New Delhi, January 3: Congress lawmaker Shashi Tharoor on Sunday questioned the approval granted to Bharat Biotech's Covaxin, a potential vaccine against coronavirus, by the Drug Controller General of India (DCGI) for emergency use in India. Shashi Tharoor said the COVID-19 vaccine Covaxin has not undergone phase 3 trials and termed the approval "premature". He sought clarification from Union Health Minister Dr Harsh Vardhan on DCGI's move.
"The Covaxin has not yet had Phase 3 trials. Approval was premature and could be dangerous. Dr Harsh Vardhan should please clarify. Its use should be avoided till full trials are over. India can start with the AstraZeneca vaccine in the meantime," Tharoor said in a tweet. His tweet came after the DCGI approved Covishield and Covaxin for "restricted use in emergency situation" in India. Akhilesh Yadav Says 'Won't Get Vaccinated For Now, Cannot Trust BJP's Vaccine'.
Shashi Tharoor Questions DCGI Approval for Covaxin:
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. https://t.co/H7Gis9UTQb
— Shashi Tharoor (@ShashiTharoor) January 3, 2021
Covaxin is developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and National Institute of Virology. it is India's first indigenous vaccine for coronavirus. "The firm had generated safety and immunogenicity data in various animal species such as mice, rats, rabbits, Syrian hamster, and also conducted challenge studies on non-human primates (Rhesus macaques) and hamsters," the DCGI said.
Phase I and phase II clinical trials of Covaxin were conducted in 800 subjects and the results demonstrated that the vaccine is safe and provides a robust immune response. According to the DCGI, the phase III efficacy trial was initiated in India in 25,800 volunteers and till date, 22,500 participants have been vaccinated across the country and the vaccine has been found to be safe as per the data available till date.