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1.
Front Immunol ; 13: 832924, 2022.
Article in English | MEDLINE | ID: covidwho-1987488

ABSTRACT

Vaccination against COVID-19 in patients with end-stage renal disease (ESRD) on replacement therapy and kidney transplant recipients (KTRs) is particularly important due to the high mortality rate. Here, we tested the local and systemic immunity to the novel Pfizer BioNTech (BNT162b2) messenger RNA (mRNA) in ESRD, KTR patients, and healthy individuals (150 subjects). The ESRD group was divided into: hemodialysis (HD) and peritoneal dialysis (PD). We investigated the local and systemic immunity based on anti-N (nucleoprotein) and anti-S (spike1/2) Immunoglobulin A (IgA) and Immunoglobulin G (IgG) antibodies, respectively. Additionally, we performed an Interferon gamma (IFN-γ) release test Interferon-gamma release assay (IGRA) to monitor the cellular component of vaccine response. The control group had the highest level of anti-S IgG antibodies (153/2,080 binding antibody units (BAU)/ml) among all analyzed patients after the 1st and 2nd dose, respectively. The HD group (48/926 BAU/ml) had a diminished antibody level compared to PD (93/1,607 BAU/ml). Moreover, the seroconversion rate after the 1st dose was lower in HD than PD (56% vs. 86%). KTRs had extremely low seroconversion (33%). IgA-mediated immunity was the most effective in the control group, while other patients had diminished IgA production. We observed a lower percentage of vaccine responders based on the IFN-γ level in all research participants (100% vs. 85% in control, 100% vs. 80% in PD, 97% vs. 64% in HD). 63% of seropositive KTRs had a positive IGRA, while 28% of seronegative patients produced IFN-γ. Collectively, PD patients had the strongest response among ESRD patients. Two doses of the Pfizer vaccine are ineffective, especially in HD and KTRs. A closer investigation of ESRD and KTRs is required to set the COVID-19 vaccine clinical guidance. Clinical Trial Registration Number: www.ClinicalTrials.gov, identifier: NCT04 905 862.


Subject(s)
BNT162 Vaccine , COVID-19 , Immunogenicity, Vaccine , Kidney Failure, Chronic , Kidney Transplantation , Peritoneal Dialysis , BNT162 Vaccine/administration & dosage , BNT162 Vaccine/adverse effects , BNT162 Vaccine/immunology , COVID-19/prevention & control , COVID-19 Vaccines , Humans , Immunogenicity, Vaccine/immunology , Immunoglobulin A , Immunoglobulin G , Kidney Failure, Chronic/therapy , Peritoneal Dialysis/adverse effects , Renal Dialysis , SARS-CoV-2
2.
J Infect Chemother ; 28(8): 1220-1224, 2022 Aug.
Article in English | MEDLINE | ID: covidwho-1983458

ABSTRACT

To control the coronavirus disease 2019 (COVID-19) pandemic, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the promotion of vaccination is important. However, adverse reactions following vaccination remain a concern. To investigate adverse events in the vaccinated Japanese population, we conducted a survey-based study among health care workers, including medical doctors and nurses; other medical staff; and medical university faculty, staff, and students in a single medical school and affiliated hospital in Japan. In addition, we analyzed the association of different adverse events with individual factors (e.g., age, sex) by performing network analysis. While young age and female sex are often considered risk factors for more severe adverse events, the regression models showed neither age nor sex was associated with local injection-site reactions after the second dose in this study. In contrast to local reactions, systemic adverse events were associated with young age and female sex. However, myalgia was unique in that it was not associated with younger age even though the network analysis showed that myalgia was consistently related to arthralgia and belonged to the group of systemic events after both the first and second vaccine doses. Further study is needed to ensure safe and effective vaccination to aid in controlling the COVID-19 pandemic.


Subject(s)
BNT162 Vaccine , COVID-19 , Health Personnel , Students, Medical , BNT162 Vaccine/adverse effects , COVID-19/epidemiology , COVID-19/prevention & control , Female , Humans , Japan/epidemiology , Myalgia/chemically induced , Myalgia/epidemiology , SARS-CoV-2 , Vaccination/adverse effects
3.
Indian J Ophthalmol ; 70(8): 3134-3136, 2022 Aug.
Article in English | MEDLINE | ID: covidwho-1975076

ABSTRACT

This report shows a case of corneal transplant rejection after vaccination against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), short after receiving the BNT162b2 vaccine, in a patient who had undergone keratoplasty more than 20 years ago, with no previous episodes of rejection and no other factor that could lead to the findings on his examinations. After treatment with high doses of topic, oral, and sub-conjunctival corticoids, the patient had a favorable therapeutic response. The signs of corneal transplant rejection must be oriented to the patients and the causing factors actively searched by ophthalmologists so that treatment is rapidly initiated and sequels are avoided. This report raises the question if these events are correlated and whether the patient should receive the second dose of the vaccine against SARS-CoV-2 or not.


