The Indian drug regulator may ask Pfizer to conduct a local clinical trial for its vaccine as the firm does not have enough data on trial participants of Indian ethnicity, experts said. You have to give data on the local population for any vaccine. If Pfizer’s global trial included some data on Indian population, they would have been considered for a clinical trial waiver, but because their data seems inadequate, it is unlikely the clinical trial waiver will be given, a researcher involved with vaccine regulatory processes said on condition of anonymity.
The researcher added that Pfizer’s global trial data alone is unlikely to be a compelling reason to sway the subject expert committee and Drugs Controller General of India V.G. Somani to grant a clinical trial waiver that it has sought, considering the risks involved with approving a new technology. Pfizer had this month submitted an application for an emergency use licence for its covid jab based on the messenger RNA platform, a relatively new technology that is a decade old. The vaccine is the first covid shot to have received clearance in the UK, US, Bahrain and Canada, and the first mRNA vaccine to get a nod anywhere in the world.
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