Thiruvananthapuram: Senior Congress leader and Thiruvananthapuram MP Shashi Tharoor on Sunday raised concerns over the approval of Bharat Biotech's COVID-19 vaccine.
He criticised the approval for Covaxin and said it was premature and dangerous.
As India's drugs regulator approved restricted use of Bharat Biotech's COVID-19 vaccine and Oxford COVID-19 vaccine Covishield, the Kerala government had said the state was ready to distribute it once the Centre gave the nod.
Meanwhile Tharoor tweeted: "The Covaxin has not yet had Phase 3 trials. Approval was premature and could be dangerous. @drharshvardhanshould please clarify. Its use should be avoided till full trials are over. India can start with the AstraZeneca vaccine in the meantime,".
The Drugs Controller General of India (DCGI) approved Oxford COVID-19 vaccine Covishield, manufactured by the Serum Institute, and indigenously developed Covaxin of Bharat Biotech for restricted emergency use in the country, paving the way for a massive inoculation drive.
The approval was granted on the basis of recommendations by a COVID-19 Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO).
State health minister K K Shailaja said the state was ready to distribute the vaccine once the Centre gives the nod.
"We will use the vaccine as instructed by the Central government. We are fully prepared for the distribution of the vaccine once the centre gives the permission. The Ice Lined Refrigerator (ILR), cold box etc are ready and the state has also finalised the places to distribute the vaccine," she told the media.
When asked about Covaxin and Tharoor's criticism, the minister said the state government was yet to receive official notification on the vaccines and would comment on it later.
"We are yet to officially receive the notification on the two vaccines approved. We cannot comment without receiving any official details," Shailaja said.
The recommendation of the DCGI came a day after the panel cleared the Serum Institute of India's emergency use authorisation application for the Oxford-AstraZeneca vaccine Covishield.
