Congress Questions Health Ministry For Allowing Bharat Biotech’s Covaxin For Emergency Use Before Phase 3 Trials
The Drugs Controller General of India (DCGI) approved Bharat Biotech’s Covaxin for emergency use after a government-appointed panel cleared it in its report. Unlike Oxford’s COVID-19 vaccine Covishield, which also got approval from India’s drugs regulator, Bharat Biotech’s Covaxin is yet to complete its phase 3 clinical trials.
Senior Congress leader Anand Sharma, who heads the Parliamentary panel on Home Affairs, questioned the Health Ministry for granting permission for emergency use of Covaxin before the completion of the mandatory protocols.
“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,” Sharma told news agency PTI.
“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,” he added.
Sharma’s also questioned the statement released by the DCGI and asked the body to share the “final data of global efficacy trials”.
“The DCGI statement is puzzling and the government must must reveal the final data of global efficacy trials and the final trials in the U.K. which has been shared officially by U.K.’s MHRA following a government to government agreement signed between the two countries which should be put in public domain to avoid any confusion on the proven efficacy of the vaccine,” he said.
“It is also a tribute to our scientists, researchers and institutions, who have established India as the largest vaccine manufacturer of the world,” Sharma added.
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