The Drugs Controller General of India has approved the manufacture and sale of a 14-valent Paediatric Pneumococcal Combination Vaccine developed by Biological E. Limited. The vaccine protects infants from Streptococcus pneumococcal infection or S. Pneumoniae, which is one of the most common causes of death in children under five years old.
On Friday, the Hyderabad-based Pharmaceutical and Vaccine Company (PCV14), announced that DCGI had approved its Investigational Pneumococcal polysaccharide conjugate vaccine.
Mahima Datla expressed her joy at receiving DCGI approval. She said the vaccine would save millions of children‘s lives in India and across the globe by preventing invasive pneumonia.
The PCV14 vaccination will be an essential paediatric shot in the country. Datla stated that the company is in the process to get approval from regulators of other countries in order to make the vaccine globally available.
What you should know about the PCV14 vaccine from BE
The BE –PCV14 contains the most serotypes available in India. It also offers protection against two serotypes, 22F and 33F that have recently been reported to cause infections. It contains 14 serotypes in total (1, 3, 5, 6B, 8F, 9V), including 18C,19A,19F, 22F 23F and 34F. The vaccine is given in three doses to infants aged 6, 10 and 14.
The Phase 3 trial showed that BE’s PCV14 was not inferior to the vaccines of a competitor’s serotypes. The study also showed non-inferiority in terms of anti-PnCPS antibody concentrations for the 22F and the 33F serotypes that are specific to BE-PCV14. The company claims that the BE-PCV14 is well tolerated and safe.
Biological E. Limited claims that their vaccine, in terms of serotype protection for infants, is equal to two other globally approved conjugate vaccines against pneumococcal disease: Prevenar13 by Merck and VAXNEUVANCE by Merck.
