Vaccine Adverse Effects Research Articles

Vaccination against covid-19: the opinion of medical students

Introduction. One of the pressing issues in public health today is the fight against the COVID-19 pandemic, including vaccine prophylaxis, its possibilities, necessity and safety. Proper professional advocacy plays an important role in the success of the vaccination campaign. Medical school students are also part of the professional community, who are as close as possible to the population and can be a source of information for them to influence their decisions about whether or not to vaccinate. The aim of the work was to study the attitudes of medical university students, as carriers of special information, toward vaccination against COVID-19. Materials and methods. A questionnaire survey was administered to 151 medical university students from Chelyabinsk and Ekaterinburg, mainly from the 4th to 6th years of medical, pediatric, and preventive medicine faculties. Results. Many of the trainees participating in the study are familiar with the new coronavirus infection (have themselves had an infection, are involved in providing medical care to patients with the new coronavirus infection), and more than 80% have been vaccinated against COVID-19. 63.0% of unvaccinated respondents do not plan to vaccinate in the near future, half of them due to uncertainty about the effectiveness of the vaccine. 44.9% of all respondents were not afraid of adverse effects of vaccination, and a large proportion (55.1%) expected reactions and even complications after vaccinated against COVID-19. They consider vaccination to be effective against COVID-19 47.5%, and 52.5% of those surveyed are not sure about vaccination effectiveness. Discussion. The effectiveness of vaccination for airborne infections is determined by the one-step coverage of a large (at least 70.0%) portion of the population. Most of the students surveyed intend to recommend vaccination against COVID-19 (almost 63%); however, 37.1% are not yet ready to do so. The motivations for their own vaccination are equally understanding of its necessity and fear of administrative restrictions. The study participants form their judgments about the problem under study mainly on the basis of popular publications and mass media appearances, which is confirmed by their low appeal to official statistics and special sources. Conclusion. To date, medical university students have not had a pronounced interest in learning about the new coronavirus infection, so the educational process under the COVID-19 pandemic needs to pay special attention to the problem under discussion.

COVID-19: Vaccination Side Effects and Sick Leave in Frontline Healthcare-Workers-A Web-Based Survey in Germany.

(1) Background: The COVID-19 vaccination has caused uncertainty among employees and employers regarding vaccination reactions and incapacitation. At the time of our study, three vaccines are licensed in Germany to combat the COVID-19 pandemic (BioNTech/Pfizer (Comirnaty), AstraZeneca (Vaxzevria), and Moderna (Spikevax). We aim to assess how often and to what extent frontline healthcare workers had vaccination reactions after the first and second vaccination. The main focus is on the amount of sick leave after the vaccinations. (2) Methods: We create a web-based online questionnaire and deliver it to 270 medical directors in emergency medical services all over Germany. They are asked to make the questionnaire public to employees in their area of responsibility. To assess the association between independent variables and adverse effects of vaccination, we use log-binomial regression to estimate prevalence ratios (PR) with 95% confidence intervals (95%CI) for dichotomous outcomes (sick leave). (3) Results: A total of 3909 individuals participate in the survey for the first vaccination, of whom 3657 (94%) also provide data on the second vaccination. Compared to the first vaccination, mRNA-related vaccine reactions are more intense after the second vaccination, while vaccination reactions are less intense for vector vaccines. (4) Conclusion: Most vaccination reactions are physiological (local or systemic). Our results can help to anticipate the extent to which personnel will be unable to work after vaccination. Even among vaccinated HCWs, there seems to be some skepticism about future vaccinations. Therefore, continuous education and training should be provided to all professionals, especially regarding vaccination boosters. Our results contribute to a better understanding and can therefore support the control of the pandemic.

A review of adverse effects of COVID-19 vaccines.

The COVID-19 pandemic has led to unanticipated pressures on all aspects of human life. Multiple approaches to eliciting protective immunity must be rapidly evaluated. Numerous efforts have been made to develop an effective vaccine for this novel coronavirus, resulting in a race for vaccine development. To combat COVID-19, all nations must focus their efforts on widespread vaccination with an effective and safe vaccine. Globally, concerns about potential long-term adverse effects of vaccines have led to some apprehension about vaccine use. A vaccine's adverse effect has an integral role in the public's confidence and vaccine uptake. This article reviews the current primary literature regarding adverse effects associated with different COVID-19 vaccines in use worldwide.

