Bengaluru: NITI Aayog member Vinod K. Paul has said that the two COVID-19 vaccine candidates that the Drug Controller General of India (DCGI) Dr V.G. Somani approved on different terms will actually be treated “equally”. Reuters reported that Paul also said those who line up to receive the vaccines won’t have a choice of which candidate to receive.
The DCGI approved Covishield on the back of preliminary efficacy data from phase 3 clinical trials and bridging trials in India, supplied by its manufacturer, Serum Institute of India. However, at the time of approval, Bharat Biotech didn’t provide efficacy data from phase 3 trials because phase 3 trials were yet to begin in full swing. So in the absence of any other clarification, most independent scientists assumed the DCGI confusingly worded the approval for Covaxin to hedge against the absence of efficacy data.
Against this background, Paul’s statement marks yet another dent in India’s vaccine roll-out programme, which was initially premised on the notion that Covishield would be rolled out for general use and that Covaxin would be deployed in “clinical trial mode” for “restricted use” in “emergency cases”, as a matter of “abundant precaution”.
The meaning of “clinical trial mode” was and remains unclear, since there is no statutory term or concept of the same name. However, Dr Samiran Panda, a scientist at the Indian Council of Medical Research (ICMR), told The Wire Science earlier this week that the “mode” is effectively a single-arm clinical trial that would have have a placebo and whose results wouldn’t be published in peer-reviewed journals – but with everything else being the same.
This sameness pertains, in part, to the notion of prior consent. Anyone who receives Covaxin has to be fully informed of the pros and cons of this vaccine candidate, and has to volunteer themselves to participate. Dr Panda had also said that those who had enrolled themselves thus would have the option to opt out.
But Paul’s latest comment confuses this part of the picture.
In a follow-up conversation, Dr Panda said his comments and Paul’s are not contradictory. According to Dr Panda, Paul’s comment relates to the first phase of the vaccine candidates’ roll-out, in which priority groups like frontline workers, including medical staff, are to be inoculated, and that a similar choice wouldn’t be presented to the general population when the time comes. (This vaccination drive is set to begin tomorrow, January 16.)
Second, say there is a healthcare worker named Selvi. In Dr Panda’s telling, Selvi will receive a message that she is invited to receive a vaccine candidate, together with the relevant information and fact-sheets of both Covaxin and Covishield. Selvi’s consent to be vaccinated will apply at this point: i.e. whether or not to be vaccinated.
“My head is spinning,” the noted clinician-scientist Dr Gagandeep Kang told The Wire Science. According to her, every potential participant of a vaccine clinical trial is told what the vaccine is as well as that the participant they may receive either the vaccine or the thing to which its effects are being compared. “That you understand this is important,” Dr Kang added.
But, she continued, “I have never heard of a vaccine roll-out or a vaccine trial where you are told the government is giving you a vaccine, agree and then find out what it is”.
If Selvi does consent to be vaccinated, she will have to proceed to a designated booth, where government personnel will inject her with either Covaxin or Covishield. This is, according to Dr Panda, what Paul meant when he said recipients will not have a choice between receiving either vaccine candidate.
Dr Kang wondered if this could mean Covishield is also part of the “clinical trial mode” – considering the trial participant will have to decide whether to consent based on two possibilities: ‘I will get Covaxin’ or ‘I will get Covishield’.
This way of securing consent could have implications for how subsequent results are evaluated. “An impact evaluation or an effectiveness design is a formal, structured process with data-capture that can be prone to misclassification, so is difficult to do even for licensed vaccines, where you start from having an idea of efficacy in clinical trials and then look to measure ‘real world’ performance,” Dr Kang said.
“For unlicensed vaccines or ‘restricted use’ vaccines, it would be great if the government actually had a process to capture data that could be useful in the future, but I have not heard that there is anything planned. So what is the ‘clinical trial mode’ going to capture? Might be safety, but without a protocol for what is being done, we really do not know.”
In the end, she said she wishes “the government and its leaders well” for “their goals are everyone’s goals.”