Awaiting approval for its dengue vaccine in India, French drug major Sanofi today said it has shared data with authorities here about the risk of administering its vaccine to patients who have not been infected with the virus previously.
The company, which is under fire in various countries, including the Philippines and Brazil over the vaccine, however, said "supplementary analysis confirmed (its) significant and persistent beneficial value" in people with a prior history of dengue infection before vaccination.
Citing results of an assay test co-developed with the University of Pittsburgh, a Sanofi Pasteur India spokesperson told PTI, "For those not previously infected by dengue virus, the analysis found, in the longer term, more cases of severe disease could occur following vaccination upon a subsequent dengue infection."
The spokesperson, however, said the results confirmed beneficial value of the vaccine in people with a prior history of dengue infection before vaccination.
"This forms the major proportion of population in endemic countries such as India," the spokesperson added.
When asked about the status of vaccine in India, the company said it had submitted the vaccine regulatory file to the Indian authorities in October 2015.
"...the vaccine received positive recommendations in 2016 from the Subject Expert Committee and the Technical Committee of the Ministry of Health and Family Welfare. Currently, the decision to approve the Sanofi Pasteur dengue vaccine in India is under review," the spokesperson added.
On the impact of issues surrounding the vaccine in Brazil and the Philippines, the spokesperson said, "Sanofi Pasteur has taken action to transparently share this new data with the health authorities in the countries where the vaccine is in use today or where it is currently being considered for regulatory approval."
Yesterday, the Philippines government ordered an investigation into the immunisation of more than 7.3 lakh children with the company's dengue vaccine.
The action came after Sanofi announced that the vaccine could worsen the disease in some cases. Already, Brazil has recommended restricted use of the vaccine.