The WHO's chief scientist, Soumya Swaminathan, believes that the rush to develop the vaccine could result in the first doses having an efficacy of less than 30%, when ideally it should be above 50%.
The World Health Organization ( WHO ) believes that a COVID-19 vaccine should be approved based on the results obtained in phase 3 clinical trials to avoid shortcuts that could compromise data on its true efficacy and safety. "Scientists around the world are urging regulatory agencies and companies to ensure that vaccine approval is based on data obtained in phase 3 clinical trials," said WHO Chief Scientist Soumya Swaminathan at a press conference. Russia has announced that it already has a vaccine ready and is preparing to vaccinate its population, even though it has only just entered phase 3 trials. China has advanced research on two vaccines that have not yet completed phase 3 clinical trials , but has begun vaccinating what it considers essential workers. Premature approval of a vaccine would entail risks, Swaminathan said, including making it more difficult to continue randomized clinical trials and, more seriously, potentially leading to the use of a vaccine " that is not yet effective. " "It has been adequately studied ." The scientist pointed out that a very specific risk is that a hastily approved vaccine might have too low an efficacy, meaning it "would not do its job of ending this pandemic." Among the criteria agreed upon between the WHO and the regulatory agencies of some countries where experimental vaccines are being researched is the level of efficacy it should have, which the organization considers should be at least 50% "and preferably higher." "Ideally, we don't want a vaccine with less than 30% efficacy to receive approval," she revealed. The WHO argues that, despite the urgency to find a COVID-19 vaccine, any experimental vaccine "with an unacceptable safety profile" must be halted. "The most important thing is that decisions are made based on science and that a group of scientists, not influenced by any vested interests, analyzes the data and recommends whether a vaccine should be approved," said Swaminathan. "The challenge we face now is that we are moving from vaccinating hundreds of people ( phase 2 clinical trials ) to hundreds of thousands of people (phase 3). We need the efficacy and safety results from these studies because if we start vaccinating millions of people too quickly, we could overlook some adverse effects," explained WHO Emergencies Director Mike Ryan .
In: https://www.abc.es/sociedad/abci-alerta-sobre-riesgos-prematuro-vacuna-contra-covid-19-202009021551_noticia.html#vca=238046&vso=nw&vmc=20200902200002-0100-100-coronavirus_0425&vli=re_pa-not-7-txt&vus=4cb349d85ae6408d998c2d6848170a5e
