WHO Prequalification of pneumococcal vaccine based on MRC Unit The Gambia study

The World Health Organisation has pre-qualified Pfizer’s new four-dose, multi-dose vial (MDV) presentation of Prevenar 13®*, based on the results of a study conducted by MRC Unit The Gambia (MRCG) in collaboration with the Ministry of Health and Social Welfare of The Gambia. The WHO pre-qualification allows for the global use of Prevenar 13® MDV by United Nations agencies and countries worldwide that require WHO pre-qualification.

Developed by Pfizer in collaboration with Gavi, the Vaccine Alliance, this Presentation offers significant benefits to developing countries, including a 75 percent reduction in temperature-controlled supply chain requirements, United Nations International, Children’s Education Fund (UNICEF) shipping costs and storage requirements at the national, regional, district, and community levels.

The results of the trial conducted at MRCG received European Union approval, following the positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in April 2016. The MDV presentation of Prevenar 13, includes the preservative 2-Phenoxyethanol, which enables use of the vaccine over a 28-day period following its first use, provided it is stored at 2-8 degrees Celsius.

The WHO pre-qualified MDV presentation is expected to be introduced under the Advance Market Commitment (AMC) program in early 2017, for shipment to countries supported by Gavi, the Vaccine Alliance (Gavi). Once the MDV presentation is introduced under the AMC, a 20 cent reduction in cost, from $3.30 per-dose to $3.10 per-dose is expected to be available to all Gavi-eligible countries. In addition, expanded availability will enable Gavi-graduated countries to access the same pricing until 2025.

“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, Program Manager, Expanded Program on Immunisation, The Gambia.

Trial Director, Prof Beate Kampmann, Theme Leader for Vaccines & Immunity 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”.

Read more about our work in this area:

The use of PCV in the Gambian EPI reduced severe pneumococcal pneumonia, sepsis, and meningitis in children by 55%

Recently completed a trial of a multi-dose vial pneumococcal conjugate vaccine, sponsored by biopharmaceutical company Pfizer.