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Objectives: Patients with immune-mediated diseases achieve lower seroconversion rates to COVID19 vaccines compared to healthy controls. The aim of this study was to assess the SARS-CoV-2-specific humoral and T-cell responses after a two-dose regimen of SARS-CoV-2 vaccine in patients with rheumatoid arthritis (RA). Method(s): Observational study. Patients with RA, >=18 years of age, who were vaccinated according to the Argentine National Health Ministry's vaccination strategy were included. Anti-SARS-CoV-2 IgG antibodies, neutralizing activity and specific T-cell responses were assessed after the first and second doses. Result(s): A total of 120 RA patients were included. Mostly, homologous regimens were used, including Gam-COVID-Vac (27.5%), ChAdOx1 (24.2%), BBIBP-CorV (22.5%) and BNT162b2 (0.8%), while the most frequent combination of vaccines was Gam-COVID-Vac/mRNA-1273 (21.7%). After the second dose 81.7% presented anti-SARS-CoV-2 antibodies, 70.0% neutralizing activity and 65.3% specific T-cell response. The use of BBIBP-CorV, treatment with abatacept (ABA) and rituximab (RTX) were associated with undetectable antibodies and no neutralizing activity after two doses of vaccine. BBIBP-CorV was also associated with the absence of T-cell response. The total incidence of adverse events was 357.1 events/1000 doses: significantly lower with BBIBP-CorV (166.7 events/1000 doses, p alpha 0.02). Conclusion(s): In this cohort of patients with RA who received 2 doses of COVID-19 vaccine, according to the Argentine strategic vaccination planwhich included homologous and heterologous regimens, two of ten did not develop IgG anti-SARS-CoV-2, 70% presented neutralizing activity and 65% specific T-cell response. The use of BBIBP-CorV was associated with deficient humoral and cellular response, while treatment with ABA and RTXaffected the development of IgG anti-SARS-CoV-2 and neutralizing activity.
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Objectives: To evaluate the humoral immune response to the third dose (booster) of vaccine against SARS-CoV-2 in patients with autoimmune rheumatic diseases who were seronegative after a two-dose regimen. Method(s): Observational study. Patients with autoimmune rheumatic diseases who had not achieved seroconversion after a two-dose vaccine schedule against SARS-CoV-2 were included. To assess the humoral immune response, anti-RBD IgG (S protein receptor binding domain) neutralizing antibody titers were determined by ELISA (cutoff titer 200). The determination was made between 30 to 45 days after the third dose. Result(s): From 66 patients who received SARS-CoV-2 vaccination, 18 patients (29.5%) were seronegative after a two-dose schedule. 61% had SLE, 77% had comorbidities (61% with hypertension, p = 0.03). Patients were on treatment: 10 with prednisone (8 with doses greater than 10 mg/d, p = 0.01), 10 with hydroxychloroquine, one with methotrexate, one with leflunomide, four with azathioprine, five with my cophenolatemofetil and five with rituximab (they are the total number of non-responders on biological treatment, p = 0.03). Regarding the primary vaccination regimen, 11 received BBIBP-CorV (p = 0.01), 5 AZD1222, 1 Gam-COVID-Vac and 1 mRNA1273/Gam-COVID-Vac heterologous scheme. Of these 18 non-responders, 14 received a third dose;nine patients (62%) presented anti-RBD IgG detectable. Of the five patients who did not respond to the booster vaccination, three had received BBIBP-CorV as the initial schedule and the vaccines applied as a third dose were Ad5-nCoV (1), BNT162b2 (1), AZD 1222 (2) and Gam-COVID-Vac (1). They were being treated with: rituximab (2), azathioprine (2) and mycophenolate mofetil (1). Treatment with higher doses of prednisone was the only factor associated with non-seroconversion to the third dose (8 +/- 4.5;p 0.02). Conclusion(s): The third dose of SARS-CoV-2 vaccine allowed to improve the serological response to vaccination, achieving a seroconversion of 62% in this group of patients.
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Although case reports have been made regarding adverse transfusion reactions, few have been made regarding blood transfusions leading to cardiac arrest. Today, we present a case of a COVID-19 positive Bahraini male, triple vaccinated, transfused with packed red blood cell (pRBC) after finding out he has low haemoglobin levels (64 g/dl) after routine laboratory investigations. During the blood transfusion, he developed hypertension, tachycardia and tachypnoea. The patient went into cardiac arrest within a few minutes of this presentation. Return of spontaneous circulation was achieved, and the patient was managed as transfusion-associated circulatory overload (TACO) with a good overall outcome.Copyright © 2023, Bahrain Medical Bulletin. All rights reserved.
