To build herd immunity against corona or Covid-19, vulnerable groups, both because of age and health conditions, are prioritized in vaccination. People with congenital diseases are given special conditions. In essence, most of them can be vaccinated under certain conditions, including vaccination of patients with chronic kidney disease (CKD).

There is a lot of news, especially on social media, about events related to vaccination. Most of the news is difficult to analyze because the information is incomplete and tends to be bombastic. So, as an effort to anticipate PIFE (post-immunization follow-up events), the side effects of Covid-19 vaccination need to be known, especially regarding CKD. This study needs to be carried out while waiting for comprehensive research on PIFE from various types of Covid-19 vaccines in CKD patients.

From various studies in many countries, it is generally known that the current level of effectiveness of the Covid-19 vaccine is very good. Currently, experts are trying to research the use of immunosuppressive drugs for the treatment of advanced kidney disease and kidney transplant recipients. Do they receive the same level of protection from the Covid-19 vaccine when compared to people not on immunosuppressive treatment? Likewise, is their tolerance to the vaccine the same as the general population?

The results of these studies will have consequences in the PIFE of Covid-19 vaccinations. This means that PIFE has the potential to have different levels of complications as a consequence for the group of CKD patients whose biological machinery is not as good as that of healthy people, either because of chronic exposure to toxins or because they have underlying diseases such as diabetes and autoimmune diseases. With this in mind, competent experts will guide those who will take part in the Covid-19 vaccination program. In this way, the vaccinated recipient has many advantages over disadvantages, including in terms of minimizing PIFE.

As a concrete example, at least these experts will ensure that patients do not have acute complaints or symptoms such as nausea, vomiting, uncontrolled hypertension, and high blood sugar in those who will undergo vaccination. This is all done to minimize PIFE.

There is one study of Pfizer vaccine in kidney patients concerned with PIFE (Polewska K., et.al., Safety and Tolerability of the BNT 162b2 mRNA Covid-19 Vaccine in Dialyzed Patients. COViNEPH Project, Medicina 2021, 57,732). The results showed that the vaccine was proved to be safe and there were only mild reactions that persisted for a short time, of course in the population being studied. It was stated in the study that PIFE was the same in the form of pain at the injection site and mild fever, although the study did not provide a specific description and still needed further research to improve health services in chronic kidney disease.

Doctors generally agree that the benefits of the vaccine for people with any stage of CKD, dialysis patients and kidney transplant recipients, far outweigh the risk of serious illness or complications from Covid-19. This is what drives the vaccination program in the CKD group. Of course, those who will receive the Covid-19 vaccination already know the advantages and disadvantages after being explained by a doctor or health professional. To be more sure, a talk to the doctor or health professional who knows the patient's medical record, including some things about PIFE, is necessary.

Different follow-up symptoms

PIFE is defined as complaints and/or symptoms experienced by vaccine recipients after receiving certain vaccines and are thought to be related to the effects of the vaccine given, regardless of any ingredients contained in the Covid-19 vaccine.

Vaccine side effects may include fever or fatigue which will generally go away in a while. Side effects may also be in the form of flu (flu-like syndrome) which may affect the ability to carry out live activities. However, that too will be gone within a few days. There is another type whose side effect may be in a form of allergic reaction. Of all the examples of these symptoms or complaints, all can appear several hours after the vaccine is injected. Its emergence may also take longer, although very rarely. In summary, there is no clear time limit for PIFE to occur, but it is usually no later than the first 48 hours after vaccination.

Similar to vaccinations in general, these post-Covid-19 immunization follow-ups are generally not dangerous. There are even reports that various side effects, both local and systemic in nature, occur less frequently in dialysis patients compared to the control group (Polack, F.P.; et al. N. Engl. J. Med. 2020). Furthermore, it was stated that there were systemic reactions of 59.1% at the first dose and 69.9% at the second dose, which, when compared, these reactions were 4x and 2x more frequent than in the hemodialysis group.

