Does ChAdOx1-S and BNT162b2 heterologous prime-boost vaccination trigger higher rates of vaccine-related adverse events?

Background: There has been significant international interest in heterologous prime-boost COVID-19 vaccination. However, it is linked with different intensity and frequency of adverse events. This study aimed to assess the safety of ChAdOx1-S and BNT162b2 vaccines when given as heterologous prime-boost vaccination in Saudi Arabia. Methods: A cross-sectional study was conducted during the period October 2021 to March 2022. The study included two groups of people based on the type of vaccination regimen. The first group (heterologous) was subjected to different prime-boost vaccination schedules irrespective of the prime and boost vaccine types. The second group included people vaccinated with the same type of COVID-19 vaccine (homologous). Results: The overall sample included 334 participants. Those included in the heterologous group were at about 1.5 fold -increased risk for developing local and systemic adverse events compared to the homologous group. Fever, headache, and vomiting were significantly more frequent among the heterologous group compared to the homologous group (p-value<0.05). In both groups, more than half of the recorded adverse events were mild/moderate in severity. Conclusion: Heterologous prime-post vaccination is associated with a slightly increased risk for the development of local and systemic adverse events compared to the homologous regimen. However, most of these adverse events are mild/moderate in nature and recede within two days with no serious adverse events documented.

Analysis of patients' complaints in primary healthcare centres through the Mawid appl in Riyadh, Saudi Arabia; a cross-sectional study.

Introduction: The Saudi Ministry of Health launched a central appointment mobile application system (Mawid) that is linked to all primary healthcare (PHC) centres in the kingdom. The application allows patients to evaluate the healthcare services they receive. This study aimed to determine the frequency and nature of the complaints of patients visiting PHC centres through the Mawid application. Method: This cross-sectional study was conducted using 3-month secondary data from the Mawid application. The study included 3134 comments from 380,493 patients who visited 38 PHC centres in Riyadh and responded to the Mawid application evaluation questionnaire. Data were analysed using SPSS version 21. Results: Approximately 59.1% of the patients' comments were negative (patients' complaints); only 19%, positive; 8.40%, mixed; and 13.6%, unrelated. The patients' complaints (n=2969) were obtained from 380,493 patients within 3 months, yielding a complaint rate of 2.6 per 1000 attendances per month. The majority of the complaints (79.3%) were from patients visiting nonspecialised PHC centres. Approximately 59.1% of the complaints fell under the management domain; 23.6%, patient-staff relationship domain; and only 17.2%, clinical domain. Conclusion: Management and interpersonal problems constituted the main patients' complaints in the PHC centres in Saudi Arabia. Therefore, future studies must clarify the reasons contributing to these complaints. Increasing the number of physicians, providing staff training and continuous auditing are mandatory to improve patients' experiences in PHC centres.

The Association Between MTHFR C677T Gene Polymorphism and Repeated Pregnancy Loss in Arabic Countries: a Systematic Review and Meta-Analysis.

The role of MTHFR C677T polymorphism in repeated pregnancy loss (RPL) among different populations has been studied with inconsistent results. The study objective was to determine the association between MTHFR C677T polymorphisms and RPL among Arab women. The review included all the available studies investigating the association between MTHFR C677T polymorphism and RPL from 2000 until now. The searched database included Cochrane, Trip, EMBASE, and Google Scholar. Two authors independently reviewed the searched articles for eligibility, judged their risk of bias, and extracted the characteristics of the studies. Review Manager 5.3 program was used for data analysis using odds ratio (OR) at a 95% confidence interval (CI). The study revealed a statistically significant difference between cases and controls regarding combined MTHFR C677T polymorphisms (OR = 1.50, 95% CI = 1.15-1.96), MTHFR C677T heterozygous (OR = 1.41, 95% CI = 1.08-1.83), and MTHFR C677T homozygous (OR = 4.19, 95% CI = 1.87-9.39). Considerable significant heterogeneity was recorded in the three analyses (P < 0.05). The review supported the hypothesis that MTHFR C677T mutation is considered a significant risk factor for RPL among Arab women.

Post-COVID-19 syndrome: nature of symptoms and associated factors.