COVID-19 vaccination in cancer patients: a narrative review.

Coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has affected over 220 million individuals worldwide, and has been shown to cause increased disease severity and mortality in patients with active cancer versus healthy individuals. Vaccination is important in reducing COVID-19-associated morbidity and mortality. Thus, the aim of this article was to review the existing knowledge on effectiveness, immunogenicity and safety of COVID-19 vaccines in patients with cancer. Fifty-four articles were included following a search of PubMed and Google Scholar databases for studies published between January 2020 and September 2021 that investigated humoral and cell-mediated immune responses following COVID-19 vaccination in patients with cancer. Immunogenicity of vaccines was found to be lower in patients with cancer versus healthy individuals, and humoral immune responses were inferior in those with haematological versus solid cancers. Patient-, disease-, and treatment-related factors associated with poorer vaccine responses should be identified and corrected or mitigated when possible. Consideration should be given to offering patients with cancer second doses of COVID vaccine at shorter intervals than in healthy individuals. Patients with cancer warrant a third vaccine dose and must be prioritized in vaccination schedules. Vaccine adverse effect profiles are comparable between patients with cancer and healthy individuals.

Prevalence of Covishield COVID-19 Vaccine (ChAdOx1 nCoV-19) Adverse Effects among Health Care Workers in Sri Lanka

PurposeA Community vaccination programme is the best approach to combat COVID-19 pandemic. The first priority was given to the health care workers (HCWs) with the introduction of Indian Covishield (ChAdOx1 nCoV-19) vaccine to Sri Lanka since February 2021. An independent post-vaccine surveillance is important to identify the occurrence of adverse effects(A/E) in the population.Methods & MaterialsA multicentered cross-sectional survey was conducted in four provinces of Sri Lanka to estimate the prevalence of A/E after covishield vaccination A/E among HCWs after the first dose. A self-administered questionnaire was used to gather demographic data and A/E. Data was analysed using descriptive statistics.ResultsOf 4834 participants, 3500(72.4%) were females. The median age was 42.23(SD±9.64) years. Only 0.8%(n=31) persons has had Covid infection in the past. 2.2% were breastfeeding mothers and 0.2% were pregnant ladies.87.4% of persons had at least one A/E and 53.1% had local A/E. Body aches(68.2%), headaches(63.8%), fever(58%), chills 51.4%), fatigue(41.2%), arthralgia(38.1%) and rigors (32%) were the most commonly reported systemic A/E.Most of the systemic A/E were more prevalent among the ≤42-year-old group, and females. Their duration was mainly 24 hours. Mean duration of onset of fever is 9.76 hours.Pain and redness at the site were the most commonly reported local A/E.All of the local A/E were more prevalent among the ≤42-year-old group and females. Mean duration of pain at the site is 4.47 hours.1.7%(n=61) had reactions within first 20 minutes. 0.08%(n=4) developed anaphylaxis, 0.8%(n=31) had urticaria.15.4% had at least one comorbidities but there were no significant association between having a comorbidity and developing systemic or local.1.3% had history of drug or food allergies, they did not show significant relation to current vaccine induced allergies or anaphylaxis.69.2% attended the routine work despite having minor A/E. 0.13%(n=7) were hospitalised and treated. 22.4% were stayed at home and rested for 24-48 hours due to A/E.ConclusionEventhough more than 60% reported minor A/E, there were only a few serious A/E. A/E were more prevalent in younger age and females. Overall, the first dose of the Covishield vaccine was well-tolerated by HCWs.

Are COVID-19 mRNA vaccine side effects severe enough to cause missed work? Cross-sectional study of health care-associated workers.

