Drug Controller General of India (DCGI) has finally given permission to an Indian drug maker, Panacea Biotec for conducting early phase clinical trials in humans (phase 1 & 2) for the dreaded Dengue virus. A single shot of the experimental vaccine developed by Panacea Biotec in collaboration with National Institutes of Health (NIH), US has shown to be effective against all four types of Dengue virus in all age groups according to early clinical trials conducted by NIH.
The disease is caused by four closely related viruses, called the Dengue viruses 1-4. Globally the only Dengue vaccine developed by French drug major Sanofi Pasteur company which was given the green light by WHO in July 2016 was denied introduction into our market by the Indian health ministry as it sought a waiver of the phase 3 clinical trials for the vaccine. The data supporting the waiver was deemed insufficient as the 3 dose vaccine was effective only in age group of 9 to 45 years in areas with high disease burden.The vaccine which was initially given license in 11 countries was subsequently withdrawn by early starter countries like Philippines.
The mosquito borne disease causes high grade fever associated with severe headache, BODY ACHE, vomiting, muscle pain, skin rashes and a fall in total white blood cell and platelet count.
The mosquito borne disease causes high grade fever associated with severe headache, bodyache ,vomiting, muscle pain, skin rashes and a fall in total white blood cell and platelet count. Infants, children,senior citizens, people with other chronic disease and pregnant women with weakened immune system are at increased risk of developing Dengue Haemorrhagic Fever , a rare complication which can cause massive bleeding and shock leading to death in 24hrs also called Dengue Shock Syndrome.
A dengue vaccine would therefore represent a major shot in the arm in the control of the disease and save significant cost to the Government and common man
The disease has suddenly come into limelight in India since 2015 when the number of cases and deaths suddenly spurted in Delhi and Punjab. The disease subsequently spread to other states like Uttar Pradesh, West Bengal, Tamilnadu, Kerala and Karnataka in 2016 and 2017 as they registered the maximum number of cases and deaths. About 140000 cases and 216 deaths have been reported so far in 2017 due to Dengue fever. According to WHO the reported numbers could only be the tip of the iceberg as most cases pass of asymptomatically and widespread laboratory facilities are not available in most developing nations. Dengue cases are expected to rise significantly due to higher temperatures in most parts of the world as a result of global warming.
There are no specific treatment for dengue and prevention is currently limited to vector control measures. A dengue vaccine would therefore represent a major shot in the arm in the control of the disease and save significant cost to the Government and common man.
