World Health Organization officials cautioned countries rushing to develop coronavirus vaccines, saying emergency use authorization must be done with great care.
China and Russia say they will start deploying vaccines before completing late-stage clinical trials, and US Food and Drug Administration Commissioner Dr. Stephen Hahn has said if the US gets enough data from advanced trials, it might be possible to authorize a vaccine before the trials are completed.
Asked about what the three countries are planning, WHO officials said it’s important to make sure a vaccine is at least safe and works before using one broadly.
“The emergency use authorization or licensing is something that has to be done with a great deal of seriousness and reflection. It’s not something that you do very lightly,” WHO chief scientist Dr. Soumya Swaminathan said during a news briefing.
While it is up to the national regulatory authority of every country to make decisions about approvals, WHO has on its website a guidance document that lays out step-by-step what the approach for their emergency use listing procedure would be, she said.
Any country’s vaccine policy “must be guided by the highest possible ethical standard, the highest possible scientific standards,” said Dr. Mike Ryan, director of WHO’s Health Emergencies Program.
There are examples of vaccines that were rolled out before data collection was complete, Ryan added. Ebola is one. But data was carefully collected even as groups rushed to vaccinate people during recent Ebola outbreaks.
“You need to maintain monitoring,” Ryan said.