Drug regulator recommends manufacture of Biological E's pediatric pneumococcal vaccine

The subject expert committee (SEC) of Central Drugs Standard Control Organisation (CDSCO) has recommended for manufacture of pediatric pneumococcal vaccine by Hyderabad based Biological E. Limited followed by review and approval of the Phase 3 infants' clinical trial data.

The vaccine is an investigational 14-valent pediatric pneumococcal vaccine named as polysaccharide conjugate vaccine (PCV14) against Streptococcus pneumoniae infection in single dose and multi dose presentations. The vaccine 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. The Biological E. has said that it would be also working with the World Health Organization (WHO) and other global regulatory agencies to make this vaccine available globally.

“The PCV14 vaccine 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 pediatric use,” Mahima Datla, Managing Director, Biological E. Limited said.

Biological E.’s PCV14 contains 14 serotypes, 12 of them same as in Prevnar13 from Pfizer. The US Centers for Disease Control and Prevention defines Serotypes as groups within a single species of microorganisms, such as bacteria or viruses, which share distinctive surface structures.

In addition, Biological E.’s PCV14 has 2 more Serotypes 22F and 33F for which there have been increasing cases of infections globally. Biological E in a statement said that PCV14 vaccine elicited functional immune responses. One month after third dose of vaccination, adequate increase in serotype-specific immune responses were observed for all 14 PCV serotypes.

“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,” the company statement said.

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, the company said.

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