Aim: Post-COVID-19 syndrome is defined as continuous symptoms related to SARS-CoV-2 infection, which can persist for several weeks or months. Previous studies identified risk factors associated with post-COVID-19 syndrome, including female sex, hypertension, and allergic respiratory diseases. This study aims to investigate the frequency of this syndrome among Arabic patients. Subject and methods: A cross-sectional study was conducted from March to August 2022. The study included 520 Arabic patients with confirmed COVID-19 diagnosis, who were asked about possible symptoms persisting for ≥28 days. Results: Twenty-five percent (25%) of the included patients developed post-COVID-19 syndrome. The most common recorded symptoms were cough (32%), anosmia (32%), fatigue (28%), headache (19%), muscle pain (19%), and shortness of breath (17%). It was found that female sex, hospitalization due to initial COVID-19 infection, and the presence of chronic diseases were significant risk factors for developing post-COVID-19 syndrome. Conclusion: The study recorded post-COVID-19 syndrome among 25% of Arabic participants. Initial COVID-19 hospitalization, initial symptomatic COVID-19, and female sex were significant risk factors for developing post-COVID-19 syndrome. Supplementary Information: The online version contains supplementary material available at 10.1007/s10389-022-01802-3.

COVID-19 vaccine acceptance: knowledge and beliefs.

Backgrounds: Vaccine acceptance varies across countries, generations, and the perceived personality of individuals. Investigating the knowledge, beliefs, and acceptability of COVID-19 vaccines among individuals is vital to ensuring adequate health system capacity and procedures and promoting the uptake of the vaccines. Results: A cross-sectional study was conducted from August 2021 to January 2022 in Saudi Arabia. The study included 281 residents to estimate their acceptance to receive COVID-19 vaccination. Around 70% of the included participants had a moderate to high COVID-19 vaccine acceptance rate during the data collection period. The risk increases to about two folds among undergraduates [OR 1.846 (1.034-3.296), p value = 0.036)] and increases to four folds among non-employed [OR 3.944 (2.310-6.737), p value = 0.001]. About 78% of participants with high and 44% with low COVID-19 vaccine acceptance (p value = 0.001) believed the vaccines were safe and effective. The belief that COVID-19 disease will be controlled within two years increased the risk for low vaccine acceptance by about two folds [OR 1.730 (1.035-2.891), p value = 0.035]. Good knowledge about COVID-19 vaccination significantly affected the acceptance rate (p value = 0.001). Conclusions: Several factors affect the intention of individuals to receive vaccines. Therefore, building good knowledge and health literacy through educational intervention programs, especially vaccine safety and effectiveness, is important for successful vaccination campaigns among the general population and ensuring control of the COVID-19 pandemic.

Protective Duration of ChAdOx1 and BNT162b2 Vaccines Against SARS-CoV-2 Infection.

BACKGROUND AND OBJECTIVE: A limited number of studies have addressed the protective duration of coronavirus disease 2019 (COVID-19) vaccines following primary and booster doses in Saudi Arabia. Therefore, this study aimed to evaluate the protective duration of primary and booster doses of BNT162b2 and ChAdOx1 COVID-19 vaccine batches in Saudi Arabia. METHODS: A cross-sectional study was conducted from 1 January to 31 December, 2021. The study included 53,354 people infected with severe acute respiratory syndrome coronavirus-2 2 weeks or more after receiving at least a primary vaccination of either the ChAdOx1 or BNT162b2 vaccine. RESULTS: The total median protective duration of both primary COVID-19 vaccinations was 134 days. Heterologous primary vaccination (ChAdOx1 followed by BNT162b2) showed a significantly higher median protective duration of 142 days. The results show that the total median protective duration of the first booster doses of COVID-19 vaccines was 57 days. ChAdOx1 batch code C1 was found to have the most extended protective duration of 173 days (range 163-192 days). CONCLUSIONS: The current study revealed that the median protective duration of ChAdOx1 and BNT162b2 COVID-19 primary vaccination regimens administered in Saudi Arabia in 2021 was 134 days and that heterologous primary vaccination (ChAdOx1→BNT162b2) exhibited a significantly higher protective duration than other vaccination regimens.

Facial rejuvenation by microneedling with irradiated amniotic collagen matrix compared to platelet rich plasma.

