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During the COVID-19 pandemic, elective surgeries were suspended for many months, and only high-risk oncological cases were addressed, although an ambulatory follow-up and management of benign conditions, which can cause lower urinary tract symptoms (LUTS), were essential. In neurologic patients, for example, LUTS have a great impact on quality of life and social life, and their clinical conditions can seriously worsen if not properly addressed.
- COVID-19 vaccines
- urology
1. Introduction
Usually, the development of a vaccine is a lengthy process, taking seven to ten years, during which time research is conducted in successive stages that include quality testing, preclinical testing, and clinical trial phases in humans. In Europe, when a pharmaceutical company believes it can demonstrate the quality, safety, and efficacy of its product for a specific therapeutic indication, it submits a marketing authorization application to the European Medicine Agency (EMA). Only after approval by the EMA and authorization by the European Commission does the company start the large-scale production process. Vaccine studies against COVID-19 started in the spring of 2020, and in less than a year, the EMA recommended granting conditional marketing authorization to a first messenger RNA vaccine: mRNA (Comirnaty, BioNTech/Pfizer). Soon thereafter, on 6 January 2021, it granted a second one for the vaccine produced by Moderna. The development process has been accelerated at an unprecedented global level, yet no step in the process failed, thanks to the concurrence of several factors: earlier research on messenger RNA (mRNA) technology; studies on human coronaviruses related to SARS-CoV-2 (e.g., those that caused SARS—Severe acute respiratory syndrome—and MERS—Middle East respiratory syndrome); substantial human and economic resources made available within a tight timeframe, and parallel running of the various evaluation and study phases [12]. To contain the spread of COVID-19 and to reduce its severity, the WHO and governments from all around the world undertook unprecedented measures and promoted massive vaccination campaigns. As of 26 October 2022, a total of 12,830,378,906 vaccine doses had been administered [13]. COVID-19 vaccines were shown to be effective and to have few adverse events in the clinical trials [14,15]. Despite the strong data on the safety of the different types of COVID-19 vaccines, some people preferred not to be vaccinated fearing possible side effects, including among others, effects on fertility [16,17]. In the field of the Safety Platform for Emergency vACcines (SPEAC), the Brighton Collaboration Group developed a priority list of adverse events of special interest (AESI), with the aim of harmonizing vaccine safety evaluations for COVID-19. The SPEAC COVID-19 list of AESI was adopted by the WHO Global Advisory Committee on Vaccine Safety [18]. The main urological disorders included in the list are acute kidney injury, collapsed glomerulopathy, renal infarction, hypernatremia, ANCA-associated vasculitis with glomerulo-nephritis, and IgA vasculitis with nephritis; however, they refer to the COVID-19 disease and not to vaccination [18]. A tool for monitoring the safety of vaccines even after they have been approved and placed on the marketing market is pharmacovigilance and vaccinovigilance, which represent a complex set of activities aimed at continuously assessing all information on the safety of medicinal products and ensuring that the benefit/risk ratio remains favorable over time. The development of serious adverse events following the administration of the first dose of the vaccine is not an absolute contraindication to continuing the vaccination cycle. Each case is assessed by the vaccinating doctor, who decides on the patient’s suitability to receive the booster, based on the clinical, anamnestic, and pharmacological information available. No medicinal product can ever be considered risk-free. Each of us, when deciding to use a drug or receive a vaccination, should keep in mind that what he or she is doing is balancing the benefits with the risks. Verifying that the benefits of a vaccine outweigh the risks and minimizing these is the responsibility of the health authorities that regulate the marketing of medicinal products.
2. Andrology
The combination of COVID-19 vaccination and fertility was one of the major areas of research of great interest to the general population. Gonzalez et al. [17] conducted a study published in JAMA regarding the possible effects of the COVID-19 vaccines on fertility. Patients were prescreened in order to exclude possible fertility issues prior to vaccination. The exclusion criteria included a positive test result within 90 days. A semen sample was provided 2 to 7 days prior to receiving the first vaccine dose and approximately 2 months after the second dose. A sperm analysis before and after the two doses showed no significant decreases. This small cohort of 45 patients showed higher sperm parameters that can be considered as physiological and within normal ranges. The small number of patients, the short follow-up, and the lack of a control group were the limitations of this study. No differences in sperm motility, volume, or concentration were observed. It is essential to remember that a sperm analysis is an imperfect predictor of fertility potential. Overall, these preliminary results suggest no negative effects on the male reproductive system.
