Pfizer Receives European Approval for New Multi-Dose Vial Presentation of Prevenar 13 – conducted by MRC Unit The Gambia

9 January 2017
On Wednesday, April 6, 2016, Pfizer announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) approved a new four-dose, multi-dose vial (MDV) presentation of Prevenar 13 (pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]).

Pfizer002The vaccine has been licensed based on the results of a study conducted by MRC Unit The Gambia (MRCG) in collaboration with the Ministry of Health and Social Welfare of The Gambia. This new MDV presentation, with a four-dose vial, was developed to maximize efficiency  by significantly reducing storage and cold-chain requirements and shipping costs.

The MDV Prevenar 13  developed by Pfizer in collaboration with Gavi, the Vaccine Alliance, was conducted by MRCG at Fajikunda Health Centre between 2013 and 2014. This was a randomized, open-label trial in which subjects received doses of either 13vPnC in MDVs or 13vPnC in a single dose syringe (SDS) as per the infant vaccine series scheme in The Gambia at 2, 3 and 4 months of age. The results of the trial showed that the new formulation was as safe, tolerable, and immunogenic as the already licensed  SDS. The trial was successfully completed thanks to the quality standards of a dedicated team lead by Dr Olubukola Idoko (Trial Coordinator),  Dr Anna Roca (local PI) and Prof Beate Kampmann (Trial Director).

The MDV presentation of Prevenar 13 offers significant benefits to developing countries, including 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.

Pfizer plans to submit its Prevenar 13 MDV presentation to the World Health Organization (WHO) for prequalification, which, if and when approved, will allow for the global use of this new presentation of Prevenar 13 by United Nations agencies and countries worldwide that require WHO pre-qualification. 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 (Gavi).

“Prevenar 13 formulated in multi-dose vials was studied in collaboration with MRC Unit The Gambia,” said William Gruber, M.D., Senior Vice President Vaccine Clinical Research and Development.


Field Team

“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” said Prof Beate Kampmann, Theme Leader for Vaccines & Immunity.

“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,” said Dr Anna Roca, Theme Coordinator, Disease Control & Elimination Theme.

“The region urgently needs affordable vaccines to ensure that the most vulnerable children can or continue to be protected from preventable diseases. This is a remarkable success in this context, which has been made possible 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” said Dr Olubukola Idoko, Clinical Trial Coordinator.

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