Many modalities are used for treatment of facial wrinkles, such as microneedling that enhances collagen production, and platelet-rich plasma (PRP) which contains concentrated levels of growth factors. The human amniotic membrane isolated from the placentae of donors (during elective cesarean sections) has high levels of growth factors that help in rejuvenation by improving the migration and proliferation of keratinocytes, fibroblasts and increased collagen synthesis. Was to confirm the efficacy of irradiated amniotic collagen matrix (IACM) versus platelet rich plasma (PRP) delivered via microneedling in facial rejuvenation. The present study included 20 patients with facial wrinkles divided into two groups using split face technique: Group A subjected to microneedling with topical IACM on the right side of the face. Group B subjected to microneedling with topical PRP on the left side of the face. Patients received six sessions 2 weeks apart. Photos by Antera camera and skin biopsies were taken to assess the clinical results. There were a statistically significant improvement in both sides after than before treatment; with better improvement in patients treated with IACM more than patients treated with PRP using microneedling in both sides as proved clinically (assessed by WSRS and GAIS scale), pathologically (Orcein and Masson trichrome stain) and by Antera camera (texture and pigmentation). Microneedling using IACM is a new, safe and effective method for facial rejuvenation, more effective when compared to microneedling using PRP; in need for further studies to evaluate the correct dose and number of sessions to get the best outcome.

Adverse drug reactions from two COVID-19 vaccines reported in Saudi Arabia.

Background: Several reports have been published about the impact of coronavirus disease 2019 (COVID-19) vaccines on human health, and each vaccine has a different safety and efficacy profile. The aim of this study was to reveal the nature and classification of reported adverse drug reactions (ADRs) of the two COVID-19 vaccines (tozinameran and ChAdOx1) among citizens and residents living in Saudi Arabia, and show possible differences between the two vaccines and the differences between each batch on the health of populations. Methods: A cross-sectional study was conducted in Saudi Arabia between December 2020 and March 2021. Saudi citizens and residents aged ≥ 16 years who had at least one dose of any batch of either of the two approved COVID-19 vaccines (tozinameran and ChAdOx1) and who reported at least one ADR from the vaccines were included. The study excluded people who reported ADRs after receiving tozinameran or ChAdOx1 vaccines but no information was provided about the vaccine's batch number. Results: During the study period, 12,868 vaccinated people, including a high-risk group (i.e., those with chronic illness or pregnant women), reported COVID-19 vaccine ADRs that had been documented in the General Directorate of Medical Consultations, Saudi Ministry of Health. The study reported several ADRs associated with COVID-19 vaccines, with the most common (> 25%) being fever/chills, general pain/weakness, headache, and injection site reactions. Among healthy and high-risk people, the median onset of all reported ADRs for tozinameran and ChAdOx1 vaccine batches were 1.96 and 1.64 days, respectively (p < 0.01). Furthermore, significant differences (p < 0.05) were recorded between the two studied vaccines in regard to fever/chills, gastrointestinal symptoms, headache, general pain/weakness, and neurological symptoms, with higher incidence rates of these ADRs observed with the ChAdOx1 vaccine than the tozinameran vaccine. However, the tozinameran vaccine was found to cause significantly (p < 0.05) more palpitation, blood pressure variations, upper respiratory tract symptoms, lymph node swelling, and other unspecified ADRs than the ChAdOx1 vaccine. Among patients vaccinated with seven different batches of the tozinameran vaccine, people vaccinated with the T4 and T5 batches reported the most ADRs. Conclusion: There were significant differences regarding most of the reported ADRs and their onset among tozinameran and ChAdOx1 vaccines on both healthy people and high-risk individuals living in Saudi Arabia. Moreover, the study found that the frequencies of most listed ADRs were statistically different when seven batches of tozinameran vaccine were compared.

Polymorphisms of genes related to phase II metabolism and resistance to clopidogrel.

Clopidogrel is an antiplatelet drug commonly used to prevent coagulation. This review aimed to investigate the effect of polymorphisms of G6PD, GCLC, GCLM, GSS, GST, GSR, HK and GLRX genes on clopidogrel during phase II metabolism through exploring previous studies. The results revealed that low glutathione plasma levels caused by several alleles related to these genes could affect the bioactivation process of the clopidogrel prodrug, making it unable to inhibit platelet aggregation perfectly and thus leading to severe consequences in patients with a high risk of blood coagulation. However, the study recommends platelet reactivity tests to predict clopidogrel efficacy rather than studying gene mutations, as most of these mutations are rare and other nongenetic factors could affect the drug's efficacy.

Typing of alpha and beta coronaviruses by DNA barcoding of NSP12 gene.