Subject(s)
BNT162 Vaccine , COVID-19 , Corneal Transplantation , Graft Rejection , BNT162 Vaccine/adverse effects , COVID-19/prevention & control , Graft Rejection/chemically induced , Humans , SARS-CoV-2
4.
J Korean Med Sci ; 37(30): e233, 2022 Aug 01.
Article in English | MEDLINE | ID: covidwho-1974634

ABSTRACT

The World Health Organization declared coronavirus disease 2019 (COVID-19) a global pandemic in March 2020. Several vaccines have been developed to overcome the COVID-19 pandemic, and messenger RNA vaccines, commonly known as mRNA vaccines, were the first COVID-19 vaccines to be authorized in Korea. With the worldwide increase in vaccinations, reports of adverse reactions are increasing. However, to the best of our knowledge, there have been no reports of eosinophilic gastroenteritis (EGE) following mRNA vaccination. Here, we present the first case of EGE in a patient who received a second dose of the mRNA vaccine, BNT162b2 (Pfizer-BioNTech). A previously healthy 34-year-old woman presented to the emergency department with generalized abdominal pain for the preceding 2 weeks. She had received a second dose of the mRNA COVID-19 vaccine 2 weeks prior. Subserosal EGE was diagnosed, oral prednisolone was administered, and she recovered completely.


Subject(s)
BNT162 Vaccine , COVID-19 , Enteritis , Eosinophilia , Gastritis , Adult , BNT162 Vaccine/adverse effects , Enteritis/chemically induced , Eosinophilia/chemically induced , Female , Gastritis/chemically induced , Humans , Vaccination/adverse effects
5.
Intern Med ; 61(15): 2319-2325, 2022 Aug 01.
Article in English | MEDLINE | ID: covidwho-1974464

ABSTRACT

A 60-year-old Japanese woman was hospitalized for cardiogenic shock 24 days after receiving the second dose of the coronavirus disease 2019 BNT162b2 vaccine. Impella CP left ventricular assist device implantation and venoarterial peripheral extracorporeal membranous oxygenation were immediately initiated along with inotropic support and steroid pulse therapy, as an endomyocardial biopsy specimen showed myocarditis. Three weeks later, her cardiac function had recovered, and she was discharged. An immune response associated with the presence of spike protein in cardiac myocytes may be related to myocarditis in the present case because of positive immunostaining for severe acute respiratory syndrome coronavirus 2 spike protein and C4d in the myocardium.


Subject(s)
BNT162 Vaccine , COVID-19 , Coronavirus , Heart-Assist Devices , Myocarditis , BNT162 Vaccine/adverse effects , COVID-19/complications , Female , Heart-Assist Devices/adverse effects , Humans , Middle Aged , Myocarditis/complications , RNA/therapeutic use , Shock, Cardiogenic/etiology , Spike Glycoprotein, Coronavirus
6.
Immun Inflamm Dis ; 10(8): e646, 2022 Aug.
Article in English | MEDLINE | ID: covidwho-1955909

ABSTRACT

INTRODUCTION: Lung transplant recipients (LuTX) represent a vulnerable population for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Even though many vaccines are already developed, more clinical data need to support effective immunological response in immunocompromised patients. METHODS: Stable LuTX recipients with no medical history of coronavirus disease (COVID-19) were enrolled. Currently available messenger RNA (mRNA) (BNT162b2-mRNA, mRNA-1273) and non-mRNA (ChAdOx1, BBIBP-CorV) vaccines were given according to availability, boosters were all mRNA-based. SARS-CoV-2 Spike1 immunoglobulin G (IgG) antibody titer was evaluated before and 2 weeks after second and third dose. Difference between mRNA versus non-mRNA vaccines was assessed. RESULTS: Forty-one patients (49% men, age 48.4 ± 13.8 years) received two doses of SARS-CoV-2 vaccines: 23 of mRNA, 18 of non-mRNA, and 24/41 (58%) received a third dose. Median 92 months passed since transplantation, and serum level of tacrolimus was median 5.5 ng/ml. Positive serology was found in 37% of all patients after the second dose, 86% had mRNA vaccine. After the third dose, 29% became positive who had no antibody before. Significantly higher level of antibody was found after the second mRNA than non-mRNA vaccines (2.2 vs. 1568.8 U/ml, respectively, p = .002). 6/23 (26%) patients received two doses of mRNA vaccine developed COVID-19 after the second injection in an average of 178 days, half of them recovered, half of them died in intensive care unit (ICU). 3/6 (50%) patients with two doses mRNA and recovered from COVID-19 had significantly higher level of antibody (average 20847.3 U/ml) than without infection. After the booster vaccine, 1/24 (4%) developed infection. CONCLUSION: Immunosuppression therapy may induce a weaker SARS-CoV-2 response in LuTX recipients; therefore, third dose is a priority in transplanted patients. The highest antibody level was measured recovering from COVID after two doses. Our data confirm that booster mRNA vaccine could increase antibody levels, even if immunization was started with non-mRNA vaccine.


