key: cord-0737913-7o8hjz5r authors: Quiroga, Borja; Sánchez-Álvarez, Emilio; Goicoechea, Marian; de Sequera, Patricia title: COVID-19 Vaccination among Spanish nephrologists: Results of survey on acceptance and side effects date: 2021-06-08 journal: J Healthc Qual Res DOI: 10.1016/j.jhqr.2021.05.002 sha: 1ee1c8f59949a0dc944dc79b77fa96903babdf0c doc_id: 737913 cord_uid: 7o8hjz5r Introduction. Four vaccines against Covid-19 have been approved to date. Their acceptance and safety have not been addressed on healthcare workers. The aim of the present study is to evaluate vaccination rates and side effects among Spanish nephrologists. Methods: All the Spanish nephrologists were invited to participate in this survey. Data on demographics, Covid-19 infection status, received vaccine doses and side effects were collected. Acceptance and side effects were analyzed for Covid-19 vaccination. Factors associated to vaccination were assessed and a multivariate adjusted model was constructed to determine independent predictors for Covid-19 vaccine side effects. Results: A total of 708 nephrologists answered the survey (460 [65%] women, mean age 44±11 years). Six-hundred and eight (86%) had received the first dose and 513 (72%) were fully vaccinated. Most of the subjects (565, 93%) received BNT162b2 (Pfizer-BioNTech®) vaccine. Among vaccinated nephrologists, 453 (75%) presented any side effect; the most frequent was local reaction (68%), followed by myalgia (44%), tiredness (39%) and headache (34%). Age (OR 0.97, 95%CI [0.95-0.99], p<0.0001) and prior Covid-19 infection (OR 2.37, 95%CI [1.27-4.42], p=0.007) were independent predictors for developing side effects with Covid-19 vaccine. Overall side effects were similar with both vaccines, being myalgia (p=0.006) and tiredness (p=0.032) more frequent with the Pfizer-BioNTech® one. Conclusion: Age and prior Covid-19 infection were predictors of vaccination side effects among Spanish nephrologists. Antecedentes y objetivo. Hasta la fecha, cuatro vacunas han sido aprobadas frente a la Covid-19. Su aceptación y la presencia de efectos secundarios en personal sanitario no ha sido evaluado. El objetivo del presente estudio fue evaluar la tasa de vacunación entre los nefrólogos que ejercen su profesión en España, así como los efectos adversos. Materiales y métodos. Se invitó a todos los nefrólogos españoles a completar una encuesta online sobre los objetivos del estudio. Se recogieron datos demográficos, sobre la situación infecciosa del Covid-19, la vacuna recibida y la aparición de efectos adversos. Se analizaron los factores asociados a la vacunación, así como las variables predictoras de reacciones adversas. Resultados. Un total de 708 nefrólogos respondieron a la encuesta (460 [65%] mujeres, edad 44±11 años). Seiscientos ocho (86%) de los nefrólogos encuestados recibieron al menos una dosis de la vacuna y 513 (72%) la vacunación completa. La mayor parte de ellos (565, 93%) recibieron la vacuna BNT162b2 (Pfizer-BioNTech®). Entre los nefrólogos vacunados, 453 (75%) presentaron algún efecto adverso; el más frecuente fue la reacción local (68%), seguido de mialgias (44%), astenia (39%) y cefalea (34%). La edad (OR 0.97, 95%CI [0.95-0.99], p<0.0001) y la infección previa por Covid-19 (OR 2.37, 95%CI [1.27-4.42 ], p=0.007) fueron predictores independientes del desarrollo de síntomas tras la vacuna. En conjunto, los efectos adversos fueron similares con ambas vacunas, siendo las mialgias (p=0,006) y la astenia (p=0,032) más frecuentes con la vacuna Pfizer-BioNTech®. Conclusiones. La edad y el antecedente de infección por Covid-19 fueron predictores de efectos secundarios con la vacuna entre los nefrólogos que ejercen en España y que conetsatron la encuesta. vaccine (temporally defined as immediate symptoms after the administration and during the next 7 days) were assessed using a multi-choice questionnaire (for both the first and the second dose). The questionnaire was opened during a week between 12 and 19 February 2021, when only BNT162b2 or mRNA-1273 vaccines were authorized for use in Spain. Side effects were defined as local reaction on the arm (pain or swelling), lymphadenopathy, tiredness, headache, diarrhea, nausea, chills, myalgia, low-grade fever (body temperature between 37 and 37.8 degrees Celsius), fever (body temperature 37.8 degrees Celsius or above), and others (free text). Finally, those 7 nephrologists receiving Covid-19 vaccine were asked if they needed a sick leave due to side effects. The survey was sent to 1,909 active members of the Spanish Society of Nephrology and 708 (37%) completed it. Of them, 460 (65%) were women and mean age was 44±11 years. 603 nephrologists (85%) worked in hospitals, 80 (11%) in dialysis centers and 25 (4%) in both types of centers. Among 708 nephrologists that responded to the survey, 607 (86%) had received the Ninety-Four (15%) of the nephrologists who had received the first dose of the Covid-19 vaccine, did not receive the second one. Reasons for not receiving the second dose were diverse. In 69 subjects (73%) the second dose was scheduled after the survey period, in 20 cases (21%) there was lack of vaccines due to delivery issues, 4 (4%) developed an intercurrent Covid-19 infection and one (1%) refused to receive the second dose. Among 607 vaccinated nephrologists, 453 (75%) presented any side effect. Fourhundred and eighteen (69%) subjects developed side effects after the first dose of the Covid-19 vaccine. Of the 513 subjects that were fully vaccinated, 291 (57%) presented side effects after the second dose. Two-hundred