Sanofi's Tetraxim Vaccine Gets CDSCO Panel Nod for Expanded Indication
New Delhi: The Subject Expert Committee (SEC), functioning under the Central Drugs Standard Control Organization (CDSCO), has approved an additional indication for Sanofi Healthcare India's combination vaccine, Adsorbed Diphtheria, Tetanus, Pertussis (Acellular Component) and Inactivated Poliomyelitis Vaccine, in line with the EU SmPC, excluding the statement that "Tetraxim can be used to reconstitute the Haemophilus influenzae type b conjugate vaccine (Act-Hib)".
This came after the firm presented the proposal for approval of the change in indication of Adsorbed Diphtheria, Tetanus, Pertussis (Acellular Component) and Inactivated Poliomyelitis Vaccine, as below, along with various changes in prescribing information.
The company sought permission to update the vaccine’s indication to cover primary vaccination in infants from six weeks of age, booster vaccination one year after the primary course during the second year of life, and a booster between 4 and 13 years, as per official recommendations.
The "Adsorbed Diphtheria, Tetanus, Pertussis (Acellular Component) and Inactivated Poliomyelitis Vaccine I. P" is a combination vaccine that protects against diphtheria, tetanus, whooping cough (pertussis), and polio. It is a type of DTaP-IPV vaccine that uses inactivated (killed) poliovirus and acellular pertussis components to stimulate the body to create its own protection against these diseases.
The committee noted that the vaccine is already approved in India for the following indications :
- For primary vaccination in infants from the age of 2 months
- For booster vaccination, one year after primary vaccination, during the second year of life.
- For booster vaccination between 5 and 13 years of age, according to the National Immunization Schedule.
After detailed deliberation, the committee recommended the proposed change in indication and various changes in prescribing information, in line with the EU SmPC, excluding the statement that “Tetraxim can be used to reconstitute the Haemophilus influenzae type b conjugate vaccine (Act-Hib)".
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