Bharat Biotech, the producer of Covaxin has presented data to WHO on a rolling basis and submitted additional info at WHO’s request on September 27.
A file image of Covaxin.
The World Health Organization (WHO) and an independent group of experts are scheduled to meet next week to carry out the risk/benefit assessment and arrive at a final judgement on whether to award Emergency Use Listing to Covaxin.
WHO & an independent group of experts are 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.#COVID19pic.twitter.com/jJyS1hiz44
— World Health Organization (WHO) (@WHO) October 5, 2021
Bharat Biotech, the producer of Covaxin, has presented data to WHO on a rolling basis and submitted additional info at WHO’s request on September 27.
The global health body experts are presently reviewing this data. If it addresses all questions raised, the WHO assessment will be finalised next week.
The Emergency Use Listing process is focussed on determining if a manufactured product (e.g. a vaccine) is quality-assured, safe and effective.
The pharma firm gave 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, according to the SAGE draft agenda.
SAGE is authorised with advising WHO on overall global policies and strategies, ranging from vaccines and technology, research and development, to delivery of immunization and its linkages with other health interventions.
According to the agenda, Hanna Nohynek, a member of SAGE, is expected to present a draft recommendation for the vaccine and the session will make its recommendations.
The WHO is currently reviewing the data submitted by the vaccine maker and the date for a decision on the jab is October 2021 according to the update available on the WHO website.
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.
(With inputs from PTI)
WHO to give final judgement on Covaxin emergency use listing next week
Source: Trend Updates Article
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