Researchers have to monitor samples and analyse data to estimate the time taken for the volunteers to develop antibodies.
A day after being called out by medical experts for making unreasonable claims to launch a COVID-19 vaccine by August 15, the Indian Council of Medical Research (ICMR) issued a clarification. It said that its letter of July 2 to the 12 hospitals selected to conduct the vaccine’s clinical trials “was meant to cut unnecessary red tape”. However, the Council’s clarification, on July 4, is silent on an issue of critical medical and ethical importance — the unrealistic timeline it had set in the July 2 letter to the 12 hospitals. The ICMR had asked these healthcare facilities to select participants for clinical trials by July 7. But finding volunteers who agree to get a shot of an untested vaccine — in this case, introducing an inactivated COVID pathogen into their bodies — may not be an easy task. The procedure requires approval by an ethics committee. At least six of the hospitals, including AIIMS Delhi, had reasoned that five days was too short a period to complete the process. The ICMR’s clarification, that it will “follow all protocols”, falls short of adequately addressing this concern.
A novel vaccine candidate undergoes an elaborate regulatory process. According to the WHO’s guidelines, Phase 1 of clinical trials involves testing the vaccine “in small numbers of healthy adults”. These trials are primarily concerned with “the safety of the vaccine”. Phase 2 studies involve “larger number of participants” and are intended to obtain information about the vaccine’s “ability to produce desired effects”. Researchers have to monitor samples and analyse data to estimate the time taken for the volunteers to develop antibodies. The human body takes its time to show if a vaccine works or not and there can be no shortcuts to these processes. Bharat Biotech, the Hyderabad-based company whose vaccine has been approved for clinical trials by the Drug Controller General of India (DGCI), estimates that the results of the first two phases of the trials would be out only by October. It’s unclear if the ICMR is on the same page with its collaborator on this time-frame.
The WHO recommends that Phase 3 trials “be conducted on 20,000 to 30,000 people”. But before giving the go-ahead to inoculating such a large number of people, regulatory agencies must ensure that the candidate vaccine has no side effects. That is why the procedures in the first two stages must stand up to all yardsticks of rigour. The WHO does note that participation in these trials “would be least risky for young healthy adults”. But the global health agency also underlines that “preserving public trust in research requires minimising harm not only to volunteers but also to research staff and third parties”. The ICMR, which has so far creditably anchored the country’s fight against COVID 19, cannot afford to relegate this imperative. In the development of a vaccine against the contagion, it must not do anything, or be seen to be doing anything, in undue haste.