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Covaxin emergency use authorisation approval a significant landmark: Dr Ella

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Covaxin emergency use authorisation approval a significant landmark: Dr Ella

The DCGI on Sunday gave its approval to two Covid 19 vaccines by the Serum Institutes of India and Bharat Biotech.

Guleria's comment came after Congress leaders raised concerns over granting emergency use approval to Bharat Biotech's vaccine before the completion of its third phase trials.

Another condition states: "The firm should submit updated safety, efficacy and immunogenicity data from the ongoing Phase 1, 2 and 3 clinical trials till the completion of trials as per the requirement of New Drugs & Clinical Trials Rules, 2019".

Immediately on the back of the Drug Controller General of India (DCGI) approving Bharat Biotech's Covaxin and the Oxford-Astrazeneca vaccine for "restricted use in emergency situations", Congress MP Shashi Tharoor warned against the use of Covaxin, saying its approval was premature.

Somani stated that vaccines would have never been permitted if they were not safe for the people.

The Serum Institute of India, the world's largest vaccine manufacturing company, has been contracted by AstraZeneca to make a billion doses for developing nations, including India.

Information and Broadcasting Minister Prakash Javadekar told reporters earlier that two other vaccines were waiting to be approved - Zydus Cadila's ZyCoV-D and Russia's Sputnik V, which are both on trial in India. It may be recalled that Covishield was recommended for emergency use on January 1, whereas Covaxin was recommended for restricted use on January 2. "As a part of our regulatory guidelines, all data has been submitted to the DCGI and CDSCO", it said.

Incidentally, the Phase II clinical trials for Covishield were conducted at JSS Medical College and Hospital in Mysuru in August this year.

The government also approved the use of a vaccine developed by AstraZeneca and Oxford University which will be the lead vaccine in India's immunization program until other shots are approved.

Health officials in India on Sunday approved two COVID-19 vaccines, including one made by AstraZeneca, for emergency use.

"The development of Covaxin was truly a public-private partnership between ICMR, NIV and Bharat Biotech, we sincerely thank the Director General ICMR, Dr Balram Bhargava for his visionary leadership in this project", Dr Ella added.

The massive exercise came a day after a government-appointed panel of experts held a meeting to review the applications of potential vaccine candidates, including front-runner Covishield, developed by Oxford University and United Kingdom -based drugmaker AstraZeneca.

Nadda said, "Time and again we have seen whenever India achieves something commendable - that will further public good - the Congress comes up with wild theories to oppose and ridicule the accomplishments".

The Phase 3 efficacy trial was initiated in India on 25,800 volunteers and till date, approximately 22,500 participants have been vaccinated across the country and the vaccine has been found to be safe as per the data available till date, Somani said.

Meanwhile, Indian regulators stated that they are still considering approvals for other vaccines.

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