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    Reported adverse event during Covaxin phase 1 trial within 24 hours: Bharat Biotech

    Synopsis

    The statement was issued following a report by Economic Times which revealed that a serious adverse event was seen in a case during the Phase I trial of its indigenous Covid vaccine.

    The company further said that got an approval for the next two phases of clinical trials only after a detailed investigation of the incident was completed.
    Bharat Biotech said on Saturday that it had reported the adverse event that happened during the Phase I clinical trials to the drug regulatory body within 24 hours.

    The statement was issued following a report by Economic Times which revealed that a serious adverse event was seen in a case during the Phase I trial of its indigenous Covid vaccine.

    “The adverse event during phase I clinical trials during August 2020 was reported to the CDSCO-DCGI within 24 hours of its occurrence and confirmation. The adverse event was investigated thoroughly and determined as not vaccine related," the company said in a statement.

    Unlike other companies like AstraZeneca and Johnson & Johnson which had temporarily halted their phase 3 clinical trial immediately after an adverse event was observed in a patient, Bharat Biotech continued with the trial and the no public disclosure was made by the company.

    According to sources the adverse event occurred in a 35-year old participant with no co-morbidities, who was part of Phase 1 trials at a site in Nagpur. “The participant was hospitalised with viral pneumonitis after being administered the vaccine,” sources said.

    “All treatment costs for the subject was fully paid for by the sponsor, and the subject is safe," Bharat Biotech said.

    The company is conducting Phase III clinical trials of Covaxin, in collaboration with Indian Council of Medical Research.

    Bharat Biotech said that all adverse events were reported to the site ethics committee, CDSCO, data monitoring board and the sport. It said that it had submitted all documentation within timelines, and as mandated by the ethics committees and CDSCO, including a complete causality report.

    The company further said that got an approval for the next two phases of clinical trials only after a detailed investigation of the incident was completed.

    ET had quoted a government official as saying the matter had been reported to the Drug Regulatory Authority.
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    14 Comments on this Story

    Suresh Kamath1 day ago
    INDIAN Pharma Company have arrived on the International Scene for a long time now and this Medical CRISIS due to COVID 19 Virus has set them well above the Norms of WORLD STANDARD and surely have the Capacity and ability to EXCEL the very Best of the World of NATION and hence such "Adverse reporting 'seems to be the Norm of ALL such Sinister Group to derail the Race to successful Proven VACCINES from the Indian Shores is being "countered by the Nexus" and SHOULD not affect the WINNERS sooner and even those who CLAIM to be 95 % SUCCESS have NOT asserted that their VACCINE would STOP the Spread of Virus for SURE and hence their CLAIMS could be said to be "half Truth " and Indian Govt wants to use VACCINES first PRIORITY on the Front Line WARRIORS who Fight/Treat the Afflicted Persons and the Volunteers under Trials are treated with Care and Caution and hope ALL success to these Indian Medical Council to declare these as SAFE for the PEOPLE of India and SERUM Institute has the capacity and ability to Produce the VACCINE on short Notice and SERVE the NATION sooner.
    Jai Hind Jai Jawan jai Sri Ram Vande Mataram
    Dyslexic 1 day ago
    hope its not competitors trying to derail this vaccine candidate. Our pharma companies r the largest vaccine producers in the world meeting the highest global standards, i highly doubt, bharth wud be so careless. more clarity will be appreciated.
    Sunil 1 day ago
    Advesr reactions to any unlnown Molecule/Viral proteins is expected and the patient is safe .... So what is the big deal..Only thing is B.B should come out with a Daily report on its own and not hide facts . Research is like that .Everytime one need not be successful...Much like the Rohini Rocket to MArs misssion...
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