Experts flag approval to Covaxin, govt defends move amid row
With the Union government permitting emergency usage of two vaccines — Serum Institute’s Oxford vaccine ‘Covishield’ and Bharat Biotech’s ‘Covaxin’, under certain conditions, several experts raised concerns over the move. In an unusual move, the Union government has granted its approval to Covaxin in a ‘clinical trial mode’, which means that the recipient will be treated like a volunteer in a clinical trial and a similar process would be followed. This was criticised by many experts, who pointed to a lack of data and transparency.
A prominent critic of the move was Dr Gagandeep Kang, the vice-chair of the board of Coalition for Epidemic Preparedness Innovations (CEPI), who also works as a professor at the Christian Medical College (CMC), Vellore. Dr Gagandeep Kang, who spent two decades researching and developing vaccines, told CNBC-TV18 that her first reaction was of “utter confusion.”
"I thought I knew the processes by which vaccines are generally approved and I can kind of understand the basis on which Covishield receives emergency use authorisation. But I have absolutely no understanding of the data that informed the decision to give exactly the same approval for the Covaxin vaccine," she told the TV channel.
Covaxin is being developed indigenously by Bharat Biotech. In an interview to the Times of India, when asked if India could defend the vaccine's efficacy internationally, she said, "How are we different from Russia and China? I really don't have an answer if anyone asks me that question."
In a series of tweets, BJP leader Dr Vijay Chauthaiwale hit back, saying, "Dr Gagandeep Kang has taken an extremely conservative view on Covaxin. She is right when she says she has never seen anything like this before. But the fact remains that no one has seen such a pandemic before. When in the past USFDA approved any vaccine so rapidly? Or when pharma companies could start clinical testing of vaccines within a few months of isolation of novel virus? Unusual circumstances demand unusual approaches."
"We need to trust our scientists, pharma companies who have taken enormous financial risk and regulators who are trying their best to control the pandemic. World is praising the way India has handled the COVID-19 pandemic. With due respect to Dr Kang (whom I know personally), the fact remains that she had signed a petition against the Modi government on an issue that had nothing to do with science. So the possibility of her political views overshadowing her thoughts cannot be ruled out," he added.
Dr Gagandeep Kang has taken extremely conservative view on COVAXIN. She is right when she says she has never seen anything like this before. But the fact remains that no one has seen such a pandemic before.
— Dr Vijay Chauthaiwale (@vijai63) January 4, 2021
Several others took to social media to voice their views on the issue.
I find the campaign against Bharat Biotech’s Covaxin quite ridiculous. Mr Modi’s government is not crazy to endanger lives of its own people through rash experimentation.
— Sanjay Jha (@JhaSanjay) January 3, 2021
Can we please trust our bureaucracy, doctors, scientists, R&D, more please if not our politicians?
This is all we are saying. Of course we will be proud if the vaccine turns out to work effectively. But offering it before Phase3 clinical trials have proven efficacy is a violation of every scientific protocol &unheard of in the world. Jingoism is no substitute for common sense. https://t.co/aRlU8TvYHT
— Shashi Tharoor (@ShashiTharoor) January 4, 2021
My analysis of the paper released by #BharatBiotech researchers & the Press Statement by the Drugs Controller General of India (DCGI) on Restricted Emergency approval of 1out of 3 COVID-19 virus vaccine from Bharat Biotech: A thread...
— Dr Sumaiya Shaikh (@Neurophysik) January 3, 2021
The government meanwhile, defended its move.
For those spreading rumours let it be known that EUA for COVAXIN is differently conditional – in clinical trial mode
— Dr Harsh Vardhan (@drharshvardhan) January 3, 2021
EUA for COVAXIN is different from COVISHIELD because its use will be in clinical trial mode.
All COVAXIN recipients to be tracked,monitored as if they’re in trial pic.twitter.com/1N8LGnhC3w
TNM had earlier highlighted how a lack of transparency around the approval provided to Covaxin had concerned experts, as phase 3 trials are still going on, and Bharat Biotech is reportedly yet to submit any result or data of the third phase of its clinical trials. Read our detailed story below.