Coronavirus, Vaccines & Side Effects: Let’s Be Clear

There has been a lot of coverage of the suspension of the COVID-19 vaccine in Italy and other countries in Europe over the past few days. Our wonderful pediatrician Francesco Gesualdo wrote an article along with his colleagues from Bambino Gesu Children’s Hospital Dr. Alberto Tozzi from the Research Area for Multifactorial and Complex Diseases and Dr. Caterina Rizzo from The Department of Clinical Pathways and Epidemiology addressing this issue for “A Scuola di Salute”, the health literacy magazine published by the hospital. As we have often looked to Dr. Gesualdo to help shed some light on the challenging year we have faced, we wanted to share his and his colleagues’ insights on what has been going on regarding this situation.

As Dr. Gesualdo and his colleagues state, some serious adverse events have recently been reported shortly after the administration of a batch of one of the anti-COVID-19 vaccines available in Europe. At the moment, these side effects cannot be directly linked to the vaccines and the suspension of the batch being distributed is a precautionary measure, pending the conclusion of the assessments that the ‘Agenzia Italiana del Farmaco (Italian Medicine Agency) is carrying out. In addition, the events that have been reported to be associated with vaccination are relatively common, and it is plausible that they were observed by chance. It is also likely that it is also coincidental that the people who looked to place blame on the vaccines received the same batch, given that it was the one that at the moment was mainly being used in Italy. However, no increase in the number of these events has been observed beyond what we normally expect in Italy. In these circumstances the benefits outweigh the risks for continuing the administration of the vaccination. They decided to look at the reasons in more detail.

The authors point out that in the development of vaccines, of any type and for any population group, before studying their effectiveness, their safety is studied. In the pre-distribution studies, if vaccines have serious side effects, as with all experimental drugs, they simply can never be used. Furthermore, the studies conducted to evaluate the safety and efficacy of the vaccines require a large number of patients and for those performed for theCOVID-19 vaccines, have been conducted on several tens of thousands of people. All the standards required for vaccine safety are verified by the European Medicines Agency today, in times of COVID-19, as in the past. This means that nothing has been overlooked and that the emergency approval process has not reduced the accuracy with which the studies are carried out, but has only reduced the time.

Once the vaccines pass all necessary testing and are available for use for the general public, the focus on potential side effects continues. In this phase the number of doses administered is obviously very high, especially in a situation such as the present one in which the majority of the population is trying to vaccinate as quickly as possible. Therefore, during large-scale administration, any suspected side effects are evaluated in order to ensure public safety and the safety of continuing vaccination campaigns.

They go on to explain, given that during the ongoing vaccination campaign for COVID-19, many people have been vaccinated in a relatively short period of time, it may happen, by pure coincidence, that some illnesses, completely independent of vaccinations, are reported within a brief time period after administration of the vaccine. The task of the health authorities is to evaluate all potentially dangerous situations and to exclude, whenever necessary, that it is the vaccine that has caused the side effect.

If, during the evaluation of the reported side effects, an event emerges that deserves further investigation, the vaccine batches involved, those administered to people who have developed the side effects, are immediately suspended as a precaution. At the same time two different evaluations start:

– An investigation is immediately carried out on the chemical composition and purity of the vaccine;

– An epidemiological investigation is also performed to evaluate the cause-effect relationship.

As Dr .Gesualdo and his colleagues state the principles upon which the basis of the cause-effect association between vaccines and side effects are evaluated are numerous, rigid and standardized, with the scope of making prudent decisions even when the data does not allow for certain conclusions to be reached. If a causal association between a vaccination and side effects is recognized, drastic measures are taken, to the point of discontinuing the administration of the particular vaccine, otherwise, the suspended batches are released again.

The suspension of vaccine batches, as with other pharmaceuticals, is therefore a frequent occurrence and is an element of the guarantee for citizens that testifies to the utmost attention paid to these events. The guarantee regarding the safety of vaccinations must obviously be balanced with the need to guarantee the safety of the population from COVID-19. In a circumstance such as the pandemic, it would be a grave mistake to stop administering vaccinations without solid evidence for the side effects of the vaccination.

It is likely that in the near future we will find ourselves in situations in which we will examine suspected cases of side effects that will be observed by chance and for which, following the investigations, the association to the vaccine will be excluded. Under these conditions we will know that it may happen from time to time that we will see the suspension of batches of available vaccines. Understanding the procedures that are in place for monitoring the side effects of vaccinations, we can see that this mechanism is a guarantee for all of us. A guarantee that is activated precisely to know if the vaccine has really caused serious side effects, or if it was a false alarm as it happens in most cases.