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Government Must Explain Why International Protocols for Approving Bharat Biotech’s Covaxin Were Ignored, Congressional Leaders Say | India News


NEW DELHI: Even when government made a triumphant note on DCGI’s emergency use approval for Covishield vaccines from the Bharat Biotech Serum and Covaxin Institute, Congress raised concerns about the hasty approval of Covaxin’s emergency use and asked the government to clarify why Internationally approved protocols related to phase 3 trials were ignored while granting approval to the domestically developed vaccine.
Top Congressional leaders, including Anand Sharma, Jairam Ramesh and Shashi Tharoor, noted that premature approval of Covaxin could be “dangerous” and use of the vaccine should be avoided until full trials are complete.
Sharma, who heads the parliamentary panel at Home that recommended to the government that any Covid-19 vaccine should be authorized for emergency use only after proper consideration and testing with a sufficient sample size, said Sunday that the government must explain why mandatory protocols were ignored when approving restricted emergency use of Covaxin.
Sharma also said that no other country in the world dispensed with mandatory Phase 3 trials and data verification. “The Ministry of Health must give compelling reasons to dispense with mandatory protocols and requirements in this case, as it is about the health and safety of frontline workers who will be vaccinated in the restricted category,” Sharma said.
“The DCGI statement is puzzling and the government should disclose final data from global efficacy trials and final trials in the UK that have been officially shared by the UK MHRA following a government-to-government agreement signed between the two countries that should be made public domain to avoid any confusion about the proven efficacy of the vaccine, “he added.
The government did not explain why the phase 3 trials for Covaxin have not been completed and the data on the safety and efficacy of the vaccine have not been reviewed prior to granting approval for emergency restricted use.
Jairam Ramesh and Tharoor echoed Sharma’s concerns. Ramesh said that Bharat Biotech is a “top tier company” but that it was “puzzling” why the government “modified” the internationally accepted protocols related to phase 3 trials for Covaxin. “Covaxin has not yet had phase 3 trials. The approval was premature and could be dangerous. @drharshvardhan should clarify. Its use should be avoided until full testing is complete. India can start the AstraZeneca vaccine in the meantime, ”Tharoor said on Twitter.
However, the head of communication for Sharma and Congress, Randeep Surjewala, added that the news of the vaccination campaign is “truly encouraging and reassuring”, and also a “tribute” to Indian scientists, researchers and institutions. “Congratulations to our Bharat Biotech scientists and researchers for the approval of the locally developed Corona vaccine and the Serum Institute and its scientists as well. India has always led the way in pioneering innovations in the past and will continue to do the same. Great start to the New Year, ”Surjewala said on Twitter.

Times of India