Editorial

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5 pages, 184 KiB

Open AccessEditorial

SARS-CoV-2 Vaccine Safety and Autoimmune Response

by Yu-Chang Tyan, Shih-Chang Chuang, Tzu-Chuan Ho, Kuo-Pin Chuang and Ming-Hui Yang

Vaccines 2024, 12(3), 334; https://doi.org/10.3390/vaccines12030334 - 20 Mar 2024

Viewed by 854

Abstract

Coronavirus disease 2019 (COVID-19) is a global public health crisis [...] Full article

(This article belongs to the Special Issue Safety and Autoimmune Response to SARS-CoV-2 Vaccination)

Research

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15 pages, 1469 KiB

Open AccessArticle

Occurrence and Risk Factors of Relapse Activity after Vaccination against COVID-19 in People with Multiple Sclerosis: 1-Year Follow-Up Results from a Nationwide Longitudinal Observational Study

by Firas Fneish, Niklas Frahm, Melanie Peters, David Ellenberger, Judith Haas, Micha Löbermann, Dieter Pöhlau, Anna-Lena Röper, Sarah Schilling, Alexander Stahmann, Herbert Temmes, Friedemann Paul and Uwe K. Zettl

Vaccines 2023, 11(12), 1859; https://doi.org/10.3390/vaccines11121859 - 16 Dec 2023

Viewed by 1408

Abstract

Several studies reported post-SARS-CoV-2-vaccination (PV) symptoms. Even people with multiple sclerosis (PwMS) have concerns about disease activity following the SARS-CoV-2 vaccination. We aimed to determine the proportion of PwMS with PV relapses, the PV annualized relapse rate (ARR), the time from vaccination to [...] Read more.

Several studies reported post-SARS-CoV-2-vaccination (PV) symptoms. Even people with multiple sclerosis (PwMS) have concerns about disease activity following the SARS-CoV-2 vaccination. We aimed to determine the proportion of PwMS with PV relapses, the PV annualized relapse rate (ARR), the time from vaccination to subsequent relapses, and identify sociodemographic/clinical risk factors for PV relapses. PwMS were surveyed several times at baseline and four follow-ups as part of a longitudinal observational study regarding the safety and tolerability of the SARS-CoV-2 vaccination. The inclusion criteria for this analysis were age ≥18 years, ≥1 SARS-CoV-2 vaccination, and ≥1-year observation period since initial vaccination. Of 2466 PwMS, 13.8% reported PV relapses (mostly after second [N = 147] or booster vaccination [N = 145]) at a median of 8.0 (first/third quantile: 3.55/18.1) weeks PV, with the shortest period following initial vaccination (3.95 weeks). The ARR was 0.153 (95% confidence interval: 0.138–0.168), with a median observation period since initial vaccination of 1.2 years. Risk factors for PV relapses were younger age, female gender, moderate-severe disability levels, concurrent autoimmune diseases, relapsing-remitting MS courses, no DMT, and relapses within the year prior to the first vaccination. Patients’ health conditions before/during initial vaccination may play a more important role in PV relapse occurrence than vaccination per se. Full article

(This article belongs to the Special Issue Safety and Autoimmune Response to SARS-CoV-2 Vaccination)

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12 pages, 1135 KiB

Open AccessArticle

Longitudinal Profiles of Anti-Platelet Factor 4 Antibodies in Thai People Who Received ChAdOx1 nCoV-19 Vaccination

by Nonthakorn Hantrakun, Peampost Sinsakolwat, Adisak Tantiworawit, Ekarat Rattarittamrong, Thanawat Rattanathammethee, Sasinee Hantrakool, Pokpong Piriyakhuntorn, Teerachat Punnachet, Piangrawee Niprapan, Ornkamon Wongtagan, Romanee Chaiwarith, Lalita Norasetthada and Chatree Chai-Adisaksopha

Vaccines 2023, 11(3), 692; https://doi.org/10.3390/vaccines11030692 - 17 Mar 2023

Cited by 2 | Viewed by 1349

Abstract

Anti-platelet factor 4 (anti-PF4) antibodies were identified as pathogenic antibodies for vaccine-induced immune thrombocytopenia and thrombosis (VITT) in subjects receiving ChAdOx1 nCoV-19 vaccinations. We performed a prospective cohort study to determine the prevalence of anti-PF4 and the effect of the ChAdOx1 nCoV-19 vaccine [...] Read more.

