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The World Health Organization considers that a vaccine against COVID-19 should be approved based on the results obtained in phase 3 clinical trials to avoid abusing the shortcuts that could affect the data on its true efficacy and safety.
«Scientists are calling for a vaccine to be approved based on data from phase 3 clinical trials“Said WHO Chief Scientist Soumya Swaminathan.
Russia announced that you already have a vaccine ready and that it is preparing to vaccinate its population, even though it has just entered phase 3 of the trials.
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China has advanced investigations of two vaccines that have not finished phase 3 of clinical trialsBut it has started vaccinating what it considers essential workers.
Premature approval of a vaccine would carry risks, Swaminathan said, mentioning that it would make it difficult to continue with randomized clinical trials and, more seriously, a vaccine could start to be used “that has not been adequately studied«.
The scientist pointed out that a very specific risk is that the hastily approved vaccine has too low an efficacy, thus “he would not do his job to end this pandemic«.
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Among the criteria agreed between the WHO and the regulatory agencies of some countries where experimental vaccines are investigated is the level of efficacy that they should have and that the organization considers should be at least 50% «and preferably higher«.
«Ideally we don’t want a vaccine less than 30% effective that gets approved“, he pointed.
The WHO defends that, despite the urgency to find a vaccine against COVID-19, any experimental vaccine should be stopped «with a safety profile that is not acceptable«.
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«We need the efficacy and safety results of these studies because if we start vaccinating millions of people too quickly we can miss some adverse effects“Said WHO Director of Emergencies Mike Ryan.
