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Delivery of self-amplifying mRNA (SAM) has high potential for infectious disease vaccination due to its self-adjuvanting and dose-sparing properties. Yet a challenge is the susceptibility of SAM to degradation and the need for SAM to reach the cytosol fully intact to enable self-amplification. Lipid nanoparticles are successfully deployed at incredible speed for mRNA vaccination, but aspects such as cold storage, manufacturing, efficiency of delivery, and the therapeutic window can benefit from further improvement. To investigate alternatives to lipid nanoparticles, a class of >200 biodegradable end-capped lipophilic poly(beta-amino ester)s (PBAEs) that enable efficient delivery of SAM in vitro and in vivo as assessed by measuring expression of SAM encoding reporter proteins is developed. The ability of these polymers to deliver SAM intramuscularly in mice is evaluated, and a polymer-based formulation that yields up to 37-fold higher intramuscular (IM) expression of SAM compared to injected naked SAM is identified. Using the same nanoparticle formulation to deliver a SAM encoding rabies virus glycoprotein, the vaccine elicits superior immunogenicity compared to naked SAM delivery, leading to seroconversion in mice at low RNA injection doses. These biodegradable nanomaterials may be useful in the development of next-generation RNA vaccines for infectious diseases.Copyright © 2023 The Authors. Advanced Therapeutics published by Wiley-VCH GmbH.
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Objective: To assess the course of COVID-19 infections and the tolerability of the mRNA vaccines of Moderna and Pfizer/BioNTech and the viral vector vaccines from Astra Zeneca and Johnson & Johnson in adult patients with epilepsy (PWE). Method(s): From July 2020 to July 2021, we consecutively included adult outpatients with confirmed epilepsy. These PWE were interviewed about COVID-19 infections and vaccinations. Results of follow-up visits were added until the cut-off date (December 31, 2021). The data of COVID-19-infected without vaccinations or fully vaccinated PWE without COVID-19 infections were analyzed. Full vaccination was defined as a double vaccination with the Pfizer/BionTech, Moderna, or Astra Zeneca vaccines or a single Johnson & Johnson vaccination. Result(s): At cut-off, 612 of 1152 PWE fulfilled the inclusion criteria: 51 PWE had been infected without vaccination and 561 had full vaccination without infection. Among the infected PWE, 76.5% presented with symptoms;9.8% had a severe course (one death). The leading symptoms were influenza-like disorders (48.7% of infected PWE with symptoms), anosmia (28.2%), and ageusia (20.5%). Seizure increases or relapses after sustained seizure freedom occurred in 7.8%. Adverse events (AEs) were reported by 113 vaccinated PWE (20.1% of all vaccinated PWE). The leading AEs were fatigue, fever, and headache. The AE rate per vaccine was 14.0% for Pfizer/BionTech, 32.7% for Moderna, 25.8% for Astra Zeneca, and 46.2% for Johnson & Johnson. Of the AEs, 93.3% lasted <=1 week. Seizure increase or relapse occurred in 1.4% and was significantly less frequent than in the infected group (p= 0.0016). Conclusion(s): The course of COVID-19 infections and the tolerability of the vaccines were similar as in the general population, yet, seizure worsening occurred more often after the infection than after the vaccination.Copyright © 2023, The Author(s), under exclusive licence to Springer Medizin Verlag GmbH, part of Springer Nature.
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Vaccination has been proved to be the most effective strategy to prevent the Corona Virus Disease 2019 (COVID-19). The mRNA vaccine based on nano drug delivery system (NDDS) - lipid nanoparticles (LNP) has been widely used because of its high effectiveness and safety. Although there have been reports of severe allergic reactions caused by mRNA-LNP vaccines, the mechanism and components of anaphylaxis have not been completely clarified yet. This review focuses on two mRNA-LNP vaccines, BNT162b2 and mRNA-1273. After summarizing the structural characteristics, potential allergens, possible allergic reaction mechanism, and pharmacokinetics of mRNA and LNP in vivo, this article then reviews the evaluation methods for patients with allergic history, as well as the regulations of different countries and regions on people who should not be vaccinated, in order to promote more safe injection of vaccines. LNP has become a recognized highly customizable nucleic acid delivery vector, which not only shows its value in mRNA vaccines, but also has great potential in treating rare diseases, cancers and other broad fields in the future. At the moment when mRNA-LNP vaccines open a new era of nano medicine, it is expected to provide some inspiration for safety research in the process of research, development and evaluation of more nano delivery drugs, and promote more nano drugs successfully to market.Copyright © 2023, Chinese Pharmaceutical Association. All rights reserved.
