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1.
Exp Ther Med ; 25(6): 291, 2023 Jun.
Article in English | MEDLINE | ID: covidwho-2323280

ABSTRACT

Severe acute respiratory syndrome coronavirus 2 (Sars-CoV-2) infection has significantly affected immunocompromised individuals and subsequently, liver transplant recipients (LTRs). Early in the course of pandemic, this vulnerable population was prioritized for vaccination, after obtaining encouraging data about the vaccination benefits on disease severity and mortality. As the published knowledge was mainly supported from studies which were limited to the healthy population, the present review summarizes the data from the literature on coronavirus disease 2019 (COVID-19) vaccination in LTRs and the available vaccination guidelines of international societies. The COVID-19 vaccination of LTRs is strongly recommended as a safe and effective measure in order to prevent severe disease and mortality.

2.
Donald School Journal of Ultrasound in Obstetrics and Gynecology ; 17(1):60-66, 2023.
Article in English | EMBASE | ID: covidwho-2315029

ABSTRACT

The COVID-19 pandemic is unprecedented in our lifetime, especially in perinatology. The gold standard is to strongly recommend COVID-19 vaccinations to those trying to get pregnant, to those who are pregnant, and to those who are postpartum. When the benefits of vaccines far outweigh the risks, it is unethical to disseminate wrong information and discourage patients from becoming vaccinated. COVID-19 vaccinations and boosters prevent severe diseases and adverse pregnancy and neonatal outcomes. A pregnant patient's vaccination also protects the newborn infant because maternal antibodies protect the fetus and newborn. COVID-19 vaccinations and boosters in pregnancy are safe for the pregnant patient and her fetus. The three root causes of physician hesitancy-misapplication of therapeutic nihilism, misapplication of shared decision-making, and misapplication of respect for autonomy should not be ignored and need to be addressed. It is important that we heed Brent 's insightful recommendations. Doing nothing with respect to vaccination is not an option, whether it applies to COVID-19 vaccines or to future pandemics. Physician hesitation is not an option. When there is sufficient evidence of vaccine safety and effectiveness without documented risks, vaccine recommendations before, during, and after pregnancy should be explicitly made to prevent maternal, fetal, and neonatal morbidity and mortality.Copyright © The Author(s). 2023.

3.
Br J Haematol ; 2022 Nov 10.
Article in English | MEDLINE | ID: covidwho-2264975

ABSTRACT

Given the lack of information about safety of the COVID-19 vaccines for sickle cell disease (SCD) patients, we sought to determine whether COVID-19 vaccine was associated with subsequent hospital admission for vaso-occlusive events (VOEs). We included 402 patients with SCD, including 88 regularly transfused. As of July 31, 2021, 213 (53.0%) of them had received a least one dose of COVID vaccine (Pfizer 93.0%). We showed similar risk of hospital admission for a VOE among vaccinated patients (whether transfused or not) and among a control group of non-vaccinated patients matched for age, sex and genotype.

4.
2022 International Conference on Biomedical and Intelligent Systems, IC-BIS 2022 ; 12458, 2022.
Article in English | Scopus | ID: covidwho-2193345

ABSTRACT

Coronavirus disease 2019 (COVID-19) has become a global pandemic, causing heavy losses to the global community. Novel Coronavirus development speed, the scope of the large, so that biomedical workers have to face together. Meanwhile COVID-19 (SARS-CoV-2) has a strong infection rate as well as certain mortality rate, which brings challenges to the treatment of the disease. Vaccination is an important means to prevent infectious diseases. At present, many research institutions around the world have launched the research as well as advance of COVID-19 vaccines. The current situation of SARS-CoV2 pandemic has triggered development and use of epidemiological vaccines in the medical community. Aiming at vaccines evolution is to acquire straight as proof of vaccines efficient in defend people from SARS-CoV-2 as well as COVID-19 in order to effective vaccine manufacture will be selectively. One vaccine candidate against COVID-19 may fight acute, disease, either contagion, or a vaccine which reduces anyone the elements may aid in disease control. This article introduces the morphological characteristics, mechanism of action, clinical utility, enhance as well as differences of COVID-19 vaccines development, In order to compare mRNA vaccine , subunit vaccine and attenuated vaccine and studied from multiple medical perspectives to promote the selection and use of vaccine in a safer way and ensure the best efficacy end points, prevent grave pathema and doom, as assessed about phase 3 clinical trials. hoping to help comprehend development as well as vaccination point at COVID-19 vaccine in the future. © 2022 SPIE. All rights reserved.

