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1.
Acta Med Indones ; 53(3): 326-330, 2021 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-34611073

RESUMEN

SARS CoV-2 virus has infected more than 200 million people worldwide and more than 4.4 million in Indonesia. The vaccination program has become one of the solutions launched by many countries globally, including Indonesia, to reduce the transmission rate of COVID-19. Various vaccination platforms are produced, such as inactivated, viral vector, mRNA, and protein subunit. The vaccination booster program with mRNA platform (Moderna) was launched by the Indonesian government to give better protection for health care workers, particularly from delta variant. In this case report, we discuss one of the typical side effects of Moderna vaccine, which is referred to as the COVID arm.


Asunto(s)
Acetaminofén/administración & dosificación , Vacunas contra la COVID-19 , COVID-19/prevención & control , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Hipersensibilidad Retardada , Piel/patología , Analgésicos no Narcóticos/administración & dosificación , Biopsia/métodos , COVID-19/epidemiología , Vacunas contra la COVID-19/administración & dosificación , Vacunas contra la COVID-19/efectos adversos , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/etiología , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/fisiopatología , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/terapia , Femenino , Fiebre/tratamiento farmacológico , Fiebre/etiología , Humanos , Hipersensibilidad Retardada/inducido químicamente , Hipersensibilidad Retardada/fisiopatología , Hipersensibilidad Retardada/terapia , Reacción en el Punto de Inyección/diagnóstico , Reacción en el Punto de Inyección/etiología , Reacción en el Punto de Inyección/fisiopatología , Persona de Mediana Edad , Médicos , SARS-CoV-2 , Resultado del Tratamiento , Vacunación/métodos
2.
PLoS One ; 16(10): e0258236, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-34597333

RESUMEN

BACKGROUND: All healthcare workers (HCWs) in Yongin Severance Hospital were allocated to receive the ChAdOx1 nCov-19 vaccine according to national policy. A report of thrombosis and thrombocytopenia syndrome (TTS) associated with ChAdOx1 nCoV-19 led to hesitancy about receiving the second dose among HCWs who had received the first dose. METHODS: From 7 to 14 May, 2021, we performed a survey to identify the factors associated with hesitancy about receiving the second vaccine dose among HCWs at the hospital who had received the first dose of the vaccine. Based on survey results, a hospital-wide campaign was implemented on 18 May 2021 to improve vaccine coverage. HCWs who completed the second dose completed a self-administered questionnaire to evaluate the effect of the campaign. FINDINGS: Of 1,171 HCWs who had received the first dose of the vaccine, 71.5% completed the online survey, of whom 3.7% refused to take the second dose and 22.3% showed hesitancy. Hesitancy to receive a second dose was significantly associated with age under 30 years and concerns about TTS, and was less common among those who trusted effectiveness and safety of the vaccine. Among HCWs who received the first dose, 96.2% completed vaccination with the second dose between 27 May and 4 June, 2021. Of those who answered the questionnaire asked about the timing of their decision to receive the second dose, 57.1% reported that they were motivated by the hospital-wide campaign. CONCLUSION: A tailored intervention strategy based on a survey can improve COVID-19 vaccination uptake among HCWs.


Asunto(s)
Vacunas contra la COVID-19/administración & dosificación , COVID-19/prevención & control , Personal de Salud/psicología , Adulto , COVID-19/virología , Vacunas contra la COVID-19/efectos adversos , Femenino , Política de Salud , Hospitales , Humanos , Internet , Masculino , Persona de Mediana Edad , República de Corea , SARS-CoV-2/aislamiento & purificación , Encuestas y Cuestionarios , Trombocitopenia/etiología , Trombosis/etiología
4.
J Stroke Cerebrovasc Dis ; 30(10): 105923, 2021 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-34627592

