Highlights:

  • Bharat Biotech cited that it does not find it “appropriate” to comment on the approval process and its timelines
  • Bharat Biotech is waiting for its COVID-19 vaccine approval for Emergency Use Listing (EUL) from the World Health Organisation (WHO)
  • Reportedly, the Phase 3 clinical trial data of Covaxin exhibited 77.8 percent efficacy

Bharat Biotech, the Hyderabad-based Indian biotechnology company which is waiting for its COVID-19 vaccine approval for Emergency Use Listing (EUL) from the World Health Organisation (WHO) cited that it does not find it “appropriate” to comment on the approval process and its timelines.

Through a series of tweets, the Hyderabad-based company affirmed that it has responded to all clarifications sought by the WHO after the submission of Covaxin’s clinical trial data to the UN health agency for the EUL in early July. Reportedly, the Phase 3 clinical trial data of Covaxin exhibited 77.8 percent efficacy.

A statement issued by Bharat Biotech reads, “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 the approval process and its timelines.” It further noted that they are continuing to work diligently on obtaining WHO EUL at the earliest.

As yet, WHO has approved COVID -19 vaccine manufactured by Pfizer-BioNTech, Johnson and Johnson, Sinopharm, AstraZeneca and Moderna. The approval acquired from UN agencies makes travel easier for travellers and the company also receives the strength to market its product in the global market.

Dr VK Paul, NITI Aayog member (Health) earlier this week, noted that the approval is likely to be any time soon as data sharing and data assessment has undergone several reviews. He assured that a positive decision will be taken in this regard by the end of this month.

He added, “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, are important in terms of licensure. We are hoping for an early decision.”

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