5.
Front Public Health ; 10: 1007637, 2022.
Article in English | MEDLINE | ID: covidwho-2109884

ABSTRACT

Introduction: Reports of unexpected side effects have accompanied the vaccination of larger proportions of the population against coronavirus disease 2019 (COVID-19), including a few cases of inflammatory myopathy (IM). In a bid to improve understanding of the clinical course of vaccine complications, a systematic review of reported cases of IM following COVID-19 vaccination has been conducted. Methods: The PRISMA guideline 2020 was followed. Two independent investigators systematically searched PubMed and Embase to identify relevant studies published up to July 2022, using the following keywords: COVID-19 Vaccine, inflammatory myositis. The Joanna Briggs Institute critical appraisal tools were used for the risk of bias. Results: A total of 24 articles presenting clinical features of 37 patients with IM following COVID-19 vaccine were identified. Female patients composed 59.5% of cases and 82.4% had been vaccinated with BNT162b2 or ChAdOx1. Onset of symptoms occurred within 2 weeks of the first or second vaccine dose in 29 (85.3%) patients and included muscular weakness in 54.1% and skin rash in 71.4% of patients. Myositis specific autoantibodies (MSAs) and myositis associated autoantibodies (MAAs) were reported in 28 patients. Specific clinical subtypes of myositis, reported in 27 patients, included 22 (81.5%) cases of dermatomyositis (DM) and 3 (11.1%) cases of immune-mediated necrotizing myopathy (IMNM). Following treatment, 32 (86.5%) patients showed improvement on follow-up. Conclusion: COVID-19 vaccine may induce various clinical myositis subtypes and related antibodies. Muscular weakness was the most common presenting symptom. Clinicians should be aware of this unexpected adverse event following COVID-19 vaccination and arrange for appropriate management. Systematic review registration: INPLASY https://inplasy.com/inplasy-2022-9-0084/ [INPLASY202290084].


Subject(s)
COVID-19 , Myositis , Female , Humans , Autoantibodies , BNT162 Vaccine , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Muscle Weakness , Myositis/etiology , Vaccination
6.
World J Virol ; 11(4): 170-175, 2022 Jul 25.
Article in English | MEDLINE | ID: covidwho-2056073

ABSTRACT

Vaccination for coronavirus disease 2019 (COVID-19) is a critical strategy in controlling the current pandemic of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). After widespread COVID-19 vaccine imple-mentation, isolated case reports about myocarditis as a potential adverse reaction started coming. As of November 12, 2021, Centers for Disease Control and Prevention (CDC) has reported 1793 cases of myocarditis or pericarditis among young people with age 12-29 years, most cases have been reported in the male adolescent age group after the second dose of mRNA COVID-19 vaccines. It is very important to monitor the safety standards and adverse reactions of vaccines to effectively implement the vaccination policies. The CDC and the United States Food and Drug Administration actively monitor vaccine-associated adverse reactions a well-known platform such as Vaccine Adverse Event Reporting System. CDC continues to recommend COVID-19 vaccines and booster doses for eligible individuals (age limit according to the type of vaccine) after careful consideration from risk-benefit assessment and favorable outcomes from vaccination. Mechanisms behind COVID-19 vaccine-induced myocarditis are not clear yet but several possibilities such as molecular mimicry between the spike protein of SARS-CoV-2 and self-antigens, immune response to mRNA, and activation of host immunological system, trigger of the pre-existing dysregulated immunological system have been documented in the literature. Overall, data suggests a good prognosis, especially in young patients. In this review article, we cover currently available data on COVID-19 vaccine-related myocarditis incidence, concerns, possible mechanisms of myocarditis, current treatment, and outcome trends, risk vs benefit assessment of COVID-19 vaccination in this current pandemic.