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Worldwide, infectious diseases have contributed significantly to morbidity and mortality;among the leading causes of death are pneumonia, respiratory infections and Covid-19. Stem cell therapy will be used to treat virus-infected patients in an effective and safe manner. A cross-sectional questionnaire was used to collect data from doctors. Most doctors are aware of the applications of stem cells, but they do not confirm their usage because clinical trials are ongoing. Instead, they show support for using stem cells to treat patients. Stem cells have been hoping to help repair damaged tissues in the respiratory system to promote faster recovery. Stem Cells are being studied in current clinical trials for their efficacy and safety in virus severe pneumonia and respiratory infections. The doctors suggested that stem cells have been used in infectious diseases to improve their health.Copyright © 2023 Health Biotechnology And Biopharma. All rights reserved.
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Introduction: Side effects related to COVID-19 vaccination are short-lived and disappear within a few days and can affect both pregnant and nonpregnant women. Aim(s): To evaluate the bibliometric profile of the worldwide scientific production on the side effects of COVID-19 vaccine in pregnant women, in Scopus. Material(s) and Method(s): A retrospective, cross-sectional, bibliometric study that analyzed metadata published in scientific journals indexed in Scopus during 2019 and 2021. The search and download of the papers were performed on May 13, 2022, and the SciVal program was used for the measurement of the bibliometric indicators. Result(s): The Lancet Infectious Diseases and International Journal of Gynecology and Obstetrics had the highest impact with 24.8 and 14.3 citations per publication, respectively. The institutions with the highest number of papers were Harvard University and National Institutes of Health, with 13 papers, respectively. Goldfarb Ilona Telefus, Kampmann Beate, and Khalil Asma were the authors with the highest number of papers, with 3 each. Only one publication on the side effects of COVID-19 vaccine in pregnant women was identified in 2019, whereas the highest scientific output was identified in 2021, with 127, of which 67 were from Q1. Conclusion(s): In Scopus, there is an increase in the production of papers on the side effects of the vaccine against COVID-19 in pregnant women, with the United States being the country with the most institutions with the highest scientific production. However, over the years, the quartile of the journals where these studies were published decreased.Copyright © The Author(s).
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Background: The objective of this research was to test the efficacy and safety profile of tozinameran (30 µg, BNT162b2, Pfizer, BioNTech) and elasomeran (100 µg, mRNA-1273, Moderna) in COVID-19 prevention in ≥16-year-old patients vaccinated with two doses. Methods: A meta-analysis of the literature was conducted using the MEDLINE and EMBASE databases, following inclusion and exclusion criteria. Eight RCTs have been selected. The results were presented using the risk ratio (RR) with a 95% confidence interval (CI). A fixed-effect model or random-effect model was applied based on the heterogeneity of the results. Results: BNT162b2 and mRNA-1273 vaccines are efficient in preventing COVID-19 in comparison to a placebo (MH, RR 0.08 [0.07, 0.09] p < 0.00001 (95% CI)). It was found that administering the vaccines BNT162b2 and mRNA-1273 was associated with a higher proportion of adverse events in comparison to the placebo (IV, RR 2.14 [1.99, 2.29] p < 0.00001 (95% CI)). Administering the vaccines BNT162b2 and mRNA-1273 was associated with a higher proportion of serious adverse events in comparison to the placebo (MH, RR 0.98 [0.89, 1.08] p = 0.68 (95% CI)). Conclusions: Tozinameran and elasomeran are effective and safe in preventing the occurrence of COVID-19.