Anti-platelet factor 4 (anti-PF4) antibodies were identified as pathogenic antibodies for vaccine-induced immune thrombocytopenia and thrombosis (VITT) in subjects receiving ChAdOx1 nCoV-19 vaccinations. We performed a prospective cohort study to determine the prevalence of anti-PF4 and the effect of the ChAdOx1 nCoV-19 vaccine on anti-PF4 in healthy Thai subjects. Anti-PF4 antibodies were measured before and four weeks after receiving the first vaccination. Participants with detectable antibodies were scheduled for repeat anti-PF4 analysis at 12 weeks after the second vaccination. Of 396 participants, ten participants (2.53%; 95% confidence interval [CI], 1.22–4.59) were positive for anti-PF4 before receiving vaccinations. Twelve people (3.03%; 95% CI, 1.58–5.23) had detectable anti-PF4 after the first vaccination. There was no difference in the optical density (OD) values of anti-PF4 antibodies when comparisons were made between pre-vaccination and four weeks after the first vaccination (p = 0.0779). There was also no significant difference in OD values in participants with detectable antibodies. No subjects experienced thrombotic complications. Pain at the injection site was associated with an increased risk of being anti-PF4 positive at an odds ratio of 3.44 (95% CI, 1.06–11.18). To conclude, the prevalence of anti-PF4 was low in Thais and did not significantly change over time. Full article

(This article belongs to the Special Issue Safety and Autoimmune Response to SARS-CoV-2 Vaccination)

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10 pages, 252 KiB

Open AccessArticle

Adverse Effects of Pfizer (BioNTech), Oxford-AstraZeneca (ChAdOx1 CoV-19), and Moderna COVID-19 Vaccines among the Adult Population in Saudi Arabia: A Cross-Sectional Study

by Jehad Aldali, Sultan Ayoub Meo and Thamir Al-Khlaiwi

Vaccines 2023, 11(2), 231; https://doi.org/10.3390/vaccines11020231 - 20 Jan 2023

Cited by 7 | Viewed by 2054

Abstract

The Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) outbreak has caused massive damage to the global healthcare system and economy. To compete with the SARS-COV-2 pandemic, several vaccines have been proposed to immunize the population. The present study aimed to investigate the adverse effects [...] Read more.

The Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) outbreak has caused massive damage to the global healthcare system and economy. To compete with the SARS-COV-2 pandemic, several vaccines have been proposed to immunize the population. The present study aimed to investigate the adverse effects following the three doses of COVID-19 vaccination, Pfizer (BioNTech), (Oxford-AstraZeneca (ChAdOx1 CoV-19), and Moderna among the adult population in the Eastern province of Saudi Arabia. In this study, the total number of participants were 426, among them 277 (65%) were females and 149 (35%) were males. An online survey using Google forms in the English language and translated into the Arabic language was used to record the information. The questionnaire was distributed to participants who received either Pfizer-BioNTech, Oxford-AstraZeneca or Moderna vaccines. The general characteristics of participants were obtained, alongside an evaluation of the vaccination’s adverse effects. The results revealed that Pfizer-BioNTech COVID-19 vaccines caused significantly less adverse effects than Oxford–AstraZeneca (ChAdOx1) and Moderna (p < 0.001), and females experienced more adverse effects after vaccination compared to males. Injection site pain was the most common adverse event among the participants (60.6%), followed by fatigue, headache, and pain (43.9%), muscle and joint pain (32.4%), increased body temperature and shivering (24.2%). In addition, the group of individuals under the age of sixty was more likely to experience side effects than the participants with other age groups. All three vaccines, Pfizer-BioNTech, Oxford–AstraZeneca (ChAdOx1 CoV-19) and Moderna, cause post-vaccinal adverse effects; however, Moderna and Oxford–AstraZeneca (ChAdOx1) causes adverse effects more frequently than the Pfizer-BioNTech. Full article

