The World Health Organization (WHO) assured that what happened with the Covid-19 vaccine from the University of Oxford and Astrazéneca, which had to stop phase three clinical trials after a patient had a serious side effect, is something common and showing that safety is being prioritized.
WHO chief scientist Soumya Swaminathan said that once the clinical trial monitoring team reviews data on the individual who became ill, the trial could proceed, but that would depend on the decision of the designated commission. for these cases.
“Each clinical trial protocol has an operating procedure to manage these side effects. The clinicians doing the trials are trained in good practice, which means that they are closely following and monitoring all participants, and there is a protocol on what to do when something happens. If it is mild there are things that can be done. If it is severe, as it was in this case of a severe side effect, the trial was stopped. This is a normal procedure and is good practice, because safety is the priority in any clinical trial ”, explained the doctor.
Swaminathan said that this is a lesson to recognize the fact that there will always be ups and downs in clinical research and development.
“It is not always just a fast and straight path, but we cannot lose hope because this kind of thing happens … We have to wait to see the data of what really happened,” he added.
The expert recalled that, although of course the WHO wants to see good results, and “the faster the better”, it is a process that takes time and cannot be rushed, since sufficient data must be collected from a certain amount of people who are then analyzed and approved by regulatory entities.
“This requires tens of thousands of people to undergo the trial. If we look at the current ones, they have 30,000 to 60,000 participants. Usually half are given the vaccine and the other half a placebo. It is a blind study, so neither the patients nor the companies know to whom they gave what and those who receive the vaccine should be monitored for a minimum of six months to prove efficacy and safety, ”she explained.
Swaminathan said that with some of the trials starting in July, results are possible by the end of this year, although the safety follow-up should continue for longer.
“Regulatory agencies will also need time to examine the results and make a decision on whether or not the vaccine is ready to be patented,” he added.
The doctor stressed that right now there is no way to predict which vaccines will be successful candidates, but that most have had promising data in phase 1 and 2.
For his part, the WHO emergency director, Michael Ryan, said that, although he understands that there is a generalized anxiety to move as fast as possible, no vaccine can skip steps and that is why there are already designed protocols.
“The purpose of this is to make sure this is done in the most direct, honest and scientific way, which takes time. This is not a race, it is a race against the virus and to save lives, but it is not a race between companies, nor between countries, it is a race to support public health in the most effective and safe way possible, and in that race it is that we are, it is not a competition and many of the drug companies have said it publicly ”, he stressed.