India drug regulator asks Dr. Reddy's for more data on Sputnik V vaccine

Sputnik V coronavirus vaccine

BENGALURU (Reuters) - An expert panel of India's drug regulator on Friday sought additional data from drugmaker Dr.Reddy's Laboratories on its Sputnik V COVID-19 vaccine trial, in its second such request after an initial evaluation in February.

The committee asked the company to submit a comparative analysis of late-stage immunogenicity data from both its Indian studies and an ongoing Russian study, as well as data on serious adverse events and positive cases reported till date.

Dr.Reddy's has been conducting small clinical trials with Sputnik V in India under a deal with Russia's wealth fund. Several Indian companies have signed deals to produce and supply over half a billion doses of the vaccine.

 

(Reporting by Anuron Kumar Mitra in Bengaluru; Editing by Arun Koyyur)


(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)


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