The Coronavirus Disease 2019 (COVID-19) pandemic, caused by the severe acute respiratory syndrome-coronavirus-2, has claimed 5,587,549 lives worldwide as of January 20, 2022. Fortunately, large-scale vaccination can mitigate the impact of COVID-19 by making the disease milder and less common. Although 75.2% of the United States population has received at least 1 dose of a COVID-19 vaccines thus far, concerns regarding vaccine side effects have contributed to vaccine hesitancy. Furthermore, nearly 50% of adults in the United States are concerned not only about side effects, but about their downstream impact, including missed work.The goal of this cross-sectional study was to investigate the effect of messenger RNA vaccine adverse effects on the propensity to miss work among employees associated with a single, large academic health center.Using Qualtrics, all employees, including faculty, staff, and trainees, of 5 large departments were surveyed to determine whether they received the COVID-19 vaccine and which type, and any symptoms they experienced after receipt of either vaccine dose. We hypothesized that vaccine recipients would be more likely to miss work or feel sick enough to miss work following the second dose.Thirty-seven percent of respondents experienced events severe enough that they needed to miss work from either of the doses, with the majority (27.8%) related to the second dose. These findings are consistent with and expand on the results from the phase 3 trials for Pfizer-BionTech and Moderna, which showed that vaccine side effects were more common after the second dose than after the first dose. Our statistically significant finding was more common among Asians, women, trainees/house staff, and nonphysician clinical employees.With an increasing number of individuals taking the vaccine, employers will need to account for the impact of adverse effects on their employees’ ability to work. These findings will further help organizations better plan for staffing as vaccinations increase to mitigate the spread of COVID-19.

The Safety of mRNA-1273, BNT162b2 and JNJ-78436735 COVID-19 Vaccines: Safety Monitoring for Adverse Events Using Real-World Data.

Two mRNA COVID-19 vaccines (mRNA-1273, Moderna; and BNT162b2, Pfizer-BioNTech) and one viral vector vaccine (JNJ-78436735, Janssen/Johnson and Johnson) are authorized in the US to hinder COVID-19 infections. We analyzed severe and common adverse events in response to COVID-19 vaccines using real-world, Vaccine Adverse Effect Reporting System (VAERS) data. From 14 December 2020 to 30 September 2021, 481,172 (50.7 ± 17.5 years, males 27.89%, 12.35 per 100,000 people) individuals reported adverse events (AEs). The median time to severe AEs was 2 days after injection. The risk of severe AEs following the one viral vector vaccine (OR = 1.044, 95% CI = 1.005–1.086) was significantly higher than that after the two mRNA vaccines, and the risk among males (OR = 1.374, 95% CI = 1.342–1.406) was higher than among females, except for anaphylaxis. For common AEs, however, the risk to males (OR = 0.621, 95% CI = 0.612–0.63) was lower than to females. In conclusion, we provided medical insight and clinical guidance about vaccine types by characterizing AEs using real-world data. In particular, COVID-19 mRNA vaccines are safer than viral vector vaccines with regard to coagulation disorders, whereas inflammation-related AEs are lower in the viral vaccine. The risk–benefit ratio of vaccines should be carefully considered, and close monitoring and management of severe AEs is needed.

A Battle against COVID-19: Vaccine Hesitancy and Awareness with a Comparative Study between Sinopharm and AstraZeneca.

Background: Awareness about the COVID-19 vaccine’s adverse effects is crucial for gaining public trust. As we still lack proof of vaccines’ safety, this survey aimed to investigate Egyptians’ general awareness of the Sinopharm and AstraZeneca vaccines against COVID-19 and provide considerable evidence on their side effects and complications. Methods: A cross-sectional questionnaire-based study was conducted in Egypt between 20 September and 10 October in 2021, with multiple-choice questions (MCQs) covering all data on vaccine administration confusion, adverse effects or intensity, and complications. Results: Among the 390 participants, 42.3% reported being hesitant before receiving one of the vaccines. About 40.3% of participants were previously infected before getting vaccinated while only 4.6% reported being infected after vaccination. The AstraZeneca vaccine demonstrated higher side effects and symptoms than the Sinopharm vaccine while the Sinopharm vaccine showed a significantly higher rate of COVID-19 infection after vaccination. Conclusions: People with higher educational levels and chronic respiratory diseases represent an excellent model for accepting COVID-19 vaccination. A booster shot is recommended for people vaccinated with the Sinopharm vaccine due to a significantly higher rate of COVID-19 infection after vaccination; however, the Sinopharm vaccine shows a more acceptable safety profile.

