Is it good to be unrelenting in matters relating to granting marketing approvals for vaccines? Perhaps. That is the message one gets from the stand taken by the Indian drug controller that has yet to grant approval to Sanofi's dengue vaccine - Dengvaxia.
The vaccine has just been granted approval by the US Food and Drug Administration (USFDA) for prevention of dengue in individuals aged 9 through 16 living in US endemic areas, albeit with severe restrictions on its use. In India, Sanofi's spokesperson says the regulatory approval of the vaccine was endorsed by the technical committee of the government in 2017 but "since then, there is no further development to share."
The Indian regulator had maintained then that it required further evaluation of its therapeutic performance on Indian population. Given the curbs now imposed by the USFDA, doctors prefer caution fearing misuse in India if not properly checked.
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