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Background: Since the outbreak of COVID-19, vaccination has been considered as an important measure against it. Side effects have always been an inseparable component of vaccination, which in this study, Sinopharm vaccine, its side effects and the differences of their manifestation amongst men and women have been investigated. Objective(s): This study aimed to compare the side effects of the Sinopharm vaccine among men and women working in some medical centers in Tehran, Iran. Method(s): This cross-sectional descriptive-analytical study on 890 healthcare workers of 7 medical centers in Tehran within 2 months, from late June to late August 2021. The samples were selected by the complete enumeration method, and the required data were collected using a questionnaire. Only those who received the Sinopharm vaccine at least 10 days before the study were included. Result(s): Of 890 participants, 22.96% and 77.30% were women and men, respectively, and 65.8% of women and 78.1% of men were in the age range of 20-29 years. It was revealed that 74.75% of women and 26.16% of men had at least one side effect. The incidence of at least one side effect was significantly higher in women than in men (P<0.001). It was also found that 12 side effects were significantly higher in women than in men. Most men and women had side effects within the first 24 h after vaccination. There was no significant difference in taking therapeutic measures to reduce or minimize the post-vaccination complications between men and women;however, 9.4% of men and 27.2% of women reported a decline in their ability to perform daily activities as they were unable to do their everyday tasks the day after vaccination which was significantly different between the two groups (P<0.001). Conclusion(s): The results showed that the occurrence rate of side effects after receiving the Sinopharm vaccine was significantly higher in women than in men. Moreover, women were significantly less able to perform daily routines than men.Copyright © 2022, Author(s).
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Adenovirus vectors have been employed to develop a vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) for curtailing the Covid-19 pandemic spreading. Many different viral vectors have been mainly targeting the SARS-CoV-2 spike (S) protein as an antigen. Spike (S) protein is comprised of S1 and S2 subunits, in which the receptor-binding domain (RBD) of S1 is responsible for recognizing and engaging with its host cellular receptor protein angiotensin-converting enzyme 2 (ACE2), S2 accounts for membrane fusion of virus and host cell. Chimpanzee adenovirus was also used as a vector vaccine for SARS-CoV-2 (ChAdSARS-CoV-2-S) by intramuscular injection, and intranasal administration has been tested. Adenovirus vector-based vaccines are the most advanced, with several vaccines receiving Emergency Use Authorization (EUA). It was shown that rhesus macaques were protected from SARS-CoV-2 challenge after a month of being vaccinated with ChAd-SARS-CoV-2-S. A single intranasal or two intramuscular ChAd-SARSCoV-2-S vaccines could induce humoral antibodies and T cell responses to protect the upper and lower respiratory tract against SARS-CoV-2. As the effectiveness was demonstrated in non-human primates, ChAd-SARS-CoV-2-Sa potential option for preventing SARS-CoV-2 infection in humans. However, detecting novel more transmissible and pathogenic SARS-CoV-2 variants added concerns about the vaccine efficacy and needs monitoring. Moreover, the cause of recently documented rare cases of vaccine indicated immune thrombotic thrombocytopenia. This review article provided details for the adenovirus vector vaccine for SARS-CoV-2 in humans and tried to provide solutions to the adenovirus vector hemagglutinin issueCopyright © 2023, World's Veterinary Journal.All Rights Reserved.
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Background: Chronic urticaria (CU) is a common chronic inflammatory disease. Vaccination against viral infections including COVID-19 can induce increased CU disease activity. As of now, it is unclear how often CU exacerbations occur after COVID-19 vaccination. Method(s): COVAC-CU is an international, multicenter, observational, cross-sectional study of the global network of urticaria centers of reference and excellence (UCAREs). COVAC-CU evaluates the effects of COVID-19 vaccination in patients with CU including rates and risk factors of CU exacerbation. Here, we analyzed 1857 patients with CU who had received at least one COVID-19 vaccination. Data were collected via a questionnaire and retrieved from patient charts. Result(s): Of 1857 patients with CU (median age: 42 years;range: 18-91 years), 72.1% were female and 71.2%, 14.4% and 14.4% had chronic spontaneous urticaria, chronic inducible urticaria, or both, respectively. Most patients had received two doses of COVID-19 vaccine (79.1%), compared to one (9.7%), three (11%), or four (0.3%). Vaccine type included: BTN162b2 (58.4%;BioNTech/Pfizer), ChAdOx1 nCOV-19 (13.8%;AstraZeneca), BBIBP-CorV (8.2%;Sinopharm), Gam-COVID- Vac (8%;Sputnik), mRNA-1273 (5.3%;Moderna), and Ad26.COV 2.5 (4.7%;Janssen/J&J). Less than 10% of patients used premedication, and less than half of patients (44.4%) reported one or more adverse reactions after vaccination. The most common adverse reactions were local injection site reactions (29.6%), fatigue (19.7%), fever (19%), muscle pain (17.9%), headache (14%), and exacerbation of CU (15%). Severe allergic reactions/anaphylaxis were reported by 0.4% of CU patients. In almost all patients who experienced exacerbation of their CU, this occurred within one week after receiving the vaccine, i.e. after 1 to 12 hours (25.8 %), after 12 hours to 48 hours (31.1%) or after 2-7 days (37.9%). Conclusion(s): Most CU patients tolerate COVID-19 vaccination well;severe allergic reaction (anaphylaxis) rates were similar or lower than the self-reported rates reported in the general population. Exacerbation of urticaria was reported in one in five patients, mostly in a week after receiving the vaccine.
