Post COVID-19 vaccination medium vessel vasculitis: a systematic review of case reports.

PURPOSE: Vaccinations are essential in minimizing the effects of global health crises including COVID-19 pandemic. This study investigates the potential association between COVID-19 vaccination and the occurrence of medium vessel vasculitis. METHODS: Several databases were utilized to conduct a comprehensive literature review. The studies were carefully evaluated to ensure their quality and eliminate any potential bias. RESULTS: After reviewing 935 search results and removing duplicates, we selected 10 case reports. We discovered that medium vessel vasculitis may occur after COVID-19 vaccination, typically appearing around 16.2 days after vaccination. The patients in the study had a median age of 43.5 years and were predominantly males (80%). Additionally, half of the cases were reported after the second dose of vaccination. CONCLUSIONS: Vaccination-associated vasculitis is a rare yet possible complication of COVID-19 vaccination and lacks a clear treatment protocol.

Vaccine-Induced Functional Neurological Disorders in the Covid-19 Era.

The large amount of information available to the public regarding vaccines against Covid-19 coupled with pandemic stress and increased somatic attention could potentially precipitate development of functional neurological disorders (FNDs) following vaccination. A growing number of reports indicate that functional symptoms may follow Covid-19 vaccination, similar to those observed with other vaccines previously. We review previously reported cases of FND following vaccination against Covid-19 and present three additional cases. While two patients presented to the Emergency Department with functional movement disorders, one patient presented with protracted limb weakness and sensory dysfunction. The superficial resemblance to Guillain-Barré syndrome, a known but uncommon complication of vaccination prompted an extensive workup. Clinicians need to convey the diagnosis of FND in clear and unequivocal terms to facilitate institution of appropriate therapy and rehabilitation, but importantly also to dispel any doubts in the minds of the public regarding the safety of the available vaccines. Given the presence of significant vaccine hesitancy in many countries, this is critical to the success of the global immunisation effort.

A prospective cohort study protocol: monitoring and surveillance of adverse events following heterologous booster doses of Oxford AstraZeneca COVID-19 vaccine in previous recipients of two doses of Sinopharm or Sputnik V vaccines in Iran.

BACKGROUND: Regarding the paucity of evidence on the side effects of the booster dose of Oxford AstraZeneca vaccine in vaccinated people with Sinopharm or Sputnik V, we aimed to set up a cohort event monitoring (CEM) study to capture adverse events occurring in individuals who will receive the booster doses of AstraZeneca (either the first or second booster dose) following being vaccinated with Sinopharm or sputnik V vaccines in Iran. METHODS: The present study is an active COVID-19 vaccine safety surveillance through an observational prospective cohort study that will be conducted in vaccination centers in Iran. The study will be conducted in twelve provinces of Iran. Study sites are vaccination centers where the AstraZeneca vaccine is administered to the cohort population. The study population includes all individuals who have received two doses of Sinopharm or Sputnik V vaccines and either the first or second booster dose of AstraZeneca according to the national guidelines for immunization in Iran in 2023. We are planning to include 30,000 eligible people in this study. Each individual will be followed up for 13 weeks after either the first or second booster dose of the AstraZeneca vaccine. Furthermore, convenience sampling is used to include participants in the present study. Participation in the study will be strictly voluntary. DISCUSSION: With the planned study we will provide a valid epidemiological evidence to improve the understanding of the safety of the booster dose of the AstraZeneca and to better evaluate the effectiveness of public health interventions. This could help policy makers in managing the COVID-19 pandemic according to scientific evidence.

Antibody response to Covid-19 vaccine (AstraZeneca) amongst Healthcare Workers in a Tertiary Hospital in Nigeria.

