DCGI approves Biological E.’s 14-valent pneumococcal conjugate vaccine

Biological E. Limited (BE), a Hyderabad-based pharmaceutical and vaccines company, announced on Friday that its 14-valent pediatric pneumococcal conjugate vaccine (pneumococcal polysaccharide conjugate vaccine PCV14) against S. pneumoniae infections the Has received approval from the Drugs Controller General of India (DCGI) to manufacture and market in India.

Streptococcus pneumoniae infection remains one of the leading causes of death in children under five in India and developing countries. BE’s PCV14 vaccine will help prevent invasive pneumococcal infections and save millions of lives worldwide, the company said.

Mahima Datla, Managing Director, Biological E. Limited said: “We are delighted to receive this important approval which will help save the lives of millions of children in India and around the world. PCV14 from A BE will help prevent invasive pneumococcal disease. With this confirmation, our country has another important pediatric vaccine. We will work with regulators in other countries to make our vaccine available globally.”

PCV14 can be given in 3 doses to infants at 6, 10 and 14 weeks of age.A

BE PCV14 contains 14 serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F). BE’s PCV14 contains the largest number of serotypes in India and offers enhanced protection against two new serotypes 22F and 33F. It has recently been reported that these new serotypes cause infections. In a phase 3 infant study, PCV14 from BE was non-inferior to all common serotypes in the comparator vaccine.

The primary immunogenicity objective of demonstrating non-inferiority of anti-PnCPS IgG antibody levels to each of the 12 common BE-PCV14 vaccine serotypes in seroconverted patients and the ratio of geometric mean levels to the corresponding serotypes in the active comparator was met. Non-inferiority was demonstrated using anti-PnCPS IgG antibody levels against the unique serotypes 22F and 33F specific for BE-PCV14.

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The safety comparison shows that the BE-PCV14 vaccine was well tolerated and considered safe.

BE’s PCV14 is comparable to Merck’s two globally approved pneumococcal conjugate vaccines, Prevenar13 and VAXNEUVANCE, in terms of infant serotype coverage.



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