News Analysis India

Tag: US Food and Drug Administration

  • Covaxin’s phase 2/3 clinical trials put on hold in the US

    Express News Service

    NEW DELHI: The US Food and Drug Administration (FDA) has put on hold the phase 2/3 clinical trials of Bharat Biotech’s Covid-19 vaccine Covaxin in the US.

    According to the statement issued by Ocugen Inc, Bharat Biotech’s partner for US and Canada for Covaxin, the biotechnology company was informed by the US FDA that the agency placed its phase 2/3 immuno-bridging and broadening study for Covaxin (BBV152), OCU-002, on clinical hold.

    “This is a result of the company’s decision to voluntarily implement a temporary pause in dosing participants of OCU-002 while it evaluates statements made by the WHO following their inspection of Bharat Biotech International Limited’s (BBIL) manufacturing facility,” Ocugen said in the statement issued on April 12. OCU-002 is Ocugen’s Phase 3 immuno-bridging study of Covaxin.

    On April 2, the WHO had said it suspended the supply through United Nations agencies of Covid-19 vaccine Covaxin by India’s Bharat Biotech after its inspectors identified good manufacturing practice deficiencies in the pharma company’s pharma plants.

    The WHO also asked countries that have received India’s indigenous Covid-19 vaccine to take appropriate actions; however, it did not specify the proper actions. We will work with the FDA to address any questions.

    After the WHO inspection, the Hyderabad-based company said it is temporarily slowing down the production of Covaxin, which is used in India’s Covid vaccination programme, across its manufacturing units for facility optimisation as it has already completed its supply obligations to procurement agencies and foresees a decrease in demand.

    The company also said after the recent WHO post-Emergency Use Listing (EUL) inspection, it is working on further improvements and upgrades to ensure that the production of Covaxin continues to meet ever-increasing global regulatory requirements.

    The WHO had, however, said the vaccine is effective, and no safety concerns exist, but the suspension of production for export will result in the interruption of the Covaxin supply.

    The central government has clarified that the suspension will not impact travel by people who have taken the vaccine, as it still continues to be recognised under the EUL.

  • US FDA puts Covaxin’s second phase trials in US on hold after fallout on WHO’s observations

    By PTI

    HYDERABAD: The US Food and Drug Administration has put on hold the phase 2/3 clinical trials of Bharat Biotech’s COVID-19 vaccine Covaxin, in USA.

    According to a press release by Ocugen Inc , Bharat Biotech’s partner for US and Canada for Covaxin, the FDA’s decision was based on the US firm’s decision to voluntarily implement a temporary pause in dosing participants of the jab, following the World Health Organisation’s observations on Covaxin manufacturing plants in India.

    “This is a result of the company’s decision to voluntarily implement a temporary pause in dosing participants of OCU-002 while it evaluates statements made by the World Health Organization following their inspection of Bharat Biotech International Limited’s (BBIL) manufacturing facility,” Ocugen said on April 12.

    WHO had earlier suspended the supply of Covaxin through US procurement agencies, after its inspectors identified GMP (good manufacturing practice) deficiencies in the Bharat Biotech’s manufacturing plants.

    Sources had said the city-based firm however, said it had not supplied the Covid vaccine to any UN agency and no impact of the suspension would be felt. OCU-002 is Ocugen’s Phase 3 immuno-bridging study of Covaxin.

    The company said it will work with the FDA to address any questions. The FDA, in February, lifted its clinical hold on Ocugen’s Investigational New Drug application (IND) to evaluate the Covaxin.

    After WHO inspection, Bharat Biotech had said it is temporarily slowing down production of Covaxin across its manufacturing units for facility optimisation as it has already completed its supply obligations to procurement agencies and foresees decrease in demand.

    The company further said after the recent WHO post Emergency Use Listing (EUL) inspection, it is working on further improvements and upgrades to ensure that the production of Covaxin continues to meet ever increasing global regulatory requirements.