BACKGROUND: With no known cure, accelerated development of vaccines became pertinent to contain the COVID-19 pandemic. OBJECTIVES: To assess the IgG antibody response to the viral spike protein and determinants of developing IgG antibodies after vaccination with two doses of the AstraZeneca vaccine. METHODS: This was a prospective cohort study amongst healthcare workers. Serum samples were obtained before vaccination and at 4 and 12 weeks after the first and second doses of the vaccine respectively. Qualitatively testing for the presence of IgG antibodies to the viral spike protein was conducted using the Vidas SARS-CoV-2 IgG and IgM analyser while IgG antibodies were quantitatively assessed by antibody titre estimation using a stepwise two-fold serial dilution method. RESULTS: A total of 155 subjects between the ages of 25 to 64 years were studied. 85 (54.8%) had positive anti-spike IgG antibodies before vaccination. Out of the remaining 70 subjects, 87.3% and subsequently 96.2% developed IgG antibodies to the viral spike protein 4 and 8 weeks after the first and second doses of the vaccine respectively. The AstraZeneca vaccine was found to stimulate antibody response more than natural infection. Prior positive IgG antibodies from natural infection was found to boost antibody response to vaccination. The antibody titre levels rose with vaccination but waned overtime after the second dose of the vaccine. CONCLUSION: The AstraZeneca COVID-19 vaccine elicits an immunogenic IgG antibody response that is augmented by prior infection but however declines a few weeks after the second dose of the vaccine. CONTEXTE: En l'absence de remède connu, le développement accéléré de vaccins est devenu pertinent pour contenir la pandémie de COVID-19. OBJECTIFS: Évaluer la réponse des anticorps IgG à la protéine de pointe virale après vaccination avec deux doses du vaccin AstraZeneca. MÉTHODES: Il s'agissait d'une étude de cohorte prospective parmi les travailleurs de la santé. Des échantillons de sérum ont été obtenus avant la vaccination et à 4 et 12 semaines après la premier et la deuxième doses du vaccin respectivement. Des tests qualitatifs pour la présence d'anticorps IgG dirigés contre la protéine de pointe virale ont été effectués à l'aide de l'analyseur Vidas SARS-CoV-2 IgG et IgM, tandis que les anticorps IgG ont été évalués quantitativement par estimation du titre d'anticorps à l'aide d'une méthode de dilution en série en deux étapes. RÉSULTATS: Au total, 155 sujets âgés de 25 à 64 ans ont été étudiés. 85 (54,8 %) avaient des anticorps IgG anti-pic positifs avant la vaccination. Sur les 70 sujets restants, 87,3 % puis 96,2 % ont développé des anticorps IgG contre la protéine de pointe virale 4 et 8 semaines après la première et la deuxième doses du vaccin respectivement. Le vaccin AstraZeneca s'est avéré stimuler la réponse anticorps plus que l'infection naturelle. Des anticorps IgG antérieurement positifs d'une infection naturelle ont été trouvés pour stimuler la réponse des anticorps à la vaccination. Les niveaux de titre d'anticorps ont augmenté avec la vaccination mais ont cependant diminué avec le temps après la deuxième dose du vaccin. CONCLUSIONS: Le vaccinAstraZeneca COVID-19 suscite une réponse immunogène en anticorps IgG qui est augmentée par une infection antérieure mais qui décline cependant quelques semaines après la deuxième dose du vaccin. Mots clés: COVID-19, Travailleurs de la santé, Vaccination, vaccin AstraZeneca, Immunogène, Anticorps, réponse d'anticorps, Titre d'anticorps.

A study on seroconversion following first & second doses of ChAdOx1 nCoV-19 vaccine in Central Kerala.

Background & objectives: Vaccination against COVID-19 induces spike protein-binding IgG antibodies, a robust correlate of protection against COVID-19. This study was undertaken to assess the humoral response after completion of both the doses of ChAdOx1 nCoV vaccine in healthcare workers (HCWs) at a tertiary care health centre in India. Methods: A cross-sectional COVID-19 vaccine-induced antibody study was conducted among HCWs. IgG antibodies against spike protein were measured at least 28 days after the first dose and the second dose of vaccination in both SARS CoV-2 naïve and recovered HCWs. Mean and median antibody titre following each dose of vaccine and its association with age, gender, co-morbidities and factors such as exercise, stress and sleep deprivation were also explored. Results: Among the 200 vaccine recipients, 91.5 per cent showed seroconversion after the first dose and 99.5 per cent after the second dose. The mean titre after the second dose was significantly higher when compared to the first dose (12.68±4.17 vs. 9.83±6.3, P=0.001). More than half (54%) had high antibody titre ≥12 S/Co (Signal/cut-off). Previous COVID-19 infection was the single most important factor influencing antibody production, where the mean titre just after a single dose [mean-17.81±5.94, median-20.5 (interquartile range [IQR]-3.7)] surpassed the titre after the second dose in SARS CoV-2 naïve individuals [mean-12.29±4.00, median-12.8 (IQR-3.7), P=0.001]. Furthermore, 28 per cent of vaccinees showed a reduction in titre after the second dose. The mean fall in titre was 2.25±1.40 and was more pronounced in males, the younger age group and those with previous COVID-19 infection. Interpretation & conclusions: ChAdOx1 nCov-19 vaccine after two doses elicited an excellent immune response. However, greater immunogenicity after the first dose was seen among those with previous COVID-19 infection, even surpassing the titre achieved by the second dose of vaccine in SARS CoV-2 naïve recipients. A fall in antibody titre after the second dose is a matter of concern and requires further studies.