Subject(s)
BNT162 Vaccine , COVID-19 Vaccines , COVID-19 , Transplant Recipients , Adult , Antibodies, Viral , BNT162 Vaccine/adverse effects , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Female , Humans , Lung , Male , Middle Aged , SARS-CoV-2 , Viral Vaccines/adverse effects
7.
Intern Med ; 61(12): 1891-1895, 2022 Jun 15.
Article in English | MEDLINE | ID: covidwho-1951861

ABSTRACT

Several vaccines have been developed for coronavirus disease 2019 - caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) - in record time. A few cases of immune thrombocytopenic purpura (ITP) following SARS-CoV-2 vaccination have been reported. We herein report a 90-year-old man who received the Pfizer-BioNTech SARS-CoV-2 vaccine (BNT162b2) and developed severe thrombocytopenia with intracranial hemorrhaging and duodenal bleeding, consistent with vaccine-related ITP. He was successfully treated with intravenous immunoglobulin, prednisolone, and eltrombopag and discharged without cytopenia. Vaccine-related ITP should be suspected in patients presenting with abnormal bleeding or purpura after vaccination.


Subject(s)
BNT162 Vaccine , COVID-19 , Intracranial Hemorrhages , Purpura, Thrombocytopenic, Idiopathic , Thrombocytopenia , Aged, 80 and over , BNT162 Vaccine/adverse effects , Humans , Intracranial Hemorrhages/chemically induced , Intracranial Hemorrhages/drug therapy , Male , Purpura, Thrombocytopenic, Idiopathic/chemically induced , Purpura, Thrombocytopenic, Idiopathic/drug therapy , Thrombocytopenia/chemically induced , Thrombocytopenia/drug therapy , Vaccination/adverse effects
8.
BMC Neurol ; 22(1): 185, 2022 May 18.
Article in English | MEDLINE | ID: covidwho-1951107

ABSTRACT

BACKGROUND: Since the beginning of the COVID-19 pandemic and development of new vaccines, the issue of post-vaccination exacerbation or manifestation of demyelinating central nervous system (CNS) disorders has gained increasing attention. CASE PRESENTATION: We present a case of a 68-year-old woman previously diagnosed with multiple sclerosis (MS) since the 1980s who suffered a rapidly progressive severe sensorimotor paraparesis with loss of bladder and bowel control due to an acute longitudinal extensive transverse myelitis (LETM) after immunization with the mRNA Pfizer-BioNTech COVID-19 vaccine. Detection of Aquaporin-4-antibodies (AQP4) in both serum and CSF led to diagnosis of AQP4-antibody positive neuromyelitis optica spectrum disorder (NMOSD). Treatment with intravenous corticosteroids and plasmapheresis led to a slight improvement of the patient's symptoms. CONCLUSIONS: Pathogenic mechanisms of post-vaccination occurrence of NMOSD are still unknown. However, cases like this should make aware of rare neurological disorders manifesting after vaccination and potentially contribute to improvement of management of vaccinating patients with inflammatory CNS disorders in the future. So far two cases of AQP4-antibody positive NMOSD have been reported in association with viral vector COVID-19 vaccines. To our knowledge, we report the first case of AQP4-antibody positive NMOSD after immunization with an mRNA COVID-19-vaccine.


Subject(s)
BNT162 Vaccine , COVID-19 , Multiple Sclerosis , Myelitis, Transverse , Neuromyelitis Optica , Aged , Aquaporin 4/blood , Aquaporin 4/cerebrospinal fluid , Autoantibodies/blood , Autoantibodies/cerebrospinal fluid , BNT162 Vaccine/adverse effects , BNT162 Vaccine/therapeutic use , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , COVID-19 Vaccines/therapeutic use , Disease Progression , Female , Humans , Multiple Sclerosis/blood , Multiple Sclerosis/cerebrospinal fluid , Multiple Sclerosis/complications , Myelitis, Transverse/chemically induced , Myelitis, Transverse/diagnosis , Myelitis, Transverse/etiology , Neuromyelitis Optica/blood , Neuromyelitis Optica/cerebrospinal fluid , Neuromyelitis Optica/diagnosis , Neuromyelitis Optica/etiology , Pandemics , RNA, Messenger , Vaccination/adverse effects
9.
Vaccine ; 40(28): 3818-3820, 2022 06 21.
Article in English | MEDLINE | ID: covidwho-1946776

ABSTRACT

INTRODUCTION: The Spanish Society of Immunology recently warned that a history of past COVID-19 could result in a higher incidence of adverse events (AEs) related to vaccination. We set out to analyze whether there were any differences in AEs between healthcare workers vaccinated for COVID-19 (either after the first or second dose) who had had a prior diagnosis SARS-CoV-2 infection at any time compared to those who had not had COVID-19 before vaccination. METHODS: This was a retrospective cohort study in a population of healthcare workers. AEs related to the first and second doses of the Pfizer vaccine were recorded. We compared the incidence of AEs and compared individuals with 0-3 different AEs to those with 4 or more AEs. The relative risks (RR) and their 95% confidence intervals were calculated. RESULTS: Past infection was associated with having more AEs after the first dose (p < 0.001), but not the second one (p = 0.476), as well as a higher incidence of AEs (p < 0.001). Common AEs that were statistically associated with past COVID infection included arthralgia, asthenia, fever, chills, headache, and myalgia (p ≤ 0.001). The RR for having an increased absolute number of different AEs was 1.18 (95 %CI [1.05, 1.33]) after the first dose and 1.05 (95 %CI [0.96, 1.14]) after the second dose. The maximum number of days between past infection and vaccination was 306. CONCLUSIONS: Our results showed that the incidence of AEs was higher in individuals with a history of prior COVID-19 infection.