(This article belongs to the Special Issue Safety and Autoimmune Response to SARS-CoV-2 Vaccination)

15 pages, 533 KiB

Open AccessArticle

Safety of Four COVID-19 Vaccines across Primary Doses 1, 2, 3 and Booster: A Prospective Cohort Study of Australian Community Pharmacy Vaccinations

by Sandra M. Salter, Dani Li, Kevin Trentino, Lisa Nissen, Kenneth Lee, Karin Orlemann, Ian Peters, Kevin Murray, Alan Leeb and Lucy Deng

Vaccines 2022, 10(12), 2017; https://doi.org/10.3390/vaccines10122017 - 25 Nov 2022

Cited by 2 | Viewed by 2131

Abstract

Four COVID-19 vaccines are approved for use in Australia: Pfizer-BioNTech BNT162b2 (Comirnaty), AstraZeneca ChAdOx1 (Vaxzevria), Moderna mRNA-1273 (Spikevax) and Novavax NVX-CoV2373 (Nuvaxovid). We sought to examine adverse events following immunisation (AEFI) at days 3 and 42 after primary doses 1, 2, 3 and [...] Read more.

Four COVID-19 vaccines are approved for use in Australia: Pfizer-BioNTech BNT162b2 (Comirnaty), AstraZeneca ChAdOx1 (Vaxzevria), Moderna mRNA-1273 (Spikevax) and Novavax NVX-CoV2373 (Nuvaxovid). We sought to examine adverse events following immunisation (AEFI) at days 3 and 42 after primary doses 1, 2, 3 and booster. We conducted active vaccine safety surveillance from 130 community pharmacies in Australia integrated with AusVaxSafety, between August 2021–April 2022. Main outcomes: AEFI at 0–3 days post-vaccination; medical review/advice at 3 days and 42 days post-vaccination; SARS-CoV-2 breakthrough infection by day 42. Of 110,024 completed day 3 surveys (43.6% response rate), 50,367 (45.8%) reported any AEFI (highest proportions: Pfizer 42%, primary dose 3; AstraZeneca 58.3%, primary dose 1; Moderna 65.4% and Novavax 58.8%, both primary dose 2). The most common AEFI reported across all doses/vaccines were local reactions, systemic aches and fatigue/tiredness. Overall, 2172/110,024 (2.0%) and 1182/55,329 (2.1%) respondents sought medical review at days 3 and 42, respectively, and 931/42,318 (2.2%) reported breakthrough SARS-CoV-2 infection at day 42. We identified similar AEFI profiles but at lower proportions than previously reported for Pfizer, AstraZeneca, Moderna and Novavax COVID-19 vaccines. Moderna vaccine was the most reactogenic and associated with higher AEFI proportions across primary doses 2, 3, and booster. Full article

(This article belongs to the Special Issue Safety and Autoimmune Response to SARS-CoV-2 Vaccination)

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9 pages, 407 KiB

Open AccessArticle

A Rare Adverse Effect of the COVID-19 Vaccine on Autoimmune Encephalitis

by Ying-Fong Huang, Tzu-Chuan Ho, Chin-Chuan Chang, Daniel Hueng-Yuan Shen, Hung-Pin Chan, Kuo-Pin Chuang, Yu-Chang Tyan and Ming-Hui Yang

Vaccines 2022, 10(7), 1114; https://doi.org/10.3390/vaccines10071114 - 13 Jul 2022

Cited by 9 | Viewed by 3617

Abstract

Since countries commenced COVID-19 vaccination around the world, many vaccine-related adverse effects have been reported. Among them, short-term memory loss with autoimmune encephalitis (AE) was reported as a rare adverse effect. Since case numbers are limited, this brief report may draw the attention [...] Read more.