A public health perspective on the responsibility of mass media for the outcome of the anti-COVID-19 vaccination campaign: the AstraZeneca case.

Abstract: On February 9, 2021, the Italian Ministry of Health made the "Covid-19 vaccine AstraZeneca" (now "Vaxzevria") available for use in the anti-COVID-19 vaccination campaign. However, in early March, the media reported that five people died a few days after receiving the vaccine. The reaction among both those already vaccinated and the vaccine candidates was one of near panic. The subsequent events have had long-lasting consequences, as 10-20% of vaccine candidates have since refused vaccination with the AstraZeneca vac-cine, so in addition to the delay in vaccination, ~200,000 doses of it were not administered. The goal of the vaccination campaign in Italy, when operating at full capacity, was to administer 500,000 doses per day, for a total of 3,500,000 doses per week. In this large amount of people, it is statistically certain that a certain number of subjects will develop non-vaccine related health problems or even die from causes unrelated to having been vaccinated. At this time in history, press reports must be inspired by a strong sense of responsibility and awareness of the potential consequences of misinformation; this is particularly true, especially because also the social media get inevitably involved.

Vaccination trials on hold: malicious and low credibility content on Twitter during the AstraZeneca COVID-19 vaccine development.

The development of COVID-19 vaccines during the global pandemic that started in 2020 was marked by uncertainty and misinformation reflected also on social media. This paper provides a quantitative evaluation of the Uniform Resource Locators (URLs) shared on Twitter around the clinical trials of the AstraZeneca vaccine and their temporary interruption in September 2020. We analyzed URLs cited in Twitter messages before and after the temporary interruption of the vaccine development on September 9, 2020 to investigate the presence of low credibility and malicious information. We show that the halt of the AstraZeneca clinical trials prompted tweets that cast doubt, fear and vaccine opposition. We discovered a strong presence of URLs from low credibility or malicious websites, as classified by independent fact-checking organizations or identified by web hosting infrastructure features. Moreover, we identified what appears to be coordinated operations to artificially promote some of these URLs hosted on malicious websites.

Perspectives on vaccine induced thrombotic thrombocytopenia.

As the novel SARS-CoV-2 continues to infect numerous individuals worldwide, one of the leading approaches in dealing with the global health crisis is vaccination against the COVID-19. Due to recent reports, vaccination with ChAdOx1 nCov-19 (developed by Oxford and AstraZeneca) may result in a vaccine-induced catastrophic thrombotic thrombocytopenia disorder. Thus, as of March 16 of 2021, vaccination programs in 18 countries had been suspended until further examination, including Sweden, Germany and France. This disorder presents as extensive thrombosis in atypical sites, primarily in the cerebral venous, alongside thrombocytopenia and the production of autoantibody against platelet-factor 4 (PF4). PF4 autoantibody has the ability to binds the human FcRγIIA receptor of platelets and contribute to their aggregation. This rare adverse effect extremely resembles the clinical presentation of the classical immune-mediated HIT disorder, which occurs following exposure to heparin. Surprisingly, none of these patients had been pre-exposed to heparin before disease onset, leading to the hypothesis that a viral antigen from the vaccine had triggered the response. Importantly, COVID-19 had been associated with numerous autoimmune manifestations, including the production of pathogenic autoantibodies, new onset of autoimmune diseases and disorders. As the ChAdOx1 nCov-19 vaccination leads to the synthesis of specific SARS-CoV-2-proteins, they may trigger a production of PF4 autoantibody though molecular mimicry phenomena, while vaccination compounds lead to a rigorous bystander activation of immune cells. If existing, removing such homological sequences from the vaccine may eliminate this phenomenon. In contrast, it needs to be emphasized that the ChAdOx1 nCoV-19 vaccine was found to be safe and efficacious against symptomatic COVID-19 in randomized controlled trials, which included 23,848 participants from the UK, Brazil and South Africa.