Subject(s)
BNT162 Vaccine , COVID-19 , Health Personnel , BNT162 Vaccine/adverse effects , COVID-19/prevention & control , Humans , Retrospective Studies , SARS-CoV-2 , Vaccination/adverse effects
10.
BMC Endocr Disord ; 22(1): 185, 2022 Jul 19.
Article in English | MEDLINE | ID: covidwho-1938308

ABSTRACT

BACKGROUND: The global COVID-19 pandemic requires urgent development of new vaccines. Endocrinological adverse effects following the new mRNA vaccine against COVID-19 have been reported in several cases. Specific to the involvement of pituitary function; however, only a single case with hypophysis has been reported. This is the first case of isolated adrenocorticotropic hormone (ACTH) deficiency (IAD) following mRNA vaccination against COVID-19. CASE PRESENTATION: A healthy 31-year-old man received the BNT162b2 SARS-CoV-2 mRNA vaccine. The first injection was uneventful. One day after the second injection, he noticed general fatigue and fever. In the following several days, he additionally developed headaches, nausea, and diarrhea. Four days after the vaccine injection, he visited a hospital with worsening of these symptoms. Physical examination revealed slight disorientation but no other deficits. Laboratory tests revealed hyponatremia, hypoglycemia, and extremely low plasma ACTH and serum cortisol levels (ACTH < 1.5 pg/ml, cortisol 1.6 µg/dl). He was diagnosed with adrenal crisis and was emergently treated with hydrocortisone. The symptoms responded well and he recovered within a few days. Magnetic resonance images after the replacement with hydrocortisone revealed an atrophic pituitary gland. The patient was referred to our tertiary hospital for further endocrinological examination. Pituitary endocrine load tests revealed isolated adrenocortical response deficiency. After other clinical assessments, he was diagnosed as having isolated ACTH deficiency. After initiation of hydrocortisone replacement, there has been no recurrence of symptoms related to adrenocortical insufficiency nor involvement of other pituitary functions. CONCLUSION: This is the first reported case of IAD potentially associated with COVID-19 immunization. Recent reports have emphasized the importance of adjuvants in the mRNA vaccine that induce the endocrinological adverse effects through disturbance of the autoimmune system, but details are still unclear. Given the broad and rapid spread of vaccinations against COVID-19, it is clinically important to consider that there could be cases with a rare but emergent adrenal crisis even among those who present common symptoms of adverse effects following inactive SARS-CoV-2 mRNA vaccination.


Subject(s)
Adrenal Insufficiency , Adrenocorticotropic Hormone , BNT162 Vaccine , COVID-19 , Endocrine System Diseases , Hypoglycemia , Adrenal Insufficiency/chemically induced , Adrenal Insufficiency/drug therapy , Adrenocorticotropic Hormone/deficiency , Adult , BNT162 Vaccine/adverse effects , COVID-19/prevention & control , Endocrine System Diseases/chemically induced , Endocrine System Diseases/drug therapy , Humans , Hydrocortisone/blood , Hydrocortisone/therapeutic use , Hypoglycemia/chemically induced , Hypoglycemia/drug therapy , Male , SARS-CoV-2 , Vaccination/adverse effects
11.
BMJ ; 378: e070483, 2022 07 13.
Article in English | MEDLINE | ID: covidwho-1932664

