Health Minister Harsh Vardhan slams Congress, says "disgraceful for anyone to politicise Covid vaccine issue

Union Health Minister Harsh Vardhan on Sunday slammed Congress after party leaders raised concern over the grant of permission for the restricted use of Covaxin without its phase 3 trials.

Congress leaders Shashi Tharoor, Anand Sharma, Jairam Ramesh and Samajwadi Party chief Akhilesh Yadav questioned the approval process for Bharat Biotech's Covid-19 vaccine, saying it is "premature" and can prove dangerous.

Reacting to Congress and opposition leaders' criticism over DGCI's nod to Bharat Biotech's Covaxin, Harsh Vardhan said it was "disgraceful for anyone to politicise such a critical issue".

Disgraceful for anyone to politicise such a critical issue. Sh @ShashiTharoor, Sh @yadavakhilesh & Sh @Jairam_Ramesh don't try to discredit well laid out science-backed protocols followed for approving #COVID19vaccines. Wake up and realise you are only discrediting yourselves!," Harsha Vardhan tweeted.

"Vaccines approved globally based on gene encoding spike proteins have protective efficacy of over 90%. However, COVAXIN based on whole inactivated virus has other antigenic epitopes in addition to spike protein. So,it’s likely to have similar protective efficacy reported for others," Harsh Vardhan said in another tweet.

India's drugs regulator DCGI on Sunday approved Oxford's Covid-19 vaccine Covishield and Bharat Biotech's Covaxin for restricted emergency use.

Congress leader Anand Sharma, Jairam Ramesh and Shashi Tharoor had asked the health minister to explain why mandatory protocols and verification of data



"had been dispensed with".

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, Anand Sharma said referring to Covaxin.

"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," Anand Sharma was quoted as saying by news agency PTI.

"The restricted use emergency authorisation for the Bharat Biotech vaccine presently undergoing Phase 3 trials raises bonafide concerns," Anand Sharma said.

Congress leader Shashi Tharoor said the approval is premature and Covaxin's use should be avoided as it could be dangerous.

"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," Shashi Tharoor tweeted.

Another senior Congress leader Jairam Ramesh asked Health Minister Harsh Vardhan to clarify why internationally-accepted protocols on phase 3 trials "are being modified".

"Bharat Biotech is a first-rate enterprise, but it is puzzling that internationally-accepted protocols relating to phase 3 trials are being modified for Covaxin. Health Minister Harsh Vardhan should clarify," Jairam Ramesh said on Twitter.