Vaccine safety and more …

Are you taking risks when you fly on an airplane? Undoubtedly – planes sometimes crash. You risk even more when getting behind the wheel of a car or in a passenger seat. Does this mean that you shouldn’t fly by airplane or drive by car? Obvious absurdity. But for some reason, the equally obvious truth – potential risks need to be assessed against potential benefits – is often ignored. There are no drugs and vaccines that are absolutely safe to use, even if everything is done strictly according to the instructions.

Let’s narrow it down to vaccines. Their safety is assessed by the set and frequency of “side effects” (in the professional jargon – “side effects”). This term suggests a causal relationship between vaccination and the development of an unwanted effect. If there is a lot of experience with a particular vaccine, then frequent side effects are known. But even in such cases, the development of a particular pathology after vaccination can not always be considered a “side effect”. Indeed – “after” does not mean “due”! And in the case when the vaccine is new and tested for the first time, the situation is even more confusing. Therefore, in clinical trials began to use the term “adverse events” (AE).

Unlike “side effects,” this term is neutral regarding the causal relationship between vaccination and the development of AE. The isolation of true side effects among AEs occurs during all phases of clinical trials and then during post-registration surveillance. In clinical trials, the main tool for this is the comparison of AEs in the vaccine and placebo groups. If you look at the results of any clinical trials, you will find that subjects in the “placebo” group (say, saline) will also have AEs.

 

Логично предположить, что «настоящими» побочными эффектами являются только те, которые не наблюдаются в группе «плацебо» и наблюдаются в группе «вакцина». К сожалению, реальность не всегда «черно-белая» – нередко одни и те же HЯ регистрируются в обеих группах. В таком случае информативными будут их частоты и степень выраженности. При всех этих «но», наличие плацебо контроля в испытаниях на безопасность (Фаза 1 или совмещённые Фаза 1-2) позволяет получить очень ценную информацию, а отсутствие этого контроля понижает качество клинического испытания.Поділитися цим:

0

Автор публікації

Офлайн 4 місяці

Amir0406

0
Коментарі: 0Публікації: 20Реєстрація: 18-01-2021

You may also like...

Залишити відповідь

Войти с помощью: 

Ваша e-mail адреса не оприлюднюватиметься.

Авторизація
*
*
Войти с помощью: 
Реєстрація
*
*
*
Войти с помощью: 
Генерація паролю