7.
Case Rep Ophthalmol ; 13(2): 459-464, 2022.
Article in English | MEDLINE | ID: covidwho-1986523

ABSTRACT

The study aimed to describe a case of rapid progression of polypoidal choroidal vasculopathy (PCV) following the third administration of the Pfizer-BioNTech (BNT162b2) mRNA vaccine. A 79-year-old Japanese man visited our hospital with a 1-week history of blurred vision in the left eye 16 h following the administration of the third BNT162b2 mRNA vaccine. The clinical examinations and imaging tests revealed massive submacular hemorrhage (SMH) and excessive subretinal fluid (SRF), owing to PCV in the left eye. No ocular abnormality was observed in the right eye. His medical history included diabetes and ocular history included cataracts, nonproliferative diabetic retinopathy, glaucoma in both eyes, and irregular retinal pigment epithelium elevation in the left eye. Since he received a single intravitreal injection of aflibercept approximately 2 years ago for the treatment of diabetic macular edema in the left eye, the left eye was stable. We performed an intravitreal injection of bevacizumab and combined phacoemulsification with pars plana vitrectomy with gas, including subretinal injection of tissue plasminogen activator to displace the SMH. Thirteen days after the surgery, the SMH and SRF decreased. Although rare, mRNA COVID-19 vaccine administrations could be associated with PCV deterioration.

8.
Yale Journal of Biology and Medicine ; 95(2):191-197, 2022.
Article in English | Web of Science | ID: covidwho-1976003

ABSTRACT

Introduction: Creation of pop-up vaccination sites at trusted community locations has been encouraged to address vaccine hesitancy and provide equitable access to COVID-19 vaccination in minority communities. This study sought to study the healthcare economics of a community-based COVID-19 pop-up vaccination center in terms of the following: costs associated with operating the vaccination center, analysis of billing data from patients who received the Moderna COVID-19 vaccine, and costs of hospitalization for COVID-19 which may be avoided with widespread vaccination. Methods: The pop-up vaccination center was located in Port Jefferson Station, NY, USA. Costs associated with operation of the COVID-19 pop-up vaccination center were quantified, itemized, and tabulated. Current Procedural Technology codes were used to identify patients who received the Moderna COVID-19 vaccine. Billing data were quantified for the cohort as well as per each patient to receive the vaccine. Costs associated with provision of urgent care, emergency, and hospital services to patients with COVID-19 were obtained. Results: The total cost to operate the vaccination center was $25,880. The vaccination center administered the initial dose of the Moderna COVID-19 vaccine to N=251 patients between March and May, 2021. The standard hospital costs for patients admitted to the medical ICU due to COVID-19 ranged from $8,913 to $190,714, per patient. Conclusion: Since the Moderna COVID-19 vaccine series is effective in preventing hospitalization for 93% of patients, this community-based vaccination center's administration of the vaccine series to 240 patients meant aversion of hospitalization due to COVID-19 related morbidity for 223 patients. Therefore, the true impact of this vaccination center, measured in averted hospital costs, ranges from $1,987,599 to $42,529,222.

9.
Yakugaku Zasshi ; 142(8): 867-874, 2022.
Article in Japanese | MEDLINE | ID: covidwho-1968825

ABSTRACT

Particular batches of Moderna mRNA Coronavirus Disease 2019 (COVID-19) vaccine were recalled after foreign particles were found in some vaccine vials at the vaccination site in Japan in August 2021. We investigated the foreign particles at the request of the Ministry of Health, Labour and Welfare. Energy dispersive X-ray spectroscopy analysis suggested that the foreign particles found in the vials recalled from the vaccination sites were from stainless steel SUS 316L, which was in line with the findings of the root cause investigation by the manufacturer. The sizes of the observed particles ranged from <50 µm to 548 µm in the major axis. Similar foreign particles were also detected in 2 of the 5 vaccine vials of the same lot stored by the manufacturer, indicating that the foreign particles have already been administered to some people via vaccine. Observation of the vials of the same lot by digital microscope found smaller particles those were not detected by visual inspection, suggesting that more vials were affected. Contrarily, visual inspection and subvisible particulate matter test indicated no foreign particles in the vials of normal lots. Possible root cause and strategies to prevent such a deviation were discussed from technical and regulatory aspects.


Subject(s)
2019-nCoV Vaccine mRNA-1273 , COVID-19 , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines , Humans , Japan/epidemiology , Particulate Matter
10.
Turk J Emerg Med ; 22(2): 111-113, 2022.
Article in English | MEDLINE | ID: covidwho-1835083

ABSTRACT

Coronavirus disease-2019 continues to have a serious impact in countries with the effect of new variant viruses emerging with mutations. While the effectiveness and protection of the vaccine have been determined all over the world, some vaccine-related side effects can be detected in the form of cases. In our case, the patient was admitted to the emergency department of our hospital with complaints of weakness and progressive rash on his legs. Diffuse petechiae purpura on the legs of the patient was observed and complete blood count revealed thrombocytopenia. Peripheral blood smear supported the blood count test results with thrombocytopenia, secondary causes of thrombocytopenia were excluded, and the patient was diagnosed with vaccine-induced immune thrombocytopenia.

