Synflorix Pneumococcal Vaccine Granted WHO Prequalification

Synflorix four-dose pneumococcal conjugate vaccine vial presentation is the lowest volume per dose cold-chain vaccine

The World Health Organization is expanding vaccination programs for low and middle income countries focused on reducing pneumococcal disease.

The WHO has awarded prequalification for the new four-dose vial presentation of Synflorix pneumococcal vaccine.

The purpose for this WHO prequalification is to ensure that vaccines secured through UNICEF have an appropriate safety and efficacy profile and are suitable for the target populations.

The WHO estimates 476,000 children under 5 years of age die from pneumococcal disease each year, accounting for approximately 5% of all-cause mortality in children in this age group.

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 2.4cm 3 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, “This 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.’

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.

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.

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.

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

GSK is one of the world’s leading research-based, pharmaceutical and healthcare companies.

For further information please visit GSK.