Study at MRC Unit The Gambia leads to WHO pre-qualification of pneumococcal vaccine
9 Nov 2017
A 2017 analysis showed that the use of the pneumococcal vaccine PCV in The Gambia reduced x-ray proven pneumonia in children by 24%, and pneumococcal pneumonia by 63%. In 2016, the World Health Organization (WHO) pre-qualified Pfizer’s new pneumococcal vaccine, based on the results of a study conducted by the MRC Unit The Gambia with the Ministry of Health and Social Welfare of The Gambia. The WHO pre-qualification allows the vaccine to be used globally by United Nations agencies and countries worldwide that require WHO pre-qualification.
In 2008, the WHO estimated that 541,000 children under five years old died from pneumococcal disease worldwide; Africa accounted for 57% of these deaths. Worryingly, antibiotic resistance to pneumococcal infections is also increasing, highlighting the importance of safe and effective vaccine strategies.
A new vaccine called PCV13 developed by Pfizer in collaboration with Gavi, the Vaccine Alliance, offers hope. In 2016, a vaccine impact trial conducted by the MRC Unit The Gambia showed that using PCV13 in the Gambian Expanded Programme on Immunisation (EPI) reduced severe pneumococcal pneumonia, sepsis, and meningitis in children by 55%. The study, on 14,650 patients, shows the real-life impact of PCV in a developing country. A recent analysis in 2017 showed that the use of PCV in The Gambia reduced x-ray proven pneumonia in children by 24%, pneumococcal pneumonia by 63%, and very severe pneumonia by 61%. The study, which enrolled 18,833 participants, also shows the real-life impact of introducing PCV in a developing country.
In October 2016, the World Health Organization pre-qualified PCV13 based on these trial results. The vaccine is now expected to be introduced under the Advance Market Commitment (AMC) program in early 2017, for shipment to countries supported by Gavi, the Vaccine Alliance. The expanded availability will enable Gavi-graduated countries to access the same pricing until 2025.
Reducing the rate of pneumococcal disease will save lives and reduce a substantial economic burden on the health system and families. PCV13 also provides significant logistical and economic benefits, including a 75% 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.
This important work highlights the success of academia and industry working together to help bring a much-needed vaccine to people all across the world, and is vital for helping more people survive pneumococcal disease.
“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” - Professor Beate Kampmann, Trial Director and Theme Leader for Vaccines & Immunity, The MRC Unit The Gambia.
Award details: MC_U190085849