An Indian pharmaceutical company registered to test the COVID-19 Sputnik V vaccine

Dr Reddy’s Laboratories of India has submitted an application to the General Department of Pharmaceutical Control of this country (DCGI) to test the vaccine COVID-19 Sputnik V of Russia.

According to ANI’s news agency IndiaThis will be a randomized controlled trial (RCT – that is, which group of patients is placed in will be randomly assigned by computer, this ensures that all, according to a government official). randomized people), “double-blind” trial (trial participants and those who treated do not know who is on the new drug, who is on placebo), multi-center.

Previously, the health regulator of India rejected the request of Dr Reddy’s Laboratories to immediately conduct the third phase of testing the Russian vaccine in the country, asking them to conduct both phase two and phase two tests. stage three.

According to Sputnik, Russian Direct Investment Fund (RDIF) and Dr Reddy’s Laboratories Ltd. India has previously agreed to conduct clinical trials of the above vaccine. Information that 100 million doses of the vaccine will be shipped to India as soon as it is approved by a regulatory authority in the country.

On August 11, the Russian Ministry of Health registered the world’s first vaccine to prevent COVID-19 called Sputnik V, developed by the Gamaleya National Center for Epidemiology and Microbiology. production cooperation with RDIF. One dose of the vaccine consists of two injections three weeks apart.

So far, three types of COVID-19 vaccines are being tested in India. In particular, Bharat Biotech and Zydus Cadila are conducting the second phase of the clinical trial for the Covaxin and ZycovD vaccines they studied.

The Indian serological institute is conducting phase 2 trials of the Oxford University ChAdOx1 vaccine at 17 medical centers and is preparing phase 3 trials. It is expected to have 1,600 participants. The Serum Institute of India is currently working with 5 international pharmaceutical companies to develop the COVID-19 vaccine, including AstraZeneca and Novavax.


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