Serum Institute gets CDSCO Panel nod to manufacture Tdap vaccine for 4-55 year age group
New Delhi: Serum Institute of India has got a green signal from the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) to manufacture Tdap Vaccine for the age group of 4-65 years.
This came after vaccine major Serum Institute of India presented the proposal for the grant of permission to manufacture Diphtheria, Tetanus and Pertussis (Acellular, Component) vaccine (adsorbed, reduced antigen(s) content) Tdap Vaccine along with Phase II/III clinical trial report, Data and Safety Monitoring Board (DSMB) recommendations, Prescribing information (PI) and Summary of product characteristics (SmPC).
Diphtheria and pertussis spread from person to person. Tetanus enters the body through cuts or wounds.
Tetanus causes painful stiffening of the muscles. Tetanus can lead to serious health problems, including being unable to open the mouth, having trouble swallowing and breathing, or death. Diphtheria can lead to difficulty breathing, heart failure, paralysis, or death. Pertussis, also known as "whooping cough," can cause uncontrollable, violent coughing that makes it hard to breathe, eat, or drink. Pertussis can be extremely serious especially in babies and young children, causing pneumonia, convulsions, brain damage, or death. In teens and adults, it can cause weight loss, loss of bladder control, passing out, and rib fractures from severe coughing.
Tdap is a combination vaccine that protects against three potentially life-threatening bacterial diseases: tetanus, diphtheria, and pertussis (whooping cough).
At the recent SEC meeting for the vaccine held on 29th August 2022,the expert panel reviewed the proposal for the grant of permission to manufacture Diphtheria, Tetanus and Pertussis (Acellular, Component) vaccine (adsorbed, reduced antigen(s) content) Tdap Vaccine along with Phase II/III clinical trial report, DSMB recommendations, Prescribing information (PI) and Summary of product characteristics (SmPC).
After detailed deliberation, the committee recommended the grant of permission to manufacture Tdap Vaccine for the age group of 4-65 years.
In accordance with the above, the expert panel directed the firm to submit the revised Summary of product characteristics (SmPC) and Prescribing information (PI).
Furthermore, the committee opined vaccine major Serum Institute of India to remove indication for pregnant women from the mentioned documents.
