CDSCO nod to Biological E’s pneumonia vaccine for infants

New Delhi: Biological E. Limited (BE), the Hyderabad-based vaccines manufacturer, announced that that the Subject Expert Committee of CDSCO reviewed and approved the Phase 3 infants clinical trial data and recommended for manufacture of its 14-valent paediatric vaccine (investigational pneumococcal polysaccharide conjugate vaccine PCV14) against S. pneumonia infection in single-dose and multi-dose presentations.

The PCV14 can be administered to infants at 6, 10 and 14 weeks of age.

Streptococcus pneumoniae infection continues to be a leading cause of child mortality under 5 years of age in India and in developing countries. With the PCV14 vaccine, BE hopes to contribute to the prevention of invasive pneumococcal disease and protect millions of lives globally.

BE’s PCV14 vaccine elicited functional immune responses. One month after 3rd dose of vaccination, adequate increase in serotype-specific OPA GMTs were observed for all 14 PCV serotypes.

The safety analysis revealed that all the adverse events were mild to moderate in their intensity and with no grade-3 & 4 events reported. The safety comparison shows that BE-PCV14 vaccine was well tolerated and found to be safe.

BE’s PCV14 is comparable in terms of serotype coverage for infants to the two pneumococcal conjugate vaccines Prevnar13 and Merck’s VAXNEUVANCE, which are currently approved globally.

Mahima Datla, Managing Director, Biological E. Limited, said “We are delighted with this remarkable development. BE’s PCV14 will protect millions of infants worldwide and contribute to the prevention of invasive pneumococcal disease. With this recommendation from SEC and the anticipated formal approval from DCGI thereafter, India will have yet another important lifesaving vaccine for paediatric use. Biological E. would be also working with WHO and other global regulatory agencies to make this vaccine available globally. “