- 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.
On Wednesday, April 6, 2016, Pfizer announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) approved a new four-dose, multi-dose vial (MDV) presentation of Prevenar 13 (pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]). The vaccine has been licensed 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. This new MDV presentation, with a four-dose vial, was developed to maximize efficiency by significantly reducing storage and cold-chain requirements and shipping costs. The MDV Prevenar 13 developed by Pfizer in collaboration with Gavi, the Vaccine Alliance, was conducted by MRCG at Fajikunda Health Centre between 2013 and 2014. This was a randomized, open-label trial in which subjects received doses of either 13vPnC in MDVs or 13vPnC in a single dose syringe (SDS) as per the infant vaccine series scheme in The Gambia at 2, 3 and 4 months of age. The results of the trial showed that the new formulation was as safe, tolerable, and immunogenic as the already licensed SDS. The trial was successfully completed thanks to the quality standards of a dedicated team lead by Dr Olubukola Idoko (Trial Coordinator), Dr Anna Roca (local PI) and Prof Beate Kampmann (Trial Director). The MDV presentation of Prevenar 13 offers significant benefits to developing countries, including a 75 percent reduction in: