Amid Doubts Over Approval to India's Covaxin, ICMR Director Says it Has Potential to Target New Strain

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Contrary to concerns raised by eminent clinical scientist and vaccine expert Gagandeep Kang over granting approval to Bharat Biotech Covid-19 shots, Indian Council of Medical Research (ICMR) director Balram Bhargava said that Covaxin has potential to target the new strain.

Health Minister Harsh Vardhan too asserted that the Indian vaccine is more likely to work against newer variants of the virus, including the UK variant, and asked politicians not to "discredit well laid out science-backed protocols" followed for approving the jab.

Some Congress leaders, including Anand Sharma, Shashi Tharoor and Jairam Ramesh, on Sunday raised serious concerns over the grant of approval to Covaxin for restricted use, saying it is "premature" and can prove dangerous.

Responding to them, Vardhan said it is "disgraceful for anyone to politicise such a critical issue." Tagging Tharoor, Ramesh and Samajwadi Party leader Akhilesh Yavad, the health minister said in a tweet, "...don't try to discredit well laid out science-backed protocols followed for approving #COVID19vaccines. Wake up & realise you are only discrediting yourselves!" 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."

SP president 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.

Drug Controller General of India (DCGI) has approved Covishield and Bharat Biotech's Covaxin for restricted emergency use. Covaxin is being indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV).

Covaxin is a highly purified and inactivated 2 dose SARS-CoV2 vaccine, manufactured in a Vero cell manufacturing platform with an excellent safety track record of more than 300 million doses, said Krishna Ella, Chairman and Managing Director of the Hyderabad-based pharmaceutical firm said.

The Phase III human clinical trials of Covaxin began mid-November, targeted to be done in "26,000" volunteers across India, and this is India's first and only Phase III efficacy study for a COVID-19 vaccine, he said.

It is the largest phase III efficacy trial ever conducted for any vaccine in India, Ella added. Covaxin has been evaluated in approximately 1,000 subjects in Phase I and Phase II clinical trials, with promising safety and immunogenicity results, with acceptance in international peer reviewed scientific journals, Ella said.

This indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) bio-containment facility. The evaluation of Covaxin has resulted in several unique product characteristics including long term persistence of immune responses to multiple viral proteins, as opposed to only the spike protein, and has demonstrated broad spectrum neutralising capability with heterologous SARS-CoV2 strains, thus potentially reducing or eliminating escape mutants, the statement by Bharat Biotech read.

KV Raghavan, principal scientific advisor to government of India, told News18 that drive to vaccinate first three crore people will begin in next "10 to 15 days".

Reuters quoted its source as saying that the efficacy of the Indian vaccine could "go up much more" than 60% after two doses are given.