The World Health Organization (WHO) on Tuesday again postponed granting approval for India’s original Covid-19 vaccine, Covaxin, seeking more technical details for a final assessment of risks and benefits.

The global body – which has been reviewing data on India’s Covaxin vaccine against Covid-19 to grant an emergency use list (EUL) – has requested additional information from Hyderabad-based Bharat Biotech to make a final assessment of the risks and benefits of approving the vaccine for global use.

The organization expects to receive the information by “the end of this week” and plans to conduct the final evaluation on November 3. Bharat Biotech submitted its EUL grant application to the World Health Organization on April 19, 2021.

While the process has already taken more than six months so far, WHO told News18.com in an email response that “the duration of the emergency-use listing process depends on the quality of the data provided by the vaccine manufacturer and on that data that meets the WHO”. international standards.”

Read also | ‘Knowing that people are waiting, but…’: WHO explains delay in nod to Covaxin for emergency use

The World Health Organization said that “the Technical Advisory Group (TAG) met today (October 26, 2021) and has determined that additional clarifications from the manufacturer are needed to make a final assessment of the risks and benefits of the EUL for global use of the vaccine.”

The Technical Advisory Group for the Emergency Use List (TAG-EUL) is an independent advisory group that makes recommendations to the World Health Organization on whether a Covid-19 vaccine can be listed for emergency use under the EUL procedure.

She added, “The technical advisory team expects to receive these clarifications from the manufacturer by the end of this week, and aims to meet again for the final risk-benefit assessment on Wednesday, November 3.”

When asked about the nature of the technical query the WHO sought from biotech company Bharat, she told News18.com that “requests to WHO for prequalification or inclusion under emergency use procedures are confidential.”

Read also | The road to a billion shots: How India’s COVID vaccination campaign picked up its pace despite speed bumps

“If the product submitted for evaluation is found to meet the inclusion criteria, the WHO will disseminate the results widely,” she added.

Covaxin’s approval holds significance for the millions of Indians who have had the vaccine but are unable to travel pending WHO approval. WHO approval will aid international travel for Indians, including students and business people, who plan to travel to countries where vaccination certificate for WHO approved vaccines is mandatory.

As of October 25, around 11.70 crores doses of Covaxin have been administered in India among various age groups over 18.

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