Clinical trial of second phase of Sputnik-V completed in India, seeking permission for third phase. Newsbaits

  • In the midst of the corona epidemic, India has received two vaccines in the form of ‘Kovishield’ of Serum Institute of India (SII) and ‘Kovaxin’ of Bharat Biotech.

    Meanwhile, the country has now increased the chances of Russia getting another vaccine in the form of ‘Sputnik-V’.

    Dr. Reddy’s Laboratories Limited of Hyderabad has completed its second phase clinical trial and has now sought permission from the Drugs Controller General of India (DCGI) for the third phase of the trial.

  • The background

    Russia launched the vaccine in August

  • The first clinic trial of Vaccine Sputnik-V, prepared by Moscow’s Gamalaya Research Institute, began on 18 June.

    38 people were dosed in it. Immunity against the corona virus was seen in all the people who took part in the results of the trial on 20 July.

    After this, Russia announced the launch of the vaccine in August. It was named in honor of the first satellite launched by the Soviet Union.

  • The second phase of the vaccine trial was started in India in December

    The second phase of the vaccine trial was started in India in December
  • Let us know that Russian Direct Investment Fund (RDIF) has tied up with Dr. Reddy’s Laboratories of Hyderabad in September for the trial and distribution of this vaccine in India.

    The company started its second phase of trial on December 2 after getting the permission. In this, the safety of the vaccine was given to 100 people and its safety was tested.

    After this, the company will now provide its dose to 1,400 volunteers in Phase III trials.

  • No safety concerns revealed in the second phase of the trial

  • In a joint statement with RDIF, Dr. Reddy’s Laboratories said that the Phase II trial was completed better. It has not revealed any security concerns.

    He further said that the safety data of the second phase trial has been submitted to DCGI for approval.

    Apart from this, permission for Phase III clinical trial of vaccine has also been sought. Trial will be started as soon as it is approved.

  • DSMB recommends Phase III trial

  • Dr Reddy’s Laboratories said that the safety data of the second phase trial has also been reviewed by the Independent Data and Security Monitoring Board (DSMB). It has been found to meet all safety standards and has recommended a third phase trial.

  • Vaccine shows better safety offerings

  • Dr. Reddy’s Laboratories Managing Director GV Prasad said, “Sputnik-V Phase II clinical trials in India reveal a much better safety profile. This data has strengthened our confidence in the use of Sputnik-V. . ”

    He added, “The vaccine has been given so far to about 1 million people in Russia and over 3 lakh in Argentina. No security concerns have been revealed.”

  • “100 million dietary target set”

  • GV Prasad said, “Our company is working towards the rapid launch of Sputnik-V in India. The trial results so far have brought about a better situation. The company aims to produce 100 million doses in India. is.”

  • Vaccine found to be 92 percent effective

  • RDIF Chief Executive Officer (CEO) Kirill Dimitriv said Sputnik-V’s analysis of internationally conducted Phase III clinical trials has yielded surprising results.

    This vaccine was found to be 91.4 percent effective at 28 days after the first dose was given to the valentiners, but it was found to be up to 95 percent effective in a 42-day analysis of the first dose. In this case, 92 percent is effective.

  • Vaccine-Dimitriv has proved to be 100 percent effective in severe cases

  • CEO Dimitriv said that the vaccine is currently undergoing clinical trials in the United Arab Emirates (UAE), Egypt, Venezuela and Belarus, in addition to India.

    Similarly, it is registered for emergency use in Algeria, Argentina, Belarus, Bolivia and Serbia.

    He said that even though the vaccine has been found to be 91.4 percent effective in normal cases, it has proved to be 100 percent effective in severe cases. This is a big achievement for Russia.

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