Serum Institute Gets DCGI Nod For Clinical Trials Of Oxford Vaccine

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COVID-19 Vaccine: Pune Firm Gets Nod For Human Trial of Covishield, 1,600 People to Participate

Russian Federation reportedly has two candidate vaccines being considered for approval: Vektor's and another developed by the Moscow-based Gamaleya Institute in cooperation with the Defense Ministry.

On the 42nd day after the first vaccination, the volunteers returned to the hospital and underwent an in-depth medical examination and diagnosis, it said.

This will hasten the development of the COVID-19 vaccine.

Gamaleya's vaccine is a so-called viral vector vaccine, meaning it employs another virus to carry the DNA encoding the needed immune response into cells.

"An urgent meeting was held by the subject expert committee on COVID-19 on Friday to consider SII's application".

The Drugs Controller General of India (DCGI) on Monday (August 3, 2020) gave approval to the Serum Institute of India in Pune to conduct Phase II+III clinical trials of Oxford University-Astra Zeneca COVID-19 vaccine (COVISHIELD) in India.

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Pfizer and BioNTech's first vaccine targeted a piece of the spike protein , a structure the virus uses to infect human cells. Clinical trials on another 1,600 people will start after the registration and will continue along with the production.

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According to the study design, each subject will be given two doses four weeks apart (the first dose on day one and the second on day 29), after which safety and immunogenicity will be assessed at predefined intervals. "The firm has to submit safety data, evaluated by the Data Safety Monitoring Board (DSMB), to the CDSCO before proceeding to Phase 3 clinical trials", a senior official said. Around 1,600 people above 18 years of age will participate in the trials across 17 selected sites.

Last month, Russian Federation was accused by officials in the U.S., Canada and Britain of trying to hack and steal coronavirus vaccine data.

Currently, the country is said to be initially planning serial production of the first domestic vaccine developed by the Gamaleya National Research Center of Epidemiology and Microbiology by September, TASS, a Russian agency reported.

In fact, the cost and effort alone is likely to take years as vaccines are required to go through multi-stage clinical trial processes to ensure it's safe for everyone, particularly those who are high-risk or have underlying conditions. The candidate, is however, yet to complete its trials.

RDIF has been involved in funding the country's vaccine research.

Sanofi-GlaxoSmithKline: Sanofi and GlaxoSmithKline have said that they are in advanced discussions to supply up to 300 million doses of an experimental COVID-19 vaccine for the 27-country European Union.

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