New Delhi: As India’s drugs regulator on Sunday approved Oxford COVID-19 vaccine Covishield, manufactured by the Serum Institute, and indigenously developed Covaxin of Bharat Biotech for restricted emergency use in the country, the way for the roll-out of at least two vaccines in the country in the coming days was cleared.

The Drugs Controller General of India (DCGI) granted the approval on the basis of recommendations by a COVID-19 Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO).

“After adequate examination, CDSCO has decided to accept the recommendations of the Expert Committee and, accordingly, vaccines of M/s Serum and Bharat Biotech are being approved for restricted use in emergency situations,” DCGI V G Somani told the media here.

“Serum and Bharat Biotech vaccines have to be administered in two doses,” Somani said, adding that these vaccines have to be stored at 2-8 C.

“We will never approve anything if there is even the slightest safety concern. Vaccines are 110 per cent safe. Some side effects like mild fever, pain and allergy are common for every vaccine,” Somani told reporters after the press briefing.

His assertion came after a few raised concerns over the safety of the vaccines.

The Serum Institute of India, the world’s largest vaccine manufacturer, has tied up with AstraZeneca to manufacture Covishield, while Covaxin has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).

Approval Hailed as Turning Point in India’s Fight Against Pandemic

Prime Minister Narendra Modi termed the approval a “decisive turning point” in India’s fight against the novel 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.

Health Minister Harsh Vardhan termed it a “watershed moment in India’s battle against COVID-19”.

The World Health Organisation also welcomed the move, saying it will “help intensify and strengthen the fight against the pandemic in the region”.

Serum Institute of India’s CEO Adar Poonawalla tweeted, “COVISHIELD, India’s first COVID-19 vaccine is approved, safe, effective and ready to roll-out in the coming weeks.”

Congress-BJP spar over approval

Meanwhile, the BJP hit out at the Congress after some of its leaders questioned the approval process for Covaxin, with party president J P Nadda alleging that whenever India achieves something commendable the opposition comes up with “wild theories” to “ridicule” the accomplishments.

Some Congress leaders, including Anand Sharma, Shashi Tharoor and Jairam Ramesh, raised serious concerns over the grant of approval to Covaxin, saying it is “premature” and can prove dangerous.

Bharat Biotech vaccine more likely to work against newer strains like UK variant: Health Minister, ICMR Chief

Health Minister Vardhan said Bharat Biotech’s vaccine is more likely to work against newer variants of coronavirus, including the UK variant, and asked politicians not to “discredit” the approval protocol.

Vardhan 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.”

ICMR Director General Balram Bhargava also said Covaxin is based on an inactivated whole virus, having potential to target mutated coronavirus strains including the UK variant, which was a major ground for giving it a conditional nod.

He, however, said no clear data regarding the efficacy of the vaccine is available so far.