There are risks in the premature use of a vaccine for COVID-19
The World Health Organization, WHO considers that a vaccine against COVID-19 should be approved based on the results obtained in phase 3 of clinical trials to avoid abusing shortcuts that could affect the data on its true efficacy and safety .
"Scientists around the world are asking regulatory agencies and companies for approval of a vaccine to be based on data obtained from phase 3 clinical trials," said WHO chief scientist Soumya Swaminathan.
Russia has announced that it already has a vaccine ready and that it is preparing to vaccinate its population, despite the fact that it has just entered phase 3 of the trials.
China has advanced research for two vaccines that has not completed phase 3 of clinical trials, but has begun vaccinating what it considers essential workers.
Premature approval of a vaccine would carry risks, Swaminathan said, noting that it would make it difficult to continue with randomized clinical trials and, more seriously, a vaccine "that has not been adequately studied" could begin to be used. The scientist pointed out that a very specific risk is that the hastily approved vaccine has too low an efficacy, which would not do its job of ending this pandemic.
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 percent "and preferably higher."
"Ideally, we don't want a vaccine with less than 30 percent efficacy that gets approved," he revealed.
The WHO defends that, despite the urgency to find a vaccine against COVID-19, any experimental vaccine "with a safety profile that is not acceptable" should be stopped.
"The most important thing is that decisions are made based on what the science says and have a group of scientists who is not influenced by any interest, who analyze the data and recommend whether a vaccine should be approved," said Swaminathan.