RESUMEN

OBJECTIVE: To assess the association of COVID-19 vaccines and non-COVID-19 vaccines with cerebral venous sinus thrombosis (CVST). MATERIALS AND METHOD: We retrospectively analyzed a cohort of 771,805 vaccination events across 266,094 patients in the Mayo Clinic Health System between 01/01/2017 and 03/15/2021. The primary outcome was a positive diagnosis of CVST, identified either by the presence of a corresponding ICD code or by an NLP algorithm which detected positive diagnosis of CVST within free-text clinical notes. For each vaccine we calculated the relative risk by dividing the incidence of CVST in the 30 days following vaccination to that in the 30 days preceding vaccination. RESULTS: We identified vaccination events for all FDA-approved COVID-19 vaccines including Pfizer-BioNTech (n = 94,818 doses), Moderna (n = 36,350 doses) and Johnson & Johnson - J&J (n = 1,745 doses). We also identified vaccinations events for 10 common FDA-approved non-COVID-19 vaccines (n = 771,805 doses). There was no statistically significant difference in the incidence rate of CVST in 30-days before and after vaccination for any vaccine in this population. We further found the baseline CVST incidence in the study population between 2017 and 2021 to be 45 to 98 per million patient years. CONCLUSIONS: This real-world evidence-based study finds that CVST is rare and is not significantly associated with COVID-19 vaccination in our patient cohort. Limitations include the rarity of CVST in our dataset, a relatively small number of J&J COVID-19 vaccination events, and the use of a population drawn from recipients of a SARS-CoV-2 PCR test in a single health system.


Asunto(s)
Vacunas contra la COVID-19/efectos adversos , COVID-19/prevención & control , Trombosis de los Senos Intracraneales/epidemiología , Vacunación/efectos adversos , COVID-19/inmunología , COVID-19/virología , Registros Electrónicos de Salud , Humanos , Incidencia , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Trombosis de los Senos Intracraneales/diagnóstico , Factores de Tiempo , Estados Unidos/epidemiología
5.
Front Immunol ; 12: 733418, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-34603311

RESUMEN

Myasthenia gravis (MG) is an autoimmune disease characterized by muscle weakness and abnormal fatigability due to the antibodies against postsynaptic receptors. Despite the individual discrepancy, patients with MG share common muscle weakness, autoimmune dysfunction, and immunosuppressive treatment, which predispose them to infections that can trigger or exacerbate MG. Vaccination, as a mainstay of prophylaxis, is a major management strategy. However, the past years have seen growth in vaccine hesitancy, owing to safety and efficacy concerns. Ironically, vaccines, serving as an essential and effective means of defense, may induce similar immune cross-reactivity to what they are meant to prevent. Herein, we outline the progress in vaccination, review the current status, and postulate the clinical association among MG, vaccination, and immunosuppression. We also address safety and efficacy concerns of vaccination in MG, in relation to COVID-19. Since only a handful of studies have reported vaccination in individuals with MG, we further review the current clinical studies and guidelines in rheumatic diseases. Overall, our reviews offer a reference to guide future vaccine clinical decision-making and improve the management of MG patients.


Asunto(s)
Vacunas contra la COVID-19/efectos adversos , Vacunas contra la COVID-19/inmunología , COVID-19/prevención & control , Miastenia Gravis/inmunología , Miastenia Gravis/patología , SARS-CoV-2/inmunología , Autoinmunidad/inmunología , Humanos , Tolerancia Inmunológica/inmunología , Vacunas contra la Influenza/inmunología , Riesgo , Vacunación/efectos adversos
6.
Chest ; 160(3): e289-e293, 2021 09.
Artículo en Inglés | MEDLINE | ID: mdl-34488970

RESUMEN

CASE PRESENTATION: A 24-year-old man, never smoker, with no medical or surgical history, not currently on medications, presented to the ED with a second episode of gross hemoptysis, 4 months after an initial episode that had not previously been evaluated. He described the current episode of hemoptysis as "enough to fill the sink"; however, he did not further quantify. He has no history of recurrent epistaxis, hematemesis, or other evidence of clotting disorder. He denied any fevers, chills, night sweats, or recent travel. He denied any sick contacts and has no history of TB exposure or risk factors. The patient denied any shortness of breath, wheezing, or chest pain. He had no lower extremity pain or swelling. He routinely exercises and generally lives a healthy lifestyle. He is a health care worker who has not routinely worked with patients infected with SARS-CoV-2, although he received his second (of two) COVID-19 vaccines 4 days before presentation.


