CDSCO panel grants GSK's proposal for Updation of Package Insert of Infanrix Hexa Vaccine
New Delhi: Pharmaceutical major GSK has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) for the updation of the package insert of Infanrix Hexa Vaccine in line with EU SmPC.
This came after the firm presented an updated package insert of Diphtheria, tetanus, pertussis (acellular component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus type b conjugate vaccine (adsorbed) [INFANRIXHEXA].
Infanrix Hexa Vaccine is a combination of multiple vaccines. It is used to prevent diphtheria, tetanus, pertusis, polio, haemophilus influenzae type B disease, and hepatitis B infection in infants and toddlers. It promotes the immune system to act against microorganisms to prevent such infections.
They help develop immunity by initiating a mild infection. This type of infection does not cause illness but stimulates the body's immune system to produce antibodies (proteins) to protect against any future infections.
Diphtheria is a serious infection caused by strains of bacteria called Corynebacterium diphtheriae that make toxins. It can lead to difficulty breathing, heart rhythm problems, and even death.
Tetanus is an infection caused by bacteria called Clostridium tetani. When these bacteria enter the body, they produce a toxin that causes painful muscle contractions. Another name for tetanus is “lockjaw”. It often causes a person's neck and jaw muscles to lock, making it hard to open the mouth or swallow.
Acellular pertussis vaccines contain inactivated pertussis toxin (PT) and may contain one or more other bacterial components (e.g., filamentous hemagglutinin {FHA}, a 69-kilodalton outer-membrane protein -- pertactin {Pn}, and fimbriae {Fim} types 2 and 3).
Hepatitis B is a viral infection that attacks the liver and can cause both acute and chronic diseases.
Polio, or poliomyelitis, is a disabling and life-threatening disease caused by the poliovirus. The virus spreads from person to person and can infect a person's spinal cord, causing paralysis (can't move parts of the body).
Haemophilus b conjugate vaccine (tetanus toxoid conjugate) is an active immunizing agent that is used to prevent infection caused by the Haemophilus influenza type b (Hib) bacteria. The vaccine works by causing your body to produce its own protection (antibodies) against the disease.
At the recent SEC meeting for Vaccine held on 21st February 2023, the expert panel reviewed the proposal presented by the firm for the updation of the package insertion of Diphtheria, tetanus, pertussis (acellular component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus type b conjugate vaccine (adsorbed) [INFANRIXHEXA].