ABSTRACT

OBJECTIVE: To assess the risk of adverse events associated with heterologous primary (two dose) and booster (three dose) vaccine schedules for covid-19 with Oxford-AstraZeneca's ChAdOx1-S priming followed by mRNA vaccines (Pfizer-BioNTech's BNT162b2 or Moderna's mRNA-1273) as compared with homologous mRNA vaccine schedules for covid-19. DESIGN: Nationwide cohort study. SETTING: Denmark, 1 January 2021 to 26 March 2022. PARTICIPANTS: Adults aged 18-65 years who received a heterologous vaccine schedule of priming with ChAdOx1-S and one or two mRNA booster doses (with either the BNT162b2 or mRNA-1273 vaccine) were compared with adults who received a homologous BNT162b2 or mRNA-1273 vaccine schedule (ie, two dose v two dose, and three dose v three dose schedule). MAIN OUTCOME MEASURES: The incidence of hospital contacts for a range of adverse cardiovascular and haemostatic events within 28 days after the second or third vaccine dose, comparing heterologous versus homologous vaccine schedules. Secondary outcomes included additional prioritised adverse events of special interest. Poisson regression was used to estimate incidence rate ratios with adjustment for selected covariates. RESULTS: Individuals who had had a heterologous primary vaccine (n=137 495) or a homologous vaccine (n=2 688 142) were identified, in addition to those who had had a heterologous booster (n=129 770) or a homologous booster (n=2 197 213). Adjusted incidence rate ratios of adverse cardiovascular and haemostatic events within 28 days for the heterologous primary and booster vaccine schedules in comparison with the homologous mRNA vaccine schedules were 1.22 (95% confidence interval 0.79 to 1.91) and 1.00 (0.58 to 1.72) for ischaemic cardiac events, 0.74 (0.40 to 1.34) and 0.72 (0.37 to 1.42) for cerebrovascular events, 1.12 (0.13 to 9.58) and 4.74 (0.94 to 24.01) for arterial thromboembolisms, 0.79 (0.45 to 1.38) and 1.09 (0.60 to 1.98) for venous thromboembolisms, 0.84 (0.18 to 3.96) and 1.04 (0.60 to 4.55) for myocarditis or pericarditis, 0.97 (0.45 to 2.10) and 0.89 (0.21 to 3.77) for thrombocytopenia and coagulative disorders, and 1.39 (1.01 to 1.91) and 1.02 (0.70 to 1.47) for other bleeding events, respectively. No associations with any of the outcomes were found when restricting to serious adverse events defined as stay in hospital for more than 24 h. CONCLUSION: Heterologous primary and booster covid-19 vaccine schedules of ChAdOx1-S priming and mRNA booster doses as both second and third doses were not associated with increased risk of serious adverse events compared with homologous mRNA vaccine schedules. These results are reassuring but given the rarity of some of the adverse events, associations cannot be excluded.


Subject(s)
COVID-19 , Hemostatics , Thromboembolism , mRNA Vaccines , 2019-nCoV Vaccine mRNA-1273/adverse effects , Adult , BNT162 Vaccine/adverse effects , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Cohort Studies , Humans , Immunization, Secondary , RNA, Messenger , Thromboembolism/etiology , Vaccination/adverse effects , Vaccines, Synthetic , mRNA Vaccines/adverse effects
12.
J Int Med Res ; 50(7): 3000605221110709, 2022 Jul.
Article in English | MEDLINE | ID: covidwho-1927982

ABSTRACT

Multifocal motor neuropathy (MMN) is an immune-mediated and acquired demyelinating motor polyneuropathy. Several cases of polyneuropathy associated with severe acquired respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination have been reported. However, MMN has not been reported as a complication of SARS-CoV-2 vaccination. In this study, we report a case of MMN with progressive muscle weakness following the second dose of the Pfizer-BioNTech mRNA vaccine. It was diagnosed by clinical evaluation and electroneuromyography. SARS-CoV-2 vaccination is increasing rapidly all over the world. Some cases of polyneuropathy, especially Guillain-Barré syndrome, have been reported after vaccination. This is the first case report of MMN after SARS-CoV-2 vaccination.


Subject(s)
BNT162 Vaccine , COVID-19 , Polyneuropathies , BNT162 Vaccine/adverse effects , COVID-19/prevention & control , Humans , Polyneuropathies/chemically induced , SARS-CoV-2 , Vaccination/adverse effects
13.
Medicina (Kaunas) ; 58(7)2022 Jun 30.
Article in English | MEDLINE | ID: covidwho-1917617

ABSTRACT

BACKGROUND: During the last two years, the COVID-19 pandemic led to millions of disease-related deaths worldwide. The efforts of the scientific community facing this global challenge resulted in outstanding achievements. Thus, within one year, new mRNA-based vaccines against SARS-CoV-2 viral infection were released, providing highly efficient protection and showing a very good safety profile in the general population. However, clinical data collection after vaccination is a continuous process for the long-term safety of any new medical product. The aim of our paper is to present two cases of hematological malignancies: diffuse large B-cell non-Hodgkin lymphoma and T/NK-cell lymphoma, diagnosed shortly after the administration of the mRNA COVID-19 vaccine. METHODS AND RESULTS: Case 1: A female patient was admitted with a suspicious cervical mass that emerged within one week after the administration of second dose of the BNT162b2 COVID-19 vaccine. Surgical removal followed by pathology assessment of the specimen confirmed the diagnosis of diffuse large B-cell non-Hodgkin lymphoma. Case 2: A male patient was admitted with multiple ulcerative oral lesions arising on the third day after the initial dose of the BNT162b2 COVID-19 vaccine. These lesions had a progressive character and during the following months were complicated with repetitive episodes of heavy oral bleeding, requiring blood transfusions. The incisional biopsy of the lesions and pathological assessment of the specimens confirmed the diagnosis of T/NK-cell lymphoma. CONCLUSIONS: The safety profile of the mRNA-based vaccines is an undeniable fact. In most cases, suspicions of potentially aggressive side effects were ruled out, proving to be transient post-vaccine reactions. Clinicians should remain alert to report any potentially aggressive manifestations emerging in the context of mRNA COVID-19 vaccination, such as these cases of hematological malignancies, in order to promote additional investigations on the particular mechanisms of action of COVID-19 vaccines and to provide the best medical care to the patients.


