"All COVAXIN recipients to be tracked, monitored as if they’re in trial": Health Minister answers to critics

Health Minister Dr Harsh Vardhan responded to opposition’s criticism on the Drugs Controller General of India’s (DCGI) approval for emergency use of the two Indian COVID-19 vaccines - Covaxin and Covishield through a tweet.

"For those spreading rumours let it be known that EUA (Emergency Use Approval) for COVAXIN is differently conditional – in clinical trial mode,” Dr Vardhan tweeted. He also added, "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.”

"COVAXIN approval is ‘Monitored Approval’ with strict follow-up & rolling review. This approval ensures India has an additional vaccine shield in its arsenal esp against potential mutant strains in a dynamic pandemic situation - A strategic decision for our vaccine security (sic),” he said in another tweet.

Prior to this Prime Minister, Narendra Modi in a tweet congratulated the country after the country's drug regulator announced the approval of Pune-based Serum Institute's Covishield and Bharat Biotech's Covaxin, for "restricted use".

Both vaccines are Indian-made.

"A decisive turning point to strengthen a spirited fight! 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," said the Prime Minister in a three-part tweet.

"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," he added.

"We reiterate our gratitude to doctors, medical staff, scientists, police personnel, sanitation workers and all Corona warriors for the outstanding work done, that too in adverse circumstances. We will remain eternally grateful to them for saving many lives," he concluded.

Earlier, DCGI VG Somani said, “CDSCO (Central Drugs Standard Control Organisation) accepts the subject expert committee reform recommendations on Serum and Bharat Biotech Covid vaccines. Vaccines of M/s Serum and M/s Bharat Biotech are being approved for restricted use in emergency situations.”

Politicians tweeted about the vaccine.

As per Union Home Minister Amit Shah, the approval given to vaccines is a “momentous achievement for India.”

Further, Union Health Minister Dr Harsh Vardhan said that it is a “watershed moment” for India’s battle against COVID-19 and that the vaccines are a “fitting tribute to our corona warriors.”

"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 Folded hands (sic)," wrote Union Minister Smriti Irani.

UP Chief Minister Adityanath also congratulated the country over a tweet. He wrote, "Under the leadership of PM Modi, India is on its way to soon becoming a COVID-free nation. The approval of Serum Institute and Bharat Biotech vaccine by DCGI for emergency use is the result of the hardwork of our renowned scientists."

"Country under PM @NarendraModi ji is embarking on a healthier path as Drug Controller General of India approves vaccines of @SerumInstIndia & @BharatBiotech. Congratulations to the people as we march towards becoming a COVID-free nation. A huge milestone in our collective fight!," wrote Union Minister Piyush Goyal.

"DCGI's approval of Serum Institute's 'Covishield' and Bharat Biotech's 'Covaxin' is good news. I hope that according to protocols we'll be able to start vaccination in Rajasthan soon," wrote Rajasthan Chief Minister Ashok Gehlot on Twitter.

Opposition leaders also reacted to the news.

Congress leader, Shashi Tharoor said that the vaccine was approved "too soon". "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," Tharoor tweeted.

Jairam Ramesh of Congress party also asked for a clarification from Union Health Minister Dr Harsh Vardhan.

Meanwhile, Bahujan Samaj Party (BSP) Chief and former Uttar Pradesh CM Mayawati welcomed the DCGI's announcement.

"Many welcome to the indigenous vaccine (vaccine) with the very deadly coronavirus epidemic and many congratulations to the scientists. At the same time, there is a special request to the Central Government that free arrangements for this vaccine be made to all the health workers in the country as well as to the very poor of the society," she tweeted.