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
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.
It would make every Indian proud that the two vaccines that have been given emergency use approval are made in India! This shows the eagerness of our scientific community to fulfil the dream of an Aatmanirbhar Bharat, at the root of which is care and compassion.
— Narendra Modi (@narendramodi) January 3, 2021
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.
These vaccines are a fitting tribute to our corona warriors!
My heartfelt gratitude to all healthcare professionals & frontline workers for their exemplary efforts during these unprecedented times.
Congratulations to all the scientists & researchers for their untiring efforts.
— Dr Harsh Vardhan (@drharshvardhan) January 3, 2021
We heartily thank our scientists, doctors, medical staff, security personnel and all Corona warriors who dedicatedly served humanity during these testing times.
Nation will always remain grateful to them for their selfless service towards mankind.
— Amit Shah (@AmitShah) January 3, 2021
India today takes a giant step towards decisively defeating the COVID-19 Pandemic with DCGI granting approval to vaccines of @SerumInstIndia and @BharatBiotech. We are proud of our scientists who made this vaccine possible in a very short span of time.
— Rajnath Singh (@rajnathsingh) January 3, 2021
Approval to indigenously made vaccines is a watershed moment in our fight against COVID-19 virus & a defining chapter in our journey towards building an #AatmaNirbharBharat. Heartiest congratulations & gratitude to our scientists for their dedication & determination 🙏 https://t.co/k4B8RFd3r8
— Smriti Z Irani (@smritiirani) January 3, 2021
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".
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. Health Minister @drharshvardhan should clarify. pic.twitter.com/5HAWZtmW9s
— Jairam Ramesh (@Jairam_Ramesh) January 3, 2021
The Covaxin has not yet had Phase 3 trials. Approval was premature and could be dangerous. @drharshvardhan should please clarify. Its use should be avoided till full trials are over. India can start with the AstraZeneca vaccine in the meantime. https://t.co/H7Gis9UTQb
— Shashi Tharoor (@ShashiTharoor) January 3, 2021
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".
The Vaccine has not gone through phase 3 trials, has not been tested for long term side effects, yet Drug controller says it is 110% safe. Let all of Modi's Cabinet & all personnel of Vaccine company & Drug controllers office take it before subjecting our people to it https://t.co/cesbyqlbW1
— Prashant Bhushan (@pbhushan1) January 3, 2021
This is what is wrong with a India. Did you hear @pfizer thank Trump? Vaccines should be approved when medically safe & effective. Govs ain’t doing a favour to producers when their regulators approve them. They are fulfilling a trust to keep people safe. https://t.co/PF3bM6jL66
— K. C. Singh (@ambkcsingh) January 3, 2021
Journalists also pointed out that the DCGI refused to take questions in the press conference in which it announced the approvals.
DCGI reads out a statement declaring emergency use approval for two vaccines. Doesn’t take questions. What kind of briefing is this??
— Teena Thacker (@Teensthack) January 3, 2021
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?"
Our in-house cynics M/s Jairam, Tharoor & Akhilesh are behaving true to form.
They first questioned the valour of our soldiers & are now unhappy that the two vaccines to get DCGI nod are made in India.
Clearly they are on a quest for permanent political marginalization.
— Hardeep Singh Puri (@HardeepSPuri) January 3, 2021
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."
Congratulate @BharatBiotech as ‘Covaxin’ vaccine is recommended by Subject Expert Committee (SEC) on #COVID19 for emergency use authorisation in India. This will strengthen the vaccination effort for entire country.
— Naveen Patnaik (@Naveen_Odisha) January 3, 2021
Additionally, TRS, the ruling party in Telangana, congratulated Ella and his team on the approval.
Many Congratulations to Dr. Krishna Ella, Suchitra Ella & the entire team of scientists @BharatBiotech on getting DCGI approval for Covaxin👍
Hyderabad continues to shines on as the vaccine capital because of the pursuit of excellence of scientists & innovative entrepreneurs
— KTR (@KTRTRS) January 3, 2021
With inputs from PTI
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