Subject(s)
BNT162 Vaccine , Lymphoma, Extranodal NK-T-Cell , Lymphoma, Large B-Cell, Diffuse , BNT162 Vaccine/administration & dosage , BNT162 Vaccine/adverse effects , COVID-19/epidemiology , COVID-19/prevention & control , Female , Humans , Immunization Programs , Lymphoma, Extranodal NK-T-Cell/diagnosis , Lymphoma, Large B-Cell, Diffuse/diagnosis , Male , Pandemics
14.
BioDrugs ; 36(4): 509-520, 2022 Jul.
Article in English | MEDLINE | ID: covidwho-1906579

ABSTRACT

BACKGROUND: The comparative safety profile of SARS-Cov2 vaccines requires further characterization in real-world settings. OBJECTIVES: The aim of the VigilVacCOVID study was to assess the short-term safety of BNT162b2 and mRNA-1273 during the vaccination campaign of healthcare professionals (HCPs) and solid-organ transplant recipients (SOTRs) at a hospital clinic. METHODS: We conducted an observational, prospective, single-center, post-authorization study to characterize short-term adverse reactions (ARs) after vaccination. The primary endpoint was to assess between-vaccine differences (HCPs receiving BNT162b2 or mRNA-1273) and between-population differences (HCPs and SOTRs, both receiving mRNA-1273) in the risk of any ARs. Propensity score and covariate-adjusted multivariate models were used. The key secondary endpoint was to provide a descriptive assessment of the frequencies and intensity distribution of ARs. RESULTS: We included 5088 HCPs and 1289 patients. mRNA-1273 showed greater reactogenicity than BNT162b2, with an odds ratio (OR) for any AR of 3.04 (95% confidence interval (CI) 2.48-3.73; p value: < 0.001) and a higher frequency and intensity of reported ARs. Compared with HCPs vaccinated with mRNA-1273, SOTRs showed a lower risk of ARs (OR = 0.36; 95% CI 0.25-0.50), with fewer and less severe ARs. Age, sex, and previous SARS-CoV-2 infection were statistically significant covariates for the risk of any AR. A history of drug allergy was significant in the comparison between vaccines (BNT162b2 vs. mRNA-1273), but not in that between SOTRs and HCPs. CONCLUSIONS: Our study shows that mRNA-1273 had greater reactogenicity than BNT162b2. Overall, both vaccines had an adequate tolerability profile. mRNA-1273 vaccination caused fewer ARs with milder severity in SOTRs.


Subject(s)
2019-nCoV Vaccine mRNA-1273 , BNT162 Vaccine , 2019-nCoV Vaccine mRNA-1273/adverse effects , BNT162 Vaccine/adverse effects , COVID-19/epidemiology , COVID-19/prevention & control , Female , Humans , Immunization Programs , Male , Prospective Studies , Tertiary Care Centers
15.
Adv Ther ; 39(8): 3789-3798, 2022 Aug.
Article in English | MEDLINE | ID: covidwho-1906546

ABSTRACT

INTRODUCTION: BNT162b1 is a lipid nanoparticle-formulated, nucleoside-modified mRNA SARS-CoV-2 vaccine. Here, we report safety and immune persistence data following a primary two-dose vaccination schedule administered 21 days apart. METHODS: Immune persistence was determined at month 3 in 72 younger participants (aged 18-55 years) and at month 6 in 70 younger and 69 older participants (aged 65-85 years). RESULTS: In younger participants, neutralizing antibody (nAb) geometric mean titers (GMTs) for the 10 and 30 µg dose levels declined from 233 and 254 (21 days after dose 2) to 55 and 87 at month 3, respectively, and to 16 and 27 at month 6, respectively. In older participants, nAb GMTs declined from 80 and 160 (21 days after dose 2) to 10 and 21 at month 6. Overall, higher antibody titers were observed in younger participants, and the 30 µg dose induced higher levels of nAb, which declined more slowly by month 6. No serious adverse events were reported in the vaccine group. CONCLUSION: This study showed BNT162b1 maintains a favorable safety profile in younger and older participants in the 6 months after vaccination. This study further extends our understanding of immune persistence and the safety of the BNT162b1 vaccine as a candidate vaccine in the BioNTech pipeline. TRIAL REGISTRATION NUMBER: NCT04523571, registered August 21, 2020.


Subject(s)
BNT162 Vaccine , COVID-19 , Vaccines , Adult , Aged , Antibodies, Neutralizing , BNT162 Vaccine/adverse effects , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , China , Double-Blind Method , Humans , Liposomes , Nanoparticles , RNA, Messenger , SARS-CoV-2 , Vaccination
16.
PLoS Med ; 19(6): e1004018, 2022 06.
Article in English | MEDLINE | ID: covidwho-1902609