Asunto(s)
Vacunas contra la COVID-19/efectos adversos , COVID-19/terapia , Hematemesis/etiología , Linfadenopatía/diagnóstico , SARS-CoV-2/inmunología , Humanos , Masculino , Tórax , Adulto Joven
7.
Int J Mol Med ; 48(5)2021 11.
Artículo en Inglés | MEDLINE | ID: mdl-34515322

RESUMEN

Soon after the beginning of the severe acute respiratory syndrome coronavirus 2 (SARS­CoV­2) pandemic in December, 2019, numerous research teams, assisted by vast capital investments, achieved vaccine development in a fraction of time. However, almost 8 months following the initiation of the European vaccination programme, the need for prospective monitoring of the vaccine­induced immune response, its determinants and related side­effects remains a priority. The present study aimed to quantify the immune response following full vaccination with the BNT162b2 coronavirus disease 2019 (COVID­19) mRNA vaccine by measuring the levels of immunoglobulin G (IgG) titers in healthcare professionals. Moreover, common side­effects and factors associated with IgG titers were identified. For this purpose, blood samples from 517 individuals were obtained and analysed. Blood sampling was performed at a mean period of 69.0±23.5 days following the second dose of the vaccine. SARS­CoV­2 IgG titers had an overall mean value of 4.23±2.76. Females had higher titers than males (4.44±2.70 and 3.89 ±2.84, respectively; P=0.007), while non­smokers had higher titers than smokers (4.48±2.79 and 3.80±2.64, respectively; P=0.003). An older age was also associated with lower antibody titers (P<0.001). Moreover, the six most prevalent adverse effects were pain at the injection site (72.1%), generalized fatigue (40.5%), malaise (36.3%), myalgia (31,0%), headache (25.8%) and dizziness/weakness (21.6%). The present study demonstrated that the immune response after receiving the BNT162b2 COVID­19 mRNA vaccine is dependent on various modifiable and non­modifiable factors. Overall, the findings of the present study highlight two key aspects of the vaccination programs: First, the need for prospective immunosurveillance studies in order to estimate the duration of immunity, and second, the need to identify those individuals who are at a greater risk of developing low IgG titers in order to evaluate the need for a third dose of the vaccine.


Asunto(s)
Anticuerpos Antivirales/sangre , Vacunas contra la COVID-19/inmunología , Inmunoglobulina G/sangre , Adulto , Anciano , Anciano de 80 o más Años , COVID-19/prevención & control , Vacunas contra la COVID-19/administración & dosificación , Vacunas contra la COVID-19/efectos adversos , Femenino , Personal de Salud/estadística & datos numéricos , Humanos , Masculino , Persona de Mediana Edad , Adulto Joven
9.
Clin Appl Thromb Hemost ; 27: 10760296211040110, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-34541935

RESUMEN

Since the outbreak of Covid-19 in December, 2019, scientists worldwide have been committed to developing COVID-19 vaccines. Only when most people have immunity to SARS-CoV-2, COVID-19 can reduce even wholly overcome. So far, nine kinds of COVID-19 vaccines have passed the phase III clinical trials and have approved for use. At the same time, adverse reactions after COVID-19 vaccination have also reported. This paper focuses on the adverse effects of thrombosis and thrombocytopenia caused by the COVID-19 vaccine, especially the adenovirus-vector vaccine from AstraZeneca and Pfizer, and discusses its mechanism and possible countermeasures.


