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The Subject Expert Committee (SEC) of Central Drugs Standard Control Organization (CDSCO) has recommended grant of permission to Biological E. Limited to manufacture the 14-valent investigational vaccine against Streptococcus pneumoniae infection.
Clinical trials and DCGI approval
The Hyderabad-based vaccine maker, on Thursday, has said the SEC reviewed and approved the phase 3 infants clinical trial data and recommended for the manufacturing of its 14-valent paediatric vaccine against S. pneumonia infection in single-dose and multi-dose presentations. The PCV14 can be administered to infants at 6, 10, and 14 weeks of age.
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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,’‘ Mahima Datla, Managing Director, Biological E. said in a release.
Biological E. would be also working with WHO and other global regulatory agencies to make this vaccine available globally, she added.
Streptococcus pneumoniae infection
Streptococcus pneumoniae infection continues to be a leading cause of child mortality under 5 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.
”BE’s PCV14 contains 14 serotypes, 12 of them 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 release said.
BE’s PCV14 vaccine elicited functional immune responses. The safety analysis ”revealed’‘ that all the adverse events were mild to moderate in their intensity and with no grade-3 & 4 events reported. ”The safety comparison shows that BE-PCV14 vaccine was well tolerated and found to be safe,’‘ the company said.
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