ABSTRACT

BACKGROUND: Safety monitoring of coronavirus disease 2019 (COVID-19) vaccines is crucial during mass vaccination rollout to inform the choice of vaccines and reduce vaccine hesitancy. Considering the scant evidence directly comparing the safety profiles of mRNA and inactivated SARS-CoV-2 vaccines, this territory-wide cohort study aims to compare the incidence of various adverse events of special interest (AESIs) and all-cause mortality between CoronaVac (inactivated vaccine) and BNT162b2 (mRNA-based vaccine). Our results can help vaccine recipients make an informed choice. METHODS AND FINDINGS: A retrospective, population-based cohort of individuals who had received at least 1 dose of BNT162b2 or CoronaVac from 23 February to 9 September 2021 in Hong Kong, and had data linkage to the electronic medical records of the Hong Kong Hospital Authority, were included. Those who had received mixed doses were excluded. Individuals were observed from the date of vaccination (first or second dose) until mortality, second dose vaccination (for first dose analysis), 21 days after vaccination, or 30 September 2021, whichever came first. Baseline characteristics of vaccinated individuals were balanced between groups using propensity score weighting. Outcome events were AESIs and all-cause mortality recorded during 21 days of post-vaccination follow-up after each dose, except anaphylaxis, for which the observation period was restricted to 2 days after each dose. Incidence rate ratios (IRRs) of AESIs and mortality comparing between CoronaVac and BNT162b2 recipients were estimated after each dose using Poisson regression models. Among 2,333,379 vaccinated individuals aged 18 years or above, the first dose analysis included 1,308,820 BNT162b2 and 955,859 CoronaVac recipients, while the second dose analysis included 1,116,677 and 821,560 individuals, respectively. The most frequently reported AESI among CoronaVac and BNT162b2 recipients was thromboembolism (first dose: 431 and 290 per 100,000 person-years; second dose: 385 and 266 per 100,000 person-years). After the first dose, incidence rates of overall AESIs (IRR = 0.98, 95% CI 0.89-1.08, p = 0.703) and mortality (IRR = 0.96, 95% CI 0.63-1.48, p = 0.868) associated with CoronaVac were generally comparable to those for BNT162b2, except for Bell palsy (IRR = 1.95, 95% CI 1.12-3.41, p = 0.018), anaphylaxis (IRR = 0.34, 95% CI 0.14-0.79, p = 0.012), and sleeping disturbance or disorder (IRR = 0.66, 95% CI 0.49-0.89, p = 0.006). After the second dose, incidence rates of overall AESIs (IRR = 0.97, 95% CI 0.87-1.08, p = 0.545) and mortality (IRR = 0.85, 95% CI 0.51-1.40, p = 0.516) were comparable between CoronaVac and BNT162b2 recipients, with no significant differences observed for specific AESIs. The main limitations of this study include residual confounding due to its observational nature, and the possibility of its being underpowered for some AESIs with very low observed incidences. CONCLUSIONS: In this study, we observed that the incidences of AESIs (cumulative incidence rate of 0.06%-0.09%) and mortality following the first and second doses of CoronaVac and BNT162b2 vaccination were very low. The safety profiles of the vaccines were generally comparable, except for a significantly higher incidence rate of Bell palsy, but lower incidence rates of anaphylaxis and sleeping disturbance or disorder, following first dose CoronaVac versus BNT162b2 vaccination. Our results could help inform the choice of inactivated COVID-19 vaccines, mainly administered in low- and middle-income countries with large populations, in comparison to the safety of mRNA vaccines. Long-term surveillance on the safety profile of COVID-19 vaccines should continue.


Subject(s)
Anaphylaxis , BNT162 Vaccine , Bell Palsy , COVID-19 , Vaccines , BNT162 Vaccine/adverse effects , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Cohort Studies , Hong Kong/epidemiology , Humans , RNA, Messenger , Retrospective Studies , SARS-CoV-2/genetics , Vaccination/adverse effects
17.
BMJ Case Rep ; 15(6)2022 Jun 20.
Article in English | MEDLINE | ID: covidwho-1901951

ABSTRACT

Immune thrombocytopenic purpura (ITP) is an autoimmune disorder caused by autoantibodies against platelet antigens resulting in platelet destruction and inhibition of platelet production. Occasionally, an inciting event such as a virus or vaccination can precipitate ITP. Several cases of ITP have been reported after the BTN162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna) SARS-CoV-2 (COVID-19) vaccines. All reported cases of post-vaccination ITP have resolved with medical therapy until this case.A man in his mid-20s developed bleeding from ITP 2 weeks after receiving the second dose of the Pfizer SARS-CoV-2 vaccine. All inpatient medical treatment attempts failed. On hospital day 40, a splenectomy was performed and he ultimately recovered and was discharged.Awareness of potential vaccination side effects is a fundamental element of refining and improving patient safety. This case illustrates that given the right circumstances, serious refractory ITP can develop in response to the second dose of the Pfizer SARS-CoV-2 vaccine.


