National Affairs

‘Premature, Dangerous’: Congress Leaders Over Approval To Bharat Biotech Vaccine Without Phase 3 Trials

Hours after India’s drug regulator approved indigenously developed ‘Covaxin’ of Bharat Biotech, Congress leaders raised concern over the grant of permission for the restricted use of Covaxin without its phase 3 trials. Congress leaders asked the government to explain why mandatory protocols and verification of data has been dispensed with and warned the approval was “premature”. Soon after the approval to the coronavirus vaccines was announced, Congress leader Anand Sharma, who heads the Parliamentary panel on Home Affairs which dealt with the issue at length, said the issue of granting authorisation to Bharat Biotech’s vaccine needs to be taken carefully as no country has dispensed with the mandatory phase 3 trials and verification of data. As per submissions made before the expert panel, phase 3 trials have not been completed and therefore, the data on safety and efficacy has not been reviewed, which is a mandatory requirement, he said. “The Health Ministry needs to give cogent reasons for dispensing with the mandatory protocols and requirements in this case, since it involves the health and safety of those frontline workers who will be vaccinated under the restricted category,” Anand Sharma was quoted as saying by PTI. “The DCGI statement is puzzling and the government must reveal the final data of global efficacy trials and the final trials in UK which has been shared officially by UK’s MHRA following a government to government agreement signed between the two countries which should be put in the public domain to avoid any confusion on the proven efficacy of the vaccine,” Anand Sharma also said. Congress MP Shashi Tharoor also expressed apprehensions over approval to Covaxin, saying it has not yet had phase 3 trials. “The Covaxin has not yet had Phase 3 trials. Approval was premature and could be dangerous. @drharshvardhan should please clarify. Its use should be avoided till full trials are over. India can start with the AstraZeneca vaccine in the meantime,” Shashi Tharoor said. Jairam Ramesh raised the same concern and said, “Bharat Biotech is a first-rate enterprise, but it is puzzling that internationally-accepted protocols relating to phase 3 trials are being modified for Covaxin. Health Minister @drharshvardhan should clarify.”

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