The Indian Council for Medical Research (ICMR) said in a statement on Saturday a letter earlier this week by its Director General Balram Bhargava was meant to “cut unnecessary red tape” and “speed up recruitment of participants”.
The letter signed by Dr. Bhargava on Thursday and sent to clinicians at 12 hospital sites selected to test a potential COVID-19 vaccine became controversial after it was seen as exhorting scientists to speed up the processes and enable the vaccine to be made available for “public health use by August 15”. This not only presumes that Covaxin, the candidate vaccine developed by the Hyderabad-based Bharat Biotech Ltd and set to enter clinical trials, will be successful but also that trials which ordinarily take several months can be compressed to a little over a month.
Government scientists and independent experts have said this is an impossibly short time-frame to test it in people.
No explanation on date
However, the ICMR’s letter of Saturday has still no explanation why August 15 was mentioned.
The latest letter notes that the ICMR’s process is “exactly in accordance” with the globally accepted norms to fast-track the vaccine development for diseases of pandemic potential wherein human and animal trials continue in parallel.
“Red tape,” the letter notes, was not allowed to become a hindrance in the fast-track approval of testing kits or introducing potential drugs. Similarly, the vaccine development process also had to be “insulated from slow file movement”.
Interactive map of confirmed coronavirus cases in India
The ICMR was exhorting scientists at trial site locations to complete early testing phases (Phase 1 and 2) at the earliest so that “population-based trials for efficacy could be initiated without delay,” the letter notes.
Phase-1 and Phase-2 are trials done on groups of people and meant to test if the vaccine is safe in people and produces protective antibodies. The potential vaccine in question is a SARS-CoV-2 strain sourced from the ICMR-National Institute of Virology. The aim is to test if the weakened form of the virus can stimulate enough immunity to protect healthy people from infections.
In clinical trial parlance, ‘efficacy’ refers to testing if the potential vaccine appears to be working in ideal conditions. Based on this, investigators proceed to test the ‘effectiveness’ in real world conditions.
Several candidates in the pipeline
There are several candidates for a vaccine in the pipeline and the most promising of them have begun Phase-3 trials, where the vaccine is tested in a large population of thousands of individuals, to determine if it can reduce disease spread.
The letter said the ICMR with top medical scientists “should not be second guessed” for their professionalism.