Asunto(s)
Adenoviridae/genética , Vacunas contra la COVID-19/efectos adversos , Vectores Genéticos , Trombocitopenia/inducido químicamente , Trombosis/inducido químicamente , Vacunación/efectos adversos , Anticuerpos/sangre , Vacunas contra la COVID-19/genética , Vacunas contra la COVID-19/inmunología , Humanos , Factor Plaquetario 4/inmunología , Medición de Riesgo , Factores de Riesgo , Trombocitopenia/sangre , Trombocitopenia/inmunología , Trombosis/sangre , Trombosis/inmunología
10.
Isr J Health Policy Res ; 10(1): 54, 2021 09 13.
Artículo en Inglés | MEDLINE | ID: mdl-34517920

RESUMEN

BACKGROUND: Following other countries, Israel passed the Vaccine Injury Compensation Law in 1989, which provides for compensation to vaccine recipients who had suffered injuries without proving negligence. In 2021, after deliberations between the ministries of health and of finance Covid-19 vaccines (administered from the beginning of the campaign on December 20, 2020 and up to December 21, 2022) were included within the compensation law. The current study aims to examine the objectives of Israel's Vaccine Injury Compensation Law, at the time of its enactment, and to explore barriers to their fulfillment. These issues are especially relevant in light of the discussions held on the option for liability exemption which excludes the possibility of redress from the Covid-19 vaccine manufacturers in case of injury attributed to the vaccine, and considering the heavy burden of proof required in standard tort law. METHODS: The study employed a qualitative methodology which made use of both content analysis of relevant documents and in-depth interviews. RESULTS: In passing the Vaccine Injury Compensation Law, legislators sought to assist vaccine recipients who had suffered injuries by both lowering their burden of proof as well as establishing a short and efficient procedure for deliberating their claims. Furthermore, legislators believed that the assurance of compensation to vaccine recipients who had suffered injuries would help to encourage a high rate of vaccination compliance. An examination of the law's implementation over time revealed that the aforementioned goals were not attained. CONCLUSIONS: Implementation of the law since its enactment missed the opportunity to fulfill its original purposes to promote public health fundamental principles of fairness and solidarity. In addition, the adversarial proceedings as well as some of the law's provisions have the potential to undermine public trust in the State's willingness to grant compensation for injuries that are attributed to vaccines and thereby subvert the law's pivotal objective of promoting trust and vaccine compliance. We suggest that allowing circumstantial evidence as to an association between vaccine and an injury, transitioning to administrative deliberation, making available to the public details of cases where compensation was awarded, as well as other possible emendations would help it better reflect the values of fairness and solidarity that underlying the law's purpose. These would also promote the level of trust in healthcare authorities which is essential to preserving high vaccine coverage.


Asunto(s)
Vacunas contra la COVID-19/efectos adversos , Compensación y Reparación/legislación & jurisprudencia , Vacunas contra la COVID-19/economía , Política de Salud , Humanos , Israel , Responsabilidad Legal , Aceptación de la Atención de Salud
12.
Front Immunol ; 12: 728513, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-34484238

RESUMEN

VITT is a rare, life-threatening syndrome characterized by thrombotic symptoms in combination with thrombocytopenia, which may occur in individuals receiving the first administration of adenoviral non replicating vectors (AVV) anti Covid19 vaccines. Vaccine-induced immune thrombotic thrombocytopenia (VITT) is characterized by high levels of serum IgG that bind PF4/polyanion complexes, thus triggering platelet activation. Therefore, identification of the fine pathophysiological mechanism by which vaccine components trigger platelet activation is mandatory. Herein, we propose a multistep mechanism involving both the AVV and the neo-synthetized Spike protein. The former can: i) spread rapidly into blood stream, ii), promote the early production of high levels of IL-6, iii) interact with erythrocytes, platelets, mast cells and endothelia, iv) favor the presence of extracellular DNA at the site of injection, v) activate platelets and mast cells to release PF4 and heparin. Moreover, AVV infection of mast cells may trigger aberrant inflammatory and immune responses in people affected by the mast cell activation syndrome (MCAS). The pre-existence of natural antibodies binding PF4/heparin complexes may amplify platelet activation and thrombotic events. Finally, neosynthesized Covid 19 Spike protein interacting with its ACE2 receptor on endothelia, platelets and leucocyte may trigger further thrombotic events unleashing the WITT syndrome.