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Objectives: This is a protocol for a Cochrane Review (intervention). The objectives are as follows:. To assess the benefits and adverse effects of vaccines for the prevention of infections in adults with haematological malignancies.Copyright © 2023 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
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The severe consequences and high mortality of COVID-19 prompted the development of a wide range of preventive vaccines. The first vaccines to be tested were developed in China and formulated as inactivated SARS-CoV-2 adsorbed on aluminium hydroxide. One of the quality indicators for inactivated adsorbed vaccines is the degree of adsorption, which can be used to control the content not only of non-adsorbed antigen, but also of specific antigen in one dose of a vaccine. The aim of the study was to investigate the possibility of desorbing SARS-CoV-2 antigen from formulated adsorbed vaccines and the possibility of measuring its concentration using the BioScan-SARS-CoV-2 (S) ELISA kit for SARS-CoV-2 S-protein content determination. Material(s) and Method(s): the study used four batches of BBIBP-CorV by CNBG, Sinopharm (China) and three batches of CoronaVac by Sinovac Biotech (China). The authors desorbed SARS-CoV-2 S antigen in accordance with monograph FS.3.3.1.0029.15 of the State Pharmacopoeia of the Russian Federation edition XIV (Ph. Rus.), and quantified it using the BioScan-SARS-CoV-2 (S) ELISA kit by Bioservice Biotechnology Co. Ltd. (Russia). Result(s): mean S-antigen concentrations in the desorbed samples ranged from 61 to 129 ng/mL for BBIBP-CorV and from 461 to 533 ng/mL for CoronaVac. Conclusion(s): the study demonstrated the possibility of specific SARS-CoV-2 antigen desorption from the surface of aluminium hydroxide using the Ph. Rus. method, as well as the possibility of S-antigen quantification in desorbed medicinal products and supernatants using the BioScan-SARS-CoV-2 (S) ELISA kit. The authors observed 3.6- to 8.7-fold difference between the S-antigen concentrations of the desorbed preparations by the two manufacturers.Copyright © 2023 Safety and Risk of Pharmacotherapy. All rights reserved.
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Introduction: Although there are several reports of COVID-19 in patients on peritoneal dialysis (PD), all of them were retrospective and mono-national-state designs, and none reported vaccination profiles. Method(s): The incidence of COVID-19 infection among PD patients and vaccination profiles of COVID-19 from 1 January 2020 to 30 September 2021 were retrieved from the survey of PD leaders in the ASEAN countries. Countries were excluded if their infection rates (IR) in PD populations were smaller than the lower limit value of 95% confidence interval (CI) of the overall pooled prevalence of 1.25 reported in kidney failure patients with COVID-19 infection globally, considering the possibility of under-reporting and if the number of PD population is less than 50 cases. Thus, Burma (45 cases, unknown IR), Cambodia (1 case, IR 0%), Indonesia (2,692 cases, unknown IR), Laos PDR (3 cases, IR 33%), and Vietnam (PD 1,500 cases, IR <1%) were excluded. Result(s): Figure 1 demonstrates the incidence of COVID-19 infection in PD populations in selected ASEAN members. The cumulative incidence of COVID-19 has gradually increased in all reported countries. The cumulative incidence rate of Singapore reached a plateau in the second quarter of 2020 but has since seen a surge in the third quarter of 2021 with an average incidence of 0.5-1.5 cases per 100 population. Overall IR ranged from 0.1% in Singapore to 23.8% in the Philippines with an average ASEAN IR of 2.6%. The majority of ASEAN had less than half of their populations fully vaccinated, ranging from only 13% in Vietnam to 46% in Brunei. Despite Laos being a low-income country, it was the first ASEAN to vaccinate its population. Singapore had the highest vaccination rates, with 83% and 81% of its population partially and completely vaccinated, respectively. Brunei, albeit being a high-income country, is the last country to roll out vaccination with a tardy vaccination rate, possibly due to the under-preparedness of the government and a false sense of security as Brunei had 15 months of zero cases before the latest wave. The incidence of ASEAN PD patients with COVID-19 infection surged during the second and third quartiles of 2021 despite the vaccine roll-out (Table 1). [Formula presented] Abbreviations: Ad26, Ad26.COV2.S;BBIBP, BBIBP-CorV;BNT, BNT162b2;Covishield, ChAdOx1 