Hyderabad-based-Biological E. Limited (BE) on December 15 announced that it has received marketing approval from the Drugs Controller General of India (DCGI) for its Pneumococcal Conjugate vaccine (PCV14) for children.
“Biological E. Limited received authorization to manufacture and market the 14-valent Vaccine against Streptococcus pneumonia Infection in India,” the company said.
Pneumococcal disease is caused by the streptococcus pneumoniae bacteria. Infection can result in diseases such as meningitis, septicaemia and pneumonia, apart from sinusitis and otitis media. The vaccine is generally given to children under the age of 5.
The DGCI grants permission for a drug or vaccine to be sold in the country after reviewing data from all phases of the clinical trials and assessing the results and recommendations of the expert group.
According to Biological E, the 14-valent paediatric Pneumococcal Conjugate Vaccine (PCV14) against S. pneumoniae infection may be administered to infants 6, 10 and 14 weeks of age in three doses.
"We are pleased with this important approval, which will help save the lives of millions of children in India and around the world. BE’s PCV14 will contribute to the prevention of invasive pneumococcal disease. With this endorsement, our country has another essential paediatric vaccine. We will be working with regulators in other countries to make our vaccine available globally," Mahima Datla, Managing Director, Biological E. Limited said.
Also read: Drug regulator stalls approval for sale of Biological E’s pneumococcal vaccine
According to the company, PCV14 contains 14 serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F) which is the largest number of serotypes in India and offers expanded protection against two new serotypes 22F and 33F.
“These new serotypes have been reported recently to be causing infections. In a Phase 3 infants trial BE’s PCV14 was non-inferior to all the common serotypes present in the comparator’s vaccine,” the company added.
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