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Vaccination has been proved to be the most effective strategy to prevent the Corona Virus Disease 2019 (COVID-19). The mRNA vaccine based on nano drug delivery system (NDDS) - lipid nanoparticles (LNP) has been widely used because of its high effectiveness and safety. Although there have been reports of severe allergic reactions caused by mRNA-LNP vaccines, the mechanism and components of anaphylaxis have not been completely clarified yet. This review focuses on two mRNA-LNP vaccines, BNT162b2 and mRNA-1273. After summarizing the structural characteristics, potential allergens, possible allergic reaction mechanism, and pharmacokinetics of mRNA and LNP in vivo, this article then reviews the evaluation methods for patients with allergic history, as well as the regulations of different countries and regions on people who should not be vaccinated, in order to promote more safe injection of vaccines. LNP has become a recognized highly customizable nucleic acid delivery vector, which not only shows its value in mRNA vaccines, but also has great potential in treating rare diseases, cancers and other broad fields in the future. At the moment when mRNA-LNP vaccines open a new era of nano medicine, it is expected to provide some inspiration for safety research in the process of research, development and evaluation of more nano delivery drugs, and promote more nano drugs successfully to market.Copyright © 2023, Chinese Pharmaceutical Association. All rights reserved.
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Intro: During the pandemic of COVD-19, several vaccines have been developed and are currently used worldwide. However, head-to-head studies comparing various vaccines are limited. Therefore, This single-center, prospective, realworld study. head-to-head study of compared the effectiveness of BNT162b2 (Pfizer BioNTech), mRNA-1273 (Moderna) ChAdOx1-S (Astra Zeneca) vaccines. The kinetics of SARS-CoV2 spike antibodies were monitored post-vaccination and following two booster doses in COVID-19 naive and previously infected adults. Method(s): The primary outcome was the emergence of virologically positive COVID-19 cases after vaccine completion. The secondary outcome was the occurrence of postvaccination COVID-19-related hospitalizations. The titers of anti-SARS-CoV-2 IgG antibodies against the S1 subunit of the virus's spike protein were measured after the first and second doses of the three vaccines and the booster doses. Finding(s): The current study enrolled and followed 1550 participants who received ChAdOx1-S or BNT162b2, or mRNA-1273, and 1550 non-vaccinated subjects between March 2021 and February 2022. After completing two vaccine doses, the effectiveness in preventing COVID-19 cases was 89.2%, 95.5%, and 94.6% for ChAdOx1-S or BNT162b2, or mRNA-1273, respectively. Four COVID-19-related hospitalizations (0.26%) were reported in the vaccinated versus 648 (41.81%) non-vaccinated participants (P<0.0001). Following the Pfizer booster dose, no COVID-19-positive cases or hospitalizations were reported. In the three vaccines, SARS-CoV2 antibody titers increased gradually after the first dose, peaked 3-4 weeks after the second dose, then declined after 28-32 weeks. Enhanced antibody response was observed after the booster dose and was maintained until the end of follow-up. Comorbidities were associated with lower antibody titers, particularly diabetes, autoimmune diseases, and advanced renal diseases. Conclusion(s): The study showed that the three COVID-10 vaccines effectively reduced the risk of virologically confirmed COVID-19 disease and prevented severe illness and hospitalizations in COVID-19 naiive and previously infected. Booster doses enhance the SARS-CoV2 antibody response and decrease the incidence of virologically proven severe COVID-19.Copyright © 2023
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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: Since its first appearance in Wuhan December 2019, SARS-CoV2 virus received great attention due to its severe symptoms and high spread causing COVID-19 disease which spread all over the world like a pandemic. The causative virus is capable of human-to-human transmission via droplet and direct contact suggesting that upper respiratory tract is the main site to virus manifestations. There is a great diversity in its clinical picture, although the severe respiratory and neurological symptoms are commonly present;however, other symptoms are present. Although otological manifestations are reported in many COVID-19 patients even in asymptomatic cases, they did not receive much attention compared with other critical manifestations. In this article, we paid our attention specifically to the otological manifestations of COVID-19 and their relevance either to the virus infection, treatment, or vaccination through literature review. Conclusion(s): COVID-19 disease has a deleterious effect on the inner ear. This effect is not only due to SARS-Cov-2 infection, but it could be also due to the ototoxic drugs used for treatment. The COVID-19 vaccinations are found to be implicated in the otological symptoms in some cases.Copyright © 2022, The Author(s).
