Preliminary results show Chinese COVID-19 vaccine safe: The Lancet

Russia pandemic

Russia pandemic

The Drug Controller General of India (DCGI) has granted approval to Dr Reddy's, a global pharmaceutical company headquartered in India, to conduct phase 2 and 3 clinical human trials of the Sputnik V, a Covid-19 vaccine made by Russian Federation.

The nod came after the Hyderabad-based company submitted a reworked application to the Drugs Controller General of India (DCGI) on October 13 with more information on phase 2 and 3 trials.

On August 11, 2020, Sputnik V, developed by the Gamaleya National Center of Epidemiology and Microbiology, was registered by the Ministry of Health of Russian Federation and became the world's first registered vaccine against Covid-19 based on the human adenoviral vectors platform.

In a statement on Saturday, Dr Reddy's said the late-stage clinical trials will be a multi-centre and randomised controlled study, including safety and immunogenicity study.

Russian Federation registered the new vaccine in August, before a large-scale Phase-3 clinical trial was conducted.

AstraZeneca had earlier paused the ongoing trial of the coronavirus vaccine (recombinant) as a volunteer had developed an unexplained illness.

BBIBP-CorV is one of at least 10 coronavirus vaccine projects globally to have entered Phase 3 trials, four of which are led by Chinese scientists, according to the World Health Organisation.

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Victoria state officials have said they would ease restrictions when the average for new daily cases over a two-week window falls below five.

A Chinese COVID-19 vaccine candidate based on the inactivated whole SARS-CoV-2 virus is safe and elicits an antibody response, according to findings from a small early-phase randomized clinical trial published Thursday in The Lancet Infectious Diseases journal.

RDIF CEO Kirill Dmitrev said that in addition to Indian clinical trials data, RDIF will provide safety and immunogenicity study from the Russian Phase-3 clinical trial as well.

Meanwhile, phase-3 trials of Sputnik V are now underway in Russian Federation since September 1 on 40,000 subjects. The trial will take six months to complete.

The authorities did not say how many in the city had been given the vaccine, which comes in two doses, administered up to 28 days apart and costing 400 yuan (S$81.50).

Chairing a meeting to review the COVID-19 pandemic situation and the preparedness of vaccine delivery, distribution, and administration, the prime minister also noted a steady decline in the daily cases and the growth rate.

Upon regulatory approval in India, RDIF shall supply Dr. Reddy's with, 100 million doses of the vaccine, the firm had announced last month.

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