Asunto(s)
Anticuerpos/efectos adversos , Vacunas contra la COVID-19/efectos adversos , COVID-19/prevención & control , Púrpura Trombocitopénica Idiopática/inducido químicamente , Púrpura Trombocitopénica Idiopática/fisiopatología , Adenoviridae/genética , Animales , Plaquetas/inmunología , Plaquetas/patología , Vacunas contra la COVID-19/inmunología , Modelos Animales de Enfermedad , Vectores Genéticos , Humanos , Ratones , Activación Plaquetaria/inmunología , Factor Plaquetario 4 , Conejos
13.
J Korean Med Sci ; 36(35): e250, 2021 Sep 06.
Artículo en Inglés | MEDLINE | ID: mdl-34490757

RESUMEN

There are still no agreed guidelines on the vaccination of coronavirus disease 2019 (COVID-19) for previously infected patients. Here, we present two seropositive healthcare workers (HCWs) working in an isolation ward who recovered from COVID-19 in April 2020 and got vaccinated with BNT162b2 vaccine in March 2021. We have assessed the clinical course, vaccine-related adverse events, and antibody response after natural infection and after first and second dose vaccination. One of the two HCWs was asymptomatic during quarantine, but the other had mild upper respiratory infection symptoms 1 day before admission, and the symptoms continued for 9 days. There was no pneumonic infiltration in chest X-ray in both patients, and no COVID-19 specific treatment was administered. Total immunoglobulin antibody and neutralizing antibody to anti-spike protein receptor-binding domain of severe acute respiratory syndrome coronavirus 2 were confirmed to be present in both HCWs in blood tests performed at 2 weeks and 4 weeks after discharge. Antibody response to mRNA vaccination showed marked elevation after the first vaccination, which was 30-40 times higher than that of antibody titer after natural infection in each patient (83.2 U/mL vs. > 2,500 U/mL in patient 1; 61.6 U/mL vs. > 2,500 U/mL in patient 2). Signal inhibition rate of neutralizing antibodies was also increased to over 97%. Due to this increased effect, there was little difference in antibody levels after the first and second dose. Both patients 1 and 2 suffered more from adverse vaccine reactions after the second vaccination than from COVID-19 symptoms.


Asunto(s)
Anticuerpos Antivirales/sangre , Vacunas contra la COVID-19/inmunología , COVID-19/prevención & control , SARS-CoV-2/inmunología , Adulto , Anticuerpos Neutralizantes/sangre , COVID-19/inmunología , Vacunas contra la COVID-19/efectos adversos , Femenino , Personal de Salud , Humanos , Vacunación
15.
Allergy Asthma Proc ; 42(5): 395-399, 2021 Sep 01.
Artículo en Inglés | MEDLINE | ID: mdl-34474708

RESUMEN

Background: Adverse reactions, including anaphylaxis, to messenger RNA coronavirus disease 2019 (COVID-19) vaccines rarely occur. Because of the need to administer a timely second dose in subjects who reported a reaction to their first dose, a panel of health-care professionals developed a safe triage of the employees and health care providers (EHCP) at a large health-care system to consider administration of future dosing. Methods: There were 28,544 EHCPs who received their first dose of COVID-19 vaccines between December 15, 2020, and March 8, 2021. The EHCPs self-reported adverse reactions to a centralized COVID-19 command center (CCC). The CCC screened and collected information on the quality of reaction, symptoms, and timing of the onset of the reaction. Results: Of 1253 calls to the CCC, 113 were identified as requiring consideration by a panel of three (American Board of Allergy and Immunology) ABAI-certified allergists for future dosing or formal in-person assessment. Of the 113 EHCPs, 94 (83.2%) were recommended to get their second dose. Eighty of 94 received their second planned dose without a severe or immediate reaction. Of the 14 of 113 identified as needing further evaluation, 6 were evaluated by a physician and subsequently received their second dose without a serious adverse reaction. Eight of 14 did not receive their second dose. Only 5 of the 113 EHCPs reported reactions (4.4%) were recommended to not take the second dose: 3 (2.6%) because of symptoms consistent with anaphylaxis, and 2 because of neurologic complications (seizure, stroke). Conclusion: The panel demonstrated that, by consideration of reaction history alone, the ECHPs could be appropriately triaged to receive scheduled second dosing of COVID-19 vaccines without delays for in-person evaluation and allergy testing.


