EU approval of pneumococcal vaccine based on MRC Unit The Gambia study

The European Medicines Agency (EMA) have approved a new multi-dose preparation of Prevenar 13®, sponsored by biopharmaceutical company Pfizer, based on a study conducted by MRC Unit The Gambia.The vaccine is a new four-dose, multi-dose vial (MDV) presentation of pneumococcal polysaccharide conjugate vaccine Prevenar 13®; it covers 13 of the more than 90 pneumococcal bacteria serotypes, the most common causing disease worldwide before the introduction of pneumococcal conjugate vaccines. Pneumococcal disease, including pneumonia and meningitis, is predominantly caused by the Streptococcus pneumoniae bacteria. It mainly affects children under five and causes significant illness and death.

A single-dose preparation of Prevenar 13® is already used in many countries as part of WHO Expanded Programme for Immunisation, including The Gambia, but the new multi-dose vial vaccine was developed to help reduce costs and improve the efficiency of vaccine delivery.

eu-vaccines1Having four doses of the vaccine in each vial, instead of one, offers a 75 percent reduction in temperature-controlled supply chain requirements, United Nations International Children’s Education Fund (UNICEF) shipping costs, and storage requirements at the national, regional, district, and community levels.

Developed by Pfizer in collaboration with GAVI, the Vaccine Alliance, the MDV Prevenar 13® study was conducted by the MRC Unit The Gambia at Fajikunda Health Centre in The Gambia between 2013 and 2014. Subjects received doses of the vaccine in multi-dose vials or in a single-dose syringe according to the infant vaccine series scheme in The Gambia at two, three and four months of age. The results of the trial showed that the new formulation was as safe, tolerable, and as immunogenic as the already licensed single-dose syringe.

Once approval of Pfizer’s submission of Prevenar 13® has also been granted by the World Health Organization (WHO), global use of this vaccine by United Nations agencies and countries worldwide that require WHO pre-qualification can proceed. If and when pre-qualified, the MDV presentation is expected to be introduced under the Advance Market Commitment program in early 2017, for shipment to countries covered by GAVI, the Vaccine Alliance.

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The field team

Trial director Professor Beate Kampmann, Theme Leader for Vaccines and Immunity, said, “We are very pleased indeed that the high standards routinely achieved in our clinical trials have enabled the swift approval from the EMA. I thank the field team and the clinical trials group for their outstanding support. The impact of this vaccine on affordability and therefore on prevention of serious disease in LMIC will be tremendous.”

 

Dr Olubukola Idoko, Clinical Trial Coordinator said, “The region urgently needs affordable vaccines to ensure that the most vulnerable children can begin to or continue to be protected from preventable diseases. This is a remarkable success on this front and, has been made possible in part by a dedicated team of staff playing a part in attaining the Unit’s goal of contributing to the control and elimination of infectious diseases of public health importance.”

Dr Anna Roca, Theme Coordinator, Disease Control & Elimination Theme said, “These results are excellent news, especially soon after The Unit has shown that Prevenar 13® can reduce pneumonia in The Gambia by 55%, as this outcome means that the new formulation will be more affordable within the region.”