India’s Bharat Biotech has applied to conduct trials in Bangladesh for its coronavirus vaccine recently approved for emergency use at home, a senior official at Bangladesh’s main medical research body told Reuters.
d 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.
ICDDR,B declined to comment. Spokespeople for Bharat Biotech had no immediate comment.
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.
Read Criticism mounts over India's 'abrupt' approval of COVAXIN
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.
“Our vaccine procurement is in good shape. We are going to start the vaccination in the first week of February,” Bangladesh Health Secretary Abdul Mannan told Reuters.
“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.
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