Hyderabad: The Dengue tetravalent vaccine, which can be used for all the four types of dengue virus, has been recommended by the Central Drugs Standard Control Organisation for use in India.
This despite the vaccine not having completed Phase III trials in India. The CDSCO committee which met on September 29 recommended that in the wake of the increasing cases of dengue in the country, and most of them becoming life-threatening, the vaccine must be made available in the Indian market.
There is, however, a case in the Supreme Court wherein the contention is that till all the three phases of clinical trials are carried out in India, no vaccine or medicine should be launched in India.
According to sources in the pharmaceutical industry, the recommendation of the CDSCO in the wake of rising dengue cases will be put before the Supreme Court to allow the vaccine to be made available in the Indian market.
The dengue vaccine is a preventive measure which will produce antibodies and protect the person from all the four types of dengue virus.
The vaccine is being produced by Sanofi Pasteur India Private Limited. It has undergone Phase I trials on animals and Phase II trials in humans aged 18 to 45 years. Its reports were submitted in 2015.
These reports were accepted by the clinical trials committee and Phase III of the trials, that are also to be conducted on humans, was to be carried out.
The company has submitted data of Phase III trials from Asian and Latin American countries to the CDSCO. The committee took these results into account and recommended the vaccine.
Based on the results of Phase III trials, the vaccine has been approved in Brazil, Mexico, Singapore and the Philippines. The committee has stated that the vaccine must be allowed for market authorisation trial only in the age group of 18 to 45 years and within three months,
Phase IV clinical trial results must be submitted to the committee. The market authorization process has to be approved by the Supreme Court and only then can the vaccine be brought into the market.