11.
Int J STD AIDS ; 33(7): 652-659, 2022 06.
Article in English | MEDLINE | ID: covidwho-1820057

ABSTRACT

BACKGROUND: Prior research has established some risk factors for an increased risk of severe disease and mortality from coronavirus disease 2019 (COVID-19). However, the impact of HIV infection on SARS-CoV-2 susceptibility and severity is a significant gap in the literature. In the same way, not many studies across the globe have analyzed the degree of vaccination willingness among people living with HIV/AIDS (PLWHA) and considerations regarding prioritizing this population during vaccination plans, particularly in developing countries. METHODS: A descriptive-analytical cross-sectional study was conducted. Self-completed electronic surveys directed to PLWHA were performed via Twitter in February 2021, using accounts of HIV activists. RESULTS: 460 (87.1%) participants were willing to be vaccinated with any COVID-19 vaccine. The reasons for that were listed as 1) the belief that vaccination prevents both the COVID-19 infection (81.3%) as well as being a spreader (52.2%); 2) having a high occupational risk of becoming infected with COVID-19 (22%); and 3) the belief that they would be at high risk of death because of COVID-19 (21.3%). Only 56 (10.6%) participants expressed hesitancy toward vaccination, and 12 (2.2%) stated they did not want to get vaccinated. CONCLUSIONS: Our results may support the prioritization of people living with HIV during the implementation of vaccination plans in developing countries. New strategies should be adopted to overcome the hesitancy and unwillingness toward the COVID-19 vaccination, especially in populations with risk factors for severe disease.


Subject(s)
COVID-19 , HIV Infections , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines , Cross-Sectional Studies , HIV Infections/epidemiology , Health Knowledge, Attitudes, Practice , Humans , Latin America/epidemiology , SARS-CoV-2 , Vaccination
12.
J Dermatol ; 49(7): 732-735, 2022 Jul.
Article in English | MEDLINE | ID: covidwho-1774698

ABSTRACT

Skin disorders are frequent adverse events after coronavirus disease 2019 (COVID-19) vaccination. However, the pathogenesis of these disorders is not fully understood. Here, we report a case series of cutaneous adverse events following COVID-19 vaccination, and the results of our investigation reveal the underlying mechanism. Case 1: a 47-year-old female developed a wheal, confined to the COVID-19 vaccination site, 2 days after her first injection. She was treated with topical steroids and oral antihistamines. Case 2: a 51-year-old female showed generalized petechial erythema accompanied by fever, genital bleeding, thrombocytopenia, liver dysfunction, and disseminated intravascular coagulation, 2 days after her second injection. She was diagnosed with vaccine-induced macrophage activation syndrome and treated with anti-inflammatory therapy. Immunohistological analysis of the skin eruption, in both these cases, showed infiltration of CD123+ BDCA2+ plasmacytoid dendritic cells (p-DC). Despite the distinctive clinical features in these two cases, this finding suggests that p-DC might be involved in different cutaneous adverse events after COVID-19 vaccination.


Subject(s)
COVID-19 Vaccines , COVID-19 , Dendritic Cells , Erythema , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Erythema/chemically induced , Female , Humans , Middle Aged , Vaccination/adverse effects
13.
J Cardiol Cases ; 26(2): 97-100, 2022 Aug.
Article in English | MEDLINE | ID: covidwho-1773443

ABSTRACT

A 59-year-old man with systemic sclerosis and interstitial pneumonia was referred to our department because he developed dyspnea and leg edema after receiving a first shot of coronavirus disease 2019 (COVID-19) vaccine. Transthoracic echocardiography showed moderate pericardial effusion with conspicuous fibrin deposition. Prednisolone was increased from 6 mg/day for systemic sclerosis to 20 mg/day. Thereafter, pericardial effusion gradually decreased. However, his symptoms continued. Transthoracic echocardiography showed disappearance of pericardial effusion and thickened pericardium. Pulsed-wave and tissue Doppler echocardiography revealed that the patient suffered from newly developed constrictive pericarditis. COVID-19 vaccination might have contributed to acute pericarditis and subsequent constrictive pericarditis in the present case of systemic sclerosis and pulmonary fibrosis. Learning objective: Incidence of adverse effects after coronavirus disease 2019 vaccination is rare. The present case suggests the risk of pericarditis that may lead to constrictive pericarditis.

