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Emergency Authorization of Vaccine Should NOT be Done ‘Lighty’

WHO Chief Scientist said, emergency use approval for any coronavirus vaccine candidate is not something that should be done ‘lightly.’

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.

According to WHO Chief Scientist Dr. Soumya Swaminathan, “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.”

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, Swaminathan 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.

In an interview that the Financial Times published August 30, FDA Commissioner Stephen Hahn said the agency would consider approving a vaccine candidate for emergency use before the final phase of clinical trials is complete if the hypothetical vaccine turns in promising early results.

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