Indian Drug Regulator asks Dr. Reddy’s for more data on Sputnik V vaccine

The committee asked the company to submit a comparative analysis of late-stage immunogenicity data

Medicine Injection Vaccine
Picture: Pixabay

Bengaluru: An expert panel of India’s drug regulator on Friday sought additional data from drug maker Dr. Reddy’s Laboratories on its Sputnik V C-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.

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