Even before the first Covid vaccine is yet to be given in India, political parties have already started politicizing the issue by questioning emergency approval given to the indigenous Covaxin vaccine developed by a Hyderabad company Bharat Biotech. On Sunday, the Drugs Controller General of India formally announced the emergency approval for ‘restricted use’ of Bharat Biotech’s Covaxin and the Covishield vaccine, developed by Oxford-AstraZeneca and Serum Institute of India.
The Controller General V G Somani said both the drug firms have submitted data on their trial runs and both have been granted permission. He said the overall efficacy of Covishield was 70.42 per cent, while Covaxin “is safe and it provides a robust immune response”. “We will never approve anything if there is slightest of safety concern”, he added. Rumours being spread that the vaccine could cause impotence is “absolutely rubbish”, he said.
Meanwhile, a professor of Christian Medical College, Vellore, Gagandeep Kang has raised questions about the approval given to Covaxin. She said, she was completely unaware of any data that suggest that Covaxin has any efficacy against SARS-Cov-2 strain, let alone the UK strain. Malini Aisola of All India Drug Action Network said, in the interest of transparency, the regulator must share detailed rationale behind the emergency approval.
The social media was soon agog with rumours about the approval given to the Covid vaccines and political leaders jumped into the fray. The political ball was set rolling by Samajwadi Party chief Akhilesh Yadav who first described it as “BJP vaccine” and later retracted his remark. On Sunday, Yadav said he would not trust the Covid vaccine and would not take it because, he said, it was the BJP’s vaccine. Later he tried to modify his remark by tweeting that Covid vaccination was a sensitive issue and BJP should not make it a “cosmetic” event. He clarified that he was not questioning the work of scientists, researchers and volunteers who worked on the vaccines.
Congress leaders Shashi Tharoor and Jairam Ramesh also jumped into the fray. Tharoor tweeted to say “if Covaxin turns out to be ineffective, the unseemly haste risks jeopardizing (India’s reputation in the field of vaccination)… Any Covaxin user should note the govt’s approval is on the basis of ‘emergency’ and ‘on a clinical trial basis’. In other words those Indians who would be administered Covaxin would, in effect, be volunteers for the required third stage clinical trial – without the mandatory ‘informed consent’. This is, to put it mildly, highly unusual. It is also ethically dubious.”
Congress leader Jairam Ramesh tweeted to say: “Bharat Biotech is a first rate enterprise, but it is puzzling that internationally accepted protocols relating to phase 3 trials are being modified for Covaxin. The Health Minister should clarify.”
On Monday, Bharat Biotech chairman Dr Krishna Ella urged people to stop politicizing the issue. Dr Ella said, “We do 200 per cent honest clinical trials and yet we receive backlash. If I am wrong, tell me. Some companies have branded our vaccine like water. I want to deny this. We are scientists.”
On Sunday, the owner of Serum Institute of India Adar Poonawala had said that “only three vaccines, made by Pfizer, Moderna and Astra-Zeneca, had proven efficacy and the rest were just safe like water.” In reply, Dr Ella said that the US and Europe had refused to accept Astra-Zeneca-Oxford vaccine trial data from the UK because it was “not clean”, but no one was questioning the Oxford data. He alleged that volunteers during Astra-Zeneca trials were given paracetamol tablets before being given the shot. “We haven’t given paracetamol to our volunteers, so whatever adverse reaction is captured it is exactly 100 per cent even if it is good or bad. It is captured in real time”, Dr Ella said.
He said that Covaxin Phase 3 trials were being handled by an American company IQVIA and IMS Health Inc and that patients in Phase 3 trials will be monitored for 12 months. Dr Ella said that as an Indian company Bharat Biotech has been struggling alone without any backup of multinationals like AstraZeneca or Pfizer.
He said, Covaxin had less than 15 per cent adverse effects “and we have vaccinated more than 24,000 people already”.
On Monday, Prime Minister Narendra Modi lauded Indian scientists for successfully developing two indigenous Covid vaccines and said that India is on the verge of starting the world’s largest vaccination drive.
BJP spokesperson Sambit Patra on Monday alleged that Congress leader Rahul Gandhi was “choreographing rumour mongering about the vaccine by enlisting his colleagues Jairam Ramesh and Shashi Tharoor to create confusion among the people”. He said, Indian Council of Medical Research and Central Drugs Standard Control Organization have already approved the vaccine that is being questioned by the Congress. “Such attacks can only help foreign forces which do not want India to be self-reliant”, he pointed out.
Firstly, I am astonished to find a former chief minister like Akhilesh Yadav saying in public that he would not take the vaccine because it was BJP’s vaccine. He was chief minister of India’s most populous state where massive polio and small pox eradication programmes were carried out. He should not have spoken so lightly, given his administrative experience.
As for Congress leaders, I want to point out that it is common protocol to give emergency approval if phase 1 and 2 trial data are given to the drugs regulator. Dr Krishna Ella has said that all the data relating to phase 1 and 2 trials have been shared with designated institutes and the phase 3 trial involves 26,000 volunteers. It is the world’s biggest clinical trial. Already the trial is over with 24,000 volunteers and as far as safety is concerned, less than 10 per cent volunteers had minor side effects. He said, the entire Phase 3 trial data will be received by March this year.
Dr Ella said Bharat Biotech has a worldwide reputation and it holds more than 400 patents. He said Covaxin, developed indigenously in India, is as efficacious as the Pfizer vaccine. ‘We are being targeted because we are an Indian company and we have Indian scientists, that is why our image is sought to be sullied’, he added.
Even if a few scientists may say that Covaxin is untested and unproven and that it should not have been given final approval, the fact remains that the DGCI has the powers to give emergency approval even if the phase 3 trial is under way. Secondly, it has been approved as a backup vaccine. If there is sudden flareup in the number of active Covid cases, Covaxin can be used in clinical trial mode. The questions raised by a few scientists have been replied to, but as far as loose remarks made by politicians about “BJP’s vaccine” is concerned, these deserve to be ignored. Let us keep politics away from vaccination.
As a footnote, I want to make a correction. In one of my tweets, I had said that Covaxin doses has been booked by 190 countries across the world. The fact is, COVAX is a WHO program, under which 2 billion doses of Covid vaccines have been booked by GAVI, a consortium of 190 countries, in association with Serum Institute of India and Bill and Melinda Gates Foundation. The error due to similarity of names, is deeply regretted.

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