nCoV-19 (Covishield);Gam, Gam-COVID-Vac;mRNA, mRNA-1273;Vaxzeria, ChAdOx1 nCoV-19 (Vaxzeria) Remarks: Yellow, Conventional inactivated vaccines (BBIBP-CorV [Sinopharm], CoronaVac [Sinovac]);Green, RNA vaccines (BNT162b2 [Pfizer-BioNTech], mRNA-1273 [Moderna]);Pink, Viral vector vaccines (Gam-COVID-Vac [Sputnik], ChAdOx1 nCoV-19 [Covishield], ChAdOx1 nCoV-19 [Vaxzeria] and Ad26.COV2.S [Johnson & Johnson]) [Formula presented] Figure 1. Cumulative incidence of COVID-19 infected PD patients in selected ASEAN Conclusion(s): Overall IR of the ASEAN PD population varied widely among countries. However, the rollout rate of vaccination lagged behind that of western countries. This should increase efforts to educate their population on the benefits of timely vaccination. There remain a lot of uncertainties regarding COVID-19, and hence there is an urgent need for large prospective studies with international collaboration, to address these questions. No conflict of interestCopyright © 2023
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Paediatric population is the high-risk segment for the infection of COVID-19 due to weak immune status and low compliance to COVID-19 prevention protocols. The first dose of vaccination for the paediatric population is started in the fifth phase of vaccination, after the vaccination was administered to health workers, elderly individuals, and young adults. Present article aims to analyse the status, trends, and challenges in the implementation of the paediatric vaccination for COVID-19 and provide recommendations that could be taken under consideration by healthcare authorities while designing the second and third vaccination protocols for the paediatric population. Relevant articles published by various journals related to paediatric COVID-19 vaccination were searched from the different databases and analysed for the current status of vaccination, trends, challenges, compliance level, implementation hurdles, and other relevant information. Limited research is available in the paediatric domain for the COVID-19 vaccination. Few vaccines are approved for the paediatric population in India, including the Covaxin, ZyCoV-D, Corbevax and Covovax. It is recommended that the vaccination trials should be accelerated by the government agencies to make COVID vaccines available from other indigenous manufacturers. It is also recommended that the COVID-19 prevention protocol should be made in such a manner that children find that interesting and like to follow them.Copyright © The Author(s) 2023.
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Coronavirus disease 2019 (COVID-19) outbreak started in Wuhan, China when people started with the symptoms of respiratory disorder. The onset of this disease have symptoms like fever, dry cough, fatigue, and difficulty in breathing. The nature of SARS-CoV-2 seems highly contagious as it also can be spread with asymptomatically infected individuals. It has been more than a year which this outbreak have been announced as a pandemic by World Health Organization (WHO) due to major public health crisis and uncontrollable around the globe. Some countries have taken initiatives in inventing vaccines and step up in the clinical trial process since a vaccine is an all-powerful tool which it always been a saviour in fighting infectious disease. In searching for the vaccine, researchers had studied the previously published article of SARS-CoV or MERS as in the beginning, in light, there will be a suitable vaccine to fight this pandemic situation. Recent research on the vaccine has been tested to seek the right vaccine for COVID-19. This study is to focus on the current vaccine development against COVID-19 and to explore the potential vaccines' characteristics that have been studied by the previous proven research findings. This review was done based on the research articles and reviews published until the end of April 2021 through established scientific search engines and related scientific platforms based on the inclusion criteria with its related keywords like coronavirus, SARS-CoV-2, COVID-19 Vaccine, clinical trials, and COVID-19 vaccine development. This review summarized a few vaccine candidates that have entered clinical trials and some supported evidence from Phase I until Phase III clinical trial studies that have been published and reported. In this review, 12 vaccine candidates have the potential to against SARS-CoV-2. Thus, their vaccine platform, characteristic as well as its efficacy studies have been discussed.Copyright © RJPT All right reserved.