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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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Objectives: Latest recommendation on SARS-CoV-2 vaccination in patients with systemic rheumatic diseases (SRD) by the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) is 3 doses while the Centers for Diseases Control and Prevention (CDC) recommends 5 doses. Method(s): We performed a cross-sectional study from April to November 2022 about SARS-CoV-2 vaccination in an outpatient rheumatology clinic in northeast Mexico. Consecutive SRD patients with a history of COVID-19 vaccination were invited to participate. Patients without SRD were excluded. Eligible participants completed a survey that included demographic data (age, sex, rheumatic disease diagnosis) and SARS-CoV-2 vaccination history (number of doses, and type of vaccine). Result(s): We recruited 252 patients.Vaccine types administered were: BNT162b2 (Pfizer-BioNTech) 55 (23.11%);ChAdOx1 nCoV-19/AZD1222 (Oxford-AstraZeneca) 130 (54.62%);Ad5-nCoV (CanSinoBIO) 31 (13.03%);Coronavac (Sinovac) 9 (3.78%);mRNA-1273 (Moderna)13 (5.46%). (See Table 1 and Table 2) Conclusion(s): Two thirds of our patients met SARS-CoV-2 vaccination recommendations by ACR and EULAR and 5.95% met CDC criteria. Population without any dose represents 6.74%. SARS-CoV-2 infection in vaccinated patients with SRD is associated with a better outcome compared with unvaccinated. Efforts to increase vaccination coverage need to be done.
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Intro: The US CDC recommends that COVID-19 vaccines may be coadministered with other age-appropriate vaccines. There is limited data assessing outcomes, including reactogenicity, on such co-administration. For the first time, we present interim safety data of RZV administered concomitantly or sequentially with an mRNA-1273 booster vaccine. Method(s): In this phase 3, randomized, open-label, multi-center study (NCT05047770), adults aged >=50 years were randomized 1:1 to receive the first RZV dose with mRNA-1273 booster (50 mug) at day 1 and the second RZV dose at week (W)8 (Co-Administration group [Co-Ad]), or mRNA-1273 at day 1, the first RZV dose at W2 and the second RZV dose at W10 (Sequential group [Seq]). Descriptive analyses of solicited/unsolicited adverse events (AEs) with onset within 7/30 days post-mRNA-1273 or first RZV dose, and of serious AEs/potential immune-mediated diseases/AEs of special interest (SAEs/pIMDs/AESIs) reported until database freeze are reviewed. Finding(s): The exposed set comprised 267 (Co-Ad) and 272 (Seq) participants. In each group, most solicited AEs were mild/moderate in intensity and each with <=2.5 days median duration, the most frequent were injection site pain, myalgia, and fatigue. Unsolicited (vaccines-related) AEs were reported by 25.0% (2.9%) of participants post-mRNA-1273 in Seq, 25.2% (0.8%) post-RZV in Seq, and 37.1% (3.7%) in Co-Ad. SAEs/pIMDs/AESIs were reported for 6/1/2 participants in Co-Ad and 5/1/3 in Seq. In Seq, one SAE/AESI (pulmonary embolism) and one pIMD/AESI (cutaneous vasculitis) occurred 2 and 9 days postmRNA-1273 (before RZV administration), respectively, and were considered mRNA-1273-related by investigators. In Co-Ad, one AESI (chronic hepatitis) occurred 35 days post-second RZV dose, considered vaccines-related by Sponsor. No fatalities occurred. Conclusion(s): No safety concerns were identified. The frequency/severity/type of AEs were comparable between groups and consistent with the known safety profile of each vaccine, whether RZV and mRNA-1273 booster were administered concomitantly or sequentially. Co-administration may enhance vaccine coverage rates. Funding(s): GSKCopyright © 2023
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Introduction: Mucosa-associated lymphoid tissue (MALT) lymphomas are extra-nodal marginal zone B-cell lymphomas, most commonly found in the stomach, associated with Helicobacter pylori infections, and generally not linked with inflammatory bowel disease. Rectal MALT lymphoma is very uncommon and often associated with painful defecation, change in bowel habits, or rectal pressure/prolapse. Here, we present a rare case of an asymptomatic female with ulcerative colitis (UC) found to have benign-appearing rectal polyps during a routine screening colonoscopy. Case Description/Methods: The patient is a 56-year-old female with a history of left-sided UC, diagnosed