WHO to consider emergency listing of Covaxin on October 26
The World Health Organisation's technical advisory group will meet on October 26 to consider the EUL of Covaxin.
The World Health Organisation's technical advisory group will meet on October 26 to consider the Emergency Use Listing (EUL) of Covaxin, a vaccine developed by Hyderabad-based Bharat Biotech against COVID-19. "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 and to expand access to populations everywhere," World Health Organisation Chief Scientist Soumya Swaminathan said in a tweet on Sunday.
An expert panel of the central drug authority had earlier recommended granting emergency use authorisation to Bharat Biotech's Covaxin for children and adolescents in the 2-to-18 years age group with certain conditions. If approved by the Drugs Controller General of India (DCGI), it will be the second COVID-19 vaccine after Zydus Cadila's needle-free ZyCoV-D to receive EUA for use in those below 18 years.
Covaxin manufacturer, Bharat Biotech, has been submitting data to WHO on a rolling basis. They had submitted additional info at WHO's request on September 27. The WHO experts are currently reviewing this info. If it addresses all questions raised, WHO assessment will be finalised in the coming week, the World Health Organisation (WHO) said in a series of tweets.
The Emergency Use Listing process done by WHO and the Technical Advisory Group of independent experts—is centred on determining if a manufactured product (eg a vaccine) is quality-assured, safe and effective, it said in another tweet.
Bharat Biotech had given a presentation on the vaccine's safety and efficacy data of clinical trials (phase 1-3 trial results and post-marketing) and risk management plans and other implementation considerations.
The indigenously developed Bharat Biotech's Covaxin is one of the six vaccines that have received emergency use authorisation from India's Drug Regulator and is being used in the nationwide anti-COVID-19 inoculation programme along with Covishield and Sputnik V.