Hyderabad: Vaccine manufacturer Biological E. Limited (BE) announced on Thursday that the Subject Expert Committee of Central Drugs Standard Control Organization (CDSCO) has approved the Phase 3 infants clinical trial data and recommended for manufacture of its 14-valent pediatric vaccine against Streptococcus pneumonia.
The investigational pneumococcal polysaccharide conjugate vaccine PCV14 can be administered in single-dose and multi-dose presentations. It can be given to infants at 6, 10 and 14 weeks of age.
Streptococcus pneumoniae infection continues to be a leading cause of child mortality under five 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, the Hyderabad-based company said.
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“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,” said Mahima Datla, Managing Director, BE.
BE’s PCV14 contains 14 serotypes, 12 of them the same as in Prevnar13 from Pfizer. In addition, BE’s PCV14 has 2 more Serotypes 22F and 33F for which there have been increasing cases of infections globally.
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 company said.
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.
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.
According to BE, the safety analysis revealed that all the adverse events were mild to moderate in their intensity and with no grade-3 and 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.