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'Not a long-drawn process': Bharat Biotech expecting WHO approval soon

As several European countries are accepting WHO-listed Covishield, Covaxin too is expected to receive WHO approval soon.
By hindustantimes.com | Written by Poulomi Ghosh
PUBLISHED ON JUL 01, 2021 04:26 PM IST
Approval from WHO is not expected to be a long-drawn process as the cell line and majority of our facilities have already been audited, Bharat Biotech has said. (PTI)

Hyderabad-based Bharat Biotech is expecting approval from the World Health Organization soon as the entire process is not likely to take much time since other vaccines of the company in the past have already been approved by the world body, Bharat Biotech co-founder Suchitra Ella has said.

"We are working closely with the World Health Organization for the inclusion of Covaxin in its Emergency Use Listing. Approval from WHO is not expected to be a long-drawn process as the cell line and majority of our facilities have already been audited and approved by WHO for our other vaccines in the past," Suchitra Ella tweeted.

According to the WHO site, the rolling data for Covishield is slated to begin in July as the pre-submission meeting has been held in June. As WHO will go through Covaxin's data, it will publish an anticipated date when the approval is likely to come.

Why WHO nod will be a landmark for Covaxin

Covaxin is the first Covid-19 vaccine that has been entirely developed in India, as Covishield in Astrazeneca and Oxford University's invention. Covaxin has been given emergency use authorisation in 16 countries. Once Covaxin gets WHO approval, more countries will open for Indian travellers and most countries will be allowing people inoculated by WHO-listed vaccines.

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Covaxin booster dose

Meanwhile, Bharat Biotech is also conducting trials of a third booster dose of Covaxin, the results of which are expected to come by November this year, news agency ANI has reported. The booster dose of the indigenously manufactured vaccine was first launched in May, after which the trials began at the All India Institute of Medical Sciences (AIIMS) in Delhi and Patna. As many as 12 centres across the country are conducting trials for Covaxin's booster shot. The results of the first trial, conducted in May, will come in August. For the second trial, final results are expected by November 2021.

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