The Drugs Controller General of India (DCGI) on Sunday approved Oxford's coronavirus vaccine, Covishield, manufactured by the Pune-based Serum Institute of India (SII). Besides, the DCGI also gave emergency use authorization for Bharat Biotech's coronavirus vaccine, Covaxin, which is yet to publish the full extent of its Phase-III trial data on public domain. This has led to a war of words between the Congress and the BJP.
"The Covaxin has not yet had Phase-III trials. Approval was premature and could be dangerous," said Tharoor. "Bharat Biotech is a first-rate enterprise, but it is puzzling that internationally-accepted protocols relating to Phase-III trials are being modified for Covaxin," tweeted Jairam Ramesh. They also demanded clarification from Union Health Minister Dr Harsh Vardhan over the same.
Meanwhile, BJP President JP Nadda, Union Minister of Civil Aviation Hardeep Singh Puri and now Union Health Dr Harsh Vardhan have hit out at the Congress leaders.
The Health Minister termed Congress' criticism as "disgraceful". He tweeted, "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 & realise you are only discrediting yourselves!"
Dr Harsh Vardhan added that Bharat Biotech's Covaxin is likely to be efficient against the United Kingdom variant of COVID-19.
"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," he tweeted. "COVAXIN is more likely to work against newer variants like N501Y Variant (UK variant) & any other that may arise due to antigenic drift as it contains immunogens (epitopes) from other genes in addition to those from Spike protein. Inactivated virus from NIV also had D614G mutation," added Dr Harsh Vardhan.
The Health Minister further explained that the data from COVAXIN Phase I & II clinical trials reveals that it not only produces neutralizing antibodies in all participants but also sensitises CD4 T lymphocytes that imparts durable immune response. "Our experience with inactivated vaccines not having serious adverse events was also observed in Phase II done among 380 study participants in BBV152 trial in 21280 Person days follow up. No serious adverse events seen. Only 7% persons receiving 6 microgram dose had mild symptoms," he tweeted. "There were no seroconversions in those who were provided vaccines in Phase II as well as Phase I of COVAXIN clinical trials," added Dr Harsh Vardhan.