Cognizance, adverse effects and motivation regarding COVID-19 vaccination amongst health care professionals: A cross-sectional study.

Coronavirus disease 2019 (COVID-19) vaccines are currently at the forefront of India's fight against the pandemic. They have been shown to prevent the disease or reduce its severity, following 2 doses given at an interval of 6-8 weeks. The present cross-sectional survey was carried out on 1,145 health care practitioners in order to recognize and evaluate the adverse effects of vaccination as well as knowledge, motivation and attitudes with regard to vaccines amongst the respondents after the 1st dose of vaccination. An anonymous survey was carried out among different age and gender groups in the medical colleges situated in the state of Maharashtra, India. The participants' responses were collected with the use of the Google Forms platform through sending a URL link to the questionnaire. The validity of the questionnaire was pilot-tested and the obtained Cronbach's alpha value was 0.80. Amongst the 1,145 participants, 92.2% of the respondents received COVISHIELD™ and 7.8% received COVAXIN®. The subjects were further scrutinized in 4 different age groups:18-27 years (73.0%); 28-37 years (14.8%); 38-47 years (9.6%); and above 47 years (2.5%). Adverse effects were common in the age group of 18-27 years and were observed significantly more frequently in females than males. A very common symptom was pain at the site of injection with an occurrence of 85.2%. Fever was present in 62.6% of the respondents, with 39.1% having low-grade fever and very few having high-grade fever. Knowledge about adverse effects and what to expect after vaccination would help to educate people, dispel misinformation and reduce vaccination hesitancy. It can also help to promote awareness about the incidence of adverse effects and the safety of COVID-19 vaccines.

Assessing Vaccine Hesitancy Among Pediatric Healthcare Providers.

Vaccine compliance has fallen short of national and international targets, generating preventable disease outbreaks. While vaccine hesitancy in the general public is a factor in under-vaccination, vaccine hesitancy among healthcare providers remains an underrecognized obstacle to pediatric vaccine completion. The aim of this quality improvement study was to assess provider attitudes and practices regarding vaccine efficacy, safety, adverse effects, and recommendations. To assess for changes in their vaccine confidence, a convenience sample of three physicians and seven advanced practice registered nurses (APRNs) from a pediatric primary care clinic anonymously completed a self-administered survey, participated in an educational intervention, and then completed another survey. All eight providers denied personal vaccine hesitancy. However, one APRN did not fully vaccinate their child due to a medical exemption and another APRN reported concerns about influenza vaccine efficacy. While the mean confidence score for educating vaccine-hesitant parents increased from pre (8.75) to post intervention (9.13), the increase was not statistically significant. The pre-intervention survey affirmed the presence of parental vaccine hesitancy, but not provider vaccine hesitancy. Further study is needed to identify and address provider vaccine hesitancy to improve their vaccine confidence and, ultimately, pediatric vaccine completion.

Influenza Vaccination Coverage, Motivators for, and Barriers to Influenza Vaccination among Healthcare Workers in Wroclaw, Poland.

Background: Influenza vaccination, as a key element of control activities intended to prevent nosocomial influenza transmission, is recommended each year for all healthcare workers (HCWs). The objectives were to determine the rate of influenza vaccination and to identify reasons for receiving or declining the influenza vaccine among HCWs in the 2018/19 and 2019/20 influenza seasons. Methods: This study is a cross-sectional observational study carried out between January and March 2020, in 2 hospitals and 15 primary health-care settings (PHCS) in Wroclaw (Poland). Results: A total of 165 questionnaires were completed. The majority of participating HCWs were female—137 (83.0%), and, by profession, the majority were physicians 92 (55.8%). Influenza vaccination coverage was 61.2% in 2019/20, and 47.9% in the 2018/19 season for all participants. Participants who were male, physicians and personnel from PHCS were more frequently vaccinated in both seasons. According to the statistical analysis, physicians were more likely to receive vaccinations than nurses (p < 0.01), as were HCWs who had been vaccinated in the previous season (p < 0.001). Conclusion: The identified barriers were mainly caused by misconceptions (fear of vaccine adverse effects and perception of not being at risk/no need to get vaccinated) and an organizational barriers (lack of time). These findings may prove useful for designing immunization campaigns to tailor strategies to reach specific groups.

