Harsh Vardhan hails clearance for COVID-19 vaccines as 'watershed moment'; Congress questions 'premature' nod to COVAXIN

India's drugs regulator on Sunday also approved the Oxford University-AstraZeneca COVID-19 vaccine 'Covishield', manufactured by the Serum Institute for restricted emergency use in the country, paving the way for a massive inoculation drive

FP Staff January 03, 2021 15:24:59 IST
Harsh Vardhan hails clearance for COVID-19 vaccines as 'watershed moment'; Congress questions 'premature' nod to COVAXIN

Representational image. PTI

The Drug Controller General of India's approval for restricted emergency use to Bharat Biotech's indigenously developed COVID-19 vaccine, 'COVAXIN' was met with mixed reactions on Sunday. Several political leaders and journalists pointed out that the firm has not completed Phase 3 trials of its vaccine candidate yet.

India's drugs regulator on Sunday also approved the Oxford University-AstraZeneca COVID-19 vaccine 'Covishield', manufactured by the Serum Institute for restricted emergency use in the country, paving the way for a massive inoculation drive.

While SII CEO Adar Poonawalla tweeted that 'Covishield' is "ready to roll out in the coming weeks", Bharat Biotech managing director Dr Krishna Ella said, "The approval of COVAXIN for emergency use is a giant leap for Innovation and novel product development in India."

Narendra Modi, Union ministers hail DCGI approval

Prime Minister Narendra Modi and Union health minister Harsh Vardhan were among the Cabinet ministers who hailed the decision to grant approval to the two vaccine candidates.

Modi termed it a "decisive turning point" in India's fight against coronavirus .

"DCGI granting approval to vaccines of @SerumInstIndia and @BharatBiotech accelerates the road to a healthier and COVID-free nation. Congratulations India. Congratulations to our hardworking scientists and innovators," he tweeted.

Harsh Vardhan called the approval "a watershed moment".

"It’s now time to reap the benefits of the robust supply chain infrastructure we’ve put in place for quick and equitable distribution of the vaccine. Urge all citizens to entrust the stringent protocols followed for ensuring safety, efficacy and immunogenicity of the approved vaccines," he added.

Union ministers Amit Shah, Rajnath Singh, and Smriti Irani also lauded Modi for "strengthening the national resolve to fight against COVID-19 ."

Congress, activists question 'premature' approval

On the other hand, Congress leaders and some activists raised questions about the approval granted to Bharat Biotech's vaccine candidate without data available on its Phase 3 trials, which began in mid-November 2020.

Congress leaders like Jairam Ramesh and Shashi Tharoor, along with activists and journalists, called the approval of the Hyderabad-based lab's vaccine "puzzling, premature, and dangerous".

Additionally, Congress leader Anand Sharma asked the government to explain why mandatory protocols and verification of data has been dispensed with.

Sharma, who heads the Parliamentary panel on Home Affairs which dealt with the issue at length, said the issue of granting authorisation to the vaccine use needs to be taken carefully as no country has dispensed with the mandatory phase 3 trials and verification of data.

As per submissions made before the expert panel, phase 3 trials have not been completed and therefore, the data on safety and efficacy has not been reviewed, which is a mandatory requirement, he said.

"The health ministry needs to give cogent reasons for dispensing with the mandatory protocols and requirements in this case, since it involves the health and safety of those frontline workers who will be vaccinated under the restricted category," he told PTI.

"The DCGI statement is puzzling and the government must must reveal the final data of global efficacy trials and the final trials in UK which has been shared officially by UK's MHRA following a government to government agreement signed between the two countries which should be put in public domain to avoid any confusion on the proven efficacy of the vaccine," Sharma also said.

On the other hand, Congress leader Randeep Singh Surjewala and former party member Sanjay Jha extended congratulations to the scientists working on the approved vaccine candidates.

Jha also weighed in on the debate around the approvals and called the objections "ridiculous".

"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. Can we please trust our bureaucracy, doctors, scientists, R&D, more please if not our politicians?" he said.

Activist Prashant Bhushan said that Modi and the vaccine manufacturers should take the vaccine "before subjecting our people to it" as they claimed that it was "110 percent safe".

Journalists also pointed out that the DCGI refused to take questions in the press conference in which it announced the approvals.

However, the BJP and Union minister Hardeep Singh Puri slammed the Congress for raising questions about the approval.

Malviya, the BJP IT Cell head, said, "India’s opposition is indulging in worst kind of fear mongering with regard to the Covid vaccine. But this isn’t the first time. We have seen similar vicious campaigns during the anti-polio drive too. But Covid, unlike polio, is fatal. Does the Opposition want more people dead?"

BSP, BJD welcome decision; TRS congratulates Bharat Biotech

Among other political leaders, BSP chief Mayawati and Odisha chief minister Naveen Patnaik welcomed the DCGI's approval.

Mayawati congratulated the scientists associated with the coronavirus vaccine and urged the Centre to make it available for the marginalised communities free of cost.

In a tweet in Hindi, she said, "The 'swadeshi' anti-Covid vaccine is welcome and congratulations to the scientists. A request to the Central government is that along with all the health workers, if the extremely poor people get the vaccine free of cost, then it will be appropriate."

Additionally, TRS, the ruling party in Telangana, congratulated Ella and his team on the approval.

With inputs from PTI

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