Covaxin WHO Approval: Technical Advisory Group To Consider EUL In Meeting On Oct 26

Covaxin has been submitting data to WHO on a rolling basis and also gave additional information at WHO's request on September 27. 

Representative Photo

New Delhi: World Health Organization (WHO) Chief Scientist Soumya Swaminathan on Sunday informed that the technical advisory group will meet on October 26 to consider EUL (Emergency use listing) for Covaxin.

WHO has been working closely with BharatBiotech to complete the dossier. Our goal is to have a broad portfolio of vaccines approved for emergency use & to expand access to populations everywhere, she tweeted.

The technical advisory group will meet on Oct 26th to consider EUL for #Covaxin. @WHO has been working closely with @BharatBiotech to complete the dossier. Our goal is to have a broad portfolio of vaccines approved for emergency use & to expand access to populations everywhere https://t.co/lqQIyqItF9

— Soumya Swaminathan (@doctorsoumya) October 17, 2021

The announcement comes after Foreign Secretary Harsh Vardhan Shringla on Thursday expressed hope that the WHO will soon give approval to Hyderabad-based Bharat Biotech's COVID-19 vaccine Covaxin.

Speaking to media in Bhubaneswar, Shringla said, "It is not the administrative or political process, rather it is a technical process of WHO. Technical Committee will evaluate the submissions made by Bharat Biotech which created Covaxin. I am sure the approval of Covaxin from WHO will come at the soonest possible", news ANI reported.

Earlier on October 5, WHO extended giving the emergency use authorisation for Hyderabad-based Bharat Biotech's COVID-19 vaccine Covaxin to next week.

"WHO and an independent group of experts is scheduled to meet next week to carry out the risk/benefit assessment and come to a final decision whether to grant Emergency Use Listing to Covaxin," WHO had tweeted.

Covaxin has been submitting data to WHO on a rolling basis and also gave additional information at WHO's request on September 27. 

Covaxin For Children

Meanwhile, the final approval for Bharat Biotech's Covaxin for children aged 2-18 years  in India is under experts opinion and evaluation, Government sources told ANI.

The news agency cited official sources as saying that the Subject Expert Committee (SEC) has given a recommendation to the Drugs Controller General of India (DCGI) for the use of Bharat Biotech's Covaxin, for the beneficiaries aged between 2-18 years.

The final approval will be given by the Drug Controller General of India (DCGI) after evaluation of the data.

Bharat Biotech in an official statement had informed they are waiting for further approvals from drug regulators. This is one of the first worldwide approval for COVID-19 vaccines for the age group of beneficiaries belonging to 2-18 years.

Bharat Biotech had submitted data from clinical trials in the 2-18 years age group for Covaxin (BBV152) to Central Drugs Standard Control Organisation (CDSCO).

The data has been thoroughly reviewed by the CDSCO and Subject Experts Committee (SEC) and both have provided their positive recommendations, the vaccine maker stated.

(With Agency Inputs)