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Home / News / India News / COVAXIN: India's COVID-19 vaccine found safe in early trial
  • India

    COVAXIN: India's COVID-19 vaccine found safe in early trial

    Shubham Sharma
    Written by
    Shubham Sharma
    Twitter
    Last updated on Aug 14, 2020, 07:50 pm
    COVAXIN: India's COVID-19 vaccine found safe in early trial
  • COVAXIN, the first indigenously developed COVID-19 vaccine from India, has proven to be safe in early human trials.

    The data has not been published publicly but the principal investigators involved in the clinical Phase-1 study, currently being carried out across 12 sites, have confirmed that the shot did not create any issues.

    Here is all you need to know about it.

  • In this article
    Well-tolerated, with no adverse effects Same is the case with AIIMS Delhi Samples being taken to judge efficacy Phase-2 likely to begin in September Bharat Biotech is behind COVAXIN
  • Confirmation

    Well-tolerated, with no adverse effects

    Well-tolerated, with no adverse effects
  • Speaking to The Economic Times, the principal investigators of COVAXIN trials in Rohtak and Delhi stated that the preliminary data shows the shot is safe and well-tolerated.

    "The vaccine is safe," Dr. Savita Verma, the in-charge of the trial at PGI Rohtak, said, adding that "We have not observed any adverse events in any of the volunteers at our site."

  • Information

    Same is the case with AIIMS Delhi

  • Like Dr. Verma, Dr. Sanjay Rai from All India Institute of Medical Sciences in Delhi also claimed that the shot has been deemed safe at their site. The institute had started trials in mid-July and had enrolled 16 volunteers by last week.

  • Work

    Samples being taken to judge efficacy

  • Both PIs added that they are in the process of administering the second dose of COVAXIN to the subjects and taking their blood samples to judge the effectiveness of the shot.

    For determining efficacy, they will look for the presence of neutralizing antibodies required to fight off the virus in the blood samples.

    If the immune response is detected, they will assess its quality.

  • Phase-2

    Phase-2 likely to begin in September

    Phase-2 likely to begin in September
  • Given that the patients have to be monitored, the Phase-1 trial is expected to continue by August-end, the investigators asserted.

    After that, in September, it will go into the second phase, which will take a few months to complete.

    If all goes according to the plan, one anonymous PI suggested, the vaccine should be available in the first half of 2021.

  • Plan

    Bharat Biotech is behind COVAXIN

    Bharat Biotech is behind COVAXIN
  • COVAXIN has been developed by Hyderabad-based Bharat Biotech through a strain of novel coronavirus isolated by ICMR's National Institute of Virology.

    In Phase-1, it is being tested on as many as 375 participants, of which 100 have to be from AIIMS, while in the second phase 750 subjects will be vaccinated.

    This will ultimately be followed by a much larger final phase.

  • AIIMS
  • Coronavirus
  • COVID-19
  • Bharat Biotech
  • COVAXIN
  •  
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