Pre-submission meeting, “Rolling Data” for Covaxin will start in July: WHO

Moving forward with the approval process, the World Health Organization (WHO) that Bharat Biotech is currently communicating with for the emergency use list for the COVID-19 Covaxin vaccine, said a pre-submission meeting has been held for it and “data rolling will begin July.”

The information on the WHO website on the status of COVID-19 vaccines was made available within the EUL-PQ WHO assessment process document. The WHO guidelines said the Emergency Use List (EUL) is a procedure to simplify the process by which new or unlicensed products can be used during public health emergencies.

Meanwhile, joint managing director of Bharat Biotech Sochitra Ella on Tuesday said that its COVID-19 vaccine Covaxin adheres to international standards, external timelines are not in the company’s hands.

“Covaxin will cross new frontiers, adhering to the highest international regulatory guidelines. A new vaccine from (India) is set to record history again, with proven data, safety and quality. We are committed to implementation no matter what, external timelines,” Ella wrote on Twitter. It’s not in our control.”

Her tweet assumes significance in the wake of the company’s attempt to obtain an EUL from the World Health Organization even as its US partner Ocugen prepares to seek approval from the US Food and Drug Administration to use the beating syringe in that country.

Ella has also tweeted a table of states and cities where Covaxin is currently available. She said the stab is used in 27 cities in 18 states.


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