Awaiting WHO approval for Covaxin, Bharat Biotech says 'inappropriate' to comment on process

  • Bharat Biotech said it has responded to all clarifications sought by the WHO following the submission of Covaxin’s clinical trial data for Emergency use Listing in early July.
The Phase 3 clinical trials data of Covaxin demonstrated 77.8 per cent efficacy.(Bloomberg)
The Phase 3 clinical trials data of Covaxin demonstrated 77.8 per cent efficacy.(Bloomberg)
Published on Sep 17, 2021 03:59 PM IST
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By hindustantimes.com | Written by Kunal Gaurav, Hindustan Times, New Delhi

Amid speculations around the awaited approval of Bharat Biotech's Covid-19 vaccine for Emergency use Listing (EUL) from the World Health Organisation (WHO), the Indian biotechnology company on Friday said that it does not find it “appropriate” to comment on the approval process and its timelines.

In a series of tweets, Bharat Biotech said it has responded to all clarifications sought by the WHO following the submission of Covaxin’s clinical trial data to the UN health agency for EUL in early July. The Phase 3 clinical trials data of Covaxin demonstrated 77.8 per cent efficacy.

“We have responded to any clarifications sought by WHO and are awaiting further feedback. As a responsible manufacturer with several prequalified vaccines, we do not find it appropriate to speculate or comment on approval process & its timelines,” the Hyderabad-based company said in a statement.

“However we are continuing to work diligently on obtaining WHO EUL at the earliest,” it added.

Also Read | Initial findings from Biotech's nasal vaccine show 'promising results': Govt

So far, the WHO has approved Covid-19 vaccines manufactured by Pfizer-BioNTech, AstraZeneca, Johnson and Johnson, Moderna and Sinopharm. UN agency’s approval makes international travel easy for people who receive those vaccines and the company also gets a boost to market its product in the global market.

Earlier this week, Dr VK Paul, NITI Aayog member (Health) told news agency ANI that the approval is expected any time soon as data sharing and data evaluation had been going on through multiple reviews. He indicated that a positive decision will be taken in this regard before the end of the month.

"We must give time to WHO to make their decisions based on science. However, we hope that these decisions can be taken quickly because people who are receiving Covaxin have certain imperatives of travel. Most of us, who chose the concurrency, is important in terms of licensure. We are hoping for an early decision," ANI quoted Paul as saying.

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Wednesday, October 20, 2021