Safety of COVID-19 vaccines.

This study is aimed to identify the adverse effects associated with three types of coronavirus disease 2019 vaccines. Approximately 1736 individuals agreed to participate in this study. The participants involved in the study were individuals who had received the first dose or full course (two doses) of the vaccine at least 30 days before the survey. A direct and interactive web-based system interview with a paper and electronic version of the questionnaire was used for all participants. A total of 1736 randomized individuals were identified. The reactogenicity of the vaccines including pain, redness, urticaria, and swelling at the site of the injection was reported in 34.56% of the participants. Local site reaction was reported in more individuals who had Pfizer and AstraZeneca vaccines than those who received the Sinopharm vaccine. The systemic events were more common with AstraZeneca and Pfizer vaccines, symptoms reported were fatigue, body pain, headache, muscle pain, fever, and gastrointestinal side effects. There were no correlations between age or gender, and the duration of the adverse effects for the three vaccines. Swelling and severe allergic reaction of the eyelids, severe hypotension, generalized body aches, shortness of breath, weakness and numbness on the injected arm, acute hyperglycemia, severe chest pain, and fever more than 39°C were among the unusual signs and symptoms reported by the participants. Pfizer, AstraZeneca, and Sinopharm vaccines were found to be safe and Sinopharm vaccine showed a lower prevalence of adverse effects compared with the other vaccines. The duration and severity of adverse effects were not affected by age or gender. Unusual side effects should be closely monitored to establish determine they are linked to the immunization.

COVID-19 vaccine-associated immune thrombosis and thrombocytopenia (VITT): Diagnostic and therapeutic recommendations for a new syndrome.

Very rare cases of thrombosis associated with thrombocytopenia have occurred following the vaccination with AstraZeneca COVID-19 vaccine. The aim of this concise review is to summarize the current knowledge on the epidemiologic and pathogenic mechanisms of this syndrome named vaccine-associated immune thrombosis and thrombocytopenia (VITT). A practical patient management section will also be dealt with using information available from national and international scientific societies as well as expert panels. A literature search on the VITT syndrome was carried out in PubMed using appropriate MeSH headings. Overall, 40 VITT cases have been reported. Continuous pharmacovigilance monitoring is needed to collect more data on the real incidence and the pathogenesis of VITT syndrome. Such information will also help us to optimize the management this rare but often clinically severe thrombotic condition associated with COVID-19 vaccination.

Oxford-AstraZeneca COVID-19 vaccine: need of a reasoned and effective vaccine campaign.

OBJECTIVES: A strong COVID-19 vaccine campaign is needed to reach the herd immunity and reduce this pandemic infection. STUDY DESIGN: In the Foch Hospital, France, in February 2021, 451 healthcare workers were vaccinated by a first dose of AstraZeneca vaccine. METHODS: Adverse effects were reported to our pharmaco-vigilance circuit, by an online and anonymous questionnaire following the first weeks of the vaccinal campaign to healthcare workers. RESULTS: Two hundred seventy-four (60.8%) of them reported multiple adverse effects. Main adverse effects reported were feverish state/chills (65.7%), fatigue/physical discomfort (62.4%), arthralgia/muscle pain (61.0%) and fever (44.5%). CONCLUSIONS: On March 2021 many European countries suspended AstraZeneca vaccine for one week due to safety uncertainty. Thus, confidence in its efficacy is undermined. However, the benefit/risk balance is clearly in favor of vaccination.

Immunogenicity and adverse events of the COVID-19 vaccines in healthy and individuals with autoimmune diseases in an Iranian population.