in 1993, with one flare after receiving the 2nd dose of the Moderna COVID-19 vaccine, taking oral Olsalazine 500 mg twice daily, low-dose Prednisone, and mesalamine suppositories as needed presenting for screening colonoscopy. The patient was asymptomatic, citing regular non-bloody bowel movements and normal stool consistency. Colonoscopy revealed two 7 mm sessile, non-bleeding rectal polyps, surrounded by congested, erythematous, friable, and ulcerated mucosa in the rectosigmoid colon. Cold forceps biopsies were taken. Hematopathology evaluation of the routine colon biopsy samples revealed chronic nonspecific colitis while pathology of the rectal polyps showed marked lymphoplasmacytic infiltrate and extra-nodal marginal zone lymphoma of MALT. Ancillary studies, immunohistochemistry, and molecular studies for B-cell gene rearrangement confirmed extra-nodal marginal zone lymphoma of MALT with prominent plasmacytic differentiation. The patient was informed and close follow-up in Gastroenterology clinic was arranged. (Figure) Discussion: Rectal MALT lymphoma is rare with unclear management options. Treatments of UC include watchful waiting, surgical resection, endoscopic mucosal resection, radiation, and/or chemotherapy. Helicobacter pylori infections, though strongly linked with gastric MALT lymphoma, have not been shown to be strongly correlated with rectal MALT lymphoma. Given that patients with UC have chronic UCassociated colonic inflammation, lymphoma is often difficult to distinguish visually during colonoscopy, frequently masked by ulcerations and pseudo-polyps. In cases like these, more definitive treatments such as surgical resection could therefore be warranted. Long-term follow-up data is sparse and definitive management remains a clinical conundrum, thus these patients require reliable long-term multidisciplinary close follow-up. (Figure Presented).
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Background: The tolerability of mRNA COVID-19 vaccines among people living with HIV (PLWH) has been understudied in vaccine trials. CoVPN 3008 (Ubuntu) is the largest multicenter Phase 3 efficacy trial of mRNA vaccines in sub-Saharan Africa. Method(s): We enrolled adults age >=18 years living with HIV or another comorbidity associated with severe COVID-19. Previously vaccinated individuals were excluded. Baseline testing included HIV, CD4 count and HIV viral load (VL) (if HIV+), anti-SARS-CoV-2 antibodies, and nasal swab SARS-CoV-2 nucleic acid amplification test (NAAT). All participants receive vaccinations at months 0 and 6, and SARS-CoV-2 seronegative individuals also receive vaccination at month 1. This analysis includes mRNA-1273 vaccinations at months 0 and 1. Reactogenicity (solicited adverse events [AEs]) was assessed among a representative subset of participants (Safety Subset, SS) for 7 days post-vaccination. Baseline characteristics associated with moderate/severe reactogenicity events were assessed by univariate and multivariate logistic regression. Result(s): 14002 participants were enrolled in the trial (1510 into the SS) at 46 sites from 2 Dec 2021 to 9 Sep 2022. At baseline in the SS, 71% (1065) were female, median age 38 years (IQR 32-46), and median BMI 25.0 (IQR 20.7-30.2). 73% (1108) were SARS-CoV-2 seropositive, and 8.7% (131) had a positive nasal NAAT swab. 16% (197) had a history of tuberculosis. 84% (1267) were PLWH, with median CD4 count of 614 cells/muL (IQR 414-861);7.8% had CD4 count < 200. 21% (238) had detectable HIV VL (>=50 copies/mL), with median VL 1660 (IQR 182-23932). 14% (172/1262) and 12% (64/542) of PLWH reported moderate/severe reactogenicity after the 1st and 2nd vaccination (Figure), with no hospitalizations. Female PLWH and CD4 count >500 had 35% (p=0.03) and 44% (p=0.04) increased odds of moderate/severe reactogenicity, respectively. Other baseline characteristics were not associated with the odds of reporting moderate/severe reactogenicity among PLWH after 1st vaccination. Similar trends were seen after the 2nd vaccination, but none reached statistical significance. In multivariate models, female sex remained associated with increased odds of moderate/severe reactogenicity after the 2nd vaccination. Conclusion(s): Similar to observations in HIV-negative populations, mRNA-1273 was well tolerated by PLWH with more reactogenicity in females. Impaired inflammatory responses among participants with CD4 counts < 500 cell/muL may explain less moderate/severe reactions.
