Panel seeks more data to clear Sputnik V

Panel seeks more data to clear Sputnik V

A Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization has sought more data on Russia’s Sputnik V vaccine trials from Dr. Reddy’s Laboratories to accord emergency use authorisation for the COVID-19 antidote.

“The committee recommended that [the] firm should submit immunogenicity and safety data of Phase II and III trial as per approved protocol for further consideration.

• Further, the firm is requested to present its data with more clarity, “We understand the importance of effective investigation and we will approach the regulator with the requisite data soon.”
• The SEC meeting asked Covaxin maker Bharat Biotech, which sought permission to conduct phase III clinical trial of the vaccine candidate in children aged 5-18 years, to submit efficacy and safety data of ongoing Phase III clinical trial in adults along with the age subgroup analysis.
• 20 mn doses for Brazil, Bharat Biotech said it has signed an agreement with Brazil for supplying 20 million doses of Covaxin.
• Under the deal worth 1.6 billion reals ($290 million), the vaccine will be delivered in the second and third quarter of 2021.
• “There is a strong interest in Covaxin from many countries and the company is fully committed to ensuring supplies promptly and efficiently,”.

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Sputnik V

• Sputnik V is the world’s first registered vaccine based on a well-studied human adenoviral vector-based platform. Sputnik V is already registered in more than 35 countries.
• The ongoing Sputnik V post-registration clinical trial in Russia involved more than 31,000 volunteers. Phase 3 clinical trials of Sputnik V have been conducting in the UAE, India, Venezuela and Belarus.
• Sputnik V is one of the three vaccines in the world with efficacy of over 90%. The Vaccine’s efficacy is confirmed at 91.6% based on the analysis of data on 19,866 volunteers, who received both the first and second doses of the Sputnik V vaccine or placebo at the final control point of 78 confirmed COVID-19 cases.
• RDIF jointly with partners and manufacturers is ramping up the production of Sputnik V. The cost of one dose of the vaccine for international markets is less than $10 (Sputnik V is a two dose vaccine). The lyophilized (dry) form of the vaccine can be stored at a temperature of +2 to +8 degrees Celsius, which allows for easy distribution worldwide, including hard-to-reach regions.
• The vaccine supplies for the global market will be produced by RDIF’s international partners in India, Brazil, China, South Korea and other countries.
• The vaccine is named after the first Soviet space satellite. The launch of Sputnik-1 in 1957 reinvigorated space research around the world, creating a so called “Sputnik moment”for the global community.

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