BioEd Online

A new pneumococcal vaccine designed for the developing world will roll out in health centres across Kenya next week as part of a global plan that could prevent more than seven million childhood deaths by 2030.

Kenya is the fifth country worldwide and the second in Africa to introduce the vaccine as part of its routine immunization schedule. More than 40 developing countries, including some of the poorest in the world, are expected to follow suit by 2015.

There is usually a lag of around 15–20 years before vaccines available to rich nations are made accessible to poor countries. But a new financial mechanism called the Advance Market Commitment (AMC) is helping to close the gap, and the pneumococcal vaccine is its first target.

"What we are observing right now simply has never happened before; we've never had the roll-out of a most advanced, most effective and safest vaccine in the world simultaneously in the richest and poorest countries," says Orin Levine, head of the International Vaccine Access Center at Johns Hopkins Bloomberg School of Public Health in Baltimore, Maryland. "This is an incredibly rewarding moment."

Killer bacteria

Pneumococcal disease, caused by the bacterium Streptococcus pneumoniae, kills more than half a million children under the age of five every year — more than malaria, AIDS and measles combined. More than 70% of the deaths are in developing countries.

Vaccines for pneumococcal disease have been available in the developed world for about 10 years, but are neither affordable nor suitable for the strains of the disease that are prevalent in developing countries. Part of the problem in creating suitable vaccines for poor countries is the gap between the development and manufacturing costs of pharmaceutical companies and what developing countries are able to pay.

"On one hand the vaccine industry needs long-term purchasing commitments to recuperate its investments, and on the other hand developing countries need low, predictable prices," says Levine.

So in 2009, the GAVI Alliance — formerly the Global Alliance for Vaccines and Immunisation — and its partners launched the AMC with the aim of stimulating the vaccine market. The pneumococcal vaccine is its first project.

Through its donors, the GAVI Alliance provides manufacturers with a guaranteed market and with financial incentives to invest in research and development. It also helps them to scale up production capacity so they can manufacture tens of millions of doses a year. In this way, the GAVI Alliance ensures that developing countries get access to vaccines at affordable prices.

Price cap

Across the developing world, the pneumococcal vaccine will have a ceiling price of US$3.50 per dose. "In developing countries, the vaccine is available basically for the price of a latte, compared to a price in the United States of close to $100," says Levine.

People need to be given three doses of the vaccine for adequate protection against 80–85% of the strains that are prevalent in the developing world. The developed world requires a total of 40 million doses of the pneumococcal vaccine per year, and the developing world requires another 250 million doses, says Levine.

Much of the small cost of the vaccine in developing countries will also be absorbed by the GAVI Alliance, explains Marina Krawczyk, who heads the AMC project for GAVI. "Right now most governments are paying around 15–30 cents per dose, but that will increase over time," she says.

At the end of the chain, the price for the end users is zero, says Shahnaaz Sharif, Kenya's director of public health and sanitation. "The Kenyan government is providing the vaccine free of charge at all public and private health facilities across the country."

So far four companies have signed up to the AMC process to help roll out the pneumococcal vaccine. GlaxoSmithKline, headquartered in London, and Pfizer, based in New York, have committed to 30 million doses per year for the next ten years. The Serum Institute and Panacea Biotec, both based in India, have also registered to provide the vaccine and are awaiting approval, according to Krawczyk. "Seventy per cent of the AMC funds are still available, so we are waiting for other offers to come in," she says.

The dollar game

The AMC mechanism depends heavily on donor funding though the GAVI Alliance's partners — the World Bank, the World Health Organization (WHO), the United Nations Children's Fund (UNICEF), the Bill & Melinda Gates Foundation and five national governments — and has experienced substantial funding gaps. The partnership for the pneumococcal vaccine is currently $1 billion short of what it will need to expand coverage to more than 40 countries by 2015, says Krawczyk. The alliance needs to raise a total of $3.7 billion over the next five years to continue its support for both the pneumococcal vaccine and the rotavirus vaccine, designed to tackle diarrhoea, the second largest cause of death among children under five. "We are looking forward to our June 2011 replenishment meeting," says Krawczyk.

With the vaccine now available in the developing world, the next step is ensuring it is administered to all eligible children, says Olivia Yambi, the head of UNICEF in Kenya. "Sometimes children are not vaccinated because parents don't know the value of the vaccine, and sometimes families are not able to access health centres where the services are being rolled out."

"The launch of the vaccine and its sustained introduction everywhere in the world will make a big difference," says Abdoulie Jack, the WHO representative for Kenya. "Now we have to make sure that when the public's confidence builds up for the vaccine, it continues to be available in the future."