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Background: Currently, the present world is facing a new deadly challenge from a pandemic disease called COVID-19, which is caused by a coronavirus named SARS-CoV-2. To date, no drug or vaccine can treat COVID-19 completely, but some drugs have been used primarily, and they are in different stages of clinical trials. This review article discussed and compared those drugs which are running ahead in COVID-19 treatments. Method(s): We have explored PUBMED, SCOPUS, WEB OF SCIENCE, as well as press releases of WHO, NIH and FDA for articles related to COVID-19 and reviewed them. Result(s): Drugs like favipiravir, remdesivir, lopinavir/ritonavir, hydroxychloroquine, azithromycin, ivermectin, corticosteroids and interferons have been found effective to some extent, and partially approved by FDA and WHO to treat COVID-19 at different levels. However, some of these drugs have been disapproved later, although clinical trials are going on. In parallel, plasma therapy has been found fruitful to some extent too, and a number of vaccine trials are going on. Conclusion(s): This review article discussed the epidemiologic and mechanistic characteristics of SARS-CoV-2, and how drugs could act on this virus with the comparative discussion on progress and drawbacks of major drugs used till date, which might be beneficial for choosing therapies against COVID-19 in different countries.Copyright © 2022 Bentham Science Publishers.
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Covid immunization commenced on 2nd Feb 2021 in Pakistan and as of 7th Sep 2021, over 84 million vaccine doses were administered in Pakistan, of which 72% procured by the government, 22% received through Covax and 6% were donated. The vaccines rolled out nationally included: Sinopharm, Sinovac and CanSinoBIO (China), AstraZeneca (UK), Moderna and Pfizer (USA), Sputnik (Russia), and PakVac (China/Pakistan). About half of the eligible population in Pakistan (63 m) had received at least one dose of Covid vaccine as of Sep 2021. Pakistan National Pharmacovigilance Centre (PNPC) in coordination with WHO, MHRA and Uppsala Monitoring Centre (UMC) established pharmacovigilance centers across Pakistan. The Covid vaccine AEFIs in Pakistan were mainly reported via NIMS (National Immunization Management System), COVIM (Covid-19 Vaccine Inventory Management System), 1166 freephone helpline and MedSafety. There have been 39,291 ADRs reported as of 30th Sept 2021, where most reported after the first dose (n = 27,108) and within 24-72 h of immunization (n = 27,591). Fever or shivering accounted for most AEFI (35%) followed by injection-site pain or redness (28%), headache (26%), nausea/vomiting (4%), and diarrhoea (3%). 24 serious AEFIs were also reported and investigated in detail by the National AEFI review committee. The rate of AEFIs reports ranged from 0.27 to 0.79 per 1000 for various Covid vaccines in Pakistan that was significantly lower than the rates in UK (~4 per 1000), primarily atrributed to underreporting of cases in Pakistan. Finally, Covid vaccines were well tolerated and no significant cause for concern was flagged up in Pakistan's Covid vaccine surveillance system concluding overall benefits outweighed risks.Copyright © 2022
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Various vaccine platforms are geared against COVID-19 vaccine development to produce immunogens in cells. To design a recombinant protein-based COVID-19 vaccine, Vaxine pty Ltd used computer models of the spike protein and its human receptor, ACE2, to identify how the virus infects human cells. Based on this, the COVAX-19 vaccine is synthesized. It does reduce not only COVID-19 disease but also blocks virus shedding and transmission. Researchers are optimistic that this vaccine candidate could be clinically available soon with sufficient vaccine efficacy with a considerable amount of reduction in vaccination-related side effects.Copyright © 2021
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Introduction: SARS-CoV2 infection is associated with significant risk of coronavirus disease (COVID-19) and represents a significant risk factor for functional deterioration in idiopathic pulmonary fibrosis (IPF) patients. Method(s): We retrospectively reviewed all IPF patients treated at our university center for their SARS-CoV2 vaccination status starting from January 2021 in Hungary. Result(s): Total of 68 (out of treated 70 IPF patients) received minimum 2 doses of SARS-CoV2 vaccines (male 52.85%, age: 72.24 +/- 9.65 years), 20 of them were vaccinated with non-mRNA vaccines (BBIBP-CorV-Sinopharm, ChAdOx1-AstraZeneca, Gam-Covid-Vac-Sputnik and Ad26. COV2.S-Janssen), while 48 with mRNA vaccines. Majority (N=57) of patients also took a third dose: most patients received BNT162b2-mRNA-Pfizer/Biontech (58.82%), followed by BBIBP-CorV and mRNA-1273-Moderna (both 11.76 %). There were no hospitalizations for COVID-19 in the vaccinated group, regardless of the type of the vaccine received and no significant adverse event was detected. One of the non-vaccinated patients (2 women, age 70 and 73 years) died in COVID-19 pneumonia. IPF patients were mainly in a good functional state (FVC = 2.52 +/- 1.03 L;78.81 +/- 22.72%) with reduced diffusion capacity (TLCO = 5.28 +/- 2.11 mmol/kPa/min;66.28 +/- 21.58%). Conclusion(s): SARS-CoV2 vaccination is utmost important in IPF patients, and independent of vaccine type used it resulted in significantly decreased risk of COVID-19 hospitalization.