Since countries commenced COVID-19 vaccination around the world, many vaccine-related adverse effects have been reported. Among them, short-term memory loss with autoimmune encephalitis (AE) was reported as a rare adverse effect. Since case numbers are limited, this brief report may draw the attention of the medical community to this uncommon adverse effect and serve as a reference for future vaccine improvement. However, given the high risk of adverse outcomes when infected with SARS-CoV-2 and the clearly favorable safety/tolerability profile of existing vaccines, vaccination is still recommended. Full article

(This article belongs to the Special Issue Safety and Autoimmune Response to SARS-CoV-2 Vaccination)

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Review

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17 pages, 1358 KiB

Open AccessReview

Adverse Hematological Effects of COVID-19 Vaccination and Pathomechanisms of Low Acquired Immunity in Patients with Hematological Malignancies

by Armand N. Yazdani, Nathaniel DeMarco, Parth Patel, Arian Abdi, Prathosh Velpuri, Devendra K. Agrawal and Vikrant Rai

Vaccines 2023, 11(3), 662; https://doi.org/10.3390/vaccines11030662 - 15 Mar 2023

Cited by 5 | Viewed by 7539

Abstract

The SARS-CoV-2 virus and the COVID-19 pandemic have spread across the world and severely impacted patients living with hematological conditions. Immunocompromised patients experience rapidly progressing symptoms following COVID-19 infection and are at high risk of death. In efforts to protect the vulnerable population, [...] Read more.

The SARS-CoV-2 virus and the COVID-19 pandemic have spread across the world and severely impacted patients living with hematological conditions. Immunocompromised patients experience rapidly progressing symptoms following COVID-19 infection and are at high risk of death. In efforts to protect the vulnerable population, vaccination efforts have increased exponentially in the past 2 years. Although COVID-19 vaccination is safe and effective, mild to moderate side effects such as headache, fatigue, and soreness at the injection site have been reported. In addition, there are reports of rare side effects, including anaphylaxis, thrombosis with thrombocytopenia syndrome, Guillain-Barré Syndrome, myocarditis, and pericarditis after vaccination. Further, hematological abnormalities and a very low and transient response in patients with hematological conditions after vaccination raise concerns. The objective of this review is to first briefly discuss the hematological adverse effects associated with COVID-19 infection in general populations followed by critically analyzing the side effects and pathomechanisms of COVID-19 vaccination in immunocompromised patients with hematological and solid malignancies. We reviewed the published literature, with a focus on hematological abnormalities associated with COVID-19 infection followed by the hematological side effects of COVID-19 vaccination, and the mechanisms by which complications can occur. We extend this discussion to include the viability of vaccination efforts within immune-compromised patients. The primary aim is to provide clinicians with critical hematologic information on COVID-19 vaccination so that they can make informed decisions on how to protect their at-risk patients. The secondary goal is to clarify the adverse hematological effects associated with infection and vaccination within the general population to support continued vaccination within this group. There is a clear need to protect patients with hematological conditions from infection and modulate vaccine programs and procedures for these patients. Full article

(This article belongs to the Special Issue Safety and Autoimmune Response to SARS-CoV-2 Vaccination)

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11 pages, 1699 KiB

Open AccessReview

A Systematic Review on the Safety and Efficacy of COVID-19 Vaccines Approved in Saudi Arabia

by Thekra Ali Alhandod, Syed Imam Rabbani, Mansour Almuqbil, Sultan Alshehri, Syed Arif Hussain, Nasser Fawzan Alomar, Manzoor Ahmad Mir and Syed Mohammed Basheeruddin Asdaq

Vaccines 2023, 11(2), 281; https://doi.org/10.3390/vaccines11020281 - 28 Jan 2023

Cited by 7 | Viewed by 2044

Abstract

Comprehensive safety and efficacy studies of COVID-19 vaccines might reduce the apprehension of the general population about the adverse reactions and duration of protection offered by them. The study aimed to conduct a systemic review on the four COVID-19 vaccines (AstraZeneca, Pfizer, Moderna, [...] Read more.

