GlaxoSmithKline receives CHMP backing for new presentation of Synflorix

GlaxoSmithKline has announced that a new four-dose vial presentation of its Synflorix pneumococcal vaccine has been recommended for regulatory approval.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion endorsing the use of the new presentation, which has been designed to significantly reduce storage requirements in developing countries.

The four-dose vial has a cold-chain volume of 2.4 cubic cm per dose, which is 50 percent lower than the existing two-dose vial presentation, making it the lowest volume for any pneumococcal conjugate vaccine.

As such, the physical space required for storage in countries where cold-chain delivery can be challenging is minimised, while clinics and healthcare workers can also vaccinate more children per vial compared to the existing Synflorix two-dose vial presentation.

Additionally, the new formulation is usable for up to 28 days after opening, compared to only six hours for the two-dose vial.

European regulatory approval would mark the first step in the process to deliver the new vaccine presentation through Gavi, the Vaccine Alliance, in needy patients in developing countries.

Thomas Breuer, chief medical officer at GlaxoSmithKline Vaccines, said: "Through this new presentation, we hope to make it easier for more healthcare professionals in the most challenging areas of the world to turn our vaccines into life-saving vaccinations."

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