Winston et al. [23] wrote of a rare case of penile Mondor’s disease (PMD) 7 days after the first dose of a COVID-19 vaccine. A one-week treatment of acetaminophen and ibuprofen was sufficient to achieve a complete cure. PMD is an uncommon disease characterized by thrombosis of the superficial veins of the penis [24]. Several cases of PMD have been reported in patients infected with the SARS-CoV-2 virus [25,26]. It is important to mention that the AstraZeneca ChAdOx1-S vaccine can cause in rare cases a hypercoagulable state, and for that reason, in some countries, no further administration of this vaccine was provided [27,28].
3. Oncology
Hatakeyama S. et al. [29] presented a study at the Annual European Association of Urology Congress of 2022 in Amsterdam that evaluated the rates of an antispike antibody response to a BNT162b2 vaccine in patients with urological cancers. Data from 195 patients with prostate cancer (PC), 57 patients with urothelial cancer (UC), 28 patients with renal cell carcinoma (RCC), and 93 patients with kidney transplantation (KT) were retrospectively analyzed. Their results suggested that age (HR 0.95, p = 0.002), metastasis (HR0.25, p = 0.021), and immunosuppression (HR 0.003, p < 0.01) were significantly associated with seropositivity. Almost all the patients (90%) showed an adequate immunological response to the COVID-19 vaccine, although further research is needed to highlight the clinical implications of a lower antispike antibody response and their protective activity on a SARS-CoV-2 virus infection.
Recently, several cases of cancer patients with 18FDG PET CT evidence of metabolically active lymph nodes after COVID-19 vaccination have been reported [30,31]. PET CT is an important tool in the initial staging and follow-up of oncological patients and can dramatically change a patient’s treatment options and strategy. In a test such as PET CT, accuracy is essential [32]. Andresciani et al. [33] reported on a case of a male patient diagnosed with prostate cancer who underwent a PET CT after the COVID-19 vaccine. The PET CT scan showed a slight 18FDG uptake and enlargement of the left axillary lymph and paratracheal nodes. Because of the previous imaging reports, the patient’s clinical history, and the absence of a PSA increase, the patient underwent a new 18FDG PET-CT scan 14 weeks later showing an important decrease in the FCH uptake in all the previously involved regions. This case report highlights the importance on considering the vaccination history to evaluate imaging findings and to avoid false-positive reports and further unnecessary examinations.
4. Kidney Transplant
COVID-19 represents a great burden on kidney transplant recipients (KTRs). Daan et al. published a systematic review and meta-analysis [34] where they estimated that the risk of mortality is around 23% in KTRs regardless of comorbidities, sex, and age, highlighting the call to accelerate vaccination programs for KTRs. Some studies reported the serological response to COVID-19 in KTRs. Haskin et al. [35] reported a higher positive antibody response in adolescent and young adult KTRs than in adult KTRs. The antibody levels were lower in this group of patients than in patients with a previous COVID-19 infection. The majority of seronegative KTRs were previously treated with rituximab, and the time from the second vaccine dose to serologic testing was longer in seropositive than in seronegative patients [35]. During the follow-up, no vaccinated patients developed symptomatic COVID-19 disease.
KTRs are usually under immunosuppressive therapies for graft function. The American Society of Transplantation stated that the vaccine administration usually does not induce autoimmune reactions nor graft rejection rates [36,37].
COVID-19 vaccines have been administered in solid organ transplant recipients, and in their study, Ou et al. described a graft rejection only in 1 of 741 participants. Adverse symptoms were in line with expected vaccine reactogenicity, and severe side effects were rare [38]. Indeed, COVID-19 vaccination in these patients should be safe. KTRs should consider COVID-19 vaccination because they are at a high risk of suffering from severe COVID-19 symptoms. It is interesting that only 38% of KTRs had a humoral response after the COVID-19 vaccination; therefore, the dose of the SARS-CoV-2 vaccine needs to be augmented to maintain a sufficient humoral response [39].
5. Miscellaneous
Several cases of macroscopic hematuria were reported in patients with a history of biopsy-proven IgA nephropathy after the administration the COVID-19 vaccines [40,41,42]. Patients developed gross hematuria hours or days after the vaccine administration, and it generally resolved with supportive therapy only. Patients who developed AKI resolved it with steroid therapy. The authors suggested that a cell-mediated immune response was the cause of such a clinical presentation, but no further studies were performed. It is important to highlight that patients with kidney diseases are at an increased risk of mortality from severe COVID-19, and several studies have demonstrated the importance of COVID-19 vaccination in these patients, which is safe and effective [43,44]. Macroscopic hematuria can be the first symptoms of cancer in the kidney, urinary tract, or prostate.
This entry is adapted from the peer-reviewed paper 10.3390/vaccines10111887
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