Premium'Bharat Biotech and Cadila Healthcare are developing vaccines. Both vaccines completed animal toxicity studies after approval,' says Health Ministry official Rajesh Bhushan
A Union Health Ministry official on Thursday clarified that 15 August deadline for an indigenous Covid-19 vaccine is "only to expedite duly approved clinical trials without compromising on safety and security concerns".
Rajesh Bhushan, Officer on Special Duty, Health Ministry said, "Please don't read something which is not there in DG-ICMR's letter."
The under-development vaccine is “envisaged" to be rolled out “for public health use by Aug. 15 after completion of all clinical trials," Indian Council of Medical Research's Director General, said in a 2 July letter to clinical trial sites.
The ICMR said that the letter by Director General of ICMR Dr Balram Bhargava to principal investigators of the clinical trial sites was meant to cut unnecessary red tape, without bypassing any necessary process, and speed up recruitment of participants.
Bhargava had written to principal investigators of select medical institutions and hospitals to fast-track human clinical trial approvals for the vaccine candidate 'Covaxin' being developed in collaboration with Bharat Biotech.
"The letter's intent is only to expedite duly approved clinical trials without compromising on safety & security concerns," said Bhushan at a press conference on Thursday.
Speaking about the vaccine progress, Bhushan said, "Bharat Biotech and Cadila Healthcare are developing vaccines. Both vaccines completed animal toxicity studies after approval."
He said that the Drug Controller General of India has permitted these two vaccines to go in for phase 1 and phase 2 clinical trials.
"Trials are yet to begin. Hope they begin soon," said Bhushan.
