News Analysis India

Tag: Covaxin trials

  • Bharat Biotech’s US partner Ocugen files request with FDA for Covaxin trials

    By PTI

    HYDERABAD: Ocugen, Bharat Biotech’s US partner for COVID-19 vaccine Covaxin, on Wednesday said it has submitted Investigational New Drug Application (IND) to the US Food and Drug Administration to conduct clinical trials.

    The development comes a day after the World Health Organisation sought more details from Bharat Biotech to consider its COVID-19 vaccine Covaxin for Emergency Use Listing.

    The US firm in a press release said the Phase 3 trial, proposed in the IND, is designed to establish whether the immune response experienced by participants in a completed Phase 3 efficacy trial in India is similar to that observed in a demographically representative, healthy adult population in the USA.

    The US drug regulator earlier in June “recommended” Ocugen Inc, to go for Biologics Licence Application (BLA) route with additional data, instead of Emergency Use Authorisation (EUA).

    The proposed trial can be to people who either have not been vaccinated for COVID-19 or who already received two doses of an mRNA vaccine at least six months earlier in the USA.

    ALSO READ | WHO seeks ‘additional clarifications’ from Bharat Biotech for Covaxin to conduct final ‘risk-benefit assessment’

    “We are very excited to take this next step in the development of Covaxin, which we hope will bring us, closer to introducing a different type of COVID-19 vaccine to the American public.

    We are hopeful that the study conducted under the IND, if allowed to proceed, will help demonstrate that the data from India will be applicable to the U.S. population, ” Dr Shankar Musunuri, Chairman of the Board, Chief Executive Officer, and Co-Founder of Ocugen said.

    If the study is allowed to proceed, Ocugen’s Phase 3 immuno-bridging study, OCU-002, will seek to enroll several hundred healthy adults in the U.S.

    Subjects will be randomized to receive either two doses of Covaxin or placebo, 28 days apart.

    The Phase 3 study conducted in India by Ocugen’s business partner, Bharat Biotech, involved 25,798 participants receiving two doses of Covaxin or placebo, 28 days apart.

    Ocugen has already sought regulatory approval from Health Canada for Covaxin to be used in that country.

    Covaxin is a whole-virion inactivated COVID-19 investigational vaccine candidate that uses the same vero cell manufacturing platform that has been used in the production of polio vaccines for decades.

  • Recruitment for clinical trial of Covaxin in 6-12 age group to start at AIIMS from June 15

    By PTI
    NEW DELHI: The recruitment for the clinical trial of the country’s first indigenously-developed COVID-19 vaccine, Covaxin, among children in the age group of 6-12 years will begin at the AIIMS here from Tuesday.

    This will be followed by the clinical trial of children in the age-group of 2-6 years.

    The enrolment of children volunteers aged 12-18 years at the All India Institute of Medical Sciences (AIIMS) has been completed and they have been given the first dose of Covaxin.

    “The recruitment process for the clinical trial of Covaxin among children in the age group of 6-12 years will begin from Tuesday,” Dr Sanjay Rai, Professor at the Centre for Community Medicine at the AIIMS, told PTI.

    The Drugs Controller General of India (DCGI) had granted permission for conducting the phase 2/3 clinical trial of Bharat Biotech’s Covaxin among children aged two to 18 years on May 12.

    The trial is to be conducted in three parts — 175 volunteers each in the groups aged 12-18, 6-12 and 2-6 years.

    In the trial, the vaccine will be given by the intramuscular route in two doses on day 0 and day 28.

    Covaxin, indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), is being used in adults in the country’s ongoing COVID-19 vaccination drive.

    The clinical trials will evaluate the safety, reactogenicity and immunogenicity of the vaccine in children.

    The government recently cautioned that even though COVID-19 has not taken a serious shape among children till now, its impact can increase among them if there is a change in the virus behaviour or epidemiology dynamics and said preparations are being strengthened to deal with any such situation.

    A national expert group has been formed to review COVID-19 cases in children and approach the pandemic in a renewed way to strengthen the country’s preparedness, NITI Aayog Member (Health) V K Paul had told a press conference.

    The group has examined signs that were not available four-five months before, he had said.

