EU CHMP recommends approval of four-dose vial of Synflorix pneumococcal vaccine- GlaxoSmithKline

GSK announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for a new four-dose vial presentation of its Synflorix pneumococcal vaccine. The approval is the first step in the process to deliver the new vaccine presentation through Gavi, the Vaccine Alliance, in developing countries.

Developed specifically to address the cold-chain and storage challenges faced in some areas of the world, the Synflorix four-dose vial has a cold-chain volume of 2.4cm3 per dose, 50 percent lower than the existing two-dose vial presentation, making it the lowest volume for any pneumococcal conjugate vaccine. This reduces the physical space required for storage in countries where cold-chain delivery can be challenging.