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Indian govt to start clinical trials of Covaxin in Bangladesh

In an effort to get recognition for the indigenous coronavirus vaccine, Covaxin developed by Bharat Biotech and the Indian Council of Medical Research (ICMR), India plans to start clinical trials in Bangladesh, according to an internal government document.

According to a report accessed by the Hindustan Times, the Indian government has received approval for funding clinical trials in Bangladesh, and the Indian government wants to boost the recognition of Covaxin abroad, especially in the neighborhood, a proposal for its trials in Bangladesh has been mooted. The Ministry of External Affairs (MEA) organized a visit to Dhaka by a team of officials from the Department of Biotechnology and Bharat Biotech to discuss the proposal with Bangladeshi officials. MEA was also granted permission to fund clinical research in Bangladesh. The trials can commence once Bangladeshi authorities have given their approval.

The government document also mentions the foreign ministry’s efforts to take Covaxin global.

“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,” it said.

India has so far not been able to export Covaxin to foreign nations, however, Bangladesh has received 3.3 million Covishield doses as grant and 7 million doses commercially and now the Bangladesh Medical Research Council (BMRC) approved the trials of Covaxin in the country on July 18.

In July, Bharat Biotech released data from the final analysis of Covaxin and said that the vaccine demonstrated overall efficacy of 77.8% against symptomatic infection and Covaxin has received emergency use authorizations in 16 countries including, Brazil, India, Philippines, Iran, Mexico, etc as discussions with World Health Organisation to obtain emergency Use Listing for COVAXIN is in process.

There are also talks of Bharat Biotech and the ICMR developing Covaxin jointly for production abroad through a technology transfer between commercial entities, and India is in talks with Hungary and Paraguay for the commercial export of 1 million doses of Covaxin, with the possibility of access to the European Union.

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