P694 COVID-19 vaccination rate and willingness of an additional dose among inflammatory bowel disease patients receiving biologic therapy

BackgroundVaccination against COVID19 prevents its severe forms and associated mortality and offers a promising action to control this pandemic. In Spain, by October 2021, 87.9% of the target population, including IBD patients had received the complete vaccination regimen. In September 2021, an additional dose of vaccine was approved in patients with immunosuppression including IBD patients on biologic agents. We evaluated the vaccination rate and additional dose willingness in this group of-at risk patients.MethodsA single-center, cross-sectional study was performed among IBD patients on biologic agents and elegibles for an additional dose of COVID19 vaccine between 19th October and 12th November 2021. Patients were identified by the list provided by the Pharmacy service. IBD clinical characteristics and type of vaccine and date of administration were checked in medical records. Acceptance and adverse effects of vaccination were evaluated after telephone or face-to-face survey in these IBD patients.ResultsOut of a total of 344 patients, 269 patients (46.1% male; mean age 47±16 years; crohn′s disease n=198/ ulcerative colitis n=66/ indeterminate colitis n=5) received at least one vaccine dose and were included. The patients were on Infliximab (40.9%), Ustekinumab (29.7%), Adalimumab (20%), and Vedolizumab (8.9%). Co-treatment with immunosuppressors was used in 73.2% of patients. Only 15 (5.6%) patients refused the COVID19 vaccine: 26.7% for fear of vaccine`s adverse effects, 33.3% for doubts about a “new-design” vaccine and 40% for conviction (COVID19 pandemic denial). 46.7% of the cases would not change their opinion, but 33.3% would re-consider after discussing with their doctor and/or receiving information on the adverse effects of the vaccine. Previous to the additional dose, COVID19 vaccination was present in 94.4% of patients (n=254) (complete regimen using Pfizer 63%,Astra-Zeneca 15.4%, Moderna 12.2% and Janssen in 9.4% of patients, respectively). 42.7% of patients personally requested the appointment for initial dose of vaccination and 59.1% contacted the IBD Unit to discuss the decision to be vaccinated. Adverse effects occurred in 53.9% of the cases after the standard vaccination regimen, mainly pain in the arm (40%). Up to 94.1% of the patients agreed for an additional dose and 57.2% had already received the additional dose at the time of the assessment.ConclusionIBD patients on biological agents and at high-risk for COVID19 accept the vaccine as well as an additional dose if recommended. Physicians in charge of IBD units should provide information and confidence in the use of the vaccine in these IBD patients. Remains to be studied the impact of the additional dose of vaccine in these patients.

Using a Machine Learning Approach to Monitor COVID-19 Vaccine Adverse Events (VAE) from Twitter Data.

Social media can be used to monitor the adverse effects of vaccines. The goal of this project is to develop a machine learning and natural language processing approach to identify COVID-19 vaccine adverse events (VAE) from Twitter data. Based on COVID-19 vaccine-related tweets (1 December 2020–1 August 2021), we built a machine learning-based pipeline to identify tweets containing personal experiences with COVID-19 vaccinations and to extract and normalize VAE-related entities, including dose(s); vaccine types (Pfizer, Moderna, and Johnson & Johnson); and symptom(s) from tweets. We further analyzed the extracted VAE data based on the location, time, and frequency. We found that the four most populous states (California, Texas, Florida, and New York) in the US witnessed the most VAE discussions on Twitter. The frequency of Twitter discussions of VAE coincided with the progress of the COVID-19 vaccinations. Sore to touch, fatigue, and headache are the three most common adverse effects of all three COVID-19 vaccines in the US. Our findings demonstrate the feasibility of using social media data to monitor VAEs. To the best of our knowledge, this is the first study to identify COVID-19 vaccine adverse event signals from social media. It can be an excellent supplement to the existing vaccine pharmacovigilance systems.

Adverse effects after first and second dose of covishield and covaxin: A longitudinal study.

