BE's pediatric pneumonia jab gets CDSCO expert panel approval

Vaccine maker Biological E (BE) on Thursday said that the Subject Expert Committee of the Central Drugs Standard Control Organisation(CDSCO) has reviewed and approved the phase-3 infants clinical trial data and recommended for manufacture of its paediatric vaccine against streptococcus pneumonia infection in single-dose and multi-dose presentations.
The BE's pneumococcal conjugate vaccine (PCV) can be administered to infants at 6, 10 and 14 weeks of age. Streptococcus pneumoniae infection continues to be a leading cause of child mortality under 5 years of age in India and in developing countries.

If the Hyderabad-based vaccine maker gets final approval from the India drug regulator, it will be the second made-in-India PCV. Serum Institute of India .(SII) had launched the first indigenous PCV - Pneumosil in December 2020.

BE's PCV which is a 14 valent provides protection against 14 serotypes of streptococcus bacteria giving more comprehensive coverage than Pfizer's top selling 13 valent Prevenar13 and SII's 10 valent Pneumosil.

BE said its 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, BE’s PCV14 has 2 more serotypes 22F and 33F for which there have been increasing cases of infections globally.

BE said its pneumonia jab in the clinical trial was compared to the top selling Pfizer's Prevenar 13, in which it has met 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 said in a statement.

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.

The safety analysis revealed that all the adverse events were mild to moderate in their intensity. The safety comparison shows that BE-PCV14 vaccine was well tolerated and found to be safe.

“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," said Mahima Datla, MD of Biological E.

Datla said the company would be also working with WHO and other global regulatory agencies to make this vaccine available globally.