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08/12/2016

Big pharma, NGO square the circle on access to vaccines

Development Policy

Big pharma, NGO square the circle on access to vaccines

A preparer fills a syringe with measles vaccine in a camp in South Sudan. [MSF]

SPECIAL REPORT: One would expect a multinational pharmaceutical group and a leading humanitarian NGO to hold radically opposed views on access to vaccines.

Yet, when EurActiv asked GlaxoSmithKline (GSK) and Médecins Sans Frontières (MSF) for comment, their analysis was broadly similar.

Rohit Malpani, Director for policy and analysis at MSF won the Nobel Prize in 1999. In his view, vaccines offer the most cost-effective approach to controlling infectious diseases. However, access to vaccines remains unequal and suboptimal, particularly in the poorer developing countries, he explained.

MSF has three main concerns. First, vaccines may simply not be available for a range of diseases. Second, the medicine may be too costly to produce or be unaffordable for the affected populations. And when they are available, vaccines are often confronted with “thermostability” issues, meaning they should be able to persist for a few days outside the cold chain, allowing their use in remote areas.

The cost

“Today the lowest cost for the basic package of vaccines which all the countries should be using in their immunisation programs is 68 times more expensive than it was in 2001,” said Malpani.

The new vaccines that have emerged on the market are far more expensive than traditional vaccines have been, Malpani explained. In his view, three vaccines from the basic package account for 86% of the overall cost, and only one of them, the Pneumococcal disease vaccine, accounts for nearly 46% of the cost.

The high price is a charge both for donors and for immunisation programs around the world, the MSF representative argued. He explained that oftentimes vaccines in developing countries, like Morocco and Tunisia, are more expensive than in France, for example. This depends on how multinational companies price their products in different markets.

Malpani appealed for transparency on behalf of both companies and governments, which he believes should release the prices that have been paid for vaccines. In addition, he appealed to the business sector to be disclose its research and development costs.

GAVI, the vaccine alliance that brings together developing countries, WHO, Unicef and public and private donors, currently provides financing, including purchasing of vaccines and improving immunisation systems for approximately 70 low-income countries. Consequently many countries don’t benefit from GAVI’s action as a result of a decision the donors have made, Malpani said.

The MSF official insisted that GAVI could do a better job of obtaining more affordable prices for the vaccines it is purchasing. MSF has asked the pharmaceutical companies GSK and Pfizer, who are the only ones to produce the Pneumococcal vaccine, to reduce its price substantially, he said.

Diseases without vaccines

There is little incentive for major global vaccine manufacturers to develop vaccines for diseases largely prevalent in the developing countries alone, Malpani said, mentioning Japanese Encephalitis, Dengue, Cholera, Tuberculosis, Malaria.

In the case of TB, he said that there was one vaccine on the market today, but it was developed in the 1920s and since then, no new TB vaccine had emerged.  This, he said, was an indication that there was no incentive for producers to develop a better TB vaccine.

“These three interrelated problems: vaccines that are too expensive, vaccines that are not suited for low-income populations and vaccines that do not exist are part of the same problem – that we don’t develop vaccines on the basis of public health needs, but we develop them on the basis which population can pay the highest prices,” he said.

A Malaria vaccine will finally emerge from the GSK laboratories, he said, but added that it would be of limited application, only for children, and that it would take another 15 years to create the next generation of vaccine that is needed.

EurActiv spoke to Corry Jacobs, Director for Global Policy and Research for Vaccines at GSK. Around 40% of the world’s children are immunised against at least one serious disease with a GSK vaccine. 

In 2013, GSK distributed over 860 million doses of vaccines to some 170 countries. 80% of the vaccine doses GSK manufactured that year went to developing countries (including the least developed, low and middle income countries).

‘Major milestone’

Jacobs said that for the past 30 years, GSK scientists have been working with others around the world to try and develop a vaccine against malaria.

Together with its partners, in 2013 GSK achieved a major milestone with its malaria vaccine candidate, RTS,S, which after 18 months of follow-up almost halved the number of malaria cases in young children (aged 5-17 months at first vaccination) and reduced by around a quarter the malaria cases in infants (aged 6-12 weeks at first vaccination).

A possible vaccine policy recommendation from WHO is expected by October 2015, meaning that the vaccine could potentially be available in sub-Saharan Africa as early as 2016, Jacobs said.

She called this a “groundbreaking achievement” which would crown the company’s 30-year commitment to combat malaria through continued R&D investment and partnerships on the ground.

Jacobs explained that GSK invested $350 million in the development of RTS,S through a public-private partnership with PATH Malaria Vaccine Initiative (MVI) and support from the Bill & Melinda Gates Foundation. The price of RTS,S will cover the cost of manufacturing the vaccine together with a small return of around 5% that will be reinvested in R&D for second-generation malaria vaccines, or vaccines against other tropical diseases, she said, asked to comment on the profitability of a vaccine which is unique in its kind.

‘Business needs to be sustainable’

Asked about what GSK does to bring down the prices of its vaccines, Jacobs said that “business needs to be sustainable”, but at the same time the company had developed a business model allowing it to facilitate broad access to vaccines, while maintaining its investment in R&D.

To increase access to its vaccines, GSK has a tiered pricing approach based on countries’ Gross National Income (GNI), she explained. GSK is one of the largest contributors to GAVI and has committed to providing it with more than 850 million vaccine doses at reduced prices, in order to help protect 300 million children in the developing world by 2024, Jacobs added.

For countries that do well economically and ‘graduate’ from GAVI support, GSK has committed to freezing vaccine prices for graduating countries for ten years to help them continue their immunisation programmes during this transition, Jacobs said.

The GSK official also said the company was working to improve the thermostability of vaccines. One of the first projects is exploring how to make adjuvants – a critical component of some vaccines – more heat stable. The project will initially focus on GSK’s RTS,S malaria vaccine candidate, she explained.

Transferring technologies

As generic medicines help bring down the cost, EurActiv asked if GSK was keen on such partnerships in developing countries. Jacobs gave the example of GSK’s joint venture with the Oswaldo Cruz Foundation in Brazil in areas essential to Brazil’s universal immunisation programme. She also mentioned a joint venture with Biological E. in India.

“The way forward in achieving total access to vaccines lies in partnership”, Jacobs said. She added: “Industry has a contribution to make – but we certainly don’t have all the answers. The more we come together as a global community – industry, NGOs, academia, governments – the more likely we are to find innovative solutions to the challenges we’re facing”. 

Background

Vaccination may be the most effective public health intervention of all time—and that’s especially true in developing countries, where many families can’t find or afford health care when they get sick. The prevention offered by vaccines can be lifesaving.

Because of vaccines, small pox is now eradicated globally, polio is nearly so, and, in countries where kids regularly get their shots, diphtheria, measles, pertussis, and rubella do not pose too big a problem.

But there are still many diseases for which vaccines are not available, and market forces alone are not always strong enough to drive the development of vaccines—especially for diseases that mainly affect poor countries.

Overall, worldwide, immunization programs reach around 83% of all children – which Unicef has hailed as an enormous achievement. With this level of immunization coverage, over 2 million deaths are prevented, year after year.

The flip side is that some 17% of kids do not get immunized - that's one out of five children.

Further Reading