WHO Doesn’t Expect Widespread COVID-19 Vaccination Until Mid-2021

The U.S. may be gearing up for vaccine distribution, but a World Health Organization (WHO) spokesperson said Friday that the international agency doesn’t expect to see widespread vaccination with a COVID-19 vaccine until the middle of next year, stressing that more time is needed for late-stage clinical trials.

WHO spokeswoman Margaret Harris said during a virtual United Nations briefing in Geneva, Switzerland, that there needs to be more time spent on phase 3 trials before concluding any vaccine candidate is viable for use on a mass scale.

“You need to see how truly protective the vaccine is. You also need to see how safe it is,” she said. “There are earlier phases [where] you do look at safety, you look at safety very, very carefully before you go into the phase 3, but you need to be following safety at all stages, so that makes it a longer process.”

A good number of vaccine candidates are now in phase 3 studies — the WHO knows of six to nine candidates that have made it to late-stage trials — and the organization wants to see all the data for those vaccine candidates in order to compare them and determine which ones will provide the best protection with the greatest safety levels, Harris said.

So far, none of the vaccine candidates in phase 3 trials have given a “clear signal” on whether they possess adequate efficacy and safety levels yet, she said. The WHO has set a bar of 50 percent efficacy for COVID-19 vaccines.

“Even if one or some of the current candidates now in phase 2 or 3 evaluation prove safe and to have worthwhile efficacity, we should not expect to see widespread vaccination before the middle of the next year,” she told FDAnews. “We need to focus now on doing all we can to suppress the virus rather than simply waiting for a vaccine.” — James Miessler