Additional panel of antibodies available to support the development of affordable pneumococcal vaccines

April 12, 2023 by Deborah Oroszlan

46 high-quality and affordable serotype-specific monoclonal antibodies (mAbs) now globally available to support the development of pneumococcal vaccines.

PATH and the Medicines and Healthcare products Regulatory Agency (MHRA) have partnered to offer 46 new serotype-specific monoclonal antibodies (mAbs) reactive with pneumococcal polysaccharides (PnPS) commonly included in polyvalent pneumococcal conjugate vaccines under development. Each of these mAbs are specific to serotypes that represent 29 of those most commonly associated with pneumococcal pneumonia. All mAbs have been evaluated and demonstrate serotype specificity against a panel of the most common PnPS antigens. The panel of mAbs are available in 0.5-milligram aliquots with a certificate of analysis provided.

Pneumococcal pneumonia, a vaccine-preventable disease, is a leading infectious cause of death among children under five. Vaccines are a critical strategy to protect children, particularly those in Africa and Asia, where more than 90 percent of all pneumococcal deaths occur.

However, barriers such as vaccine price and availability often prevent children in low- and middle-income countries from accessing these lifesaving tools. Furthermore, the current vaccines do not target all of the disease-causing pneumococcal serotypes for children in these parts of the world.

PATH has been working with partners to advance the development of new pneumococcal vaccines that are low-cost, broadly protective, and tailored for use in low-resource settings. Providing high-quality and affordable reagents such as mAbs will help to ensure that critical pneumococcal vaccines are affordable and accessible to children in low- and middle-income countries.

MHRA plays a key role in assuring the quality of biological medicines through the development of their National Institute of Biological Standards and Control (NIBSC) biological reference materials and standards.

These antibodies were developed with funding to PATH from the Bill & Melinda Gates Foundation and are available from the MHRA via the NIBSC online catalog of biological reference materials.

Contact dxinfo@path.org for more info.

About the MHRA

The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices, and blood components for transfusion in the UK. The MHRA is responsible for making sure these products meet set standards for safety, quality, and effectiveness. The MHRA is an Executive Agency of the Department of Health and Social Care. For more information visit gov.uk/mhra

NIBSC standards from the Medicines and Healthcare products Regulatory Agency (MHRA) are available globally to set the quality of biological medicines. MHRA develops and produces over 90% of the WHO International Standards in use around the world. The MHRA also offers NIBSC contract and control testing services.