Lambasting Opposition leaders for politicising the approval of Bharat Biotech's COVAXIN, Union Health Minister Dr Harsh Vardhan on Sunday, said the Opposition was only discrediting themselves by questioning the well laid out science-backed protocols followed for approving the vaccines. Congress leaders like - Shashi Tharoor and Jairam Ramesh have questioned why Bharat Biotech - ICMR's 'COVAXIN' vaccine has been approved while Phase-3 trials are underway, modifying 'internationally accepted protocols'. The DCGI has allowed AstraZeneca - SII's 'COVISHIELD' and Bharat Biotech - ICMR's 'COVAXIN' vaccines for restricted use in an emergency situation.
He explained that COVAXIN which is based on whole inactivated virus is likely to have efficacy similar to gene encoding spike proteins - over 90%. Moreover, he added that COVAXIN is more likely to work against newer variants like N501Y Variant (UK variant) & any other variant. Citing Phase-I and Phase-II data, Dr. Vardhan stated that no adverse effects were seen after the clinical trials. He also clarified that COVAXIN was given a different approval i.e 'clinical trial mode' - where all COVAXIN recipients will be tracked,monitored as if they’re in trial.
Disgraceful for anyone to politicise such a critical issue.— Dr Harsh Vardhan (@drharshvardhan) January 3, 2021
Sh @ShashiTharoor, Sh @yadavakhilesh & Sh @Jairam_Ramesh don't try to discredit well laid out science-backed protocols followed for approving #COVID19vaccines
Wake up & realise you are only discrediting yourselves !
For those spreading rumours let it be known that EUA for COVAXIN is differently conditional – in clinical trial mode— Dr Harsh Vardhan (@drharshvardhan) January 3, 2021
EUA for COVAXIN is different from COVISHIELD because its use will be in clinical trial mode.
All COVAXIN recipients to be tracked,monitored as if they’re in trial pic.twitter.com/1N8LGnhC3w
After Subject Expert Committee (SEC)'s nod to both vaccines on Saturday, former Uttar Pradesh Chief Minister and Samajwadi Party chief Akhilesh Yadav, said that 'I will not get vaccinated - that too on BJP's vaccine (COVID-19), as I don't trust it, at a press conference in Lucknow. He also added that his government comes to power, the vaccine will we be provided free - 'not BJP's vaccine'. His statement drew severe flak from BJP, which termed it an 'insult to scientists', while other parties reiterated their faith in the vaccines.
Similarly, after the DCGI's nod to COVAXIN and COVISHIELD, Ramesh said that Phase 3 trials protocol have been modified for the Bharat Biotech vaccine candidate, urging Health Minister Harshvardhan to clarify on the same. Meanwhile, Tharoor stated that the DCGI 'approval was premature and could be dangerous', opining that its use should be avoided till full trials are over. Their doubts over COVAXIN has been slammed by several politicians included ex-Congress member Sanjay Jha who said he will 'willing to publicly take Covaxin'.
On Sunday, Drug Controller General of India (DCGI) VG Somani announced that the vaccines of Serum Institue of India (Covishield) and Bharat Biotech (Covaxin) have been granted permission for restricted use in an emergency situation. Covishield - a Recombinant Chimpanzee Adenovirus vector vaccine - has an efficacy of 70.42%, with interim safety and immunogenicity data of Phase-II/III trials submitted to the SEC. Covaxin - a Whole Virion Inactivated Corona Virus Vaccine - 22,500 participants vaccinated in Phase-III trials and was found to be safe as per the data available till date. Meanwhile, Zydus-Cadilla's nCov-Vaccine using DNA platform technology has been allowed to conduct Phase-III clinical trial in 26000 Indian participants. The government has stated that the first phase of the vaccination drive will be free including one crore healthcare workers and two crore frontline workers, aiming to vaccinate 27 crore priority beneficiaries until July.