A day after Drug Controller General of India gave restricted emergency approval to Covaxin and Covishield vaccine, the Investigators attached with the phase III trial of Bharat Biotech’s Covaxin said that while they have at least four months of data to assess safety and immunogenicity from phase I/II trials, they are yet to gather statistical data on its efficacy from phase III trial, TheIndianExpress reported.
“I am surprised the DCGI made an overnight decision based on subject expert committee’s (SEC) recommendation. Ideally DCGI reviews the documents recommended by SEC and that can take a few days,” said Dr Dhananjay Lad, attached with Redkar Hospital and Research Centre, Goa, a site for phase I/II and now phase III trial of Covaxin.
The issue has triggered strong reactions from opposition political leaders. After former Uttar Pradesh chief minister Akhilesh Yadav three senior Congress leaders Shashi Tharoor, Jairam Ramesh and Anand Sharma on Sunday expressed concern over DCGI approval to Covaxin and Covishield vaccine.
While calling the step pre-mature Tharoor asked the people to avoid it till the full trials are over. On the other hand Jairam Ramesh asked the Union health minister Dr Harsh Vardhan as to why internationally accepted protocols on safety trials have been modified in India.
Anand Sharma said that the DCGI statement is puzzling and the Centre must reveal the final data of the efficacy trial and the final trial in the United Kingdom, which has been shared officially by that country’s MHRA following a government-to-government agreement signed between the two countries. This should be put in the public domain to avoid any confusion on the proven efficacy of the vaccine.”
Incidentally, the Congress party’s spokesman Randeep Singh Surjewala congratulated scientists and doctors for this achievement.
The BJP president J P Nadda charged the opposition parties with coming up with wild theories to ridicule India’s achievement. The civil aviation minister Hardeep Puri came down heavily on the Congress leaders for raising doubts over the trials.
Another BJP minister Giriraj Singh also criticized the three Congress leaders and said that they would keep the people confused while they would themselves take the vaccine in private.
However, the president of All India Majlis-e-Ittehad-ul-Muslimeen Asaduddin Owaisi on Sunday flayed Akhilesh Yadav for his statement that he would not be taking the BJP’s vaccine. Owaisi said that it is up to him to decide but the truth is that the whole world is taking it.”
If Akhilesh Yadav has his own vaccine he can take it,” the AIMIM leader said, teasingly.