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Vaccination is essential to manage the COVID-19 pandemic. Vaccination significantly protects against severe COVID-19, hospitalization and death;it also protects against symptomatic infection and reduces the risk of transmission to other people. Protection against the new SARS-CoV-2 variants may be lower, but protection against severe course and death remains high. Two mRNA vaccines (BNT162b2 and mRNA-1273) and two vector vaccines (AZD1222 and Ad26.COV2.S) are currently available in the Czech Republic. Vaccination of persons over 60 years of age and immunocompromised persons, who are demonstrably at the highest risk of a serious course of the disease, is of the utmost importance. In order to achieve adequate vaccination coverage, it is necessary to motivate other groups of people to be vaccinated, including children over 12 years of age and young adults. Vaccination is also recommended in preg-nant women in the 2nd and 3rd trimesters and in breastfeeding women. For selected groups of vaccines, a third dose of vaccination is recommended (additional third dose 4 weeks after the second dose or a booster dose 8 to 12 months after the second dose). The side effects are usually mild, with serious complications (including anaphylaxis, thrombocytopenia with thrombosis syndrome, myocardi-tis, Guillain-Barre syndrome and capillary leak syndrome) being rare.Copyright © 2021, Trios spol. s.r.o.. All rights reserved.
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Background. The COVID-19 pandemic has become a substantial global health crisis, unparalleled in world history. Infection dynamics can have specific characteristics in different countries due to social, economic, climatic, or geographic factors. Aim(s): to study features of SARS-CoV-2 collective immunity among the Armenian population. Materials and methods. A cross-sectional, randomized study of collective immunity was carried out according to a program developed by Rospotrebnadzor and the St. Petersburg Pasteur Institute, taking into account WHO recommendations. The study was approved by the ethics committees of the National Center for Infectious Diseases (Armenia) and the St. Petersburg Pasteur Institute (Russia). A volunteer cohort was formed (N = 6057), randomized by age and region. The study's analysis included: shares and distributions of antibodies (Abs) to nucleocapsid (Nc) antigen (Ag) and receptor binding domain (RBD) S-1 Ag in the cohort;and quantitative determination of these Abs by ELISA. During the survey, a history of vaccination was indicated by 4395 people. Results. Overall seropositivity formed in the whole cohort (by April 14, 2022) was 98.6% (95% CI: 98.1-98.7). It did not depend on age, place of residence, or occupation. When quantifying Nc and RBD Abs, the proportions of volunteers with Nc Ab levels of 1-17 BAU/ml and RBD Ab levels of 22.6-220 BAU/ml were the smallest, amounting to 6.9% (95% CI: 6.2-7.5) and 20.4% (95% CI: 19.4-21.4), respectively. With increasing serum concentrations (Nc > 667 BAU/ml, RBD > 450 BAU/ml), the proportions of individuals with the corresponding levels were 20.2% for Nc (95% CI: 19.2-21.3) and 54.2% for RBD (95% CI: 52.9-55.5). Vaccination coverage was 72.6% (95% CI: 71.5-73.7). The most frequently used were Sinopharm/BIBP (32.4%), AZD1222 (22.3%), and Gam-COVID-Vac (21%). The remaining vaccines (CoronaVac, mRNA-1273, BNT162b2, CoviVac) were used by 24.3% of vaccinated individuals. When summing vaccines by platform, it was found that: vector vaccines were used in 40.34% (95% CI: 33.57-42.39) of cases;whole-virion vaccines were used in 26.83% (95% CI: 24.76-32.20);and mRNA vaccines were used in 6.33% (95% CI: 4.84-8.91). Conclusion. The epidemic situation in Armenia by April 2022 was characterized by a high level of collective immunity, independent of age or regional factors. Vector and whole-virion vaccines have been used most widely.Copyright © Popova A.Yu. et al., 2023.