Vaccine, covid and transaminases: "There is no excessive incidence nor should it be a cause for alarm"

Dr. Magdalena Salcedo, head of the Hepatology and Liver Transplant Section at the Gregorio Marañón Hospital, calls for "calm" after the study that associates this drug with the alteration found in 13 patients.

An elevation in transaminases after covid-19 vaccination may indicate the onset or exacerbation of autoimmune hepatitis, according to a national multicenter study that was presented at the 47th Congress of the Spanish Association for the Study of the Liver (AEEH). Behind him is the doctor Magdalena Salcedo, Head of the Hepatology and Liver Transplant Section at the Gregorio Marañón Hospital Madrid, who calls for "calm" after the unrest that has caused this research clinic in some sectors of the population.

"Millions of Vaccines en Spain, and these are specific cases of people who have consulted the health system for different reasons," points out this doctor, a member of the COLHAI group (Registry of Cholestatic and Autoimmune Diseases of the Spanish Association for the Study of the Liver, AEEH) and principal investigator of this project that includes 25 patients from 9 hospitals Spanish academics, among whom at the moment there is no Aragonese. "The data is preliminary and it is a communication that we made for a Congress, we have to publish it and we are collecting some more data from the rest of Spain, but we do not have the definitive results. So far there are 25 cases from nine hospitals, and there are probably some more that we have to review," he explains in reference to the Community.

This multicenter study, whose "casuistry remains open" and samples continue to be analyzed, establishes the possible causal relationship between drugs and transaminase alterations, when the researchers found an association between the vacuna of covid and liver impairment in more than half of the patients observed (13 of 25).

- The transaminases They are enzymes that fulfill an important metabolic function. If your blood levels rise more than normal, it may indicate a health problem, especially enfermedades of the liver. In the aforementioned work, the observed relationship is very minor. Millions of Vaccines en Spain, and they are specific cases of patients who have consulted their doctor or emergency services for different reasons. Some would get with jaundice, others had nausea or vomiting, and when doing the analysis we saw alterations in the transaminases. Whenever you see that you have to discard many things, which in these cases were discarded. A liver biopsy was performed in most of them and there were data compatible with autoimmune hepatitis.. Causation in this case is established by ruling out the rest of the reasons and establishing a temporal relationship with the administration of the vacuna. 

- He insists that it should not be alarming, although the study is still open.

- That's right, we are talking about a very minority relationship. It is described in other Vaccines that any immune reaction to these drugs can trigger something like this. But among millions of cases that have been administered, This is a situation that should not be alarming or generate other types of attitudes. Only alert doctors to ask when they detect a patient with high transaminases.

- The average onset in these cases was 19 days. Are there patients who are more susceptible to this reaction?

- Yeah, a predominance of of and in our study, specifically, There were 9 patients who had an underlying immune process. The results of this work coincide with those of another international study that has just been published in the 'Hepatology' magazine, and which has been carried out in 18 countries with the same way of working that we have followed in Spain. The aforementioned work is coincident in terms of the age profile and the clinical manifestations that have occurred.

The average onset of our cases was 19 days, and in this other study it was 14. The population sample was similar and with respect to age it varied a little: in ours it happened more in middle-aged women (around fifty-odd years), and in the other work referred to he was around 60.

- What symptoms were observed in affected patients?

- The symptoms are those produced by any hepatitis: from very mild symptoms of nausea, fatigue o vomiting… until yellow coloring, which responds to a jaundice syndrome in the most serious forms.

- What treatment is applied in these cases?

- In all diseases that are of autoimmune origin, there tends to be anti-inflammatory, which are corticosteroids. Seeing from the biopsy and the analyzes that it was compatible with a condition of this type, this medicine. Corticosteroids are given as a shock treatment, and then you withdraw it. In the Spanish series we prescribed it in 80% of the cases.

- Should people with autoimmune diseases or those who are going to be vaccinated follow any special recommendations?

- Do not. The message of this study is only directed to health professionals, that if they see a high transaminase, apart from investigating the usual, they should think that there may be a history of a vaccination, in this case of the Covid, which is what we are talking about in the study. But the message we send to the population is absolutely reassuring: You don't have to do anything special to the people who are going to be vaccinated, neither monitoring nor prior analysis. 

In the case of people with autoimmune diseases, some of the immunosuppressants can facilitate the development of severe covid, that is why it is so important that these patients get vaccinated. In any case, It should be professionals who evaluate each circumstance, because in that "pool" or battery of symptoms and pathologies that you have to check, they would have to look at whether a covid vaccine has been administered a few days before. This falls within the issues that we already address with the Vaccines. The incidence detected is not excessive nor should it be a cause for alarm in any case, nor does it invalidate vaccination policies.

- You yourself launch an argument in favor of the Vaccines.

- They are very sensitive topics, but The benefit of vaccines is unquestionable right now in Spain. We are in a much calmer situation compared to what is happening. in China, which has used less effective vaccines or has not given them to the entire population, and now there are people who have serious symptoms. Here in Spain, in the last wave of omicron we have seen that unvaccinated people were at greater risk of entering the uvi and suffering from pneumonia. That is why it is very important to provide information that is as rigorous as possible, and the rigor is that 25 cases have been detected, which is a minority caseload. What is known at the moment is that this exists, but just as other reactions can occur.

- For example?

- This is something that has somehow been reported in another type of Vaccines, immune reactions, and in covid-19, specifically, it has been detected at the level of other organs. When you put an antigen, a stimulus, you trigger a series of reactions. And in certain susceptible people there may be proteins, antigens, with which these antibodies also react. It is what is known as molecular mimicry phenomena. But it is a very anecdotal issue that we are observing. In fact, We have open registration, and in scientific societies one of our philosophies or reason for being is to advance scientific knowledge, which advances in part thanks to these sharings. You see a case and ask if other services have seen a similar one, and This is how this concern has been generated. It's not something we've seen just in Spain, we are analyzing it to publish it with the global data, which is 80 or so cases worldwide.

- You and your group combine research with clinical practice. What evolution is Omicron having and how do you see the situation of the coronavirus en Spain? 

- We make research clinic, but the bulk is the healthcare activity. What is happening now, or what I see here in Madrid, is that there are many mild respiratory symptoms... For two or three weeks, perhaps now it is going down a little, What is not happening is more admissions to the ICU or ward. This probably means that we have already reached a phase with the virus we have now flu. There will probably be successive waves and hopefully the virus will be less aggressive. For their part, the Vaccines They will have to adapt to how the virus changes.