Covaxin Likely to Get Global Authorisation by This Month-end, Health Min to Meet WHO Officials Today

Bharat Biotech’s Covaxin is likely to get global authorisation from the World Health Organisation (WHO) by the end of this month. Top sources told CNN-News18 that representatives of the global health watchdog will meet Union Health Minister Mansukh Mandaviya on Wednesday to hold talks in the matter.

The Hyderabad-based company had in May this year submitted an application to the WHO for Emergency Use Listing (EUL). Emergency Use Listing is a procedure to streamline the process by which new or unlicensed products can be used during public health emergencies, according to WHO guidelines.

Dr. Mariangela Simao, a WHO assistant director-general for vaccines, says the UN health agency’s assessment of the Bharat Biotech vaccine was “quite advanced” and officials hoped for a decision by mid-September. Few studies have been published on the shot. Indian researchers have yet to share any advanced research about the vaccine, which has been authorised and used in India.

Scientists in India say the vaccine is about 78% effective, but there are some questions about how the vaccine performs in the real world, including against COVID-19 variants.

Simao said WHO is also considering other versions of vaccines already licensed by the agency, including one made by Sinopharm. She expects they’ll begin evaluating vaccines made by Sanofi Pasteur and Novavax in September.

“There are many, many vaccines in the final stages of the pipeline, Simao says. Last week, the US makers of Novavax said they would prioritise seeking authorization in developing countries and from WHO before getting the green light in the U.S. and European Union.

Bharat Biotech had earlier said that the vaccine has received Emergency Use Authorisation in 16 countries, including, Brazil, India, Philippines, Iran and Mexico, with the EUA in process in 50 countries worldwide.

The emergency approval by WHO will bring in many benefits as it will allow Covaxin to get global approval for its use, which will in turn facilitate easy movement of Indians who have been vaccinated by it.

On July 28, Minister of State for Health Bharati Pravin Pawar had told Rajya Sabha that all the relevant documents required for the EUL have been submitted to WHO by Bharat Biotech.

On February 15, WHO gave emergency use approval to the Covishield vaccine produced by the Serum Institute of India. So far, these vaccines globally have been given approval by WHO for EUL — Pfizer’s Comirnaty, AstraZeneca’s AZD1222, Janssen’s Ad26.COV2.S, Moderna’s mRNA-1273, and Sinopharm’s SARS-CoV-2 Vaccine.

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