Covid vaccination drive set to begin under shadow of doubt over Covaxin efficacy

The Union Health Ministry’s last-minute 180 degrees turn on Covaxin – an indigenous Covid-19 vaccine - has generated concerns among doctors and healthcare workers as a section of them is reluctant to accept it without the efficacy data even as India is set to publicly roll out the two shots, Covishield and Covaxin, on Saturday in the world’s largest adult vaccination drive.

On the eve of the rollout by Prime Minister Narendra Modi at 3,006 sites, a senior Health Ministry official wrote to the States and Union Territories making it clear that both vaccines made by Serum Institute and Bharat Biotech would be used.

Many doctors are discussing among themselves why they are being forced to take a vaccine that lacks efficacy data. "Some of them feel as if they're being forced into a clinical trial," said a senior doctor and researcher, describing discussions among peers.

Read: All you need to know about SII’s Covishield and Bharat Biotech’s Covaxin

The Tamil Nadu Government Doctors Association in a statement told its members to insist on Covishield till the Covaxin phase-3 results are out.

The Centre, however, made it clear that the recipients would not be given a choice.

A factsheet shared by Additional Secretary Manohar Agnani with the states gives a head-to-head comparison of the two vaccines with no distinction in the roll out protocol between the two. The dos and don’ts are the same. “Both the vaccines will be used for introduction,” he wrote.

Read: Can you contract Covid-19 from the vaccine? Harsh Vardhan clarifies

This contradicts the government’s earlier claim that the Bharat Biotech vaccine would be a “back up” in case of any spurt by the UK variant, which has been found in 114 Indians so far. Both ICMR director general Balram Bhargava and AIIMS director Randeep Guleria publicly spoke on the use of Covaxin as a “back up.”

But a day before the vaccination, the officials completely changed their stand. “No vaccine is a backup to the other - both vaccines are equally important, both vaccines are hugely immunogenic. They excite immunity against the virus. There is no choice for the individual at this point of time," Vinod Paul, member, NITI Ayog said in an interview to Reuters.

Paul, Bhargava and Guleria are the three doctors and medical researchers advising the Centre on various aspects of the Covid-19 pandemic from the beginning.

Read: Here's who shouldn't be taking Covid-19 vaccine

DH reached out to top officials as well as Bhargava and Guleria seeking to know the reasons behind the turn-around, but did not receive any response.

“The fact that we are going ahead with both the vaccines at the same time when efficacy data as of yet is not available for one does raise concerns,” Anant Bhan, former president, International Association of Bioethics and an adjunct professor at the Yenepoya University, Mangalore told DH.

After reviewing the preparations for the Saturday launch, the Union Health Minister Harsh Vardhan reiterated that both indigenously manufactured vaccines, Covishield and Covaxin had proven safety and immunogenicity records and were the most important tools to contain the pandemic. There is no mention of Covaxin’s “restricted use in emergency situations in public interest as an abundant precaution, in clinical trial mode,” as stated by the regulator.

“I can only think that this is a political decision. Any decisions regarding Covaxin could easily have been taken some weeks later, if supported by the efficacy data for which trials are ongoing,” said a senior biologist. “The love and promotion of the swadeshi vaccine, even if that is not something that has finished phase-3 trial, was pretty obvious right from the beginning,” added a public health professional.