and fifty-six (42%) had side effects with both doses. We did not observe gender differences regarding adverse events in males and females (p=0.237 for the first dose and p=0.458 for the second dose). Presenting symptoms after the first dose was associated to any side effect after the second one (Odds ratio [OR] 9.6, 95%CI [6.1-14.9], p<0.0001). Local reaction (412, 68%), myalgia (267, 44%), tiredness (239, 39%) and headache (206, 34%) were reported by more than 30% of the vaccinated nephrologists. Figure 2 shows side effect rates for each vaccine dose in detail. Factors associated to development of side effects were lower age (p<0.0001) and prior Covid-19 infection (p=0.002). Figure 3 shows the analysis of adverse events stratified by age. As shown in Our study demonstrates that most of the Spanish nephrologists have been vaccinated against Covid-19 with an acceptable safety profile. During the same dates, only the 5,7% of the Spanish population had been vaccinated in comparison to the 88% of the Nephrologists. Our national campaign, started 28 December 2020, included HCWs within the first group of people to be vaccinated. At 9 march 2021, vaccinated HCWs achieved rates of 86% and 46% for the first and second doses, respectively. As suggested by previous published data, nephrologists are healthcare professionals working at first-line, hence their vaccination was considered as a priority. Although our data reveal high rates of acceptance, 12% of nephrologists have not been vaccinated yet due to personal decision, a low but surprising rate considering their knowledge of the devastating effects of the pandemic 10 . Indeed, according to a previous report of the Spanish Society of Nephrology, nearly 20% of nephrologists were infected by SARS-Cov-2, of whom 8% required hospitalization 7 . Reasons for this high rate of infection included lack of an appropriate personal protective equipment as well as their high exposure to Covid-19 patients. Although side effect data from the randomized clinical trials (RCT) of the four approved Covid-19 vaccines have been reported 1, 2, 3, 4 , there is a lack of information about vaccine side effects in real world. Indeed, a very recent nationwide-based study involving 596,618 persons in Israel confirmed the efficacy of the BNT162b2 mRNA vaccine, although its adverse effects were not analyzed 11 . Our survey shows that more than 75% of the vaccinated nephrologists suffered from any symptom, the most frequent being local reaction, myalgia, tiredness or headache. In addition, they declared up to 22 different side effects of the vaccine. The appearance of such a wide variety of symptoms probably conditioned the refusal of some subjects to complete the vaccination. Contrary to previous published data 2 , prior Covid-19 infection increased the rate of post-vaccination reactions in nephrologists. Among the published studies, the only one addressing prior Covid-19 infection of the included subjects demonstrated that less than 1% of the participants presented a previous infection 2 . Our study shows that previous Covid-19 infection was specifically associated to higher rates of tiredness, chills, myalgia and fever. This flu-like syndrome has been constant in the extrapulmonary symptoms of Covid-19 infections, in infections by other endemic human coronaviruses as well as in side effects of vaccines against other viruses 12, 13 . In this regard, some experts and preliminary studies have suggested that one dose could confer enough efficacy to allow for a delayed administration of the second dose, especially in those patients with prior Covid-19 infection 14, 15 . BNT162b2 (Pfizer-BioNtech®) and mRNA-1273 (Moderna®) vaccines (both based on nucleoside-modified RNA) presented a similar safety profile in their phase 2/3 studies, with local reactogenicity in more than the 70% of the participants. Those studies showed that local and systemic events were more frequent in younger vaccine recipients and also after the second dose 1,2 . Our survey also shows higher reaction in younger recipients; however, unlike those pivotal studies, our results showed lower reactogenicity after the second dose. The comparison between both vaccines revealed similar overall adverse events, being myalgia and tiredness more frequent with Pfizer-BioNTech®. Our study have some limitations. First, it is a survey-based analysis relying on data provided voluntarily that lack information such as comorbidities or laboratory values. However, as previously stated, nephrologists can be considered as healthy population with higher rates of previous Covid-19. In addition, we obtained a large sample size that provides sufficient statistic power to support the results of the study. Second, the study subjects provide subjective information based on how they feel their symptoms, which could lead to some heterogeneity. Nevertheless, the results are in accordance with previous published data in other populations 16 . Finally, this survey included the situation of the members of the Spanish Society of Nephology and not all the Spanish Nephrologists. However, we understand the sample is representative in terms of size and also in place of work of the total Nephrologists in Spain. In conclusion, Spanish nephrologists who answered survey, as first-line HCWs, have received Covid-19 vaccines with acceptable self-limited side effects. Lower age and prior Covid-19 infection were predictors of higher side effect rates, especially tiredness, chills, myalgia, low-grade fever and fever. 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