CDSCO rejects GSK request to skip Phase III trial for Influenza Vaccine for higher age groups
New Delhi: One of the oldest pharmaceutical and healthcare companies in India, GlaxoSmithKline recently presented before the Subject Expert Committee functional under the Central Drugs Standard Control Organization (CDSCO) for a waiver of clinical trial of Inactivated Influenza Vaccine (Split Virion). However, CDSCO did not grant permission to skip the clinical trial and directed them to conduct the Phase III trial.
The recommendation came after the firm presented the proposal for waiver of the clinical trial requirement for an extension of the indication to higher age groups.
Much to its dismay, the committee did not rule in favour of the proposal presented by GSK. Instead, the SEC committee recommended that "the firm should conduct Phase III local clinical trial in the proposed age group."
An inactivated vaccine (or killed vaccine) is a vaccine consisting of virus particles, bacteria, or other pathogens that have been grown in culture and then killed, thereby implying extra caution needs to be exercised as compared to a drug (formulation) trial.
According to the WHO guidelines for clinical evaluation of vaccines, the phase III studies that are large-scale clinical trials designed to provide data on vaccine efficacy and safety are necessary.
These studies are usually performed in large populations to evaluate the efficacy and safety of formulation(s) of the immunologically active component(s).
A couple of years ago, CDSCO had shown a green flag to Zydus Cadila's tetravalent inactivated influenza vaccine for seasonal flu. Medical Dialogues had earlier reported that Zydus had received approvals from the Drug Controller General of India (DCGI), CDSCO and Central Drug Laboratory (CDL) to market the tetravalent inactivated influenza vaccine Vaxiflu 4 for seasonal flu. For instance, Influenza is a major respiratory pathogen causing annual outbreaks and occasional pandemics.
Presently, GSK's proposal for a waiver of the phase III trial regarding the Inactivated Influenza Vaccine has not been considered and the firm has been recommended to conduct the same.
GSK is an Indian subsidiary of GlaxoSmithKline plc, one of the world's leading research-based pharmaceutical and healthcare companies.
Its product portfolio includes prescription medicines and vaccines. It's prescription medicines range across therapeutic areas such as anti-infectives, dermatology, gynaecology, diabetes, oncology, cardiovascular disease and respiratory diseases.
The company also offers a range of vaccines, for the prevention of hepatitis A, hepatitis B, invasive disease caused by H, influenza, chickenpox, diphtheria, pertussis, tetanus, rotavirus, cervical cancer and others.