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Indian firm waits for WHO approval for Covaxin

International Desk, Rtv

  24 Jun 2021, 19:46

Indian company Bharat Biotech received approval for their Covaxin in January for emergency use in the country before the completion of clinical trials. This month, it reportedly gave conditional approval for four million doses to be imported. The agency will analyse data from the use of the vaccine before deciding on the quantity of further imports.

Meanwhile, the US Food and Drug Administration (FDA) has rejected Bharat Biotech's application for emergency use authorisation of Covaxin in the country and sought more data on the clinical trials.

In April, Brazilian health regulator Anvisa decided against the import of Covaxin - made by Bharat Biotech - after denying its plant a certificate for good manufacturing practices.

Meanwhile, India started free vaccination of all adults and hit a record 5 million doses in a day. The aim is to vaccinate all adults by the end of the year. Given that Covaxin is not yet on the World Health Organisation (WHO) Emergency Use Listing, Indian students who have received the vaccine and are travelling to the United States, Canada and other countries face the prospect of having to get Covishield jabs, the only WHO-approved vaccine available in India right now.

Bharat Biotech is working to get its vaccine on the WHO Emergency Use Listing. The firm submitted its letter of interest on April 19 to the WHO, which noted "more information required" at the time.

A meeting between the WHO committee and Bharat Biotech has been planned for tomorrow, after the firm reportedly submitted the additional information.

The company has said in media statements that the vaccine is 78 per cent effective against the coronavirus in clinical trials and that complete data for phase one and two and partial data for phase three trials have been thoroughly scrutinised by India's regulators.

Source: The Straits Times

B.M./ Rtv

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