Introduction: Recent studies have proposed various COVID-19 vaccines to control the disease and protect susceptible individuals. However, immunogenicity and safety of COVID-19 vaccines in various populations are not well identified yet. Therefore, this study aimed to elucidate the efficacy and safety of the BBIBP-CorV (Sinopharm) and ChAdOx1 nCoV-19 (Oxford-AstraZeneca) vaccines in healthy subjects and patients with autoimmune diseases.Methods: Study population included 121 healthy subjects and 100 patients with autoimmune diseases. Immunization was performed based on the national vaccination protocols. Of the 221 volunteers, 201 subjects received Sinopharm and 20 cases were vaccinated with Oxford-AstraZeneca. During a 1-year follow-up, the immunogenicity was measured by ELISA before primary vaccination and 1 to 3 months after secondary immunization. Side effects were studied before entering the study and 1 week after the second dose.Results: Vaccination had a positive impact on the induction of immunogenic response (p < .0001). The rates of seropositive vaccine responses were 80% and 75% in subjects vaccinated with the Sinopharm and Oxford-AstraZeneca, respectively. The neutralizing antibody values were significantly higher in subjects with autoimmune diseases than those without autoimmunity (p < .05). The rate of adverse events were 38% and 42% in subjects vaccinated with the Sinopharm and Oxford-AstraZeneca, respectively. The rates of immunogenic responses induced with the Sinopharm and Oxford-AstraZeneca were, respectively, 76% and 81.5% in seropositive subjects, while they were 63.8% and 79.1% in seronegative subjects vaccinated with the Sinopharm and Oxford-AstraZeneca, respectively. Individuals previously infected with SARS-CoV-2 showed a significant reduction in the value of SARS-CoV-2 neutralizing antibodies compared with seronegative subjects (p < .01-.05). Seropositive individuals vaccinated with the Sinopharm had significantly higher the percentages of vaccine-related adverse events than seronegative persons (p < .05). There was no significant difference between seronegative and seropositive individuals vaccinated with the Oxford-AstraZeneca.Conclusion: Our findings revealed that the Sinopharm and Oxford-AstraZeneca vaccines are effective in the production of neutralizing antibodies in healthy subjects and patients with autoimmune disorders undergoing immunosuppressive therapies without considerable reactogenicity.

Short-term COVID-19 vaccine adverse effects among adults in Ekiti State, Nigeria.

BACKGROUND: The safety of the COVID-19 vaccines has been a topic of concern globally. This issue of safety is associated with vaccine hesitancy due to concerns about the adverse effects of the vaccines. Consequently, this study determined the short-term safety profile of the Oxford/AstraZeneca COVID-19 vaccine in Ekiti State, Nigeria. METHODS: Descriptive cross-sectional study conducted between May and July 2021 among individuals who had received the first dose of the first batch of the Oxford/AstraZeneca COVID-19 vaccine at Ekiti State University Teaching Hospital (EKSUTH), Ado-Ekiti, Nigeria. A Google form was used to collect data on the adverse effects of the vaccine. RESULTS: Out of over 1,000 individuals who were approached, 758 respondents completed the study. A large percentage (57.4%) of those who received the vaccines were healthcare workers. Adverse effects were reported in 70.8% of the participants with most manifesting on the first day of the vaccination. The predominant adverse effects were injection site soreness (28.5%), followed by fatigue (18.7%) and muscle pain (8.6%). There was no report of severe adverse effects such as anaphylactic reactions, thrombosis, myocarditis, transient myelitis, or Guillen-Barre syndrome. CONCLUSION: This study found that self-reported adverse effects of the Oxford/AstraZeneca COVID-19 vaccine were mild and short in duration. This outcome has promising implications for improving COVID-19 vaccine uptake in the immediate environment and Nigeria.

Lower Motor Neuron Facial Palsy Following COVID-19 Infection and COVID-19 AZD1222 Vaxzervria (AstraZeneca) Vaccine Administration: Two Case Reports.

Bell's palsy is a lower motor neuron lesion rarely associated with COVID-19 infection or vaccinations. We documented two cases of Bell's palsy in this report, one after contracting COVID-19 infection and the other after administration of AZD1222 Vaxzervria (AstraZeneca) Vaccine. After excluding all possible causes of Bell's palsy in both cases, we determined that COVID-19 infection and the AZD1222 Vaxzervria (AstraZeneca) vaccine were the causes. Thus, we believe COVID-19 and the AZD1222 Vaxzervria (AstraZeneca) vaccine should be considered as causes of Bell's palsy.

Pityriasis Rosea Eruption Following the Administration of Oxford-AstraZeneca Vaccine.

