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Combination of Sputnik V component with AstraZeneca, Sinopharm and Moderna shows high safety: RDIF study

by Medically Speaking Team
written by Medically Speaking Team

In a finding that could provide a boost to the global fight against COVID-19, Russian researchers have discovered that a combination of variants of Sputnik V with vaccines of AstraZeneca, Sinopharm, and Moderna could provide immunity against COVID-19. A study by the Russian Direct Investment Fund (RDIF) has said that the approach could provide a longer and more durable immunity against the deadly virus.

“A study was conducted in Argentina, in which, the heterogeneous boosting approach (‘vaccine cocktail’ using human adenovirus serotype 26 as the first component and human adenovirus serotype 5 as the second component) was at the core of Sputnik V, the world’s first registered vaccine against coronavirus. With this approach proving successful in creating a longer and more durable immunity against the coronavirus,” RDIF said in a statement.

According to news agency ANI, 121 volunteers were analysed in the regimens – Sputnik Light/AstraZeneca, Sputnik Light/Moderna, Sputnik Light/Sinopharm, Sputnik Light/Sputnik Light compared to control group Sputnik V 1 Comp./Sputnik V 2 Comp.

Sputnik V is effective against the Delta variant of COVID-19: Study

“RDIF is the first country to offer vaccine cooperation to other producers to conduct joint mix and match studies. This approach is the most promising one to fight the pandemic and new strains of coronavirus emerging around the world,” Kirill Dmitriev, CEO of RDIF said.

The outcome of the study may be important given that it could strengthen the ongoing global fight against the deadly virus. In India, Sputnik is being produced in partnership with the Serum Institute of India, the largest vaccine producer in the world. A recent study has shown that it is one of the most effective vaccines against COVID-19, including its Delta variant.

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Sputnik V
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Serum enters into agreement with RDIF to make Sputnik V, to begin first batch production in September

by Medically Speaking
written by Medically Speaking

Russia’s sovereign wealth fund Russian Direct Investment Fund (RDIF) and Serum Institute of India (SII) has entered into an agreement to produce the Sputnik V COVID-19 vaccine.

The first batch of Sputnik V vaccine doses is expected to be produced at SII’s facilities in September, SII and RDIF said in a joint statement on July 13.

The parties intend to produce over 300 million doses of the jab in India per year.As part of the technical transfer process, SII has already received cell and vector samples from the Gamaleya Center.

“With their imprort approved by the Drug Controller General of India (DCGI), the cultivation process has begun,” RDIF said.

RDIF had earlier reached agreements with a number of pharmaceutical companies in India such as Gland Pharma, Hetero Biopharma, Panacea Biotec, Stelis Biopharma, Virchow Biotech and Morepen for production of the Russian vaccine. Most of these are fixed-price contract manufacturing arrangements.

Dr. Reddy’s holds the sole distribution rights for the first 250 million doses of Sputnik V in India.

The Russian Sputnik V vaccine has been registered in 67 countries that together have a population of over 3.5 billion people. The data obtained by regulators of a number of countries including Argentina, Serbia, Bahrain, Hungary, Mexico, San Marino and the United Arab Emirates, demonstrates that Sputnik V is one of the safest and most effective vaccines against the novel coronavirus.

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Sputnik V
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Sputnik V vaccine production launched in India by RDIF, Panacea Biotec

by Medically Speaking Team
written by Medically Speaking Team

The production of Sputnik V, the COVID-19 vaccine granted emergency use authorisation, has been launched in India, said a joint statement issued by Russian Direct Investment Fund (RDIF) and pharmaceutical firm Panacea Biotec on May 24.

The first batch of doses produced at Panacea Biotec’s facilities at Himachal Pradesh’s Baddi will be shipped to the Moscow-based Gamaleya Centre for “quality control”, the statement said.

Full-scale production of the vaccine is due to start this summer, it stated, adding that the company’s facilities “comply with GMP standards and are prequalified by the WHO (World Health Organisation)”.

Panacea Biotec’s Managing Director Dr Rajesh Jain said the launch of Sputnik V production is a significant step in India’s battle against the virus. “Together with RDIF, we hope to help bring a sense of normalcy back to people across the country and around the world,” he added.

RDIF’s chief executive officer Kirill Dmitriev said the domestic production of Sputnik V supports India’s efforts to “leave behind the acute phase of coronavirus as soon as possible”.

“The vaccine will also be exported at a later stage to help prevent the spread of the virus in other countries around the world,” he added.

Sputnik V was registered in India under the emergency use authorisation procedure on April 12, 2021. As announced in April, RDIF and Panacea have agreed to produce 100 million doses per year of Sputnik V.

The RDIF has also partnered with the Hyderabad-based Dr Reddy’s Laboratories for localised production and distribution of the vaccine.

To date, Sputnik V has been registered in 66 countries globally with a total population of over 3.2 billion people. The efficacy of Sputnik V is 97.6 percent based on the analysis of data on coronavirus infection rate among those in Russia vaccinated with both components of Sputnik V from December 5, 2020, to March 31, 2021.

The vaccine is based on a proven and well-studied platform of human adenoviral vectors and uses two different vectors for the two shots in a course of vaccination, “providing immunity with a longer duration than vaccines using the same delivery mechanism for both shots”, the statement said.

Sputnik V is the third COVID-19 vaccine that would be administered to the beneficiaries across India. The country has so far conducted its inoculation drive using Covishield and Covaxin, manufactured by the Pune-based Serum Institute of India and Hyderabad’s Bharat Biotech Limited, respectively.

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Sputnik V Covid-19 vaccine gets final approval from India

by Medically Speaking Team
written by Medically Speaking Team

New Delhi- Russian -made first COVID-19 vaccine in the world gets final approval in India , it will be manufactured by five pharma firms in the country and 850 million doses are going to be produced annually. It is expected to supply limited doses by the end of April.

The  India’s drug regulator , DCGI has approved the Russina vaccine fater it got a green signal from the Subject expert committee that comes under CDSCO

“M/s DRL was permitted to conduct a Phase-II/III clinical trial in the country. The firm has submitted interim data from the ongoing Phase-II/III clinical trial in the country. The data from the clinical trial is being continuously assessed by the CDSCO in consultation with the Subject Expert Committee (SEC) as a rapid regulatory response. The SEC consists of domain knowledge experts from the fields of pulmonology, immunology, microbiology, pharmacology, paediatrics, internal medicine, etc.” says statement issued by the union health ministry

The vaccine will be administered on above 18 years of age group with a interval of 21 days, “The vaccine is indicated for active immunization to prevent COVID-19 disease in individuals of ≥ 18 years of age. The vaccine should be administered intramuscularly in two doses of 0.5 ml each with interval of 21 days. (Day 0: Component I & Day 21: Component II). The vaccine has to be stored at -18°C. The vaccine comprises of two components I & II, which are not interchangeable. After careful consideration, the recommendations of the SEC have been accepted by the Drugs Control General (India). M/s DRL will import the vaccine for use in the country.” says the statement.

Dr Reddy’s Laboratories co-chairman and managing director GV Prasad said, “We are very pleased to obtain the emergency use authorisation for Sputnik V in India.  With the rising cases in India, vaccination is the most effective tool in our battle against COVID-19. This will enable us to contribute to our nation’s effort of vaccinating a significant proportion of our population.”

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