SEC recommends Biological E’s vaccine against Streptococcus pneumonia for infants
Biological E Limited (BE) announced that the CDSCO approved the Phase 3 infants clinical trial data and recommended for manufacture of its 14-valent paediatric vaccine against Streptococcus pneumoniae infection in single-dose and multidose presentations.
Hyderabad: Hyderabad-based vaccines manufacturer Biological E Limited (BE) announced Thursday that the Central Drugs Standard Control Organisation (CDSCO) approved the Phase 3 infants clinical trial data and recommended for manufacture of its 14-valent paediatric vaccine against Streptococcus pneumoniae infection in single-dose and multidose presentations.
The PCV14 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. With the PCV14 vaccine, BE hopes to contribute to the prevention of invasive pneumococcal disease and protect millions of lives globally.
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The safety analysis revealed that all the adverse events were mild to moderate in their intensity and with no Grade3 (severe or medically significant but not immediately life-threatening) or Grade 4 (life threatening consequences and urgent intervention indicated) events reported. The safety comparison shows that BE-PCV14 vaccine was well tolerated and found to be safe, the company said.
BE’s PCV14 is comparable to the two vaccines Prevnar13 and Merck’s Vaxneuvance, which are currently approved globally, it said.
“BE’s PCV14 will protect millions of infants worldwide and contribute to the prevention of invasive pneumococcal disease. With this recommendation from the Subject Expert Committee and the anticipated formal approval from DCGI thereafter, India will have yet another important lifesaving vaccine for paediatric use. Biological E would be also working with WHO and other global regulatory agencies to make this vaccine available globally,” said Mahima Datla, Managing Director, Biological E.
BE, founded in 1953, is the first private sector biological products company in India and the first pharmaceutical company in Southern India. BE develops, manufactures and supplies vaccines and therapeutics. BE supplies its vaccines to more than 130 countries and its therapeutic products are sold in India and the USA, Europe. It has 8 WHO-prequalified vaccines and 5 USFDA approved Injectables in its portfolio, a release said.
