India’s Bharat Biotech seeks Bangladesh trial for COVID vaccine approved at home

Reuters      20 January 2021

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FILE PHOTO: Indian Health Minister Harsh Vardhan holds a dose of Bharat Biotech’s COVID-19 vaccine called COVAXIN, during a vaccination campaign at All India Institute of Medical Sciences (AIIMS) hospital in New Delhi, India, January 16, 2021. REUTERS/Adnan Abidi

If allowed to go ahead, this would be the first trial of any coronavirus vaccine in Bangladesh and could give the densely-populated country of more than 160 million faster access to the shot for mass use.

The vaccine, developed with the Indian Council of Medical Research, was given the green light for restricted use in India this month without any efficacy data from a late-stage trial. Early tests, however, found it to be safe and generating an immune response in humans.

“We have received their proposal,” said Mahmood-uz-Jahan, a director at the state-run Bangladesh Medical Research Council, adding that its ethics committee would review the application.

He declined to give details.

The Dhaka-based International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR,B), has applied to run the trial on behalf of Bharat Biotech, said a source with direct knowledge of the matter who declined to be named citing internal rules.

Sinovac Biotech’s late-stage trial of a potential vaccine in Bangladesh has become uncertain after Dhaka refused to meet the Chinese company’s demand for co-funding.

Bharat Biotech started a late-stage trial for COVAXIN at home in November and a top Indian government vaccine official, Vinod Kumar Paul, has told Reuters that a smaller study involving 1,000-2,000 people could also be done in Bangladesh.

Bangladesh will from Thursday start receiving millions of India-made doses of another vaccine licensed from Oxford University and AstraZeneca. It is being mass produced by the Serum Institute of India, the world’s largest vaccine maker.

Bangladesh, however, has no immediate plans to buy COVAXIN whose efficacy data from the late India trial are expected by March.

“No plan to buy from Bharat Biotech at present.”

Brazil is the only country that has publicly announced plans to buy COVAXIN doses from India.

The company on Thursday submitted an application for the emergency use of the vaccine in the Philippines.

Additional reporting by Neha Arora and Krishna N. Das; Editing by Raju Gopalakrishnan

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