Misleading claims on efficacy, questions on rollout cast shadow on India's Covid-19 vaccination campaign

Misleading government claims on efficacy and unanswered questions on the mysterious vaccine rollout “in a clinical trial mode” have cast a shadow on India’s Covid-19 vaccination campaign which is about to take off as one of the world’s biggest adult mass inoculation drives.

Over the last two days such misleading claims came from Union Health Minister Harsh Vardhan, Drugs Controller General of India V G Somani and All India Institute of Medical Sciences, director Randeep Guleria further muddying the water in the backdrop of confusion created by two different types of regulatory approvals given to Covishield (made by Serum Institute) and Covaxin, made by Bharat Biotech, Hyderabad.

"Lack of transparency, lack of details on what basis such decisions were made and the language made the entire process confusing and would add to people’s concerns and anxiety on the new vaccines,” Anant Bhan, past president, International Association of Bioethics and an adjunct professor at the Yenepoya University, Mangaluru, told DH.

Read: Covaxin 200% safe compared to other coronavirus vaccines: Bharat Biotech CMD Krishna Ella

Noted virologist Shahid Jameel, director of the Trivedi School of Biosciences at Ashoka University concurred. “There are already reports of increasing vaccine hesitancy in India. Such confusion would fuel that. Transparency and openness are a key to building trust. This (the confusion) helps no one.”

Misleading claims compounded the problem. Guleria, for instance in a video message, had stated that the Covid-19 vaccine introduced in India would be as effective as any vaccine developed by other countries.

But since different vaccines have different efficacy levels, it's not clear what exactly the AIIMS director meant. For both Pfizer and Moderna, the efficacy is over 94% while for Oxford University-AstraZeneca, it is 62% in the two full-dose regimen and 90% in a half-dose, full-dose regimen. The Russian origin Sputnik V also claims to have more than 90% efficacy.

Somani was guilty of quoting an efficacy figure of 70.42% for Covishield relying on a controversial Lancet publication on the overseas trial of the Astra vaccine.

Read: Experts question govt's claim of Covaxin efficacy against new coronavirus strains

The Lancet study drew flak from several quarters as the researchers mixed up two different protocols - the two full doses regimen vis-a-vis one-half followed by one-full dose regimen – to arrive at a misleading efficacy number. The flaw in the method was admitted by the Oxford team and the Astra top brass.

Experts said for the two full dose regimen approved in India, the actual efficacy should have been 62% and not 70% as claimed by the DCGI in what seems to be an effort to inflate the efficacy.

Minister Harsh Vardhan claimed "all recipients would be monitored and tracked as if they are in a clinical trial", which the experts said is neither sufficient for nor equivalent to a true clinical trial as that would demand continued measurement of the vaccine's performance on efficacy in a randomized manner.

“In the absence of ongoing surge in cases or deaths, ideally the regulators after studying the data, should have deferred making a decision for full approval. The ideal action should have been to wait for phase-3 results from both vaccine candidates. The phrase “clinical trial mode” is difficult to interpret. If it’s emergency use authorization, they should have stated only that,” said Giridhar Babu, an epidemiologist at the Public Health Foundation of India.

"The regulator can still clarify to allay the apprehensions. It would help towards building trust and confidence in the vaccine,” Bhan added.