New Delhi: French pharmaceutical company Sanofi has applied for permission to market its dengue vaccine in India.
The first dengue vaccine, Dengvaxia, was licensed by the World Health Organization in December 2015.
The French company submitted its marketing authorization proposal, as well as safety and immunogenicity data from phase 2 clinical trials in the country, to government expert group Narendra Modi on June 2. . He had also submitted the efficacy results of studies carried out in other countries.
The Subject Matter Experts Committee (SEC) – which advises the Drug Controller General of India (DCGI) on applications for approval of new drugs, vaccines and clinical trials – deliberated on the proposal on July 2 and asked the company to “identify endemic areas based on the Indian Council of Medical Research’s serological survey”.
The SEC also took note that the vaccine is approved in the United States and other countries for use in dengue-infected patients in endemic areas, according to the meeting minutes recently posted online. on the Central Drugs Standard Control. Organization website (CDSCO).
The live attenuated dengue vaccine is now approved in more than 50 countries for the prevention of dengue caused by four types of dengue virus serotypes, numbered 1, 2, 3 and 4. A person infected with one serotype can be infected with the other. three too.
The vaccine should be given to people between the ages of 9 and 45 who have been infected with the dengue virus in the past and who live in areas where this infection is endemic.
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Sanofi to submit more details on previous infection test kits
The vaccine can only be given to children and to people who have had a laboratory-confirmed case of dengue fever in the past.
However, the expert group noted that the test to confirm a previous dengue infection is currently not available in the country.
Therefore, the panel also asked the company to present full details of the manufacturer’s claims of the diagnostic test that identifies previous dengue infections for further consideration.
Only those who have been infected with dengue can receive the vaccine because the results of further analysis showed that the subset of trial participants who were not infected with the disease and who were vaccinated had a higher risk of developing severe dengue and being hospitalized for dengue compared to unvaccinated participants.
In 2018, the European Union approved the vaccine followed by the United States in 2019.
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