The president of the National Medicines Authority (Infarmed) said today, September 9, that the arrival of a vaccine against Covid-19 depends on the evolution of research on its quality, safety and efficacy, therefore, no date will be advanced. .
"The arrival of the vaccine will only occur when the conditions of quality, safety and efficacy are met", therefore not putting forward any date for this purpose, since the arrival on the market of the various vaccines against Covid-19, which are under investigation , depend on the evaluation and authorization of the European Medicines Agency.
Rui Ivo was speaking at today's press conference of the General Directorate of Health to monitor the pandemic in the country.
The official clarified today that the suspension of clinical trials of the vaccine against Covid-19, announced by the pharmaceutical company AstraZeneca, is due to an "adverse reaction" detected.
"Since an adverse reaction has arisen, which is the purpose of the trials themselves, this was stopped in order to carry out its assessment, we realized what type of reaction it is, which may be related to the administration of the vaccine or not, and not we have that information at the moment», referred Rui Ivo.
The president of Infarmed explained that this is "a normal situation" during the testing phase, "to have the answers that are needed to proceed with the investigation", bearing in mind that this phase of the study covers a "larger number of participants either in terms of age groups or in terms of clinical situations».
In a statement released today, Infarmed underlines that the announced suspension "is evidence of the necessary rigor for the proper development of a vaccine" and explains that "none of the vaccines for Covid-19 can be made available without having been subjected to a safety assessment and effectiveness', the objective of the studies to which they are subject.
Clinical trials are also intended, "in the early stages, to identify possible adverse reactions in participants as well as their degree of severity and causality."
The information collected "will serve to outline the safety profile of the drug under study, improving its future use."
The National Medicines Authority also clarifies that, "if serious side effects are detected in the vaccines under evaluation, they will not be made available in the European Union", continuing to be "the target of a rigorous monitoring process even after their authorization".
Drugmaker AstraZeneca has suspended late-stage testing of the vaccine it is developing against Covid-19, in partnership with the University of Oxford, after a suspected serious adverse reaction in a study participant.
The information was released late on Tuesday by the health information website Stat News and later confirmed by the pharmaceutical company itself, in a statement sent to the North American television channel CNN.
AstraZeneca stressed that this is "a routine action, which should take place whenever there is a potentially unexplained disease in one of the trials while it is being investigated", to ensure that "the integrity of the trials" is maintained.
Thus, studies on the final stage of the vaccine are suspended while the company investigates whether a report from a patient with a serious side effect is related to the product under development.
An AstraZeneca spokesman confirmed that the vaccination break covers testing in the United States of America (USA) and other countries.
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