Subject(s)
BNT162 Vaccine , COVID-19 , Purpura, Thrombocytopenic, Idiopathic , Splenectomy , BNT162 Vaccine/adverse effects , Humans , Male , Purpura, Thrombocytopenic, Idiopathic/chemically induced , Purpura, Thrombocytopenic, Idiopathic/surgery , SARS-CoV-2
18.
Cardiovasc Res ; 118(10): 2329-2338, 2022 Jul 27.
Article in English | MEDLINE | ID: covidwho-1901160

ABSTRACT

AIMS: Concern about the cardiovascular safety of coronavirus disease 2019 (COVID-19) vaccines among individuals with cardiovascular disease (CVD) may lead to vaccine hesitancy. We sought to assess the association between two COVID-19 vaccines, BNT162b2 and CoronaVac, and the risk of major adverse cardiovascular events (MACE) in individuals with established CVD. METHODS AND RESULTS: We identified individuals with a history of CVD before 23 February 2021 and a diagnosis of MACE between 23 February 2021 and 31 January 2022 in Hong Kong. MACE was defined as a composite of myocardial infarction, stroke, revascularization, and cardiovascular death. Electronic health records from the Hong Kong Hospital Authority were linked to vaccination records from the Department of Health. A self-controlled case-series method was used to evaluate the risk of MACE for 0-13 and 14-27 days after two doses of COVID-19 vaccine. We estimated incidence rate ratios (IRRs) to compare the risk of MACE between each risk period and the baseline period. A total of 229 235 individuals with CVD were identified, of which 1764 were vaccinated and had a diagnosis of MACE during the observation period (BNT162b2 = 662; CoronaVac = 1102). For BNT162b2, IRRs were 0.48 [95% confidence interval (CI) 0.23-1.02] for the first dose and 0.87 (95% CI 0.50-1.52) for the second dose during the 0-13 days risk period, 0.40 (95% CI 0.18-0.93) for the first dose and 1.13 (95% CI 0.70-1.84) for the second dose during the 14-27 days risk period. For CoronaVac, the IRRs were 0.43 (95% CI 0.24-0.75) for the first dose and, 0.73 (95% CI 0.46-1.16) for the second dose during the 0-13 days risk period, 0.54 (95% CI 0.33-0.90) for the first dose and 0.83 (95% CI 0.54-1.29) for the second dose during the 14-27 days risk period. Consistent results were found in subgroup analyses for different sexes, age groups and different underlying cardiovascular conditions. CONCLUSION: Our findings showed no evidence of an increased risk of MACE after vaccination with BNT162b2 or CoronaVac in patients with CVD. Future research is required to monitor the risk after the third dose of each vaccine.


Subject(s)
BNT162 Vaccine , COVID-19 Vaccines , COVID-19 , Cardiovascular Diseases , BNT162 Vaccine/adverse effects , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Cardiovascular Diseases/diagnosis , Cardiovascular Diseases/epidemiology , Cardiovascular Diseases/etiology , Humans , Risk Factors
19.
Eur J Heart Fail ; 24(7): 1319-1322, 2022 Jul.
Article in English | MEDLINE | ID: covidwho-1898655

ABSTRACT

Herein we report the case of a young man, admitted to the Department of Cardiology and Angiology at Hannover Medical School with shortness of breath and elevated troponin. Few weeks earlier the patient received the first dose of BioNTech's mRNA vaccine (Comirnaty, BNT162b2). After diagnostic work-up revealed giant cell myocarditis, the patient received immunosuppressive therapy. In the present context of myocarditis after mRNA vaccination we discuss this rare aetiology and the patient's treatment strategy in the light of current recommendations.


Subject(s)
BNT162 Vaccine , COVID-19 , Myocarditis , BNT162 Vaccine/adverse effects , COVID-19/prevention & control , Giant Cells , Humans , Male , Myocarditis/complications , Myocarditis/etiology , Vaccination/adverse effects
20.
Vaccine ; 40(32): 4328-4333, 2022 Jul 30.
Article in English | MEDLINE | ID: covidwho-1895480

ABSTRACT

In this randomized, observer-blinded, phase 2/3 study, S-268019-b (n = 101), a recombinant spike protein vaccine, was analyzed for noninferiority versus BNT162b2 (n = 103), when given as a booster ≥6 months after 2-dose BNT162b2 regimen in Japanese adults without prior SARS-CoV-2 infection. Interim results showed noninferiority of S-268019-b versus BNT162b2 in co-primary endpoints for neutralizing antibodies on day 29: geometric mean titer (GMT) (124.97 versus 109.70; adjusted-GMT ratio [95% CI], 1.14 [0.94-1.39]; noninferiority P-value, <0.0001) and seroresponse rate (both 100%; noninferiority P-value, 0.0004). Both vaccines elicited anti-spike-protein immunoglobulin G antibodies, and produced T-cell response (n = 29/group) and neutralizing antibodies against Delta and Omicron pseudovirus and live virus variants (n = 24/group) in subgroups. Most participants reported low-grade reactogenicity on days 1-2, the most frequent being fatigue, fever, myalgia, and injection-site pain. No serious adverse events were reported. In conclusion, S-268019-b was safe and showed robust immunogenicity as a booster, supporting its use as COVID-19 booster vaccine.


Subject(s)
BNT162 Vaccine , COVID-19 , Adult , Antibodies, Neutralizing , BNT162 Vaccine/adverse effects , COVID-19/prevention & control , Humans , Immunogenicity, Vaccine , Japan
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