On the safety of coronavirus vaccines as exemplified by the Pfizer-BNT vaccine

On the safety of coronavirus vaccines as exemplified by the Pfizer-BNT vaccine

 

 

 

There are no absolutely safe vaccines and cannot be. What does the so often sounding words mean – “the vaccine is safe”. The implication of this statement is that the potential risk of using the vaccine is significantly lower than the expected benefit. Risk is the sum of side effects (“side effects”), their nature, frequency and degree of danger. The term “side effect” suggests a causal relationship between vaccination and the development of a “side 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 they began to use the term “adverse events” (AE), in English – “adverse events”. In contrast to 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 trial, you will find that subjects in the “placebo” group (say, saline) will also have AEs (see pictures below). It would seem that the “real” side effects are only those that are not observed in the placebo group and are observed in the vaccine group. Unfortunately, reality is not always “black and white” – often the same HYs are registered in both groups. In this case, their frequency and severity will be informative.Поділитися цим:

0

Автор публікації

Офлайн 2 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