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The severe consequences and high mortality of COVID-19 prompted the development of a wide range of preventive vaccines. The first vaccines to be tested were developed in China and formulated as inactivated SARS-CoV-2 adsorbed on aluminium hydroxide. One of the quality indicators for inactivated adsorbed vaccines is the degree of adsorption, which can be used to control the content not only of non-adsorbed antigen, but also of specific antigen in one dose of a vaccine. The aim of the study was to investigate the possibility of desorbing SARS-CoV-2 antigen from formulated adsorbed vaccines and the possibility of measuring its concentration using the BioScan-SARS-CoV-2 (S) ELISA kit for SARS-CoV-2 S-protein content determination. Materials and methods: the study used four batches of BBIBP-CorV by CNBG, Sinopharm (China) and three batches of CoronaVac by Sinovac Biotech (China). The authors desorbed SARS-CoV-2 S antigen in accordance with monograph FS.3.3.1.0029.15 of the State Pharmacopoeia of the Russian Federation edition XIV (Ph. Rus.), and quantified it using the BioScan-SARS-CoV-2 (S) ELISA kit by Bioservice Biotechnology Co. Ltd. (Russia). Results: mean S-antigen concentrations in the desorbed samples ranged from 61 to 129 ng/mL for BBIBP-CorV and from 461 to 533 ng/mL for CoronaVac. Conclusions: the study demonstrated the possibility of specific SARS-CoV-2 antigen desorption from the surface of aluminium hydroxide using the Ph. Rus. method, as well as the possibility of S-antigen quantification in desorbed medicinal products and supernatants using the BioScan-SARS-CoV-2 (S) ELISA kit. The authors observed 3.6- to 8.7-fold difference between the S-antigen concentrations of the desorbed preparations by the two manufacturers.
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Background & Aims: Liver injury with autoimmune features after vaccination against severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) is increasingly reported. We investigated a large international cohort of individuals with acute hepatitis arising after SARS-CoV-2 vaccination, focusing on histological and serological features. Methods: Individuals without known pre-existing liver diseases and transaminase levels ≥5x the upper limit of normal within 3 months after any anti-SARS-CoV-2 vaccine, and available liver biopsy were included. Fifty-nine patients were recruited;35 females;median age 54 years. They were exposed to various combinations of mRNA, vectorial, inactivated and protein-based vaccines. Results: Liver histology showed predominantly lobular hepatitis in 45 (76%), predominantly portal hepatitis in 10 (17%), and other patterns in four (7%) cases;seven had fibrosis Ishak stage ≥3, associated with more severe interface hepatitis. Autoimmune serology, centrally tested in 31 cases, showed anti-antinuclear antibody in 23 (74%), anti-smooth muscle antibody in 19 (61%), anti-gastric parietal cells in eight (26%), anti-liver kidney microsomal antibody in four (13%), and anti-mitochondrial antibody in four (13%) cases. Ninety-one percent were treated with steroids ± azathioprine. Serum transaminase levels improved in all cases and were normal in 24/58 (41%) after 3 months, and in 30/46 (65%) after 6 months. One patient required liver transplantation. Of 15 patients re-exposed to SARS-CoV-2 vaccines, three relapsed. Conclusion: Acute liver injury arising after SARS-CoV-2 vaccination is frequently associated with lobular hepatitis and positive autoantibodies. Whether there is a causal relationship between liver damage and SARS-CoV-2 vaccines remains to be established. A close follow-up is warranted to assess the long-term outcomes of this condition. Impact and implications: Cases of liver injury after vaccination against severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) have been published. We investigated a large international cohort of individuals with acute hepatitis after SARS-CoV-2 vaccination, focusing on liver biopsy findings and autoantibodies: liver biopsy frequently shows inflammation of the lobule, which is typical of recent injury, and autoantibodies are frequently positive. Whether there is a causal relationship between liver damage and SARS-CoV-2 vaccines remains to be established. Close follow-up is warranted to assess the long-term outcome of this condition. © 2022 The Author(s)
