Biological E gets CDSCO Panel Nod To study vaccine for 6- 8 weeks old infants
New Delhi: Reviewing the Phase I clinical trial report, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the vaccine maker Biological E to conduct a Phase II clinical trial of Diphtheria, Tetanus, Pertussis (Whole cell), Hepatitis B (rDNA), inactivated Poliomyelitis and Haemophilus influenzae Type b Conjugate Vaccine (Adsorbed) for 6- 8 weeks-old infants.
This came after the vaccine maker Biological E presented its proposal for the conduct of a Phase II clinical trial in 6- 8 weeks-old infants along with a Phase I clinical trial report.
The above vaccine helps to protect against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and serious diseases caused by Haemophilus influenzae type b.
Diphtheria toxoid is one of the safest vaccines available. Individuals with an anti-diphtheria toxin antibody level of more than 0.1 IU/mL are considered fully protected from disease. DTP-containing multi-antigen vaccines (Hep B, Hib, or IPV) are increasingly used in national immunization campaigns.
The tetanus vaccine, also known as tetanus toxoid (TT), is a toxoid vaccine used to prevent tetanus. Five doses are recommended during childhood, with a sixth given during adolescence. After three doses, almost everyone is initially immune, but additional doses every ten years are recommended to maintain immunity. A booster shot should be given within 48 hours of an injury to people whose immunization is out of date.
The pertussis vaccine is a vaccine that protects against whooping cough (pertussis). There are two main types: whole-cell vaccines and acellular vaccines. The whole-cell vaccine is about 78% effective while the acellular vaccine is 71–85% effective. The effectiveness of the vaccines appears to decrease by between 2 and 10% per year after vaccination with a more rapid decrease with the acellular vaccines.
Hepatitis B vaccine is a vaccine that prevents hepatitis B. The first dose is recommended within 24 hours of birth, with two or three more doses after that. This includes those with poor immune function such as from HIV/AIDS and those born premature.
The inactivated polio vaccine (IPV) was developed in 1955 by Dr Jonas Salk. Also called the Salk vaccine IPV consists of inactivated (killed) poliovirus strains of all three poliovirus types. IPV is given by intramuscular or intradermal injection and needs to be administered by a trained health worker.
The Haemophilus influenzae type b (Hib) vaccine is used to prevent invasive H. influenzae infections (usually caused by H. influenzae type b). It is in the vaccine class of medications. This activity describes the indications, mechanism of action, and contraindications for the Hib vaccine. Hib vaccine's role as a valuable agent in preventing early childhood meningitis and other complications of H. influenzae.
At the recent SEC meeting for Vaccines held on 14th and 15th December 2023, the expert panel reviewed the proposal presented by the vaccine maker Biological E to conduct a Phase II clinical trial in 6- 8 weeks old infants along with a Phase I clinical trial report.
After detailed deliberation, the committee noted the results of the Phase I clinical trial report and recommended the grant of permission to conduct a Phase II clinical trial as per the protocol presented.