Comprehensive safety and efficacy studies of COVID-19 vaccines might reduce the apprehension of the general population about the adverse reactions and duration of protection offered by them. The study aimed to conduct a systemic review on the four COVID-19 vaccines (AstraZeneca, Pfizer, Moderna, and Janssen) approved in Saudi Arabia. The study was conducted by reviewing the published articles from electronic databases such as PubMed, Embase, Cochrane Library and Web of Science using the search terms “COVID-19”, “Vaccine”, “Safety”, “Efficacy” and “Human trials” and as per the standard guidelines for systemic review. The review analyzed eighteen articles and the data from them were evaluated to analyze the safety and efficacy of the vaccines in different groups of population such as males, females, those above 18 years and people with co-morbidities. The common local reactions observed after vaccination were pain at the site of injection (40–70%), redness (16–30%), swelling (18–39%) and tenderness (20–40%). The systemic reactions reported were fever (40–60%), chills (12–23%), fatigue (44–65%), headache (30–42%) and muscle pain (15–40%). The efficacy was observed to be above the threshold value (60%) stipulated by the WHO. However, precautions need to be followed while vaccinating special groups of population such as those that are pregnant, lactating or experiencing severe illness. Additionally, the rare and serious adverse events reported remotely after vaccination need more studies. Full article

(This article belongs to the Special Issue Safety and Autoimmune Response to SARS-CoV-2 Vaccination)

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35 pages, 943 KiB

Open AccessReview

Can COVID-19 Vaccines Induce Premature Non-Communicable Diseases: Where Are We Heading to?

by Altijana Hromić-Jahjefendić, Debmalya Barh, Vladimir Uversky, Alaa A. Aljabali, Murtaza M. Tambuwala, Khalid J. Alzahrani, Fuad M. Alzahrani, Saleh Alshammeri and Kenneth Lundstrom

Vaccines 2023, 11(2), 208; https://doi.org/10.3390/vaccines11020208 - 17 Jan 2023

Cited by 5 | Viewed by 4687

Abstract

According to the WHO, as of January 2023, more than 850 million cases and over 6.6 million deaths from COVID-19 have been reported worldwide. Currently, the death rate has been reduced due to the decreased pathogenicity of new SARS-CoV-2 variants, but the major [...] Read more.

According to the WHO, as of January 2023, more than 850 million cases and over 6.6 million deaths from COVID-19 have been reported worldwide. Currently, the death rate has been reduced due to the decreased pathogenicity of new SARS-CoV-2 variants, but the major factor in the reduced death rates is the administration of more than 12.8 billion vaccine doses globally. While the COVID-19 vaccines are saving lives, serious side effects have been reported after vaccinations for several premature non-communicable diseases (NCDs). However, the reported adverse events are low in number. The scientific community must investigate the entire spectrum of COVID-19-vaccine-induced complications so that necessary safety measures can be taken, and current vaccines can be re-engineered to avoid or minimize their side effects. We describe in depth severe adverse events for premature metabolic, mental, and neurological disorders; cardiovascular, renal, and autoimmune diseases, and reproductive health issues detected after COVID-19 vaccinations and whether these are causal or incidental. In any case, it has become clear that the benefits of vaccinations outweigh the risks by a large margin. However, pre-existing conditions in vaccinated individuals need to be taken into account in the prevention and treatment of adverse events. Full article

(This article belongs to the Special Issue Safety and Autoimmune Response to SARS-CoV-2 Vaccination)

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Other

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8 pages, 1165 KiB

Open AccessCase Report

Alopecia Areata Occurring after COVID-19 Vaccination: A Single-Center, Cross-Sectional Study

by Francesco Tassone, Simone Cappilli, Flaminia Antonelli, Ruggiero Zingarelli, Andrea Chiricozzi and Ketty Peris

Vaccines 2022, 10(9), 1467; https://doi.org/10.3390/vaccines10091467 - 05 Sep 2022

Cited by 5 | Viewed by 10498

Abstract

Limited data concerning the development of autoimmune skin diseases after COVID-19 vaccination are currently available. Recently, a few reports described the development, worsening or recurrence of alopecia areata after the administration of COVID-19 vaccines. High variability in terms of disease onset following vaccination [...] Read more.

