Biological E. Ltd. has secured World Health Organisation (WHO) prequalification for its 14-valent pneumococcal conjugate vaccine, Pneubevax 14 (BE-PCV-14). The approval paves the way for the vaccine’s inclusion in global immunisation programmes, improving access to life-saving protection against pneumococcal diseases worldwide.

With this authorisation, Pneubevax 14 becomes the company’s 11th vaccine to achieve WHO prequalification, underscoring Biological E.’s long-standing role in strengthening global public health. The WHO PQ status assures international procurement agencies of the vaccine’s quality, safety, and effectiveness, enabling supply through major platforms such as Gavi, UNICEF and PAHO.

Mahima Datla, Managing Director, Biological E., said the recognition reinforces the company’s mission to deliver dependable and affordable vaccines globally. “We remain committed to supporting public health partners in improving access to high-quality immunisation solutions across India and around the world,” she noted.

Broader Serotype Coverage for Stronger Protection

Pneubevax 14 is developed to prevent invasive pneumococcal infections caused by 14 Streptococcus pneumoniae serotypes, including 22F and 33F strains not covered by some existing pneumococcal conjugate vaccines. This expanded spectrum aims to address evolving epidemiological needs and enhance real-world protection.

The vaccine is administered to infants from six weeks of age and forms part of the primary childhood vaccination schedule. According to the company, clinical studies demonstrate a favourable safety profile and strong, serotype-specific immune responses across all 14 targeted strains.

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Strengthening Global Vaccine Security

Pneumococcal diseases such as pneumonia, meningitis and sepsis remain major causes of childhood morbidity and mortality globally. The prequalification of BE-PCV-14 is expected to improve supply security and support countries seeking broader serotype coverage within their national immunisation programmes.

The approval marks another step in India’s expanding contribution to global vaccine supply, reinforcing the nation’s role as a trusted partner in public health.

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