COVID-19 vaccines have been rolled out recently in several parts of the world. Although the protective efficacy is frequently discussed, little is known about the factors associated with COVID-19 vaccine adverse effects. The study was conducted with the aim to evaluate the occurrence of adverse events following immunization (AEFI) with two doses of covishield and covaxin and to assess factors associated with these adverse effects. A longitudinal study was conducted for a period of three months in the adults above 18 years of age attending rural health training center (RHTC) either to receive their first or second dose of covishield or covaxin. After vaccination, the participants were observed at the health facility for 30 min for any AEFI and also followed up telephonically on seventh day from vaccination. Data was collected on predesigned and pretested questionnaire and appropriate statistical tests were applied. Out of 532 participants, 250 (47%) came for their first dose while 282 (53%) came for second dose. In both the groups maximum participation was seen by males and those belonging to age group 18-30 years. Majority of the participants reported local tenderness (39.3%) after first dose of covaxin and fever (30.5%) after first dose of covishield. Mainly significant association was observed after vaccination in participants with comorbidities. The short-term adverse events with both the vaccines were observed, but these were mild and short lived. In this context, our study becomes more relevant in disseminating short-term safety data post vaccination. This will help individuals in their decision to accept vaccination.

Fear about adverse effect on fertility is a major cause of COVID-19 vaccine hesitancy in the United States.

Although COVID-19 vaccine access has increased nationwide, vaccination rates have been slow-moving, with many studies showing significant vaccine hesitancy in the U.S. We conducted an online survey using Amazon Mechanical Turk (MTurk) to identify reasons for vaccine hesitancy among unvaccinated adults between June 30 and July 1, 2021. We found that 58% of unvaccinated respondents were worried about unknown long-term adverse effects. Of these, 41% believed that the COVID-19 vaccines can negatively impact reproductive health and or fertility, and 38% were unsure of the effects on fertility. Our study demonstrates that fear regarding COVID-19 vaccine adverse effects and belief that they can negatively impact fertility is a major cause of vaccine hesitancy in the United States. We identified that urban residents, married individuals, those born outside the U.S., those with health insurance, and people with higher education and income greater than $100,000 felt that the vaccine would affect fertility more than their counterparts did. Finally, we found that 48% of unvaccinated respondents cited 'more information and research conducted on the COVID-19 vaccines' as the action that would most encourage vaccine uptake.

Comparative Evaluation of the Adverse Effects of Vaccination against COVID-19 Infection among the Population in Central India

Background: India's Covaxin and Covishield has associate effectiveness rate of 81% preliminary info. Both vaccines have shown excellent safety and efficacy.&#x0D; Objectives: To seek the information about vaccination side effect and Covid-19 infection after getting vaccination.&#x0D; Methodology: We are examining the self-reported vaccination side effect on local and systemic side-effects within 8 to 15 days and covid 19 infections who received one or two doses of the covisheld or a covaxin.&#x0D; Expected Results: The expected results of this study will determine the vaccination adverse-effects of covaxin and covishield with its probability of Covid-19 infection among the dental professionals after getting vaccination in state of Maharashtra.&#x0D; Conclusion: An observational based study in which we have to identify vaccination side effects and infection after administration of both Coronavirus vaccines which are use in India. Both the vaccines area associate effectiveness rate of 81%.