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In the 1930's the corona virus was first identified as a highly contagious chicken respiratory virus. Two human coronaviruses were later identified, the human coronavirus 229E causing the flu and secondly the human coronavirus OC43. Others are also important as SARS-CoV. In late 2019 the outbreak of Pneumonia occurred in the Chinese city of Wuhan which was investigated as a result of the corona virus, renamed as 2019-nCoV by the World Health Organization (WHO) and. now called as SARS-CoV-2. The WHO has identified the global health problem as an epidemic. Respiratory droplets produced during coughing and sneezing are the main means of transmission of COVID-19. Infection with COVID-19 in an infected person may remain undetected. Common symptoms of fever and dry cough are less common in the production of sputum, fatigue and in some cases may be dyspnoea or shortness of breath. The COVID-19 virus is a type of RNA virus, the outer envelope containing a lipid bilayer in which various proteins are synthesized such as membrane (M), envelope (E) and spike (S). Hand washing, coughing, social isolation, wearing a face mask in public, disinfection areas, and isolation are various ways to prevent the disease. The diagnosis of COVID-19 can be made on the basis of symptoms and confirmed using reverse transcription polymerase chain reaction (RT-PCR) tests. There are currently no antiretroviral drugs approved for COVID-19, only symptomatic and supportive treatment is used to treat people with this viral infection. Drugs that have been approved for the purpose of treating other viral infections are under investigation. Vaccination is an ultimate prevention and protection;few vaccines are given emergency approval and some are in progressive development phase in various countries to prevent this deadly pandemic.
ABSTRACT
Background: Several trials have reported lower seroconversion rates in patients with autoimmune rheumatic diseases than in healthy patients. In Argentina, the vaccines that were available during the development of this study were: Sputnik V (Gam-COVID-Vac), AstraZeneca (ChAdOx1 nCov-19), Sinopharm (BBIBP-CorV) and Moderna (mRNA-1273). Limited information is available about vaccines against SARS-CoV2 with inactivated virus or viral vector in autoimmune patients. Objectives: To evaluate the humoral immune response to vaccines against SARS-CoV2 in patients with autoimmune rheumatic diseases;to compare the humoral response among patients with Systemic Lupus Erythematosus (SLE) and other autoimmune diseases and to analyse the variables associated. Methods: We included patients with autoimmune rheumatic diseases (Rheumatology Unit of Padilla Hospital, Tucumán, Argentina), who received vaccination against SARS-CoV2 from June 2021. Sociodemographic, comorbidities, related to rheumatic disease, vaccination and SARS-CoV2 infection were the variables recorded. To evaluate the humoral immune response, the neutralizing anti-S-RBD IgG antibody titres were determined by ELISA 'In House' test with a cut-off titre of 200 (IMMCA). The times established for the serological determinations were: T0 or baseline: 1st vaccine dose, T1: 14 ± 2 days after the 1st dose, T2: 2nd dose, T3: 21-45 days after the 2nd dose, T4: 30 days after the 3rd dose, T5: 6 months and T6: 12 months after the 3rd dose. Results: 66 patients were included, 91% women and 92.4% Amerindians. The mean age was 40.7 ± 11.4 years;53% with SLE, 15.2% Rheumatoid Arthritis, 7.6% Systemic Sclerosis, 7.6% Juvenile Idiopathic Arthritis, 7.6% Systemic Vasculitis and 9% other diagnoses;mean disease duration was 12.05 ± 7. 5 years;63.6% had at least one comorbidity (57% HBP, 31% overweight or obesity). At baseline, the treatments received were: corticoster-oids (37.9%, prednisone mean dose 4.12 ± 8 mg/day), cDMARDs (75.7%), bDMARDs (18.2%): Rituximab (58.3%) and anti TNF (25%). Sixteen patients (24.2%) had previous COVID19 (75% mild symptoms). The vaccines applied were: AstraZeneca 38.2%, Sinopharm 31.7%, Sputnik V 19%, and combined schedule Sputnik V/Moderna in 11%. At baseline, 28.8% had detectable anti-S-RBD IgG antibodies. This frequency increased to 48.4% at 1st dose and 70.2% at 2nd dose. The variables that were associated with lower sero-conversion rates and lower antibody titre were vaccination with Sinopharm (p 0.028) and treatment with bDMARDs (p 0.02), none of the 5 patients with Rituximab showed seroconversion. There were no significant differences in the levels of anti-S-RBD IgG antibodies between patients with SLE and the other rheumatic diseases. Patients who had SARS-CoV2 infection prior to vaccination had higher antibody titres in both T1 (p 0.006) and T2 (p 0.002) but after the two doses this difference was not significant (p 0.67). In the regression analysis, the variables that were independently associated with seroconversion were the type of vaccine applied at the 1st dose and the hypertensive disease. The chance of responding to vaccination was 13 and 9 times higher for those who received Sputnik V (OR 12.78;95% CI 1.46-315.9) or AstraZeneca (OR 8.61;95% CI 1.63-72.5) respectively, than Sinopharm in the 1st dose. The chance of being a responder was 88% lower for hypertensive patients (OR 0.12;95% CI 0.02-0.58). Conclusion: In this preliminary analysis, a seroconversion rate of 70.2% was associated with two-dose vaccination for SARS-CoV2 in patients with autoimmune rheumatic diseases. There were no differences in the serological response between patients with SLE and other rheumatic diseases. The humoral immune response was lower in patients with bDMARDs and null in those who received Rituximab. Seroconversion and antibody titres levels were associated with the type of vaccine applied, being Sinopharm who presented the lowest response. The follow-up will provide more knowledge about the behaviour of the humoral response in our patients.
