Hyderabad 1st, September : Manufacturer of vaccines Biological E.Limited (BE) announced on Thursday that the Subject Expert Committee of Central Drugs Standard Control Organization (CDSCO) has approved the Phase 3 infants clinical trial and recommended the manufacture of its 14-valent vaccine for infants against Streptococcus pneumonia.The experimental pneumococcal polysaccharide conjugate (PCV14) vaccine can be administered in single-dose or multi-dose formats.It is recommended to infants between 10, and 14 weeks of age.
Streptococcus pneumoniae is continuing to be a major cause of infant mortality below five years of age in India as well as in emerging countries.
Through the PCV14 vaccine, BE hopes to contribute to the prevention of the invasive pneumococcal disease and safeguard millions of lives across the globe the Hyderabad-based firm said.
“BE’s PCV14 will protect millions of children around the world and aid in the prevention of the invasive pneumococcal disease.Thanks to this recommendation by SEC and the expected official approval by DCGI in the coming months, India will have yet another life-saving vaccine that is essential for use in the paediatric population.Biological E.would be working with WHO as well as other global regulatory bodies to ensure that this vaccine accessible all over the world,” said Mahima Datla as the Managing Director of BE.
BE’s PCV14 comprises 14 serotypes with 12 of which are identical to those in Prevnar13 by Pfizer.Additionally BE’s PCV14 contains two additional Serotypes: 22F and 33F with increasing instances of infections throughout the world.
The main goal of immunogenicity of showing non-inferiority with IgG concentrations of anti-PnCPS for every one of the 12 serotypes common to all of BE-PCV14’s vaccine in regards to the number of subjects who were seroconverted as well as the ratio of geometric mean concentrations against the serotypes in Prevenar 13 was achieved.The non-inferiority was also confirmed with anti-PnCPS IgG concentrations against the unique 22F and 33F serotypes specifically for BE-PCV14, the company stated.
The antibody response against serotype 6, which can be found in Prevenar 13 (not found in BE’s PCV14 vaccine) was also obtained through cross protection with the Be-PCV14’s serotype 6B.
The PCV14 vaccine of BE produced functional immune responses.After a month following the 3 doses of vaccination, an adequate growth in OPA GMTs specific to serotypes were seen for all 14 PCV serotypes.
According to BE the safety analysis showed that all adverse events were moderate to light in their severity, with no grade 3 or 4 adverse events reported.The safety comparison indicates that the BE-PCV14 vaccine was tolerated and was found to be safe.
BE’s PCV14 is comparable in terms of the coverage of serotypes for infants to the pneumococcal conjugate vaccinations Prevnar13 and Merck’s VAXNEUVANCE that are currently approved worldwide.
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