The explanation is that it is, in part, due to the weakening of the innate immune defense mechanisms. Therefore, it is nothing to worry about even if it happens frequently. This is actually part of a normal sign that the vaccinated body is building protection from the virus in question. However, there is a severe type of PIFE, ie. severe allergic shock known as anaphylaxis.

This condition requires treatment with an injection of the drug Epinephrine or has to go to the hospital when the PIFE requires follow-up. However, such incidents are very rare, considering that before the injection, the officers first select whether there is a history of a moderate or severe allergy before. Additionally, the vaccination service provider is equipped with drugs and equipment to anticipate these unwanted events.

It was mentioned earlier that the presence of PIFE illustrates that the vaccinated body is building protection from the virus in question. However, for those who do not experience follow-up symptoms (no side effects at all), the injected vaccine is not necessarily useless. According to the World Health Organization (WHO), there are many people who do not have side effects after receiving the Covid-19 vaccine.

In the absence of a reaction, that doesn't mean the vaccine isn't working. In this regard, everyone who is vaccinated is actually different in how they respond to vaccination and still has the benefit of being vaccinated.

This is in agreement with reports from Pfizer-BioNTech and Moderna, which is 95% effective and was found in half of people in clinical trials who reported side effects after vaccination. The rest do not show PIFE. In some other places, the incidence of PIFE is 70%-90% in Pfizer vaccination recipients (CDC).

Based on its nature, the side effects of Covid-19 vaccination may include local side effects and systemic (whole body) side effects. In local side effects, it looks like pain and there is swelling in the arm where the vaccine injection was done. The systemic side effects may be in the form of fever, chills, fatigue, headache, or it can also be in the form of allergies, some are mild-moderate to severe.

However, for the sake of safety, those who develop a non-severe allergic reaction within 4 hours of being vaccinated should be considered thoroughly. This is known as an immediate allergic reaction. If they experience such as itching, swelling, and breathing problems, the vaccination should not be continued on the second dose because of the risk of having a severe allergic reaction. As a follow-up, the doctor on duty will refer to a allergist and immunologist for more treatment or advice.

Given all that, Covid-19 vaccination providers should have prepared/anticipated the possibility of the vaccine recipient experiencing a severe allergic reaction by preparing specific skills, instruments, and drugs in dealing with potential unwanted events.

Minimizing PIFE

The general principle for minimizing PIFE in any grade is that all persons receiving Covid-19 vaccine should be monitored on the spot for at least 15 minutes after obtaining the vaccine shot.

A person who has had a severe allergic reaction or an immediate allergic reaction to a vaccine or injection therapy should be monitored for at least 30 minutes after receiving the vaccine. In all vaccination sites, appropriate drugs and equipment should be available, such as epinephrine, antihistamines, steroids, RL infusion fluids and infusion sets, stethoscopes, blood pressure cuffs, and pulse timers.

If a person experiences a severe allergic reaction after getting the Covid-19 vaccine, the vaccination provider should provide prompt treatment and call emergency medical services. They should be continuously monitored in a medical facility for at least a few hours.

To reduce pain and discomfort at the vaccine site, wipe the area with a clean, cool, wet towel. Arm movement or exercise should also be done sufficiently. However, more attention needs to be paid and a doctor or health care provider should be immediately contacted if two things happen. First, the symptoms worsen or there is inflammation with significant redness and tenderness in the arm where the vaccination was injected. Second, there are side effects that are worrying and still remains after a while or a few days.

In essence, there needs to be awareness of anticipating PIFE carefully in the Covid-19 vaccination for CKD sufferers. However, doubts about the effectiveness of the COVID-19 vaccine must be removed so that we can overcome this pandemic with planned herd immunity. Health protocols must still be maintained with discipline, including by maintaining physical fitness. These are efforts that we have to pursue with a believe that the pandemic will surely pass.

Djoko Santoso
Professor, Nephrologist, 
Faculty of Medicine, Universitas Airlangga
Chairman of Health Department, Indonesian Council of Ulama, East Java
Covid-19 Survivor

Translated from Indonesian:
"Mengelola Efek Vaksinasi Korona pada Pasien Ginjal Kronis" by Djoko Santoso
Media Indonesia, 24 August 2021