Indian government plans Covaxin trials in Bangladesh to enhance its recognition abroad

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 government has secured approval for funding the clinical trials in Bangladesh. The Indian government, through its missions abroad, also facilitated the regulatory approval of Covaxin by drug regulators in various countries, the document said.

"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."

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 vaccine supply web portal maintained by the external affairs ministry.

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 chairman Syed Modasser 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 that the Indian govt 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.