Biological E Limited, based in Hyderabad, announced on Thursday that 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 single and multi-dose presentations. The PCV14 vaccine may be given to newborns at 6, 10, and 14 weeks of age, according to the firm.
Streptococcus pneumoniae infection is a prominent cause of child death in India and other nations, according to Biological E. Biological E expects that the PCV14 vaccine will help to avoid invasive pneumococcal illness and save millions of lives throughout the world.
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.
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The primary immunogenicity objective of demonstrating 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 third dose of vaccination, an adequate increase in serotype-specific OPA GMTs were observed for all 14 PCV serotypes.
According to the safety study, all of the adverse events were mild to moderate in severity, with no grade 3 or 4 incidents observed. The BE-PCV14 vaccination was well tolerated and judged to be safe, according to the safety comparison.
In terms of serotype coverage for newborns, PCV14 is equivalent to the two presently licenced pneumococcal conjugate vaccines, Prevnar13 and Merck’s VAXNEUVANCE.