the time by the South African Department of Health). Currently, the South African Government has a 47,5% equity stake in the company, made up of the Department of Science and Technology (35%) and the Technology Innovation Agency (12,5%). The Biovac Consortium holds 52,5% of the shares through ENDO (previously Litha Healthcare Group Limited) (44,6%) and Disability Empowerment Concerns (7,9%).

Biovac aims to revitalise human vaccine manufacturing in South Africa by building capacity in all aspects of vaccine development and manufacturing, from products for clinical trials to full scale commercial production. Biovac is the only vaccine manufacturer in sub-Saharan Africa and it currently sources the vaccines it supplies to the Department of Health from appropriately registered pharmaceutical companies in South Africa.

We have a small pharmaceuticalindustry that boasts some of the fastest growing companies in the country. We have the largest market for HIV drugs in the world. We have a well developed generics industry. We have globally respected researchers.

But we face a number of challenges.

At the level of commercialisation and manufacturing processes, the challenges are mainly around the lack of infrastructure for pre-commercial and commercial development and, in particular, appropriately accredited infrastructure for technology development.

Small scale production facilities for drugs and biologics are also needed. These pre-commercial facilities will provide an impetus for local industry to participate in new market segments such as biosimilars.

In addition, we lack critical platforms for in-bound technology transfers, so as to be able to leverage international expertise and catalyse private sector investments.

South Africa is committed to the establishment of the necessary initiatives and infrastructure that will assist in the development of the pharmaceutical value chain. This includes medicinal chemistry, high-throughput screening, preclinical testing facilities and capabilities and the manufacturing of active pharmaceutical ingredients (APIs).

Building on existing networks and creating new synergies, we also look to extend our collaborations in this regard with partners in both developed and developing countries, including research institutions, governments, pharmaceutical and biotech companies - as in this agreement - and international organisations.

We hope these initiatives will allow us to promote our pharmaceutical industry by contributing towards the development of essential vaccines and medicines for diseases that affect the majority of the people in Africa. The development of a strong and vibrant pharmaceutical industry is of enormous importance in Africa. The development and provision of high quality medicines has saved lives, improved life expectancy and enhanced the quality of life for so many people. The debilitating effects of conditions such as asthma, diabetes, ulcers, cancer and mental illness have been alleviated by the tremendous advances which have been made in the area of medicines.

We recognise that providing essential vaccines and medicines to our people presents a unique challenge that requires greater effort, cooperation and collaboration at the international level. Partners such as the World health Organisation, the Council on Health Research and Development, the African Network for Drugs and Diagnostics Innovation and drug companies like Pfizer are very valuable in this process. It is through these innovative vehicles that the advances in medicine and public health have continued to improve lives for many and to postpone death for some.

Thank you.

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