Meningitis and sepsis: two diseases caused by the bacterium Haemophilus influenzae type B (Hib). Until 2007, vaccines were too expensive for developing countries. Ahd Hamidi helped pioneer the development of a much cheaper vaccine. It is partly thanks to her that 200 million children in developing countries can now be vaccinated.
A child is vaccinated in Pernambuco, Brazil. By making vaccines with other process steps, they are affordable for developing countries. Photo: George Mollering / ANPFoto
Intravacc, formerly RIVM (National Institute for Public Health and the Environment), is the home base for Ahd Hamidi, TU Delft alumna and technology transfer expert. When she started working at the RIVM in 1998, she heard that colleagues wanted to make a new Hib vaccine for developing countries. She immediately signed up as a process technologist. Last month, she was awarded her doctorate for her analysis of this work.
“Europe and America had already had a Hib vaccine for more than ten years. Developing countries had to do without, because it was too expensive. In 2000, 400,000 children aged between 1 and 59 months died of Hib-related diseases, such as meningitis, pneumonia and sepsis. Thousands of other children suffered lifelong damage, such as deafness. The challenge was to reduce the cost price and enable vaccine manufacturers in developing countries to have access to the technology.”
“We had to use a new process to manufacture the cheap Hib vaccine in order to work around existing patents. Often it’s the steps in the process that are patented rather than the end product. Our aim was to make what is known as a me-too product. It is identical to an existing vaccine in terms of its quality, but created using different procedural steps. In the case of Hib, you can divide the process into three sub-processes: growing the bacteria in a bioreactor, purifying the antigen, the polysaccharide, and conjugating the polysaccharide with a protein. For each step, we checked whether there was already a patent. If so, we chose an alternative step. This enabled us to work more cheaply. For a long time, UNICEF had to pay $3.5 per dose. With our partners, we were able to reduce the price to $1.19.”
“Until the late 1990s, our partners – the major manufacturers in countries such as Indonesia, India and China – only had access to conventional vaccines. Conjugation technology is innovative and a specialist field. For them, developing it themselves was a bridge too far. Thanks to the Hib project, our partners gained access to this technology and were therefore able to make other conjugate vaccines as well, such as meningococcal A. That vaccine is now available for African children via one of our partners, at a very low price. It shows that access to technology is very important.”
“Our vaccine is not used in Europe and America. For many pharmaceutical products, it is difficult to back out of a contract with one of the big pharmaceutical companies. Can we dissolve these contracts? If you asked me, my response would be: why not? Compare the cost price to the market price and there can be a big difference. Take cancer drugs, for example. For these, we pay thousands of euros per patient, whereas the cost price is much lower. Often the prices are high because the manufacturers have a monopoly. Technology transfer creates increased competition and a reduction in price. For every product, if there are sufficient people willing to pay a specific price, that price will be maintained. From an ethical perspective, that should not be
Ethically responsible price
“People should look at what the product actually costs, including research, development, production and marketing costs. A generous margin, perhaps 40%, can possibly be added to that cost price to enable investment in further research. But we have no idea how the big pharmaceutical companies work. Their costing models are a mystery. If we wanted to, we could calculate what an ethically responsible price would be, as we did in the case of the Hib vaccine. Of course, that should be the job of the government, before entering into price negotiations with pharmaceutical companies. How can you negotiate properly if you have no idea of the real value of the product you want to buy?”
“After the Hib project, I was up for a new challenge. I spent almost three years working as a consultant, including in India. At the end of 2009, I got another job at Intravacc. I felt the need to safeguard the work we had done.
I approached Luuk van der Wielen and Marcel Ottens (Bioprocess Engineering department, Applied Sciences faculty) with an idea for a PhD. I had already graduated and done a PDEng (Technological Designer programme, Ed.) under their supervision. We discussed what needed to happen to complete a PhD. They said: ‘you should create a mathematical model of the process’. That would be interesting, because it would enable us to check whether the data we have generated in the lab is accurate, whether the cost price is right or can be reduced further.”
“When we started modelling, we did not know if it would be possible to reduce the cost price further. Based on this model, the price could be reduced by another third. This does not involve any major stages, but small reductions in the fixed costs. Every option can contribute a little bit. It would be great if we could present our findings to our partners and enable them to choose what they consider to be of interest. But it is even more important to be able to apply the software and tools we used on other vaccines on which not so much work has been done to reduce the price. That could prove a great success.”
“I am now working on another project. We have developed a polio vaccine and are in the middle of the transfer phase. In a few years’ time, our partners will need to market it. The aim is to completely eradicate polio, but this is difficult with the existing vaccines. The inactivated intramuscular vaccine always used in the Netherlands is too expensive. With the oral vaccine, used for mass vaccinations, it is not possible to completely eradicate the disease. The problem is that the strains in the intestines of one in a million children can mutate back to the wild type. These children will develop polio. In itself, this is not so bad if you wish to reduce the number of cases from millions to just a few. That has worked very effectively, as the statistics show. But eventually you end up only encountering cases that have been caused by vaccination, which then becomes a problem. To complete the process of eradication, you then need to switch to an inactivated vaccine.”
“Working for wider society, with a global impact really appeals to me. This is why I first opted for bioprocess technology. This work, serving a noble objective, gives me fulfilment.”
Ahd Hamidi (Morocco, 1972) joined her parents in Rotterdam at the age of 18 in order to study chemical engineering. She graduated in 1995, starting a two-year PDEng in Delft in 1996. Two years later, she joined the RIVM. At the end of 2006, she and her husband established a consultancy firm, working in India and other countries and for the World Health Organisation (WHO). Three years later, Hamidi
rejoined the RIVM, now Intravacc. She is married with three sons.