14.
Case Rep Nephrol Dial ; 12(1): 44-49, 2022.
Article in English | MEDLINE | ID: covidwho-1759571

ABSTRACT

This is the first report in an adolescent of minimal change disease (MCD) after the first injection of the BNT162b2 COVID-19 vaccine (Pfizer-BioNTech) with complete remission following steroid treatment. An 18-year-old white male with no prior medical history complained of gastrointestinal symptoms 11 days after his vaccination. Ascites and lower extremity edema were observed a few days later. He was admitted to a hospital as laboratory testing revealed proteinuria of 10.5 g/24 h, normal creatinine levels, and serum albumin of 1.8 g/dL, confirming the presence of nephrotic syndrome. Immunology and serology tests were unremarkable. A diagnostic kidney biopsy showed no significant glomerular or tubular abnormalities in light microscopy with negative immunofluorescence. Treatment with methylprednisolone 48 mg daily was initiated. A week after discharge, proteinuria declined to 1.2 g/24 h, and edema had disappeared, and 6 weeks later, complete remission was evident. As COVID-19 vaccination has been associated with the development of de novo and relapsing MCD, and this case provides additional support for this possible correlation.

15.
BMC Neurol ; 22(1): 54, 2022 Feb 12.
Article in English | MEDLINE | ID: covidwho-1677495

ABSTRACT

BACKGROUND: Acute disseminated encephalomyelitis (ADEM) is a rare immune-mediated inflammatory demyelinating disease of the central nervous system. We report a case of ADEM presenting with bilateral optic neuritis temporally associated with the ChAdOx1 vaccine against SARS-COVID19 virus. CASE PRESENTATION: A 36-year-old female presented with bilateral optic neuritis following her first dose of the ChAdOx1 vaccine. Initial MRI Brain showed evidence of demyelination within the subcortical white matter, with no radiological involvement of the optic nerves. Visual evoked potentials were consistent with bilateral optic neuritis which was confirmed radiologically on follow up MRI. She was treated with intravenous steroids with improvement both in symptoms and radiological appearance. A pseudo-relapse occurred which was treated with a further course of intravenous steroids followed by an oral taper. The clinical, radiological and serological results were most consistent with diagnosis of ADEM. CONCLUSIONS: ADEM is an exceedingly rare complication of ChAdOx1 vaccine despite millions of doses. While it is imperative clinicians remain aware of neurological complications of vaccines, the importance of vaccination to control a pandemic should not be undermined.


Subject(s)
COVID-19 , Encephalomyelitis, Acute Disseminated , Optic Neuritis , Adult , COVID-19 Vaccines , Encephalomyelitis, Acute Disseminated/diagnostic imaging , Encephalomyelitis, Acute Disseminated/drug therapy , Encephalomyelitis, Acute Disseminated/etiology , Evoked Potentials, Visual , Female , Humans , Optic Neuritis/drug therapy , Optic Neuritis/etiology , SARS-CoV-2 , Vaccination
16.
J Cardiol Cases ; 25(6): 400-403, 2022 Jun.
Article in English | MEDLINE | ID: covidwho-1670673

ABSTRACT

Kounis syndrome is an acute coronary syndrome occurring in the setting of a hypersensitivity reaction. It occurs as a consequence of mast-cell activation and degranulation causing coronary artery spasm, atherosclerotic plaque erosion, or stent thrombosis. We report the case of a man who presented to the emergency department with typical angina that started 20 minutes after coronavirus disease 2019 (COVID-19) vaccine administration. Electrocardiogram showed inferior ST-elevation myocardial infarction, and coronary angiography confirmed right coronary artery stent thrombosis. Five months before, he had an acute coronary syndrome after influenza vaccine administration. Both vaccines share a common excipient, polysorbate 80. Considering the reproducibility of the reaction and the temporal association between vaccine administration and coronary events, a hypersensitivity reaction to polysorbate 80 was admitted and the patient was instructed to further avoid drugs containing it. To our knowledge, this constitutes the first reported case of type 3 Kounis syndrome after COVID-19 vaccine administration. Kounis syndrome is an uncommon disease, often undiagnosed. Its recognition and proper management are crucial to prevent future events. .

