Hyderabad-based vaccine maker Bharat Biotech has rejected reports that it did not report an adverse incident during its coronavirus vaccine test in August, adding that the company reported the adverse incident within 24 hours.
In a statement on Saturday, Bharat Biotech said: “The adverse event during phase I clinical trials in August 2020 was reported to CDSCO-DCGI, within 24 hours of its occurrence and confirmation.”
It should be noted that Bharat Biotech and ICMR are working on Covaxin, one of the indigenous coronavirus vaccine candidates. The Central Drugs Standard Control Organization (CDSCO) has also given its approval to Bharat Biotech to launch phase III trials of the COVID-19 candidate vaccine.
In response to media reports that the adverse event during the phase I trials that were underway in August was not reported by Bharat Biotech, the pharmaceutical giant on Saturday (November 21) confirmed the incident and issued the clarification. According to Bharat Biotech, the adverse incident was thoroughly investigated and found to be unrelated to the vaccine.
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It should be noted that, according to the guidelines established by the Center, all adverse events should be reported to the site ethics committee, CDSCO-DCGI, the data security monitoring board, and sponsors. Bharat Biotech and ICMR are currently conducting clinical trials for Covxain at 21 medical institutes across the country.
“The adverse event was thoroughly investigated and submitted to CDSCO-DCGI, prior to obtaining permission for phase II and III clinical trials,” said Bharat Biotech.
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“Bharat Biotech is one of the few companies conducting human provocation studies at the University of Oxford, UK, while also conducting other clinical trials in the US and UK. Bharat Biotech has supplied more than 4 billion doses, to more than 80 countries, with an excellent safety follow-up report during vaccine development, ”he added.
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