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Monday
September 2020
6:37 AM IST
News Headlines
Burkina Faso striker Traore leaves Lyon for Aston Villa        AIFF to conduct three-day International Virtual Conference for coaches        Looking to play good brand of cricket to make this season a memorable one: KL Rahul        US stocks fall as market decline extends for third week        No decision to discontinue printing of Rs 2000 note: FinMin        Iran vows 'hit' on all involved in US killing of top general        Russia's Navalny says he's now more than 'technically alive'        Pak uses drone to weapons in J-K's Rajouri; 3 LeT terrorists arrested        Centre rejects study which claims India is world's largest emitter of anthropogenic sulphur dioxide        Garib Kalyan Rojgar Abhiyaan not implemented in Bengal as state did not provide any info: FM        Parliament's monsoon session likely to be curtailed, may end by mid-next week        Kerala reports 4,000 plus fresh COVID-19 cases for second day in row; Toll crosses 500        China flies 18 warplanes near Taiwan during US envoy''s visit        US bans WeChat, TikTok citing national security        IPL 2020: Dhoni''s CSK lock horns with Rohit led MI in opener        US Open champion Osaka out of French Open due to injury        NIA questions Ker Minister Jaleel for over 8 hours; No need for him to resign, says CM        Delhi riots: Police files charge sheet under UAPA against 15 for larger conspiracy        Serum Institute gets DGCA''s nod to resume testing of Covid vaccine again        Russia''s RDIF collaborates with Dr Reddy''s Laboratories for Sputnik V vaccine trials, distribution: CEO        
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National News
Russia''s RDIF collaborates with Dr Reddy''s Laboratories for Sputnik V vaccine trials, distribution: CEO
 
New Delhi: The Russian Direct Investment Fund is collaborating with Indian pharma giant Dr Reddy''s Laboratories to conduct clinical trials of the Sputnik V vaccine against COVID-19 as well as its distribution, RDIF CEO Kirill Dmitriev said on Wednesday. The RDIF is in talks with Indian regulators to ensure that all the requirements for clinical trials are being met, he said. “The RDIF and Dr Reddy''s Laboratories Ltd, a global pharmaceutical company with headquarters in India, have agreed to supply 100 million doses of the Russian Sputnik V vaccine and collaborate on clinical trials and distribution of the vaccine in India,” Dmitriev told PTI in an email interview.

The deliveries could begin as early as November 2020 after the registration of the vaccine by regulatory authorities in India if all goes well, the RDIF chief said. This is subject to successful trials and the regulator''s approval. An RDIF official said Phase 3 trials will be conducted in India and an announcement on this is expected soon. The Russian sovereign wealth fund also issued a statement quoting G V Prasad, co-chairperson and managing director of Dr Reddy''s Laboratories as saying, “We are pleased to partner with RDIF to bring the vaccine to India.

The Phase I and II results have shown promise, and we will be conducting Phase-III trials in India to meet the requirements of the Indian regulators. Sputnik V vaccine, he said, could provide a “credible option” in the fight against COVID 19 in India. The Sputnik V vaccine has been developed by the Gamaleya National Research Center of Epidemiology and Microbiology and RDIF. It uses a two-vector technology. It does not contain live human adenoviruses, but human adenoviral vectors, or genetically modified viruses, which are unable to reproduce and are completely safe, Dmitriev said. Through the use of two different vectors - based on human adenovirus serotypes Ad5 and Ad26 - in two separate shots, it is possible to achieve a more effective immune response, Dmitriev said.

He said additional clinical studies of Sputnik V will be conducted in several countries, including Brazil, India, Saudi Arabia, Egypt, United Arab Emirates (UAE) and Belarus. Unlike western companies, Dmitriev added, RDIF will not require the inclusion of clauses on legal protection against possible negative consequences of the vaccine when working with India and other partners. “We are confident in the safety and validity of the human adenovirus platform. Our Indian partners have opted for a guaranteed safe and efficacious vaccine, understanding the benefits of human adenoviral vector technology. “We are also in talks with India''s regulators to ensure that all the requirements for clinical trials are being met,” Dmitriev added.

Russia, he said, is well aware of Indian companies'' excellence in drug manufacturing and considers it an important asset in its plans to scale up Sputnik V production worldwide. Apart from Dr Reddy''s Laboratories in India, the RDIF has signed supply agreements with Mexico''s Landsteiner Scientific for 32 million doses and with Bahia state in Brazil for up to 50 million doses, Dmitriev disclosed. Earlier this month, a research paper on the results of Phase 1 and Phase 2 clinical trials of the Sputnik V vaccine was published in The Lancet, demonstrating no serious adverse effects and a stable immune response in participants.

Post-registration clinical trials of the Sputnik V vaccine involving 40,000 volunteers are going on. More than 55,000 volunteers have applied to take part in post-registration trials. The first results of these trials are expected to be published in October-November 2020, the RDIF said in its statement. Dmitriev said Phase 1 and 2 of the Sputnik V trial had 76 participants. "It seems smaller in size compared to 1,077 people that, for example, AstraZeneca (the Oxford vaccine) had in its Phase 1-2 studies. However, the design of the Sputnik V trial was much more efficient and based on better assumptions,” he said.

Vaccine testing typically begins with lab and animal model studies before going on to different stages of human trials. The human testing phase comprises many phases. Phase 1 trials are small-scale, usually involving a few participants, to assess whether the vaccine is safe for humans. Phase 2 trials often involve several hundred subjects, and mainly evaluate the efficacy of the vaccine against the disease. The final, Phase 3, involves thousands of people to further assess the efficacy of the vaccine over a defined period of time, and can last several months.


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