Limited data concerning the development of autoimmune skin diseases after COVID-19 vaccination are currently available. Recently, a few reports described the development, worsening or recurrence of alopecia areata after the administration of COVID-19 vaccines. High variability in terms of disease onset following vaccination as well as the heterogeneous topical and/or systemic treatment approaches have been described. Methods: All patient-related data and images were obtained as part of clinical routine. Diagnosis of alopecia areata was established according to clinical and trichoscopic findings, along with the exclusion of common differential diagnoses. Results. Twenty-four patients, 20 females (83.3%) and four males (16.7%), with a mean age of 39.1 years (age range: 14–66 years), were examined for the occurrence of alopecia areata within 16 weeks after COVID-19 vaccination. Out of 24, 14 patients (58.3%) experienced a patchy alopecia areata, while an extensive disease occurred in 10/24 patients (41.7%): six patients with whole scalp involvement (alopecia areata totalis) and four patients with the whole body affected (alopecia areata universalis). Twelve patients reported a history of autoimmune disease (50%). Treatment with topical corticosteroid was performed in almost all patients with patchy alopecia areata, whilst it was associated with systemic drugs (corticosteroids, minoxidil, cyclosporin) in the case of generalized alopecia areata and alopecia areata universalis. Mean baseline values of Severity of Alopecia Tool (SALT) score decreased from 43.4 to 36.6 after 12 weeks of treatment, with evidence of hair regrowth in 16/21 patients. Conclusion. This study described the occurrence of alopecia areata after COVID-19 vaccination and its management that implicates the use of both topical and systemic therapies. Full article

(This article belongs to the Special Issue Safety and Autoimmune Response to SARS-CoV-2 Vaccination)

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13 pages, 844 KiB

Open AccessSystematic Review

Graves’ Disease Following SARS-CoV-2 Vaccination: A Systematic Review

by Armando Patrizio, Silvia Martina Ferrari, Giusy Elia, Francesca Ragusa, Sabrina Rosaria Paparo, Valeria Mazzi, Alessandro Antonelli and Poupak Fallahi

Vaccines 2022, 10(9), 1445; https://doi.org/10.3390/vaccines10091445 - 01 Sep 2022

Cited by 12 | Viewed by 2211

Abstract

(1) Background: Autoimmune diseases, including autoimmune endocrine diseases (AIED), are thought to develop following environmental exposure in patients with genetic predisposition. The vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) could represent a new environmental trigger for AIED, including Graves’ disease (GD). [...] Read more.

(1) Background: Autoimmune diseases, including autoimmune endocrine diseases (AIED), are thought to develop following environmental exposure in patients with genetic predisposition. The vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) could represent a new environmental trigger for AIED, including Graves’ disease (GD). (2) Methods: We performed a literature search of MEDLINE/PubMed databases regarding thyroid dysfunction after SARS-CoV-2 vaccination since 1 January 2020 to 31 July 2022, considering only cases of thyrotoxicosis that meet the 2016 American Thyroid Association guidelines criteria for the diagnosis of GD and arising after administration of the anti-SARS-CoV-2 vaccine, regardless of the number of doses. (3) Results: A total of 27 articles were identified, consisting of case reports or case series, of which 24 describe the appearance of 48 new diagnoses of GD and 12 GD recurrences arising after the administration of the anti-SARS-CoV-2 vaccine, and 3 papers that instead report only 3 cases of GD relapse following vaccination. (4) Conclusions: physicians should be aware of the possibility of developing GD and other autoimmune sequelae following SARS-CoV-2 vaccination. Regardless of the underlying pathogenetic mechanisms (autoimmune/inflammatory syndrome induced by adjuvants (ASIA syndrome), cytokines induction, molecular mimicry, and cross-reactivity), an individual predisposition seems to be decisive for their development. Full article

(This article belongs to the Special Issue Safety and Autoimmune Response to SARS-CoV-2 Vaccination)

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