CDSCO Panel grants Sanofi's Protocol Amendment Proposal for Quadrivalent Meningococcal Conjugate Vaccine
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved Sanofi Healthcare's protocol amendment proposal for Quadrivalent Meningococcal Conjugate Vaccine with a condition that the firm should conduct the study in statistically a significant number of subjects.
In addition, the firm also opined the firm to revise the protocol and submit CDSCO for further evaluation.
This came after the firm presented the proposal for Protocol number MET55 amendment version 3.0, dated 06 June 2022 before the committee.
Meningococcal infection is caused by bacteria. Meningococcal infection due to types A, C, Y and W is very rare in B.C. Although rare, it can cause serious and life-threatening infections including meningitis, an infection of the lining that covers the brain, and septicemia, an infection of the blood. For every 100 people who get sick, up to 15 will die, even if they receive treatment. Permanent complications of infection include brain damage, deafness, and loss of limbs.
Meningococcal infection is spread from person to person by coughing, sneezing, or close face-to-face contact. It can also be spread through saliva. This can occur through activities such as kissing or sharing of food, drinks, cigarettes, lipsticks, water bottles, mouthguards used for sports, or mouthpieces of musical instruments.
Meningococcal quadrivalent vaccines protect against 4 types of meningococcal bacteria: types A, C, Y and W. The vaccines are either polysaccharide or conjugate vaccines. The conjugate vaccine used in B.C. provides longer-lasting protection against disease.
After detailed deliberation, the committee recommended the approval of the protocol amendment subject to the condition that the study should be conducted in statistically a significant number of subjects, accordingly the firm should submit the revised protocol to CDSCO for further review.
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