Covaxin's approval premature, dangerous: Shashi Tharoor
New Delhi/UNI: Congress leader and Thiruvananthapuram MP Shashi Tharoor on Sunday expressed apprehensions over the DCGI's nod for the emergency use of Bharat Biotech's COVID-19 vaccine 'Covaxin'.
In a tweet, Tharoor said that the Covaxin has not completed its phase 3 trials.
"Approval was premature and could be dangerous. Dr Harsh Vardhan should please clarify," the parliamentarian averred.
Notably, the drug regulator's Subject Expert Committee (SEC) had on January 1 recommended the emergency use authorization to Serum Institute of India's Covishield and on January 2 recommended approval for both Bharat Biotech's Covaxin. The Drugs Controller General of India cleared both the vaccines for emergency approval today.
He further said that the use of Covaxin should be avoided till trials are completely over.
"India can start with the AstraZeneca vaccine in the meantime," he added.
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
The final decision to recommend Bharat Biotech's Covaxin after it presented updated data and justification and request for consideration of their proposal amid cases of mutant Coronavirus strain.
However, the SEC stated that the firm should continue with phase 3 clinical trial and submit the results emerging from the trial whenever available, sources said, reported the India Express.