India's Bharat Biotech seeks emergency use approval for vaccine in Philippines

Reuters
New Delhi, India Published: Jan 21, 2021, 10.13 AM(IST)

Bharat Biotech (India) Photograph:( WION )

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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

India's Bharat Biotech submitted on Thursday an application for the emergency use of its COVID-19 vaccines in the Philippines, Food and Drug Administration chief Rolando Enrique Domingo said.

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.

"We have received their proposal. The committee will review it," Mahmood-uz-Jahan, a director at the state-run Bangladesh Medical Research Council, told Reuters, declining 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.

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.

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