Govt pushes Covaxin trials in Bangladesh
NEW DELHI: The Indian government, in a bid to enhance the recognition of indigenous coronavirus vaccine, Covaxin that has been jointly developed by Bharat Biotech and the Indian Council of Medical Research (ICMR), plans to facilitate its clinical trials in Bangladesh, according to an internal government document.
The document, which has been reviewed by HT, adds that the Centre has secured approval for funding the clinical trials in Bangladesh. “To enhance the recognition of Covaxin abroad, especially in the neighbourhood, a proposal was mooted for its trials in Bangladesh. Towards this end, MEA (ministry of external affairs) 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,” it said.
Reuters reported in January, citing an official at Bangladesh’s medical research body that Bharat Biotech applied to conduct trials for Covaxin in the country.
No Covaxin doses have been supplied to Bangladesh. India has so far provided 3.3 million Covishield doses as grant and 7 million doses commercially to Bangladesh, according to the MEA’S vaccine supply portal.
According to people familiar with the developments in New Delhi and Dhaka, the Bangladesh Medical Research Council (BMRC) approved the trials of Covaxin in the country on July 18.
BMRC chief and former health adviser to PM Sheikh Hasina, Syed Modasser Ali, signed off on the move, the people said. However, the people said, 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 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. 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 in July. The first is expected to make vaccines easily available to its members.
In July, 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.
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 ICMR, for production abroad through a technology transfer between commercial entities.