Prime Minister Narendra Modi on Sunday lauded scientists of the country after the Drug Controller General of India (DCGI) gave approval to Serum Institute of India’s ‘Covishield’ vaccine and Bharat Biotech’s ‘Covaxin’ for emergency use, paving the way for its roll-out and administration to millions.
“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,” the Prime Minister said in a series of tweets.
He further said 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. 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.”
Prime Minister’s remarks came after Drugs Controller General of India V.G. Somani announced that the CDSCO has decided to accept the recommendations of the Subject Expert Committee and accordingly, vaccine of Serum and Bharat Biotech are being approved for restricted use in emergency situation after adequate examination.
This is a major relief for India which has the second highest number of infections in the world after the US. The Central government plans to vaccinate nearly 30 crore people in the first phase of drive in the next six to eight months.
Meanwhile, Union Health Minister Dr Harsh Vardhan criticised Congress and other Opposition leaders over their comments on Bharat Biotech’s Covaxin, which was cleared for emergency use in the country along with the Oxford-AstraZeneca vaccine manufactured by the Serum Institute of India.
Congress leaders Shashi Tharoor and Jairam Ramesh, and Samajwadi Party chief Akhilesh Yadav had pointed out that Covaxin lacked efficacy data to show the vaccine’s effectiveness before it was approved for emergency use.
“Disgraceful for anyone to politicise such a critical issue. Sh @ShashiTharoor, Sh @yadavakhilesh & Sh @Jairam_Ramesh don’t try to discredit well laid out science-backed protocols followed for approving #COVID19 vaccines. Wake up & realise you are only discrediting yourselves,” Dr Harsh Vardhan tweeted.
The Health Minister said Covaxin is “likely to have similar protective efficacy reported for others”, despite the lack of efficacy data from phase 3 trials.
“Vaccines approved globally based on gene encoding spike proteins have protective efficacy of over 90%. However, Covaxin based on whole inactivated virus has other antigenic epitopes in addition to spike protein. So, it’s likely to have similar protective efficacy reported for others,” the minister said.
“Covaxin is more likely to work against newer variants like N501Y Variant (UK variant) & any other that may arise due to antigenic drift as it contains immunogens (epitopes) from other genes in addition to those from Spike protein. Inactivated virus from NIV also had D614G mutation,” Harsh Vardhan said.
“For those spreading rumours let it be known that EUA for Covaxin is differently conditional—in clinical trial mode 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,” the minister tweeted, referring to emergency use authorisation.
Earlier in the day, Congress leaders had said the government must explain why mandatory protocols and verification of data from phase 3 trials have been dispensed with while granting permission for emergency use of Covaxin.
«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 too raised concerns and asked the Health Minister to clarify why internationally-accepted protocols on phase 3 trials are being modified. «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 Harsh Vardhan should clarify,» the senior Congress leader said on Twitter.
Akhilesh Yadav, however, politicised the issue the most when he called it a “BJP vaccine”. He said he would not take the Covid-19 vaccine “at this moment”. “That too given by Bharatiya Janata Party. How can I trust the BJP’s vaccine, no chance? When our government is formed, everyone will get a free vaccine. We cannot take the BJP vaccine. The inoculation programme under the BJP-led regime cannot be trusted,” the former UP CM said.