GSK receives World Health Organization Prequalification for Synflorix pneumococcal vaccine four-dose vial

Issued: London UK

GSK today 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.

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.[i],[ii],[iii]

About Synflorix

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.2

Synflorix is licensed in more than 125 countries,[iv] and is used in more than 53 national or regional immunisation programmes.[v]

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.

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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.

[i] World Health Organization. Estimated Hib and pneumococcal deaths for children under 5 years of age, 2008. March 14, 2012. Available at: Last accessed October 2017.

[ii] GSK Biologicals. Synflorix™ EU SmPC, 2017.

[iii] GSK. Data on file. DNG No. 2014N203625_00.

[iv] 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.

[v] GSK Data on file. DNG No. 2016N30961900 December 2016.