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The Indian governa bid to enhance the recof indigenous coronaviine, Covaxin that has tly developed by Bharat nd the Indian Council of Research (ICMR), plans ate its clinical trials in esh, according to an government document. ocument, which has iewed by HT, adds that ernment has secured l for funding the clinis in Bangladesh. The overnment, through its s abroad, also faciliregulatory approval of by drug regulators in countries, the docuid. nhance the recognition in abroad, especially in hbourhood, a proposal oted for its trials in esh. Towards this end, ministry of external facilitated the visit of a officials from Departf Biotechnology and iotech to Dhaka to disproposal with Banglaofficials. MEA also d approval for funding ical trials in Banglae trials can begin upon al by Bangladeshi ies.” rs reported in January, n official at Banglaedical research body rat Biotech applied to trials for Covaxin in ntry. vaxin doses have been d to Bangladesh. India r provided 3.3 million ld doses as grant and 7 doses commercially to esh, according to the supply web portal ned by the external inistry. ding to people familiar developments in New nd Dhaka, the Bangladical Research Council approved the trials of in the country on July
Ali, the former health adviser to Prime Minister Sheikh Hasina, signed off on the move, the people said.
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.
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.
HT reached out to Bharat Biotech for a comment but did not get a response immediately.
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.
Earlier this month, the Hyderabad-based Bharat Biotech released data from the final analysis of Covaxin and said that the vaccine demonstrated overall efficacy of 77.8% 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.
Bharat Biotech has cancelled its agreement with two firms, one based in Brazil, and another in Dubai, for the supply of Covaxin to Brazil after the country scrapped a deal to buy Covaxin following graft allegations.
Late last week, the country’s drugs regulator also rejected Bharat Biotech’s application for an emergency use licence. In a response to a Parliament query last wee the health ministry said it is “aware of media reports of some controversy around contracts and regulatory approvals for supply of Covaxin to Brazil. This however relates exclusively to an agreement between a commercial entity i.e. M/s Bharat Biotech and a foreign country.”
Bharat Biotech’s repeated announcements about enhancing capacity have not resulted in an increase in output of Covaxin.
Health minister Mansukh Mandaviya said in Parliament last week that the company would deliver 25 million doses in July and 35 million in August.
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.
HT on May 1 reported Centre is exploring the possibility of offering the locally developed coronavirus vaccine, Covaxin that has been jointly developed by Bharat Biotech and the Indian Council of Medical Research (ICMR), for production abroad through a technology transfer between commercial entities
India has also received enquiries from other countries for the export of Covaxin, HT reported on May 24. New Delhi has been approached by at least two countries, Hungary and Paraguay for the commercial export of 1 million doses of Covaxin, with the first holding forth the possibility of access to the EU.