EUL timelines: WHO is not creating differential requirements, says a top representative

The speed with which vaccines get an “emergency use listing” from the World Health Organization depends on “how fast the manufacturer submits all the data”, said WHO’s Dr Mariângela Simão, Assistant Director-General for Access to Medicines, Vaccines and Pharmaceuticals.

She responded to a journalist query on criticism directed at the WHO by the President of Mexico, involving “delays” on the Russian Covid-19 vaccine Sputnik V and the Chinese CanSino vaccine.

Dr Simao’s response provides insight into the EUL process and its timeline, as Bharat Biotech’s Covid-19 vaccine goes through the regulatory process to get the emergency-use tag.

“The WHO uses international standards , and the procedures that guide the EUL are published on the WHO website...they are followed by all manufacturers,” she said. Manufacturers make a submission to the WHO, once accepted, they need to submit all data. “WHO is not inventing new data or creating differential requirements. We use internationally accepted, recognised standards and norms for the quality and safety of health products,” she said.

Read also: Importance of having an EUL for Covid vaccines

Explaining that the speed of the EUL approval depended on the manufacturers’ nimble-footedness in submitting data, she said, sometimes production facility inspections were needed if the manufacturers inspections were not recent.

With Sputnik, she said, a rolling submission had been initiated - “which is the applicant starts to upload in WHO’s website, the technical data, the clinical data, the clinical trial, the Good Manufacturing Practices, the quality managment systems...there is a series of data that needs to come in.”

Since all submissions had not come in, the process was on hold till recently, she said, “because of a legal procedure which still needed the applicant to sign that they agreed to the WHO’s rules and procedures to continue to do the assessment”. The process has since restarted, she added.

“This is the process that works for everyone, WHO does not differentiate from where the manufacturer is, which country it is... whether it is state owned or private sector, we follow the rules that are equal to every one,”she said, adding “there are different timelines because of the different processes in terms of the speed with which the manufacturer can provide the data to WHO.”