The decision to grant emergency use authorisation to Covishield and Covaxin without sufficient data follows the precedent set during the COVID-19 pandemic of not following the rule-book, argue experts.
On January 3, Drugs Controller General of India granted emergency use authorisation to Serum Institute of India and Bharat Biotech for their COVID-19 vaccines Covishield and Covaxin respectively, a move which has been criticised by experts.
Serum Institute of India is manufacturing Covishield, the adenoviral vector vaccine that is produced by Oxford-AstraZeneca. Covaxin is India's indigenous vaccine candidate that is being manufactured by Bharat Biotech.
Bioethics and health policy researcher Dr Anant Bhan has questioned the rationale behind granting EUA for Covaxin and Covishield without acquiring sufficient data. Considering vaccines are a preventive modality given to a healthy population, data backing its safety and efficacy is crucial before it is rolled out, argued Dr Bhan.
"Globally, that is what is the kind of data that regulators have been looking for and regulators should be looking for. With respect to any vaccine, and specifically also COVID-19 vaccines, there is no science exceptionalism. You can probably make things happen faster, including regulatory turnaround times, but you cannot take away the fundamental requirements of how you find out if a vaccine works or not," Dr Bhan told BOOM.
"In India, we don't have local efficacy data for AstraZeneca Oxford's vaccine, which is being tried out by Serum. We know that the bridging study is ongoing but we don't know if it's completed and what is the nature of data that they have collected. For Covaxin, there is a phase three efficacy study happening. But that has just about started a couple of months ago.
"Given these two backgrounds, you know, on what basis was a decision made is what I think we are all questioning. What was the rationale? If there was actually data available to the subject expert committee, why is that not in the public domain?" he added.
Echoing Dr Bhan's view, former pharmaceutical industry lawyer Murali Neelakantan believes that the DCGI and other authorities have been winging it while approving drugs for treatment against COVID-19.
"Recent precedent regarding drug regulation and approvals have been different from what has happened earlier. In 2020, the regulator has been willing to approve drugs which have not shown efficacy. For example, remdesivir, favipiravir and HCQ had no efficacy trial data available when they were approved for COVID-19. So that is the context in which you now you have to understand how vaccines have been approved," he said.
"We made a departure by saying in 2020, that we have decided not to follow the rulebook. Basically, the drug regulator is saying, come and talk to us and we'll figure it out as we go along. That means that we don't know what the rules are," he added.
Bharat Biotech MD Dr Krishna Ella on Monday defended the EUA granted to Covaxin by stating that studies have shown good safety and immunogenicity in its phases 1 and 2 trials which entitled them to seek EUA under the CDSCO's New Drugs and Clinical Trials Rules.
However, Bhan and Neelakantan believe that a safe vaccine would not automatically translate it to being an effective vaccine.
"If you could just make recommendations based on safety and immunogenicity, then we did not even have waited this long. The subject expert committee met a few weeks ago and I think phase one and phase two data was available at that point of time. But obviously, they also wanted more data. So what was that more data that they asked for? What was the nature of that data? What does that data indicate, which has made them now satisfied that they are willing to go ahead and give clearance?" Dr Bhan said.
"Credibility means that you follow the rules. So you can't short circuit the rules. If you need one year's data, you cannot get it in 40 days. You just have to accept that if you need scientific data of one year, you have to wait one year. Even if you have data from somewhere else, you have to show that it will be efficacious," Neelakantan said.
"As Dr Bhan said perhaps by March, you would have had the data, you could have prepped for an immunization program. Nothing is going to be achieved by this vaccination, nothing good is going to be achieved by this vaccination in the next six weeks," he added.
Considering the lack of data available in the public domain and the opacity in which the DCGI's subject expert committee functions, Bhan and Neelakantan opine that the public's trust in pharma companies and regulators will erode.
"Many regulators have been open about their processes. The FDA, for example, has livecast its decision meeting the equivalent of the subject expert committee meetings there. And that helps build trust in the fact that there is a process which is transparent.
Now in India, we don't know who the subject expert committee members are. We don't know what the process is. We don't know what they are looking at in terms of data based on which they are making a decision. And then you have language, which is not decipherable," Dr Bhan said.
Arguing that the credibility of the regulator is at stake should any of the vaccine prove to be not as efficacious as claimed, Neelakantan said that the common public would incorrectly assume that they are safe since they have been vaccinated.
"If it is not efficacious, people may think they are vaccinated, they are immune and start behaving irresponsibly. Let's say the efficacy turns out at 50%. Does the common man understand what that 50% efficacy means? It causes a change in behavior right of people and we are already suffering as a consequence of irresponsible behavior," Neelakantan said.
Watch the whole discussion below or click this link.