Hyderabad-based vaccine maker Biological E Ltd on Thursday announced that the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) has reviewed and approved clinical trial data of Phase III infants and its 14- Recommends the manufacture of Valeant Pediatric Vaccine. (Investigational Pneumococcal Polysaccharide Conjugate Vaccine PCV14) against S. pneumoniae infection in single-dose and multi-dose presentation.
The company said that PCV14 can be given to babies at 6, 10 and 14 weeks of age. According to Biological E, Streptococcus pneumoniae infection remains a leading cause of death in children under the age of 5 in India and developing countries.
With the PCV14 vaccine, Biologicals E hopes to contribute to the prevention of aggressive pneumococcal disease and save millions of lives globally. Mahima Datla, Managing Director, Biologicals E Ltd. 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. This recommendation from the SEC and the anticipated formal follow-up. After getting approval from DCGI, India will have another important life saving vaccine for pediatric use. Biological E. will work with WHO and other global regulatory agencies to make this vaccine available globally.”
PCV14 has 14 serotypes, 12 of which are identical to 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 cases of infection are increasing globally, the company said.
The primary immunogenicity objective of demonstrating non-inferiority with PNCPS IgG antibody concentrations against each of the 12 common serotypes of BE-PCV14 vaccine in the context of seroconverted subjects and the ratio of geometric mean concentrations against the respective serotypes in prevenar 13 was met was.
Non-inferiority was also demonstrated with PnCPS IgG antibody concentrations against the 22F and 33F unique serotypes specific for BE-PCV14. The immune response to serotype 6a that is present in Prevenar 13 (not in BE’s PCV14 vaccine) was also achieved through cross-protection from BE-PCV14 vaccine serotype 6b.
The biological E`s PCV14 vaccine elicited a functional immune response. One month after the third dose of vaccination, a substantial increase in serotype-specific OPA GMT was observed for all 14 PCV serotypes. Safety analysis revealed that all adverse events were mild to moderate in their intensity and there were no reports of Grade-3 and 4 events.
The safety comparison shows that the BE-PCV14 vaccine was well tolerated and found to be safe.
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PCV14 is comparable in terms of serotype coverage to the two pneumococcal conjugate vaccines Prevnar13 and Merc’s VAXNEUVANCE that are currently approved globally.