Pre-submission meet held, Covaxin’s ‘Rolling Data’ to start in July: WHO

Taking the approval process ahead, World Health Organisation (WHO) which is currently approached by Bharat Biotech for an Emergency Use Listing of its COVID-19 vaccine Covaxin, has said pre-submission meeting for it was held and the “Rolling Data will starting in July.”

The information was provided in the WHO website in the status of COVID-19 vaccines within WHO EUL-PQ evaluation process document. Emergency Use Listing (EUL) is a procedure to streamline the process by which new or unlicensed products can be used during public health emergencies, WHO guidelines said.

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

“Covaxin will cross new frontiers, adhering highest international regulatory guidelines. A new vaccine from (India) is all set to make history once again, with proven data, safety & quality. We stand committed to deliver no matter what, external timelines not in our control,” Ella tweeted.

Her tweet assumes significance in the wake of the company trying to get EUL from the WHO even as its US partner Ocugen preparing to get US Food and Drug Administrations nod to use the jab in that country.

Ella also tweeted a table of states and cities in which Covaxin is currently available. It said the jab is used in 27 cities in 18 states.