Setback: GSK proposal to market Meningococcal group B Vaccine rejected by CDSCO panel
New Delhi: In the major setback to GSK, citing that the firm has not submitted any safety and immunogenicity data in Indian population, the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) has rejected the the drug maker's proposal to import and market Meningococcal group B Vaccine (rDNA, component, adsorbed) with local clinical trial waiver before the committee.
This came after pharma major GSK presented its proposal for grant of permission to import and market Meningococcal group B Vaccine (rDNA, component, adsorbed) with local clinical trial waiver before the committee.
The meningococcal vaccines protect against meningococcal disease, which can lead to bacterial meningitis and other serious infections. The meningococcal B vaccine (MenB) protects against a fifth type of meningococcal bacterium called type B. Kids and teens who are at increased risk for meningococcal disease should get it starting from age 10. Others who are not at increased risk may also get it between the ages of 16 and 23, preferably between 16 through 18 as that is when the risk of getting infected is highest.
Vaccines are the only way to prevent meningitis and have almost eliminated some other causes of this deadly disease. The MenB vaccine can cause side effects, but studies suggest they're generally mild and do not last long. Babies are given the MenB vaccine alongside their other routine vaccinations at 8 and 16 weeks are likely to develop a high temperature within 24 hours of vaccination. It's important to give your baby liquid paracetamol following vaccination to reduce this risk.
At recent SEC meeting of Subject Expert Committee (SEC), the committee evaluated the pharma major GSK's proposal for grant of permission to import and market Meningococcal group B Vaccine (rDNA, component, adsorbed) with local clinical trial waiver.
The committee noted that the firm has not submitted any safety and immunogenicity data in the Indian Population, the dosing schedule proposed by the firm does not correspond to the immunization schedule in India for this age group and has also not submitted the prevalence data of Meningococcal B serotype in the country.
After detailed deliberation, the committee did not recommend for grant of marketing authorization with local Phase III clinical trial waiver.
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