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India plans Covaxin trials in Bangladesh

Published : Wednesday, 4 August, 2021 at 12:00 AM
Indian government plans trials of Covaxin, the indigenous coronavirus vaccine, in Bangladesh shortly to enhance its recognition abroad, according to the Hindustan Times (HT).
Earlier, Bangladesh Medical Research Council (BMRC) approved the trials of Covaxin in the country on July 18 and India is now waiting for the approval from the Director General of Drug Administration (DGDA) of Bangladesh. Bharat Biotech and the Indian Council of Medical Research (ICMR) jointly developed the Indian indigenous coronavirus vaccine, Covaxin.
"To enhance the recognition of Covaxin abroad, especially in the neighbourhood, a proposal was mooted for its trials in Bangladesh. Towards this end, MEA facilitated the visit of a team of officials from Department of Biotechnology and Bharat Biotech to Dhaka to discuss the proposal with Bangladeshi officials. MEA also obtained approval for funding the clinical trials in Bangladesh. The trials can begin upon approval by Bangladeshi authorities," HT writes on August 2.
Bangladesh is one of five countries (the others are Sri Lanka, Afghanistan, Nepal,
and Pakistan) that are part of the China-led China South Asian Countries Emergency Supplies Reserve and the Poverty Alleviation and Cooperative Development Centre, both formed earlier this month. The first is expected to make vaccines easily available to its members, it reads.
India has so far provided 3.3 million Covishield doses as grant and 7 million doses commercially to Bangladesh, No Covaxin doses have been supplied to Bangladesh.
"The approval apparently followed a push from the Indian side. However, the people cited above said that there wasn't much interest in Covaxin in some quarters in Bangladesh as the country has signed agreements with China for 30 million doses of Sinopharm vaccine and is set to ink a separate deal for millions of doses of Russia's Sputnik V," HT said.
"The Bangladeshi side is also upset over the Serum Institute of India's inability to deliver 30 million doses of the Covishield vaccine under a contract signed last November. Vaccine exports from India were halted in April amid a devastating second wave of infections. Under the agreement with SII, Bangladesh was to get five million doses each month from January to June 2021," it reads.
"The Hyderabad-based Bharat Biotech released data from the final analysis of Covaxin and said that the vaccine demonstrated overall efficacy of 77.8 per cent against symptomatic infection. It added that Covaxin has now received emergency use authorizations in 16 countries including, Brazil, India, Philippines, Iran, Mexico, etc. with EUA's in process in 50 countries worldwide. The company is in discussions with WHO to obtain emergency Use Listing for COVAXIN, it noted.
According to the report, Bharat Biotech has cancelled its agreement with Brazil and UAE, Late last week, the Brazil's drugs regulator has rejected Bharat Biotech's application for an emergency use licence.
"MEA, through its Missions abroad, facilitated the regulatory approval process of COVAXIN by drug regulators in various countries. We facilitated meetings of regulatory authorities of various countries with Bharat Biotech�Our Missions continue to facilitate the approval process in several other countries by reaching out to the host government at various levels and sharing various technical data as provided by Bharat Biotech. Foreign Secretary held a meeting with the leadership of Bharat Biotech and assured full support of MEA in its application process for WHO Emergency use listing (EUL) of COVAXIN," HT said, adding that the MEA's efforts are on to take Covaxin global.






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