WHO approves first alternative pneumonia vaccine

Inclusion of vaccine on list of WHO prequalified products ensures protection against a leading cause of death of children worldwide

An MSF health worker prepares to vaccinate a child against pneumonia

Greece 2019 © Anna Pantelia/MSF

The World Health Organization (WHO) has just added a third pneumococcal vaccine (PCV) to its list of approved medical products to prevent one of the leading causes of death of children under five worldwide. The vaccine, manufactured by the Serum Institute of India, will be much more affordable than existing vaccines. 

The granting of WHO pre-qualified status to this vaccine means it meets WHO quality, safety, and efficacy standards and will enable countries and treatment providers to procure more affordable versions of the vaccine. This vaccine has long been out of reach for millions of children because of the high prices of the existing vaccines produced by Pfizer and GlaxoSmithKline (GSK).

The Serum Institute has stated previously that they plan to sell the vaccine at about US $6 per child to Gavi, the Vaccine Alliance—, a donor-funded organization that helps the poorest countries access vaccines—, and to the poorest countries. It has said it will charge no more than about US $11 in middle-income countries, significantly less than Pfizer and GSK’s products. The Serum Institute product is the first pneumococcal vaccine produced by a developing country manufacturer.

The Bill & Melinda Gates Foundation provided some pioneering support for the development of the vaccine.

Statement from Kate Elder, senior vaccines policy advisor for Doctors Without Borders/Médecins Sans Frontières (MSF) Access Campaign

“This is a monumental day for kids around the world and the governments that are trying to protect them from life-threatening pneumonia. A more affordable pneumonia vaccine is a game changer in protecting more children against the world’s number one childhood killer.

“MSF has been calling for a more affordable pneumonia vaccine for years, asking that it be priced at no more than $5 per child. This new and more affordable vaccine from an Indian manufacturer will finally break the longstanding stranglehold by pharmaceutical corporations Pfizer and GSK, meaning that the more than 55 million kids around the world that have been left out largely due to corporate greed can finally have a fair shot at being protected. Many of these children reside in countries deemed ‘middle-income,’ who cannot benefit from special prices negotiated by Gavi.

“To save as many lives as possible, we call on WHO, UNICEF and Gavi to step-up and help governments access this more affordable vaccine as rapidly as possible. We also expect the Serum Institute of India to extend the lowest global price for its new pneumonia vaccine to all humanitarian organizations.”

Breaking the duopoly on PCV

Until now, pharmaceutical corporations Pfizer and GSK have maintained a duopoly on the vaccine for nearly 20 years[1]* that has allowed them to keep prices high. Pfizer and GSK charge Gavi, the Vaccine Alliance –– roughly US$9 for each child to be vaccinated in the poorest countries, and as much as $80 per child for middle-income countries that don’t qualify for Gavi support.

Pfizer and GSK have earned over $50 billion in sales of the pneumococcal vaccine in the past ten years, with Pfizer winning the lion’s share of these revenues. Today, 55 million children around the world still do not have access to the pneumonia vaccine, largely due to high prices.

Governments that wish to purchase this new more affordable vaccine should consider using the WHO Collaborative Registration Procedure to accelerate its registration.

[1] Wyeth’s pneumococcal conjugate vaccine (PCV) 7-valent was licensed by the US Food and Drug Administration (FDA) in 2000. Pfizer purchased Wyeth in 2009; and in 2010 the US FDA approved Pfizer’s PCV13, which replaced PCV7. GlaxoSmithKline (GSK)’s PCV10 was approved by the European Medicines Agency (EMA) in 2009.