GSK receives WHO Prequalification for Synflorix pneumococcal vaccine four-dose vial
GSK announced that the World Health Organization (WHO) has awarded prequalification for the new four-dose vial presentation of Synflorix pneumococcal vaccine targeted mainly for countries that receive support from Gavi, an international organisation created to improve access to new and underused vaccines for children living in the world’s poorest countries. The aim of WHO prequalification is to ensure that vaccines secured through UNICEF for use in national immunisation services in low and middle income countries have an appropriate safety and efficacy profile and are suitable for the target populations at the recommended immunisation schedules. This endorsement follows a positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in June 2017.
Developed specifically to address the cold-chain and storage challenges faced in some areas of the world, the Synflorix four-dose vial presentation has a cold-chain volume of 2.4cm3 per dose, making it the lowest volume per dose for any pneumococcal conjugate vaccine. This reduces the physical space required for storage in countries where cold-chain delivery can be challenging, and adequate storage facilities limited. Clinics and healthcare workers will be able to vaccinate more children per vial compared to the existing Synflorix two-dose vial presentation, and the new presentation allows usage across a longer period of time after opening, up to 28 days, as compared to six hours for the two-dose vial.
Thomas Breuer, Chief Medical Officer, GSK Vaccines said, “Today’s WHO prequalification for our Synflorix four-dose vial is an important step in helping to ensure children under the age of five in developing countries are protected against this deadly disease. Since 2009, we have delivered more than 500 million doses of this critical pneumococcal vaccine. Through this presentation, we are committed to expanding access to children in Gavi countries where the need is greatest.”
The supply of Synflorix to Gavi-eligible countries started in 2010 where more than 300 million doses of Synflorix have been delivered today in these countries under the Advance Market Commitment (AMC) mechanism. As part of this ongoing commitment, GSK has agreed to make 720 million doses of Synflorix available by the mid-2020s to help protect children in the developing countries.
The WHO prequalification process began in July 2017. The local registration process for Synflorix four-dose vial in Gavi countries is ongoing, and approval in Kenya was received in September 2017. GSK expects to start supply of the presentation to Gavi-supported countries in 2018.