Analysis of COVID-19 Vaccine Type and Adverse Effects Following Vaccination

Little is known about the factors associated with COVID-19 vaccine adverse effects in a real-world population. To evaluate factors potentially associated with participant-reported adverse effects after COVID-19 vaccination. The COVID-19 Citizen Science Study, an online cohort study, includes adults aged 18 years and older with a smartphone or internet access. Participants complete daily, weekly, and monthly surveys on health and COVID-19-related events. This analysis includes participants who provided consent between March 26, 2020, and May 19, 2021, and received at least 1 COVID-19 vaccine dose. Participant-reported COVID-19 vaccination. Participant-reported adverse effects and adverse effect severity. Candidate factors in multivariable logistic regression models included age, sex, race, ethnicity, subjective social status, prior COVID-19 infection, medical conditions, substance use, vaccine dose, and vaccine brand. The 19 586 participants had a median (IQR) age of 54 (38-66) years, and 13 420 (68.8%) were women. Allergic reaction or anaphylaxis was reported in 26 of 8680 participants (0.3%) after 1 dose of the BNT162b2 (Pfizer/BioNTech) or mRNA-1273 (Moderna) vaccine, 27 of 11 141 (0.2%) after 2 doses of the BNT162b2 or mRNA-1273 vaccine or 1 dose of the JNJ-78436735 (Johnson & Johnson) vaccine. The strongest factors associated with adverse effects were vaccine dose (2 doses of BNT162b2 or mRNA-1273 or 1 dose of JNJ-78436735 vs 1 dose of BNT162b2 or mRNA-1273; odds ratio [OR], 3.10; 95% CI, 2.89-3.34; P < .001), vaccine brand (mRNA-1273 vs BNT162b2, OR, 2.00; 95% CI, 1.86-2.15; P < .001; JNJ-78436735 vs BNT162b2: OR, 0.64; 95% CI, 0.52-0.79; P < .001), age (per 10 years: OR, 0.74; 95% CI, 0.72-0.76; P < .001), female sex (OR, 1.65; 95% CI, 1.53-1.78; P < .001), and having had COVID-19 before vaccination (OR, 2.17; 95% CI, 1.77-2.66; P < .001). In this real-world cohort, serious COVID-19 vaccine adverse effects were rare and comparisons across brands could be made, revealing that full vaccination dose, vaccine brand, younger age, female sex, and having had COVID-19 before vaccination were associated with greater odds of adverse effects. Large digital cohort studies may provide a mechanism for independent postmarket surveillance of drugs and devices.

COVID-19 Vaccination: The Voice of Adolescents and Young Adults

Introduction: As a non-priority group for SARS-CoV-2 vaccination, adolescents and young adults (AYA) also deserve the opportunity to participate in a topic that affects them. Aim: AYAs’ knowledge, advantages, fears and opinions related to vaccination are presented. Method: 558 participants aged 16-24 years (M = 19.34 years, SD = 2.266), mostly girls (72%), of Portuguese nationality (93.2%) and university students (60.8%). Results: They believe that vaccination will take time to have an effect (74.7%) and that the use of masks and detachment will last (72.4%). Confident in the protective role of the vaccine, especially for risk groups (81%) and in avoiding further health complications in the event of infection (50.2), they were afraid of the side effects (37.8%). 55.6% believe that the vaccine should be for everyone. Conclusion: We intend to raise awareness among policy-makers about the need to decontruct this group’s fears of the adverse effects of vaccination, including them in this process.

A Systematic Review of the Sex and Gender Reporting in COVID-19 Clinical Trials

Sex and gender have implications for COVID-19 vaccine efficacy and adverse effects from the vaccine. As vaccination is one of the key responses to the COVID-19 pandemic, it is vital that sex and gender differences be acknowledged, measured, and analysed in clinical research. Here, we systematically review published COVID-19 vaccine trials, both interventional and observational, to assess the quality of reporting of sex and gender. Of the 75 clinical trials on COVID-19 vaccines included in this review, only 24% presented their main outcome data disaggregated by sex, and only 13% included any discussion of the implications of their study for women and men. Considering the sex differences in adverse events after vaccination, and the gendered aspects of vaccine hesitancy, these oversights in clinical research on vaccines have implications for recovery from the COVID-19 pandemic and for wider public health.

Safety and Tolerability of Sars-Cov-2 Vaccination and Natural History of Infection Among Patients with Castleman Disease