17.
Reviews in Medical Microbiology ; 33(1):E198-E211, 2022.
Article in English | Web of Science | ID: covidwho-1583945

ABSTRACT

Guillain-Barre syndrome (GBS), the most frequent cause of acute paralytic neuropathy, is an inflammatory polyneuropathy that is autoimmune in nature. Many infectious agents such as Campylobacter jejuni (the most commonly identified bacteria associated with GBS), cytomegalovirus, Epstein-Barr virus, measles virus, influenza A virus, and Mycoplasma pneumonia, as well as enterovirus D68 and Zika virus and noninfectious agents such as vaccines and surgeries have been reported to trigger GBS. Three main variants of GBS include the classic acute inflammatory demyelinating polyneuropathy (AIDP), which is the most common presentation of GBS, Miller Fisher syndrome, and the recently defined axon loss variants (acute motor axonal neuropathy and acute motor and sensory axonal neuropathy). One of the assumptions about the mechanisms of GBS is molecular mimicry, which is a process caused due to the structural resemblance between a microorganism and the host. The original concept of GBS is rooted in molecular mimicry defined as the similarity between the microorganisms' peptide sequences or epitopes and ganglioside sequences or structures. Since the coronavirus disease-2019 outbreak in January 2020 there have been cases of GBS reported. Our review aims at providing an overview of some case reports of the severe acute respiratory syndrome coronavirus-2-related GBS. Copyright (C) 2021 Wolters Kluwer Health, Inc. All rights reserved.

18.
J Am Coll Emerg Physicians Open ; 2(5): e12531, 2021 Oct.
Article in English | MEDLINE | ID: covidwho-1427086

ABSTRACT

Immune thrombocytopenic purpura (ITP) is a rare complication associated with vaccines targeting various diseases, including influenza, measles-mumps-rubella, hepatitis B, and diphtheria-tetanus-pertussis. We report 2 cases of ITP in healthy 20-year-old and 21-year-old women presenting to Emory University in Atlanta, GA, 2 days after the second dose and 11 days after the first dose (respectively) of the Pfizer-BioNTech messenger RNA severe acute respiratory syndrome coronavirus 2 vaccine. Both patients recovered quickly. With more than a billion doses of coronavirus disease 2019 vaccines safely administered worldwide as of May 2021, discussions with patients should put into perspective the low risks of vaccination against the enormous societal benefit of the coronavirus disease 2019 vaccine.

19.
Am J Obstet Gynecol ; 224(5): 479-483, 2021 05.
Article in English | MEDLINE | ID: covidwho-1064723

ABSTRACT

Challenges arise when treatment to improve maternal health brings the possibility of risk to fetal health. The coronavirus disease 2019 (COVID-19) vaccine is the most recent, but hardly the only, example. Because pregnant patients are often specifically excluded from trials of new therapies, this is often the dilemma that patients and providers face when considering new treatments. In this study, we used the COVID-19 vaccine as an exemplar to question the broader issue of how society, in general, and obstetricians, in particular, should balance obligations to pregnant women's right of access to new therapeutic agents with the physician's desire to protect the fetus from potential risks. We will argue that in almost all circumstances (with few exceptions, as will also be discussed), maternal benefit and respect for autonomy create the uncertainty that absent safety data bring. Consequently, if pregnant women choose to try new interventions and treatments, such as the COVID-19 vaccination, they should be offered those new regimens and their decision supported. In addition, we will argue that the right solution to avoid the dilemma of absent data is to include pregnant individuals in clinical trials studying new treatments, drugs, and other therapies. We will also discuss the basis for our opinion, which are mainstream obstetrical ethics, precedents in law (supreme court ruling that forbids companies to exclude women from jobs that might pose a risk to the fetus), and historic events (thalidomide). The ethical framework includes the supposition that sacrifice to improve fetal outcome is a virtue and not a mandate. Denying a pregnant patient treatment because of threats to their life can create absurd and paradoxical consequences. Either requiring abortion or premature delivery before proceeding with treatments to optimize maternal health, or risking a patient's own life and ability to parent a child by delaying treatment brings clear and significant risks to fetal and/or neonatal outcomes. With rare exceptions, properly and ethically balancing such consequential actions cannot be undertaken without considering the values and goals of the pregnant patient. Therefore, active participation of both the pregnant patient and their physician in shared decision making is needed.


Subject(s)
COVID-19 Vaccines/immunology , COVID-19/prevention & control , Decision Making , SARS-CoV-2/immunology , Vaccination/ethics , COVID-19 Vaccines/adverse effects , Female , Humans , Patient Safety , Personal Autonomy , Pregnancy
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