Global roll-out of pneumococcal vaccine
8 Dec 2016
The World Health Organisation has pre-qualified Pfizer’s new four-dose, multi-dose vial presentation of pneumococcal vaccine Prevenar 13®, based on the results of a study conducted by MRC Unit The Gambia in collaboration with the Ministry of Health and Social Welfare of The Gambia.
Pneumococcal disease is one of the biggest vaccine-preventable killers of children and the majority of these deaths occur in developing countries. WHO pre-qualification allows for the global roll-out of this life-saving vaccine, by United Nations agencies and countries worldwide that require WHO pre-qualification.
Developed by Pfizer – in collaboration with Gavi, the Vaccine Alliance (Gavi) – the vaccine offers significantly reduced prices to developing countries. It contains a preservative, called 2-Phenoxyethanol, enabling use of the vaccine over a 28-day period following its first use, when stored at between 2-8 degrees Celsius. It offers a 75 per cent reduction in temperature-controlled supply chain requirements, shipping costs and storage requirements from the national to the community level, the cornerstones for sustainable vaccine introduction in developing countries.
The vaccine received European Union approval in April 2016 following the positive results of a non-inferiority trial conducted at MRC Unit The Gambia comparing the immunological responses of this new formulation with the previously licensed single-dose syringe Prevenar 13®. This followed a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency.
It is anticipated that the WHO pre-qualified vaccine will be introduced in early 2017 and shipped to countries supported by Gavi. It will be introduced under an innovative funding mechanism, namely the pneumococcal Advance Market Commitment (AMC) which is designed to encourage pharmaceutical companies to develop affordable vaccines at guaranteed prices.
Thanks to the pneumococcal AMC the cost of the vaccine could be reduced by 20 per cent. This is a huge step towards ensuring children in developing countries are protected against this preventable disease. The vaccine is likely to be available to all Gavi-eligible countries.
“It is encouraging to see vaccine manufacturers committed to addressing the unique conditions and challenges experienced by those of us working in communities whose health systems are still developing,” said Dawda Sowe, Programme Manager, Expanded Program on Immunisation, The Gambia.
Trial Director Professor Beate Kampmann, Theme Leader for Vaccines and Immunity at MRC Unit The Gambia, said: “The MRC Unit The Gambia generated the key data for both licensure and WHO pre-qualification, and we are delighted to see this product come to market so speedily, as it will influence the availability of the pneumococcal vaccines in resource poor settings. I wish to congratulate our clinical trials team on this achievement with immediate and valuable impact.”
To read about the grant(s) that funded this research, please see Gateway to Research reference MC_UP_A900_1122.