Asunto(s)
Anafilaxia/etiología , Vacunas contra la COVID-19/efectos adversos , COVID-19/prevención & control , Personal de Salud , Enfermedades Profesionales/prevención & control , Triaje/métodos , Vacunas Sintéticas/efectos adversos , Adulto , Anciano , Anafilaxia/diagnóstico , Anafilaxia/prevención & control , Vacunas contra la COVID-19/administración & dosificación , Femenino , Humanos , Masculino , Persona de Mediana Edad , Servicios de Salud del Trabajador/métodos , Servicios de Salud del Trabajador/normas , Mejoramiento de la Calidad , Estudios Retrospectivos , Autoinforme , Triaje/normas , Vacunas Sintéticas/administración & dosificación
17.
Eur Rev Med Pharmacol Sci ; 25(17): 5525-5528, 2021 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-34533798

RESUMEN

The Pfizer-BioNTech coronavirus disease 2019 (COVID-19) vaccine is the first novel nucleoside-modified messenger ribonucleic acid (modRNA) vaccine to receive Emergency Use Authorization from the Food and Drug Administration in the United States. It is indicated to be used in patients ≥12 years-of-age as of May 25th, 2021, including populations with high atherosclerotic cardiovascular disease (ASCVD) burden. However, little is known about the potential impact this vaccine may have on serum lipoprotein levels in patients with familial hypercholesteremia (FH), who are predisposed to high ASCVD burden due to elevated low-density lipoprotein cholesterol (LDL-C). We present an interesting case where a patient with heterozygous FH (HeFH) and elevated triglycerides (TG)-controlled for years on medication and apheresis-experienced significantly elevated TG, one day after receiving his second Pfizer-BioNTech COVID-19 vaccine dose. It is not known whether this adverse event may be seen in other FH patients and may be worth assessing in such patients to determine the possibility of a rare adverse reaction from a COVID-19 vaccine.


Asunto(s)
Vacunas contra la COVID-19/efectos adversos , Hiperlipoproteinemia Tipo II/sangre , Hipertrigliceridemia/etiología , COVID-19/prevención & control , Colesterol/sangre , Humanos , Hipertrigliceridemia/sangre , Masculino , Persona de Mediana Edad , SARS-CoV-2/inmunología , Triglicéridos/sangre , Vacunación
18.
JAMA Netw Open ; 4(9): e2125524, 2021 09 01.
Artículo en Inglés | MEDLINE | ID: mdl-34533570

