WHO Says Vaccine Can Be Listed For Emergency Use Before Phase 3 Trials Completed

WHO Says Vaccine Can Be Listed for Emergency Use Before Phase 3 Trials Completed

Katherine O'Brien, the director of the World Health Organization's (WHO) Department of Immunization, Vaccines and Biologicals, said on Friday that regulators do not need to wait for the final results of phase 3 clinical trials to list the vaccines for emergency use, but can use interim data instead

MOSCOW (Pakistan Point News / Sputnik - 09th October, 2020) Katherine O'Brien, the director of the World Health Organization's (WHO) Department of Immunization, Vaccines and Biologicals, said on Friday that regulators do not need to wait for the final results of phase 3 clinical trials to list the vaccines for emergency use, but can use interim data instead.

"Stringent regulatory authorities and WHO are requiring that the results of phase 3 clinical trials are the basis for an early use listing or an emergency use listing. That does not mean that the trial necessarily has to be completed as designed because each of the trials has interim looks at the data that are stipulated in the protocols that can allow an evaluation of the data once the data meets certain apriori established numbers of cases that would allow some kind of conclusion to be drawn, depending on the actual efficacy of the vaccine," O'Brien said at a briefing.

Countries have been developing dozens of vaccines since the start of the COVID-19 outbreak earlier this year. The vaccine developed by Russia's Gamaleya Research Institute for Virology and Microbiology, Sputnik V, is so far the furthest ahead in its clinical trials compared to vaccines developed in other countries. Many vaccines are expected to be registered with the WHO by the end of the year.