In mid-October, Union Health Minister Mansukh Mandaviya met WHO Director-General Dr Adhanom Ghebreyesus Tedros and discussed the pending approval at length. Between August and October 2021, eight communications arrived from the WHO seeking additional information about Covaxin, including clinical and non-clinical information and manufacturing information. The Hyderabad-based firm had submitted EOI (Expression of Interest) to the World Health Organization (WHO) on April 19 for its vaccine candidate and applied for emergency use listing in May 2021.Īnd then began the long-drawn back and forth between Bharat Biotech and the WHO over pending documents and insufficient data for EUL. The move had come a day after the COVID-19 Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) had recommended grating emergency use authorisation for the vaccine developed by Bharat Biotech. While giving emergency use nod, DCGI VG Somani had noted that the clinical trials will continue. The DCGI on January 3 granted restricted emergency use authorisation for Covaxin vaccine against COVID-19 - the disease caused by the novel coronavirus. Nearly 15 crore doses of Covaxin have been administered in India since then. PM Modi said: “The DCGI (Drugs Controller General of India) gave approval after they were satisfied with the data of the two vaccines. He went on to get the Covaxin jab on March 1, to encourage more Indians to readily accept the indigenous vaccine. However, Prime Minister Narendra Modi urged Indians to overcome their vaccine hesitancy and not pay heed to controversies surrounding the approval. This sparked a controversy – Opposition parties raised questions about the efficacy and safety of Covaxin. The vaccine was given emergency use authorisation by India’s drugs regulator while its Phase-III efficacy data was still awaited. Hyderabad-based Bharat Biotech developed India’s first COVID-19 vaccine candidate – COVAXIN - in collaboration with the Indian Council of Medical Research (ICMR)’s National Institute of Virology (NIV).Īn inactivated vaccine developed and manufactured in Bharat Biotech’s BSL-3 (Bio-Safety Level 3) bio-containment facility, this was rolled out by the Government of India along with the Serum Institute of India (SII)-manufactured Covishield when the country began its mega vaccination drive on January 16, 2021. Many of these people, who have opted for Covaxin since it is indigenously developed and had a shorter wait time between two doses, among other reasons, are now waiting for government intervention to obtain mutual recognition of vaccine certificates in more countries. Though the World Health Organization (WHO) earlier this month approved Covaxin, the COVID-19 vaccine developed by Indian pharmaceutical company Bharat Biotech, for emergency use, hundreds of Indians who have travel plans to countries such as Italy, Japan, Saudi Arabia, and Denmark remain in a tight spot.
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