Vaccine approval hailed as decisive turning point in India's fight against pandemic; Leaders laud scientists, corona warriors

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New Delhi, Jan 3 (PTI) The approval given to two COVID-19 vaccines is a 'decisive turning point' in the spirited fight against the pandemic, Prime Minister Narendra Modi said on Sunday as the development was greeted with a sense of relief and hope in the country that has been reeling from the impact of the virus for over 10 months.

The World Health Organisation too welcomed the much-anticipated approval by Drugs Controller General of India (DCGI) to Oxford vaccine Covishield and Bharat Biotech's Covaxin for restricted emergency use, saying it will help 'intensify' and 'strengthen' India's efforts to combat the coronavirus.

While the Congress' chief spokesperson Randeep Surjewala lauded scientists and researchers of Bharat Biotech for the indigenous vaccine, some party leaders like Anand Sharma, Jairam Ramesh and Shashi Tharoor raised concern over the grant of approval to it without the phase 3 trials, saying it is 'premature' and can prove dangerous.

Their remarks triggered a sharp reaction from the BJP which alleged that the opposition party is in the habit of undermining India's achievements and is on a 'quest for permanent political marginalisation'.

In his message, Prime Minister Modi said it will make every Indian proud that both vaccines 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 said, congratulating the nation, scientists and innovators.

'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,' Modi tweeted and also again thanked the frontline workers.

Union Health Minister Harsh Vardhan termed it a 'watershed moment' in India's battle against COVID-19 and called the vaccines a fitting tribute to the corona warriors.

“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 & immunogenicity of the approved vaccines,” Vardhan said in another tweet.

The Serum Institute of India, the world's largest vaccine manufacturer, has tied up with Oxford-AstraZeneca to manufacture Covishield.

'Happy new year, everyone! All the risks @SerumInstIndia took with stockpiling the vaccine, have finally paid off. COVISHIELD, India's first COVID-19 vaccine is approved, safe, effective and ready to roll-out in the coming weeks,' Serum Institute of India CEO Adar Poonawalla tweeted.

Covaxin has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).

The approval of Covaxin is a giant leap for innovation and novel product development in India, Krishna Ella, Chairman and Managing Director of the Hyderabad-based pharmaceutical firm Bharat Biotech said in a statement.

Ella said it was a proud moment for the nation, a great milestone in India's scientific capability, and a kickstart to the innovation ecosystem in India.

The approval by the DCGI was given on the basis of recommendations submitted by a COVID-19 subject expert committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO).

India, which has recorded 1.03 crore coronavirus cases and 1.49 lakh deaths, conducted a dry run on Saturday involving all states and union territories in preparation for a major inoculation drive.

'WHO welcomes the first emergency use authorization given to COVID-19 vaccine in the WHO South-East Asia Region. This decision taken today by India will help intensify and strengthen the fight against COVID-19 pandemic in the Region,' said Dr Poonam Khetrapal Singh, the regional director, WHO South-East Asia Region.

According to Khetrapal, the use of vaccines in the 'prioritised population', as well as the implementation of other public health measures, will be important in reducing the impact of the pandemic.

Ruling BJP leaders and Union ministers including party chief J P Nadda, Amit Shah and Rajnath Singh saluted the scientists and congratulated Prime Minister Narendra Modi for striving towards a coronavirus-free India.

Describing it as a 'defining and historic' moment for the country's health, Nadda said that the country has emerged as a global health centre under the leadership of Modi who took everyone along with him in the fight against the deadly virus.

Applauding the scientists for the domestically manufactured vaccines, Union Home Minister and senior BJP leader Amit Shah said, 'Nation will always remain grateful to them for their selfless service towards mankind.' 'We heartily thank our scientists, doctors, medical staff, security personnel and all Corona warriors who dedicatedly served humanity during these testing times,” he said.

The BJP, however, hit out at the Congress after some of its leaders questioned the approval process for Bharat Biotech's COVID-19 vaccine.

Asking the Congress and other opposition parties not to do politics on the vaccine issue, Nadda accused them of trying to cause panic among people to further their 'failed politics and nefarious agendas'.

'Congress and the Opposition are not proud of anything Indian. They should introspect about how their lies on the COVID-19 vaccine will be used by vested interest groups for their own agendas,' the BJP chief said in a series of tweets.

While the entire nation is happy about the development of vaccines, the opposition led by the Congress is filled with anger, ridicule and disdain, he alleged.

In a tweet, Union Minister Hardeep Puri said, '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.' Jairam Ramesh retorted, 'So says the in-house Goebbels-cum-Albert Speer.' Both Goebbels and Speer were close allies of German dictator Hitler.

Tharoor, a Congress MP and former union minister, also countered Puri, saying he had never questioned the valour of our soldiers.

'I would be happy and proud if more Indian vaccines are approved — but only after a full 3-phase trial confirms they are safe & effective. Short-circuiting the process is unprecedented, inadvisable & risks lives.

'We are baffled to understand what scientific logic has motivated the SEC (subject expert committee) to approve this vaccine posthaste... in violation of the criteria in the draft regulatory guidelines for the development of Covid-19 vaccines published by CDSCO on 21/9/20,' he tweeted, referring to Bharat Biotech's Covaxin.

Ramesh had earlier said that Bharat Biotech is a first-rate enterprise while adding that it is puzzling that internationally-accepted protocols relating to phase three trials are being modified for Covaxin.

He asked Health Minister Harsh Vardhan to clarify.

Echoing him, Tharoor said Covaxin has not yet had Phase three 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,' he said.

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

'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 said.

Delhi Chief Minister Arvind Kejriwal said that approval for the emergency use of two 'made in India' vaccines will give a positive direction to the country's fight against coronavirus.

Samajwadi Party president Akhilesh Yadav said the COVID-19 vaccination programme is a 'sensitive process' and the government should not treat it as a 'cosmetic' event as it is a matter of lives.

Yadav had on Saturday termed the anti-Covid vaccine to be rolled out in the country as a 'vaccine of the BJP' and said he would not take the shot, prompting a sharp reaction not only from the ruling party but also from NC vice-president Omar Abdullah.

Bahujan Samaj Party supremo Mayawati congratulated the scientists associated with the coronavirus vaccine and urged the Centre to make it available to the poor free of cost. PTI KR SKC NAV VVK VT MG VIT RT