GSK receives CHMP positive opinion for Synflorix pneumococcal vaccine four-dose vial
New presentation designed to significantly reduce storage requirements in developing countries
Issued: London UK
GSK today 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, 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 formulation of the Synflorix four-dose vial allows usage across a longer period of time after opening to 28 days, compared to six hours for the two-dose vial.
Thomas Breuer, Chief Medical Officer, GSK Vaccines said, “Synflorix has already had an enormous impact since it was launched, helping to protect against pneumonia – the world’s leading infectious killer of children under the age of five. 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.”
More than 415 million doses of Synflorix have been distributed worldwide since 2009, helping to protect more than 100 million children.  GSK was one of the first companies to sign an agreement with Gavi, the Vaccine Alliance, and since 2010, has delivered more than 250 million doses of Synflorix to developing countries, including countries with large annual birth cohorts.1 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 worldwide.
Following EMA approval, GSK will submit the new four-dose vial presentation to WHO for prequalification. Depending on WHO prequalification and local regulatory approvals, GSK expects to start supply of the new presentation to Gavi-supported countries in 2018.
About pneumococcal disease
Pneumococcal disease refers to infections caused by the bacterium Streptococcus pneumoniae, which can result in severe, and sometimes fatal, invasive disease, such as meningitis, sepsis and bacteraemic pneumonia. More common non-invasive manifestations of pneumococcal disease include sinusitis and AOM, an inflammatory infection of the middle ear, which affects millions of children worldwide.
An estimated 476,000 children under 5 years of age die from pneumococcal disease each year; this accounts for approximately 5% of all-cause mortality in children in this age group.-
Synflorix is indicated for Active immunisation against invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants and children from 6 weeks up to 5 years of age.3
Synflorix is licensed in more than 125 countries, and is the vaccine of choice for more than 53 national or regional immunisation programmes.
Important Safety Information
The most common adverse reactions observed after primary vaccination with Synflorix™ in infants were redness at the injection site and irritability. For further important safety information about the currently licensed indications for Synflorix™, please visit the Electronic Medicines Compendium to view the Synflorix™ EU Patient Information Leaflet.
GSK – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com/about-us.
GSK cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D 'Principal risks and uncertainties' in the company's Annual Report on Form 20-F for 2016.
 GSK. Data on file. DNG No. 2017N324090_00
 World Health Organization. Estimated Hib and pneumococcal deaths for children under 5 years of age, 2008. March 14, 2012. Available at: http://www.who.int/immunization/monitoring_surveillance/burden/estimates/Pneumo_hib/en/. Last accessed June 2015.
 GSK Biologicals. Synflorix™ EU SmPC, 2017.
 GSK. Data on file. DNG No. 2014N203625_00.
 Izurieta P, et al. Vacuna neumocócica 10-valente conjugada a la proteína del Haemophilus influenzae no tipificable (PHiD-CV): revisión de 6 años de experiencia después de su introducción. Abstract presented at XVI Congreso Latinoamericano de Infectología Pediátrica (SLIPE 2015), Puerto Rico, 24-27 June 2015.
 GSK Data on file. DNG No. 2016N30961900 December 2016