Covid: Indian vaccine maker seeks permission for first international rollout despite concerns over data

Bharat Biotech, India’s homegrown vaccine maker, has sought permission for the emergency use of its Covid-19 vaccine, Covaxin, in the Philippines, even as concerns remain over its efficacy and safety data.

Dr Rolando Enrique Domingo, the chief of the Food and Drug Administration in Philippines, said Bharat Biotech on Thursday submitted an application for the emergency use of its Covid-19 vaccines in that country.

Bharat Biotech is the fourth vaccine maker that has applied for emergency use in the Philippines. Covaxin is developed with the Indian Council of Medical Research.

Besides the Philippines, Bharat Biotech has also sought permission from Bangladesh authorities to conduct trials of Covaxin, Reuters news agency reported.

Mahmood-uz-Jahan, a director at the state-run Bangladesh Medical Research Council, confirmed receiving the proposal and stated that its ethics committee would review the application.

If authorities in Bangladesh allow the Covaxin trial, it would be the first trial of any Covid-19 vaccine in Bangladesh.

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

India gave emergency approval to two vaccines — Covaxin and AstraZeneca/Oxford University’s Covishield — earlier this month for its Covid-19 vaccination programme. But Covaxin’s rollout has been controversial as it got the approval without the crucial data to prove its effectiveness even though Indian authorities claim that it is safe.

Bangladesh’s health secretary Abdul Mannan told Reuters that they at present have no plans to buy Bharat Biotech’s Covaxin. “Our vaccine procurement is in good shape. We are going to start the vaccination in the first week of February,” he said.

So far, only Brazil has announced plans to buy Covaxin doses from India.

According to the Indian government, they have received several requests from “neighbouring and key partner countries” for the supply of Covid-19 vaccines manufactured in India. The government had said that “supplies under grant assistance to Bhutan, Maldives, Bangladesh, Nepal, Myanmar and Seychelles” will begin from 20 January 2021.

Bangladesh is scheduled to start getting millions of India-made doses of AstraZeneca’s coronavirus vaccine from Thursday.

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