ABSTRACT
Background: Vaccination for COVID-19 is an essential tool to fght the pandemic. Evidence suggests that patients with immune mediated infammatory diseases (IMIDs) have less response. The application of a booster shot is a strategy that has been implemented in this population, however there is scarce information about its efficacy. Objectives: To assess the humoral and cellular immune response after a third dose of SARS-CoV-2 vaccine in patients with rheumatoid arthritis (RA) with undetectable antibodies titles after primary regimen of two doses. Methods: Observational study. Patients with RA (ACR/EULAR 2010 criteria) from two rheumatology centers, ≥18 years old, with no seroconversion after two doses of SARS-CoV-2 vaccine, who received a third dose of either mRNA or vector-based vaccines (BNT162b2 or ChAdOx1 nCoV-19) were included. Anti-SARS-CoV-2 IgG antibodies, neutralising activity and T cell responses were assessed between 21 and 40 days after the third dose. Sociodemographic data, comorbid-ities, treatment, vaccine applied and the presence of adverse events (AE) were recorded. Statistical analysis: descriptive analysis. Chi2 or Fischer test and T test. Results: A total of 21 non-responder patients were included, all of them females with a mean age of 63.7 years (SD 11,6) and mean disease duration of 15.8 years (SD 8). Most of them (81%) reported comorbidities, being the most frequent arterial hypertension, obesity and dyslipidemia. At vaccination time, 6 (28.6%) were receiving glucocorticoids, 3 of them ≥10 mg/day, 17 c-DMARDs (methotrexate 57.1%) and 18 (85.1%) b-DMARDs, 6 abatacept (ABT) and 4 rituximab (RTX). Regarding the primary vaccination regimen, 13 (61.9%) received two doses of BBIBP-CorV, 3 (14.3%) Gam-COVID-Vac, 3 (14.3%) ChAdOx1 nCoV-19 and 2 (9.5%) a mix regimen of Gam-COVID-Vac/mRNA-1273. The majority (95.2%) received BNT162b2 vaccine and only one of them ChAdOx1 nCoV-19, with a mean time between the second and third dose of 151,4 days (SD 46,4). After the third dose, 90.5% of the patients presented detectable anti-SARS-CoV-2 IgG and 76.2% presented neutralizing activity. The median of neutralizing antibodies titers was 1/12 (IQR 1/7-1/48). Both patients who did not present detectable antibodies were obese, recieved BBIBP-CorV during the primary regimen and BNT162b2 as the third dose, one of them was taking methotrexate and ABT and the other one RTX. Compared to other treatments, ABT and RTX was associated with no neutralizing activity in 4 (80%) patients and lower titers of neutralizing antibodies [median 1/3 (IQR 0-1/20) vs median 1/8 (IQR 1/4-1/128), p=0.197]. A T-cell response was present in 41.2% of all patients after the second dose, increasing to 75% after the third dose. The use of ABT was associated with a lower frequency of T-cell response (80% vs 20%, p=0.014). Sixteen (76.1%) patients reported at least one AE, 66.7% injection site reaction and 25% fu-like syndrome. Conclusion: In this RA cohort who failed to seroconvert after two doses of SARS-CoV-2 vaccine, 90.5% presented detectable anti-SARS-CoV-2 IgG and 75% T-cell responce after a third dose. The use of ABT was associated with a lower frequency of T-cell response. This data highlights the importance of a third vaccine in this group of patients.