Castleman Disease (CD) represents a group of rare and heterogeneous hematologic disorders that have common lymph node histopathology. Patients with CD are often immunosuppressed as a consequence of immunemodulating therapy or possibly due to an underlying immunologic dysfunction attributable to B-cell dysfunction. The most severe CD cases experience a cytokine storm disorder, a life-threatening exacerbation of circulating cytokines and immune-cell hyperactivation. Infection with SARS-CoV-2 progresses to a severe cytokine storm in the most severe cases of COVID-19. Interleukin-6 (IL-6) is central to the pathogenesis of CD, and increased IL-6 often accompanies severe COVID-19 cases; inhibition of IL-6 with monoclonal antibodies has been shown to be effective therapy for both CD and severe COVID-19. We therefore sought to understand the impact of COVID-19 infection on the natural history of CD and also examined the safety and tolerability of COVID-19 vaccines in this vulnerable patient population.Patients enrolled in a longitudinal natural history study of CD (N=298) were invited to participate in a survey designed to characterize their experience with COVID-19 disease and vaccination. Surveys were emailed to all eligible patients, and reminders were sent up to 3 times. All data is self-reported; descriptive analyses are reported herein.Of the 298 patients who received a survey, 101 (33.9%) completed it. Sixty-nine (68%) had been tested for SARS-CoV-2 at least once, and 10 (14.5%) reported testing positive - including 6 UCD, 3 iMCD, and 1 HHV8+ MCD patients. The reported prevalence of SARS-CoV-2 infection in the US compares at 10.5%. Two of the 10 patients reported asymptomatic disease (both UCD), 7 reported mild disease (4 UCD, 1 iMCD, 1 HHV8+MCD), and 1 reported moderate disease requiring hospitalization but not a ventilator or intensive care (iMCD). This severity distribution suggests that these potentially immunocompromised patients experience a range of disease severity consistent with SARS-CoV-2 infection in the broader US population. The most commonly-reported symptoms included fevers/chills, headaches, and loss of taste or smell (N=7 each), as well as shortness of breath/difficulty breathing, muscle and body aches, and cough (N=5 each). Rarer symptoms were also noted among the iMCD patients, including discoloration of skin, lips, or nailbeds (N=1) and newfound confusion (N=2). Two of the 10 patients reported stopping siltuximab treatment during their COVID-19 diagnosis; both subsequently resumed treatment. No other treatment changes were reported.Of the 101 respondents, 87 (86%) had received at least 1 vaccine dose. Treatments, such as immunosuppressants and immunomodulators, were paused for 7 of these patients including, during the vaccination period; this was presumably done to increase the likelihood of a robust response to the vaccine. Fifty-one patients (59%) reported side effects to either dose 1 or 2. Side effects were generally mild, and none required hospitalization. Side effects were more commonly reported after dose 2, with the most common being arm pain (N=34), fatigue (N=30), and headache (N=26). Of those who reported not receiving the vaccine, 2 intend to receive it in the future, 5 reported being unsure about receiving it, and 7 do not intend to receive the vaccine. Common concerns include potential interaction with CD (N=9) and limited safety data (N=8).This study represents the first investigation into the experience of CD patients with SARS-CoV-2 testing, diagnosis, and vaccination. We did not observe a markedly increased inflammatory response to SARS-CoV-2 infection, and vaccination was well-tolerated. A limitation is self-selection survey bias; it is possible that those who chose to participate represent those who had a milder reaction in general. However, it is noteworthy that there were no reports of severe disease in this sample. The prevalence of confirmed SARS-CoV-2 infection in this cohort (14.5%) is marginally higher than reported in the US population (10.5%) but statistical comparisons were not performed given that this study does not provide a general epidemiological estimate. However, the distribution of symptoms and vaccine adverse effects in this sample were comparable to the general population. Though additional follow-up is planned for the future, these data are an important basis for understanding the interaction of SARS-CoV-2 and CD. DisclosuresCasper: EUSA Pharma: Consultancy. Fajgenbaum: Pfizer: Other: Study drug for clinical trial of sirolimus; N/A: Other: Holds pending provisional patents for ‘Methods of treating idiopathic multicentric Castleman disease with JAK1/2 inhibition’ and ‘Discovery and validation of a novel subgroup and therapeutic target in idiopathic multicentric Castleman disease’; EUSA Pharma: Research Funding. OffLabel Disclosure:Our abstract makes reference to the following: “Interleukin-6 (IL-6) is central to the pathogenesis of CD, and increased IL-6 often accompanies severe COVID-19 cases; inhibition of IL-6 with monoclonal antibodies has been shown to be effective therapy for both CD and severe COVID-19.” Inhibition of IL-6 with monoclonal antibodies for use in COVID-19 is off-label.