WHY FAST TRACKING COVID CLINICAL TRIALS IS NOT A GOOD IDEA

The number of COVID – 19 cases are increasing every day. While there has been a slight dip in the graph of some countries, some have experienced a surge. The pressure on the medical research community to come out with a vaccine is also increasing day by day. Researchers all over the world are trying their best to develop a vaccine as soon as possible. Therefore, people everywhere were taken aback on Friday (2nd July) when Indian Council of Medical Research (ICMR) declared that it has envisaged that a vaccine will be launched for public use by 15th August 2020.

 

The top medical research agency of the country sent out a letter to 12 hospitals to fast track the clinical trials. They had also asked these hospitals to select their candidates for the Phase I of the clinical trial by 7th July. Some of these hospitals, including AIIMS had opined that 5 days is a very short period to select candidates for the trial as convincing healthy adults to inject a pathogen of the novel virus into their bodies is difficult. The hospitals should also get a go ahead from the ethical council before they admit candidates for the trial. There has been a slight relaxation in rules concerned with vaccines and drug trials due to the pandemic but rushing the process will not produce the desired results. Hence, the medical community disagreed with this 6-week deadline. The doctors and virologists expressed their concern. They said that the fast tracking of the trial will reduce the safety standards and efficiency of the drug. They also said that the immunogenicity (which is the ability to induce cell mediated immune responses) of the vaccine cannot be established in a smaller time frame. They are also worried that if the process is highly rushed, then with it will also come the undesirable risks and inefficiency. Medical experts worldwide think it will be 8-12 months before an effective COVID vaccine can be launched. Each phase of a clinical trial might take months and, in some cases, years together to conclude. According to WHO guidelines for the trial of a novel vaccine, during the Phase I of clinical trial, the main concern is safety of the vaccines. It is only tested among a small population of healthy adults. During Phase II the immunogenicity (if the vaccine is providing desirable results) is tested. The number of participants in this phase is slightly larger than the first phase. Extensive sampling and lab tests are done in this phase to find out the time taken for the vaccine to act. The final phase or Phase III is administered on 20 to 30 thousand people if the earlier phases have proven that there are no harmful side effects from the vaccine. Bharat Biotech, the Hyderabad based company whose drug ‘Covaxin’ is approved by the Drug Controller General of India estimates that their first two phases might be cleared by the end of October. Thus, naturally arises the concern of how the ICMR can declare that the vaccine will be ready for public usage by August 15th. After the backlash that was received as a response to their letter, the ICMR on Saturday said, “The letter by DG-ICMR to investigators of the clinical trial sites was meant to cut unnecessary red tape, without bypassing any necessary process, and speed up recruitment of participants”. The hunt for a potential vaccine for Corona virus is going on vigorously in many countries in the world. India is also one of the leading researchers with 7 vaccines being researched and a couple of them ready for clinical trials. The world is currently in a state of fear and anxiety as the year has not been so good for the humankind. The researchers and health agencies must keep in mind that the clinical trial of a vaccine means sickening a healthy person. Hence, they should take necessary steps to ensure that the vaccine will only benefit human beings and not work the other way around. Even if the development takes a little bit longer, slow and steady will always win the race.

  • Jahnavi TR

  • Bengaluru

References – https://indianexpress.com/article/opinion/editorials/make-haste-slowly-6491654/

https://www.thehindu.com/opinion/editorial/surely-even-if-slowly-the-hindu-editorial-on-attempts-to-fast-track-a-covid-19-vaccine/article31996609.ece

https://www.ndtv.com/india-news/coronavirus-vaccine-scientists-strike-caution-as-made-in-india-covid-19-vaccine-chases-august-15-launch-date-2257088

Picture credits – indiatvnews.com

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