  • Stop Covaxin trial in Bhopal: NGOs working for gas victims

    By PTI
    BHOPAL: At least four NGOs working for the survivors of the 1984 Bhopal gas tragedy on Sunday wrote to Prime Minister Narendra Modi demanding that the ongoing clinical trials for Covaxin, an indigenously developed COVID-19 vaccine, be stopped in the Madhya Pradesh capital in view of the “gross violation of laws and guidelines”.

    In the letters addressed to the PM and Union Health Minister Harsh Vardhan, these NGOs have also sought punishment for the “responsible parties who were negligent in ensuring the safety, well being and the rights of the trial participants”.

    They also demanded monetary compensation for “damages caused during the Covaxin trial in Bhopal”.

    These letters have been written by Rashida Bee of Bhopal Gas Peedit Mahila Stationery Karmchari Sangh, Nawab Khan of Bhopal Gas Peedit Mahila Purush Sangharsh Morcha, Rachna Dhingra of Bhopal Group for Information and Action, and Nausheen Khan of Children Against Dow Carbide.

    Covaxin is developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).

    “We are writing to you to apprise you of the onground situation with regard to the conduct of the trial. Evidence has emerged that the trial in Bhopal is being conducted in gross violation of laws and guidelines governing clinical trials in India,” the NGOs stated in the letters, copies of which were shared with media persons.

    “This is leading to exploitation and harm to a community of people that are not just economically and socially deprived, but whose health is compromised owing to the destructive impact and its consequences,” they said.

    The NGOs alleged that vulnerable people were being misguided and herded to participate in the trials, and the consent procedure and other protocol of the testing are being flouted.

    ALSO READ: Man dies in Bhopal days after participating in COVID vaccine trial, police begins probe

    “The (clinical) trial should be stopped immediately and an impartial probe be conducted,” they demanded.

    Talking to reporters virtually, Rashida Bee said, “At least 700 of the 1,700 people on who this vaccine, with unknown efficacy, is being tested, are the people poisoned by Union Carbide (gas leak in 1984).

    “One gas victim has already died within 10 days of getting the trial shot and many continue to have health complaints of serious nature,” Bee alleged.

    A 42-year-old man, who had taken part in the clinical trial for Covaxin in Bhopal on December 12, died nine days later, with doctors suspecting that poisoning could be the cause.

    Bharat Biotech had said in a statement that preliminary reviews indicated that the death was unrelated to Covaxin.

    Bee claimed that nobody was punished for the “death of 13 gas victims during the trials by pharma companies at the Bhopal Memorial Hospital & Research Centre some 12 years ago”.

    ALSO READ: COVID-19 vaccine race – Where they stand currently

    She demanded compensation of Rs 50 lakh for the people “whohave diedduring the Covaxin trial, as being given in the case of deceased corona warriors”.

    Alleging irregularities in the conduct of the Covaxin trials, Dhingra said, “People whose health is compromised due to Union Carbide’s poisons are being given the Covaxin trial shots without their knowledge or consent”.

    She said audio and video consent should be taken of all the vulnerable people (before allowing them to volunteer for this clinical trial).

    “No records are kept of the health problems the trial’s participants have had following the shots and several have been turned away without tending to the adverse effects of the shots.

    Trial participants who leave or are excluded halfway are denied care and are not followed up,” she alleged.

    Shehzadi Bee of Bhopal Gas Peedit Mahila Purush Sangharsh Morcha said, “In addition to immediate stopping of the trial and awarding compensation for the gas victim who has died during this trial, we demand a thorough and impartial audit, criminal punishment to officials and institutions responsible for this public health disaster and compensation for injuries caused due to the trial vaccines”.

    “By ignoring the ongoing criminal irregularities in the Covaxin trial in Bhopal, the Government is potentially unleashing a public health disaster on the 16th of this month,” said Nousheen Khan of the Children Against Dow Carbide.

    The Drugs Controller General of India last week approved Oxford COVID-19 vaccine Covishield, manufactured by Serum Institute, and Covaxin of Bharat Biotech for restricted emergency use in the country.

    The Central government on Saturday said India will launch its COVID-19 vaccination drive from January 16, with priority to be given to nearly three crore health care and frontline workers.