The coronavirus disease 2019 (COVID-19) infection has led to accelerated development and utilization of vaccines to prevent its implications on health. One of these vaccines is a vector-based, Oxford-AstraZeneca Vaccine (AZD1222). Frequently reported side effects are related to host-immune response. While dermatologic manifestation is peculiar in nature and denotes a serious eruption that might defer future vaccination. Herein, we present a case of a medically free 37-year-old female who developed clinical and histological evidence of pityriasis rosea (PR) after administration of a second-dose vaccination of AZD1222. The first dose of vaccination was administered as Pfizer BioNTech COVID-19 mRNA (BNT162b2) vaccine. This case is unique in nature as this patient developed AZD1222-induced PR, while some reports in the literature have linked PR to the BNT162b2 vaccine. This patient continued to receive a booster vaccination with BNT162b2 with no reportable side effects.

Post-COVID-19 Vaccination Infection Among Adults in Saudi Arabia: A Cross-Sectional Study.

BACKGROUND: While vaccines were one of the most effective tools to combat the COVID-19 pandemic, breakthrough infections have been reported. AIM OF THE WORK: We aim to evaluate the effectiveness of Pfizer and AstraZeneca vaccines in preventing breakthrough infection, as well as to determine the possible risk factors and outcomes of post-vaccination infection. METHODS: This is a cross-sectional study using self-reported data of adult Saudi residents, including Saudi and non-Saudi people who received at least two doses of either Pfizer or AstraZeneca vaccines. Based on the presence of COVID-19 symptoms that were confirmed by PCR, the participants were classified into three groups: (1) those with evidence of infection before vaccination, (2) those who had infection after vaccination, and (3) those who had infection before and after vaccination. For further evaluation, we compared the severity and outcomes in the participants who were infected before and after vaccination. RESULTS: The study included 694 participants: 69.1% received three doses of the vaccine, and 71.1% of them were vaccinated with the Pfizer vaccine. COVID-19 infection was reported in 48.3% of the total subjects, with a higher infection rate (17.8%) after vaccination compared to 12.5% before vaccination. Additionally, 18.32% of participants experienced infection both before and after vaccination. Out of the total 694 participants, 137 (19.7%) had breakthrough infections. Pfizer vaccine was more prevalent among the non-infected group (74.25% vs. 65.5%), while AstraZeneca vaccine was more prevalent among the infected group (6.4% vs. 5.9% (p<0.039). Diabetes was significantly higher among the infected group (16.9% vs. 8.1%, p=0.001, OR=2.29, 95% CI=1.42-3.68). Among those who were infected before and after vaccination, 71.9% reported less severe symptoms after vaccination. CONCLUSION: Breakthrough infections may occur after vaccination; however, vaccines are overall effective in preventing severe symptoms. Pfizer vaccine appeared to be more effective in preventing COVID-19 infection. The presence of comorbidities, including diabetes, may increase the risk of infection.

Vaccine efficacy against SARS-CoV-2 for Pfizer BioNTech, Moderna, and AstraZeneca vaccines: a systematic review.

The purpose of this systematic review was to report on the vaccine efficacy (VE) of three SARS-CoV-2 vaccines approved by Health Canada: Pfizer BioNTech, Moderna, and AstraZeneca. Four databases were searched for primary publications on population-level VE. Ninety-two publications matched the inclusion criteria, and the extracted data were separated by vaccine type: mRNA vaccines (Pfizer and Moderna) and the AstraZeneca vaccine. The median VE for PCR-positive patients and various levels of clinical disease was determined for the first and second doses of both vaccine types against multiple SARS-CoV-2 variants. The median VE for PCR-positive infections against unidentified variants from an mRNA vaccine was 64.5 and 89%, respectively, after one or two doses. The median VE for PCR-positive infections against unidentified variants from the AstraZeneca vaccine was 53.4 and 69.6%, respectively, after one or two doses. The median VE for two doses of mRNA for asymptomatic, symptomatic, and severe infection against unidentified variants was 85.5, 93.2, and 92.2%, respectively. The median VE for two doses of AstraZeneca for asymptomatic, symptomatic, and severe infection against unidentified variants was 69.7, 71, and 90.2%, respectively. Vaccine efficacy numerically increased from the first to the second dose, increased from the first 2 weeks to the second 2 weeks post-vaccination for both doses, but decreased after 4 months from the second dose. Vaccine efficacy did not differ by person's age.