New Delhi: French pharmaceutical company Sanofi has sought permission to market its dengue vaccine in India.
The first dengue vaccine, Dengvaxia, was licensed by the World Health Organisation in December 2015.
The French company placed its proposal seeking marketing authorisation, along with safety and immunogenicity data from phase 2 clinical trials in the country, before the Narendra Modi government’s expert panel on 2 June. It had also submitted the efficacy results from studies from other countries.
The subject expert committee (SEC) — which advises the Drug Controller General of India (DCGI) on applications seeking approvals for new drugs, vaccines, and clinical trials — deliberated on the proposal on 2 July and has asked the company to “identify the endemic areas based on the Indian Council of Medical Research’s serosurvey”.
The SEC also took note of the fact that the vaccine is approved in the US and other countries for use in patients who have been infected with the dengue infection in endemic areas, according to the minutes of the meeting recently uploaded on the Central Drugs Standard Control Organisation (CDSCO) website.
The live attenuated dengue vaccine is now approved in more than 50 countries for the prevention of dengue disease caused by four kinds of dengue virus serotypes, numbered as 1, 2, 3 and 4. A person infected with one serotype can get re-infected with the other three serotypes as well.
The vaccine is to be administered in individuals from 9 to 45 years of age who have been infected with dengue virus before and who live in areas where this infection is endemic.
Sanofi to submit more details on previous infection testing kits
The vaccine can only be given to children and people who have had one previous laboratory-confirmed case of dengue.
However, the expert panel noted that the test to confirm previous dengue infection is currently not available in the country.
Consequently, the panel has also asked the company to present full details of the claims of the manufacturer of the diagnostic test that identifies previous dengue infections for further consideration.
Only those who have been infected by dengue can receive the vaccine because the results of an additional analysis showed that the subset of trial participants who were not infected by the disease and were vaccinated had a higher risk of developing severe dengue and hospitalisations from dengue compared to unvaccinated participants.
In 2018, European Union approved the vaccine followed by the US in 2019.