A day after scientists and experts raised serious concerns over Indian Council of Medical Research’s (ICMR) letter to all 12 principal investigators to speed up the trial process of Bharat Biotech’s COVID-19 vaccine and enable it to be launched for “public health use latest by August 15”, the nodal agency issued a clarification saying the letter was meant only to “cut unnecessary red tape” and “speed up recruitment of participants”. Experts around the world have been saying that it would take at least 12-18 months to launch a vaccine for COVID-19.
The vaccine, being jointly developed by a Hyderabad-based pharmaceutical company Bharat Biotech and ICMR, is one of several candidates being tested globally to fight the coronavirus pandemic. So far, no vaccine has been approved for commercial use against the infection.
“A realistic (but very optimistic) timeline from the start of Phase I to the completion of Phase III could be about six to nine months (if all goes exactly according to plan),” Swaminathan told The Hindu.
The Drug Controller General of India has only approved Bharat Biotech’s application to conduct a Phase I and II clinical human trial of Covaxin. To launch of the vaccine by August 15 would involve either skipping or rushing through the Phase III trial, which tests the efficacy of the vaccine on a large number of participants and takes the longest time to complete.
Covaxin was the first indigenous vaccine to get permission for human trials by the Drug Controller General of India, on June 29. The letter signed by ICMR Director General Balram Bhargava and sent to clinicians at 12 hospital sites selected to test a potential vaccine became controversial after it was seen as exhorting scientists to speed up the processes. Medical experts expressed concern the trials would compromise patient safety and ethics. However, the ICMR on Saturday claimed that the letter was meant to “cut unnecessary red tape” and “speed up recruitment of participants”.
