Last Updated on September 30, 2024 by The Health Master
Clinical Trial
Clinical Trial: India has taken a significant stride in its battle against dengue, a debilitating mosquito-borne disease that has plagued the country for years.
The Indian Council of Medical Research (ICMR) and Panacea Biotec have jointly initiated the first-ever Phase 3 clinical trial for a dengue vaccine made entirely in India.
This groundbreaking development marks a crucial step towards eradicating the disease and underscores India’s growing prowess in vaccine research and development.
DengiAll: India’s Hope Against Dengue
The vaccine at the heart of this trial is called DengiAll, a tetravalent dengue vaccine developed by Panacea Biotec.
The term ‘tetravalent’ signifies its ability to protect against all four serotypes of the dengue virus, a key challenge in vaccine development.
The first participant to receive the DengiAll vaccine was administered the dose on August 14, 2024, at the prestigious Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS), Rohtak.
Government’s Commitment to Public Health
Union Health Minister, JP Nadda, hailed the commencement of the Phase 3 trial as a monumental achievement.
He emphasized the government’s unwavering dedication to safeguarding the health and well-being of Indian citizens.
The minister also highlighted the trial as a testament to India’s growing self-reliance in the healthcare sector, aligning with the government’s ‘Atmanirbhar Bharat‘ initiative.
The Challenge of Dengue and the Need for a Vaccine
Dengue, a viral infection transmitted primarily by the Aedes mosquito, has been a persistent public health threat in India.
Despite being a common disease, there has been no effective antiviral treatment or licensed vaccine available until now.
he complexity of developing a dengue vaccine lies in the need to provide protection against all four dengue serotypes, as immunity to one serotype does not guarantee protection against others.
Building on Promising Results
The tetravalent dengue vaccine strain used in DengiAll was originally developed by the National Institutes of Health (NIH) in the USA.
Panacea Biotec, one of three Indian companies to acquire the strain, has invested substantial efforts in refining the vaccine formulation.
The company holds a process patent for its work and has demonstrated promising results in the previous Phase 1 and 2 clinical trials conducted in 2018-19.
A Massive Clinical Trial
The Phase 3 clinical trial is an ambitious undertaking involving over 10,335 healthy adult participants across 19 sites in 18 states and union territories of India.
The trial is primarily funded by the ICMR, with additional support from Panacea Biotec.
Researchers will closely monitor participants for two years to evaluate the vaccine’s efficacy, safety, and long-term impact.
India’s Fight Against a Global Menace
Dengue is a global health concern, with over 129 countries reporting cases in 2023.
While India contributes significantly to the global dengue burden, the country’s efforts to develop an indigenous vaccine hold immense promise for the world.
The successful development of DengiAll could be a game-changer in the global fight against dengue.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
India allows Clinical Trial waivers for Drugs from these 6 Countries
CDSCO Panel approval granted for Clinical Trial On Linaclotide Capsules
CDSCO Panel approval granted for Clinical Trial of this Anti Cancer Drug
Specific Regulations required for New Drugs and Clinical Trial Rules for Homoeopathy
NPPA revised Ceiling price of 4 scheduled formulation: August 2024
Saudi FDA fines 6 Pharma Companies for violating Law
USFDA new norms on Container Closure System: A Boon for Indian Pharma?
Draft guidelines issued for Good Distribution Practices for Pharmaceuticals
New Rules for Cosmetic Registrations and Imports
USFDA grants VAI classification to Dr Reddy’s at Visakhapatnam
CDSCO Panel nod granted to study Fexuprazan HCL Tablet
Indian Pharma gets Fast Track export to Argentina
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon: