Sputnik V batch arrives, human trials to begin soon

While there is no clarity on when phase 2 trials will start here, a source close to the development told The Indian Express towards the end of last week that testing was expected to start “soon”. (Reuters)

A batch of Sputnik V has finally made it to India in the run up to mid-stage human trials that will soon kick off in the country to test the safety and effectiveness of the Russian Covid-19 vaccine candidate on the population here.

“The Sputnik V vaccine has landed in India for clinical trials,” confirmed a spokesperson for Hyderabad-headquartered Dr Reddy’s Laboratories (DRL), which got the Indian drug regulator’s nod last month to conduct phase 2/3 trials of the vaccine here.

According to the spokesperson, the batch for testing arrived in Delhi “early last week”, though the phase 2 trial “is yet to start”.

Spokespersons for DRL and the Russian Direct Investment Fund (RDIF), which tied up with the Hyderabad vaccine maker to bring the vaccine to India, declined to elaborate on the details like how many doses of Sputnik V have arrived here for testing.

While there is no clarity on when phase 2 trials will start here, a source close to the development told The Indian Express towards the end of last week that testing was expected to start “soon”.

The phase 2 trial here will enroll 100 volunteers and, if the data collected from this trial is satisfactory, the vaccine candidate will progress to phase 3 trials testing around 1,500 volunteers.

One “dose” of Sputnik V, RDIF’s spokesperson had earlier told The Indian Express, consists of two shots that are to be given nearly a month apart.

The first shot consists of a genetically modified and weakened human ‘adenovirus’, or common cold virus, which will be used to carry the code for the cells in the body to make the spike protein–the spiky outer layer of the SARS-CoV-2 virus that causes Covid-19.

The second shot performs this function using a different genetically modified and weakened human adenovirus.

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