·        PNEUBEVAX 14TM induced robust & functional serotype specific immune response in infants to 14 serotypes offering broadest serotype coverage of any paediatric pneumococcal conjugate vaccine available in India

·        The Phase-III clinical trial data indicates that PCV-14 is non inferior to all the twelve common serotypes present in the comparator vaccine PCV-13 used in the study

Hyderabad, April 30, 2024: Biological E. Limited (BE), a Hyderabad-based Vaccine and Pharmaceutical Company, today announced the publication of Phase-III clinical trials results of BE's 14-Valent Pneumococcal Conjugate Vaccine (PCV) (PNEUBEVAX 14TM; BE-PCV-14) conducted in paediatric population (6-8-week age group). The study results have been accepted and published by Vaccine, a reputed peer-reviewed international journal.

In this study, the immunogenicity and safety of the BE's 14-Valent PCV (PNEUBEVAX 14TM; BE-PCV-14) containing two additional epidemiologically important serotypes (22F and 33F) were evaluated in infants, in comparison to the licensed comparator vaccine PCV-13.

This was a pivotal Phase-III single blind randomized active-controlled study conducted at 12 sites across India in 1290 healthy infants at 6-10-14 weeks dosing schedule to assess immunogenic non-inferiority and safety of PNEUBEVAX 14TM. Immunogenicity was assessed by measuring anti-Pneumococcal Capsular Polysaccharide (anti-PnCPS) IgG concentration and functional antibody titres through Opsonophagocytic Activity (OPA), one month after completing a three-dose schedule. Cross- protection against serotype 6A offered by serotype 6B was also assessed in this study.

PNEUBEVAX 14TM was found to be safe and induced robust and functional serotype specific immune responses to all 14 serotypes. It also elicited cross-protective immune response against serotype 6A.These findings suggest that PNEUBEVAX 14TM can be safely administered to infants and achieve protection against pneumococcal disease caused by serotypes covered in the vaccine.

The safety profile of PNEUBEVAX 14TM was comparable to that of the PCV-13 vaccine. The majority of reported Adverse Events (AEs) were mild in nature. The NI criteria for the 12 common serotypes and the additional serotypes (22F and 33F) in PNEUBEVAX 14TM were demonstrated according to WHO TRS-977. All 14 serotypes of PNEUBEVAX 14TM had IgG immune responses that met the primary immunogenicity endpoint. Furthermore, a significant proportion of subjects (69%) seroconverted against serotype 6A, even though this antigen was not present in PNEUBEVAX 14TM. This indicates that serotype 6B of PNEUBEVAX 14TM cross-protects serotype 6A. PNEUBEVAX 14TM also elicited strong functional OPA immune responses comparable to those of all the serotypes common to PCV-13.

Ms. Mahima Datla, Managing Director, Biological E. Limited, said: ``we are pleased to announce that our Phase-III clinical trial results for PNEUBEVAX 14TM have been published by the Vaccine Journal. We have reached a significant milestone in our ongoing fight against pneumococcal disease, and we are now one step closer to the finish line with our 14-Valent PCV Vaccine PNEUBEVAX 14TM. These findings underscore the success of our R&D and serve as a source of motivation for all of us at BE.’’

About Biological E. Limited

Biological E. Limited (BE), a Hyderabad-based Pharmaceuticals & Biologics Company founded in 1953, is the first private sector biological products company in India and the first pharmaceutical company in Southern India. BE develops, manufactures and supplies vaccines and therapeutics. BE supplies its vaccines to more than 130 countries and its therapeutic products are sold in India, the USA and Europe. The portfolio of BE currently consists of 9 WHO-approved vaccines and 10 USFDA-approved Generic Injectables. Recently, DCGI has approved BE’s 14-Valent Pneumococcal Conjugate vaccine.

In recent years, BE has embarked on new initiatives for organizational expansion such as developing specialty injectable products for global markets as a means to manufacture APIs sustainably and developing novel vaccines for the global market.