A long post shared dozens of times on Facebook says that “Vaccines have not passed the appropriate testing protocols and are not safe”. This is the seventh point of a text with a total of 27 arguments against vaccination against Covid-19. But, like many of the statements in that text, it is false.
According to the World Health Organization, vaccine testing goes through two steps. First, they are applied to animals, to check if they are safe and show potential to prevent a disease. If the results are satisfactory and the vaccines prove to be safe, proceed to the second step: human trials.
As a rule, human clinical trials follow three phases. In the first, the vaccine is administered to a small number of volunteers to confirm their safety, to understand whether it generates an immune response and to calculate the correct dose to trigger the production of antibodies.
In the second phase, the number of participants in clinical trials climb to the order of hundreds, all with the same characteristics – those of the population that, if the vaccine reaches the market, will receive it. Half of the group receives the vaccine, the other half a placebo. The idea is to draw the first conclusions about the advantage of vaccination.
At this point, researchers are also looking to monitor the side effects that the vaccine can cause and deepen their knowledge of how it elicits an immune response. Furthermore, begin to collect data on the vaccine’s ability to avoid the appearance of a disease.
In the third phase, the vaccine is administered to thousands of people and, as in the previous phase, one part does receive the drug while the other part receives a placebo. It is at this point that data are compared to conclude whether the vaccine is safe and effective against the disease against which it was developed.
All of these steps were accomplished during clinical trials of Covid-19 vaccines, but with one difference: in human trials, the first and second phases occurred simultaneously to accelerate the process of developing a solution against the coronavirus. And the third phase started as soon as the preliminary results of the two previous phases demonstrated that there was security to move forward.
Maria do Carmo Fonseca, president of the Institute of Molecular Medicine, had already explained to the Observer that, during clinical trials on vaccines against Covid-19, despite having been compacted in a few months, which is normally done in a longer time, “No steps were skipped”.
“Vaccines are no less safe, they were not less tested because everything was done faster,” explained the expert. They were developed, tested and went through an approval process in a faster time than usual, but only because “There was a concentration of efforts, companies and institutions gave all priority to the development of the vaccine ”, reported Maria do Carmo Fonseca.
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Even after clinical trials, vaccines enter the market only when regulatory authorities – the Food and Drug Administration (FDA) in the United States, the European Medicines Agency (EMA) in the European Union and national institutions – confirm that vaccines are safe and effective against the disease.
This is precisely what happened with all vaccines that have already been approved by the European Medicines Agency and authorized in Portugal. In the statement about the first vaccine recommended by the agency, that of Pfizer / BioNTech, the experts concluded that there were “Sufficiently robust data on the quality, safety and efficacy of the vaccine”, making it available to people over 16 years of age using an authorization for emergency use. The same happened with Moderna and AstraZeneca vaccines.
Maria do Carmo Fonseca explains that this authorization allows a drug to be approved in a faster period of time to stop a serious illness or that affects a very high number of people – such as Covid-19. Throughout this process, however, the safety and efficacy of this drug must be proven, something that occurs with any medicine that enters the market.
The European Medicines Agency itself clarifies, on the official website, that a medicine can only be approved by the European health authorities if “The benefits of a vaccine in protecting people from illness are far greater than any potential risk”. It is only after a team of experts makes sure that this is the case that the medicine enters the market.
It is not true that vaccines against Covid-19 approved so far by regulatory authorities have not passed the appropriate testing protocols. Clinical trials have been adjusted to accelerate the vaccine development process, when a large part of the scientific community focused on this mission, but that did not condemn the analysis to its security. This was confirmed when experts from regulatory agencies analyzed data from pharmaceutical companies and proved the safety and efficacy of vaccines.
Thus, according to the Observer’s classification, this content is:
In the Facebook rating system, this content is:
FAKE: The main claims of the content are factually inaccurate. Generally, this option corresponds to the “false” or “mostly false” classifications on fact checkers’ websites.
Note: this content was selected by the Observer as part of a fact checking partnership with Facebook.