Russia’s Sputnik V COVID-19 vaccine gets expert panel nod for emergency use in India


Dr Reddy’s conducted the bridge trials in India and will distribute some 100 million doses of the vaccine in India.

Russia's Sputnik V COVID-19 vaccine gets expert panel nod for emergency use in India

Russian’s Sputnik V COVID-19 vaccine is also under WHO’s pre-approval process. Image: RDIF

India is set to get a third COVID-19 vaccine to aid in its fight against the COVID-19 pandemic after the Russian vaccine Sputnik V has been approved for emergency use by an expert panel of India’s central drug authority, according to several media reports.

The Subject Expert Committer (SEC) has recommended that the vaccine be allowed for use in India with certain conditions, sources told PTI.

Now, the Drugs Controller General of India (DCGI) will take the final call.

This comes as India hit a new coronavirus infection record with 1,68,912 new cases, the highest single-day rise so far, taking the total tally of cases to 1,35,27,717, according to the Union Health Ministry data updated on Sunday.

The national COVID-19 recovery rate fell below 90 percent.

Currently, only two vaccines are being used in India: Bharat Biotech’s Covaxin and Serum Institute’s Covishield.

As India continues to grapple with a second, more potent wave of coronavirus pandemic, the country’s vaccination plan hit another roadblock as at least six states have complained of a shortage of vaccine doses with many centres being forced to temporarily shut down.

According to a report by MoneyControl, a Dr Reddy spokesperson confirmed the news.

The Indian pharma giant and the Russian Direct Investment Fund (RDIF) partnered up to conduct clinical trials for the vaccine in September. Dr Reddy’s will also take on the distribution of some 100 million doses of the vaccine in India.

The Russian vaccine has an efficacy of 91.6 percent and is conducting Phase III clinical trials in the UAE, India, Venezuela and Belarus, according to the Sputnik-V’s website.

Also read: Russia’s Sputnik V vaccine has 91.6% efficacy against COVID-19 , says study based on Phase 3 trials

According to a report by The Statesman, Russia’s RDIF has also tied up with Virchow Biotech Private Limited to produce up to 200 million doses per year of the COVID-19 vaccine in India. Stelis Biopharma Pvt Ltd and Panacea Biotec also signed on with RDIF to produce 200 million and 100 million doses per year respectively.

About the vaccine

The Sputnik V vaccine is being developed by Gamaleya Scientific Research Institute of Epidemiology and Microbiology along with the Russian Defence Ministry and the Russian Direct Investment Fund (RDIF) has bankrolled the project.

Sputnik V uses a combination of two viral vectors adapted from the common cold-causing adenovirus, for pharmaceutical use – the adenovirus type 26 (rAd26) vector and a recombinant adenovirus type 5 (rAd5) vector. The vector carries the genetic code of the “spike” protein, which is spread across the surface of the COVID-19 -causing SARS-CoV-2 virus. This code acts as a tag for the immune system to recognize the virus if a genuine infection by the coronavirus comes along.

According to a statement by the RDIF, the use of two different vectors in two separate shots achieves a more effective immune response, as compared to the use of the same vector in two shots. By using the same vector twice, the immune system launches a defence mechanism against the virus and starts to reject the drug in the second injection,

The vaccine can be given to a person in two ways – frozen or lyophilised- is the process of freeze-drying a vaccine to make it more convenient to transfer and increase its shelf life. It is administered via an intramuscular injection – which is a technique used to deliver the vaccine deep into the muscles, allowing it to be absorbed into the bloodstream quickly.

On Sunday, multi-disciplinary teams deployed by the Centre to 50 districts across Maharashtra, Chhattisgarh and Punjab, flagged several problems with the states’ approach to contain the spread of the coronavirus pandemic.

Meanwhile, in view of increased demand for Remdesivir due to a surge in COVID-19 cases, the government banned the export of the antiviral injection and its Active Pharmaceutical Ingredients (API) has been banned till the situation improves.

 



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