By Dinesh C Sharma
The race for an Indian vaccine to combat Covid-19 is heating up with the Hyderabad-based Bharat Biotech announcing on June 29 that its vaccine, Covaxin, has regulatory approvals for phase 1 and 2 human clinical trials. The approval is based on data of preclinical studies that “demonstrated safety and immune response,” according to the company.
Bharat Biotech is collaborating with the Indian Council of Medical Research (ICMR) and Pune-based National Institute of Virology (NIV) for the project. The company said trials will begin in July, but it didn’t say when the vaccine would be available. The reason is that it would depend on the outcome of clinical trials and submission of data to the regulatory authority. This is as per the standard protocol followed for new vaccines and drugs.
While Bharat Biotech was cautious about the availability of the vaccine in its statement, the ICMR has jumped the gun. On July 2, the ICMR wrote a letter to centers where the trials will be conducted, saying it plans to “launch the vaccine for public health use latest by August 15 after completion of clinical trials.” The letter directs all the centers to enroll people for the vaccine trial by July 7 and warns that “non-compliance will be viewed very seriously.” The letter also says that “the project is being monitored at the topmost level in the government.”
The ICMR diktat is unprecedented and raises serious concerns. The deadline to begin the trial on July 7, collect data, analyze it and present it to regulators so that the vaccine could be manufactured and launched by August 15 is unrealistic, unethical and illegal. It can be met only if some vital steps in the process are bypassed, overlooked or compromised.
These steps include ethical approval at the institutional level, selection of right candidates for trials, obtaining informed consent of participants and so on. The letter also prejudges that the trials will be successful.
The institutes participating in the human trials will be under tremendous pressure to rush through all procedures if they follow ICMR warning that the trials are being monitored at the “topmost level” in the government.
The undue hurry shown by the apex medical agency of the country is perplexing. Should science be compromised just because a project is being monitored at the ‘topmost level’ in government or a deadline has been fixed from the top?