Hyderabad-based vaccines manufacturer Biological E Limited announced on Thursday that the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) reviewed and approved the Phase III infants clinical trial data and recommended the manufacture of its 14-valent paediatric vaccine (investigational pneumococcal polysaccharide conjugate vaccine PCV14) against S pneumoniae infection in a single dose and multi-dose presentations.
The company said the PCV14 can be administered to infants at 6, 10 and 14 weeks of age. According to Biological E, Streptococcus pneumoniae infection continues to be a leading cause of child mortality under 5 years of age in India and developing countries.
With the PCV14 vaccine, Biological E hopes to contribute to the prevention of invasive pneumococcal disease and protect millions of lives 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.”
PCV14 contains 14 serotypes, 12 of them same as in Prevnar13 from Pfizer (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F). In addition, PCV14 has 2 more Serotypes 22F and 33F for which there have been increasing cases of infections globally, the company said.
The primary immunogenicity objective of demonstrate non-inferiority with anti-PnCPS IgG antibody concentrations against each of the 12 common serotypes of BE-PCV14 vaccine in terms of subjects seroconverted and the ratio of geometric mean concentrations against corresponding serotypes in Prevenar 13 was met.
Non-inferiority was also demonstrated with anti-PnCPS IgG antibody concentrations against 22F and 33F unique serotypes specific to BE-PCV14. The immune response to serotype 6A which is in Prevenar 13 (not there in BE`s PCV14 vaccine) was also achieved through cross-protection from BE-PCV14 vaccine serotype 6B.
Biological E`s PCV14 vaccine elicited functional immune responses. One month after the third dose of vaccination, an adequate increase in serotype-specific OPA GMTs was 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 the BE-PCV14 vaccine was well tolerated and found to be safe.
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.