Submit PMS data in Indian Population: CDSCO Panel Tells Sanofi Healthcare on updation prescribing information of Adacel vaccine
New Delhi: Responding to the proposal presented by Sanofi Healthcare India for updating prescribing information for Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed (Adacel), the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has opined the firm to submit the data/publication in support of the proposed changes and post-marketing surveillance (PMS) data in the Indian population.
This came after the vaccine maker Sanofi Healthcare India presented its proposal to update prescribing information of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed.
Adacel is a vaccine that helps prevent whooping cough (pertussis), tetanus, and diphtheria. It's manufactured by Sanofi Pasteur Limited and is approved for use in people aged 10-64 who have previously received childhood immunizations. Adacel can also be used during the third trimester of pregnancy to prevent pertussis in infants under 2 months old.
Adacel is a suspension for injection that should be administered into the deltoid muscle. It should not be mixed with other vaccines or drugs, and it should only be used once on one patient. After use, any remaining vaccine should be discarded.
Common side effects of Adacel include headache, injection site redness, pain, swelling, weakness, and gastrointestinal symptoms.
At the recent SEC meeting for vaccines held on August 22, 2024, the expert panel reviewed the revised proposal for an update of prescribing information for Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, or Adacel vaccine.
After detailed deliberation, the committee recommended the firm to submit
1. Data/publications in support of the proposed changes.2. Post marketing surveillance data in Indian Population.