RESUMEN

Importance: As of May 2021, more than 32 million cases of COVID-19 have been confirmed in the United States, resulting in more than 615 000 deaths. Anaphylactic reactions associated with the Food and Drug Administration (FDA)-authorized mRNA COVID-19 vaccines have been reported. Objective: To characterize the immunologic mechanisms underlying allergic reactions to these vaccines. Design, Setting, and Participants: This case series included 22 patients with suspected allergic reactions to mRNA COVID-19 vaccines between December 18, 2020, and January 27, 2021, at a large regional health care network. Participants were individuals who received at least 1 of the following International Statistical Classification of Diseases and Related Health Problems, Tenth Revision anaphylaxis codes: T78.2XXA, T80.52XA, T78.2XXD, or E949.9, with documentation of COVID-19 vaccination. Suspected allergy cases were identified and invited for follow-up allergy testing. Exposures: FDA-authorized mRNA COVID-19 vaccines. Main Outcomes and Measures: Allergic reactions were graded using standard definitions, including Brighton criteria. Skin prick testing was conducted to polyethylene glycol (PEG) and polysorbate 80 (P80). Histamine (1 mg/mL) and filtered saline (negative control) were used for internal validation. Basophil activation testing after stimulation for 30 minutes at 37 °C was also conducted. Concentrations of immunoglobulin (Ig) G and IgE antibodies to PEG were obtained to determine possible mechanisms. Results: Of 22 patients (20 [91%] women; mean [SD] age, 40.9 [10.3] years; 15 [68%] with clinical allergy history), 17 (77%) met Brighton anaphylaxis criteria. All reactions fully resolved. Of patients who underwent skin prick tests, 0 of 11 tested positive to PEG, 0 of 11 tested positive to P80, and 1 of 10 (10%) tested positive to the same brand of mRNA vaccine used to vaccinate that individual. Among these same participants, 10 of 11 (91%) had positive basophil activation test results to PEG and 11 of 11 (100%) had positive basophil activation test results to their administered mRNA vaccine. No PEG IgE was detected; instead, PEG IgG was found in tested individuals who had an allergy to the vaccine. Conclusions and Relevance: Based on this case series, women and those with a history of allergic reactions appear at have an elevated risk of mRNA vaccine allergy. Immunological testing suggests non-IgE-mediated immune responses to PEG may be responsible in most individuals.


Asunto(s)
Vacunas contra la COVID-19/efectos adversos , Hipersensibilidad/diagnóstico , Adolescente , Adulto , Anciano , Vacunas contra la COVID-19/uso terapéutico , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/diagnóstico , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Femenino , Humanos , Hipersensibilidad/epidemiología , Masculino , Persona de Mediana Edad , Factores de Riesgo , Estados Unidos/epidemiología , United States Food and Drug Administration/organización & administración , United States Food and Drug Administration/estadística & datos numéricos , Vacunación/efectos adversos
19.
PLoS One ; 16(9): e0257668, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-34543337

RESUMEN

BACKGROUND: Adverse reactions are more common after the second injection of messenger RNA vaccines such as Pfizer/BioNTech's BNT162b2. We hypothesized that the degree and severity of reactogenicity after the second injection reflects the magnitude of antibody production against the SARS CoV-2 virus spike protein (spike IgG). METHODS AND RESULTS: Blood samples were obtained from 67 Japanese healthcare workers three weeks after the first injection and two weeks after the second injection of the BNT162b2 vaccine to measure spike IgG levels. Using questionnaires, we calculated an adverse event (AE) score (0-11) for each participant. The geometric mean of spike IgG titers increased from 1,047 antibody units (AU/mL) (95% confidence interval (95% CI): 855-1282 AU/mL) after the first injection to 17,378 AU/mL (95% CI: 14,622-20,663 AU/mL) after the second injection. The median AE score increased from 2 to 5. Spike IgG levels after the second injection were negatively correlated with age and positively correlated with spike IgG after the first injection. AE scores after the second injection were not significantly associated with log-transformed spike IgG after the second injection, when adjusted for age, sex, AE score after the first injection, and log-transformed spike IgG after the first injection. CONCLUSIONS: Although the sample size was relatively small, reactogenicity after the second injection may not accurately reflect antibody production.


Asunto(s)
Grupo de Ascendencia Continental Asiática , Vacunas contra la COVID-19/inmunología , Inmunoglobulina G/sangre , Inyecciones , Glicoproteína de la Espiga del Coronavirus/inmunología , Adulto , COVID-19/sangre , COVID-19/inmunología , COVID-19/virología , Vacunas contra la COVID-19/efectos adversos , Femenino , Humanos , Modelos Lineales , Masculino , Persona de Mediana Edad , Análisis Multivariante , SARS-CoV-2/fisiología
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