Since the spread of the COVID-19 pandemic, the world paid attention to coronaviruses (CoVs) evolution and their diverged lineages because many researches studies supposed that the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is evolutionarily developed from a lineage of bats CoVs. This is due to the ability of some mutant CoVs to transmit from a host to different hosts. For this reason, there are many fears about the pathogenicity of the upcoming variants of CoVs. Thus, it is important to get a rapid and economic technique for typing a wide range of human and animal CoVs species for following up their mutant transmission. Therefore, the present study aims at approaching a simple design of DNA barcoding of a wide range of mammals' CoVs (including alpha and beta CoVs), by universal amplification of a species-specific sequence inside a conserved gene (NSP12) followed by amplicon sequencing. The in silico evaluation involved 96 nucleotide sequences of different CoVs (18 alpha CoVs and 78 beta CoVs), and was applied experimentally into the lab on 5 human CoVs isolates; 3 of them belong to beta CoVs (OC43, MERS, and SARS-CoV-2) and 2 are alpha CoVs (229E and NL63). The results indicated that the designed universal primers are able to amplify 332 bp of a taxonomic region inside the NSP12 coding sequence that facilitates the identification and classification of mammals' CoVs upon the resulting phylogenetic tree.

Knowledge, beliefs, and acceptability of people toward new COVID-19 vaccines: a pilot study.

A cross-section pilot study was done to determine the knowledge and belief toward new COVID-19 vaccines among a small sample size group of people. A new Vaccine Acceptability Questionnaire (VAQ) consists of 31 questions that were concerned about three elements: underlying factors, knowledge, and beliefs. The study included 96 people from the different regions of Saudi Arabia who had accepted to participate in this pilot study. Around 31% of the included people had low to very low acceptability toward COVID-19 vaccines; however, the other 69% had moderate to high acceptability. The new simple designed questionnaire (VAQ) could be effective in assessing knowledge, beliefs, and acceptability toward COVID-19 vaccination among a specific group of population.

Safety of English ivy (Hedera helix) leaf extract during pregnancy: retrospective cohort study.

BACKGROUND: English ivy (Hedera helix) is commonly used to reduce productive cough symptoms by acting as expectorant therapy. The safety of Hedera helix extract during pregnancy was not established yet. This study aims to determine the safety of English ivy leaf extract on newborns. OBJECTIVES: To determine the weight, APGAR (Activity-Pulse-Grimace-Appearance-Respiration) score, and health status of the newborns among the studied groups. METHODS: A retrospective multicenter cohort study was conducted during the fourth quarter of 2020 on 245 pregnant women and their newborns in two hospitals located in Riyadh, Saudi Arabia. The women were divided into an exposed group (N = 165) who used English ivy leaf extract syrup during pregnancy, and a control group (N = 80) who were not using any natural-pharmaceutical product for cough. RESULTS: The mean weight of the newborns in the exposed group was 3 kg compared to 2.8 kg in the control group (p-value < 0.05). The median APGAR score of the newborns in the exposed group was 8.5/10 compared to 8.0/10 in the control group (p-value > 0.05). There were no significant differences regarding the percentages of full-term and preterm newborns in the exposed and control groups (78.8% vs. 76.3%, and 21.0% vs. 24.0%, respectively, odds ratio [OR] = 0.86, 95% confidence interval [CI] = 0.45-1.63, p-value > 0.05). Regarding the newborns' health complications reported, there was no statistical difference in the percentages of full-term newborns diagnosed with at least one health complication between the exposed and control groups (0.6 vs. 3.8, OR = 0.15, 95% CI = 0.01-1.47, p-value > 0.05). CONCLUSION: Hedera helix (English ivy) leaf extract syrup was safe to be used in short term during pregnancy for the fetus.

Hydroxychloroquine Safety Outcome within Approved Therapeutic Protocol for COVID-19 Outpatients in Saudi Arabia.

BACKGROUND: Global healthcare is challenged following the COVID-19 pandemic, since late 2019. Multiple approaches have been performed to relieve the pressure and support existing healthcare. The Saudi Arabian Ministry of Health (MOH) launched an initiative to support the National Healthcare System. Since the 5th of June 2020, 238 outpatient fever clinics were established nationwide. This study aimed to assess the safety outcome and reported adverse events from hydroxychloroquine use among suspected COVID-19 patients. METHOD: A cross-sectional study included 2,733 patients subjected to MOH treatment protocol (hydroxychloroquine) and followed-up within 3-7 days after initiation. Data was collected through an electronic link and cross-checked with the national database (Health Electronic Surveillance Network, HESN) and reports from the MOH Morbidity and Mortality (M&M) Committee. RESULTS: 240 patients (8.8%) discontinued treatment because of side effects (4.1%) and for non-clinical reasons in the remaining (4.7%). Adverse effects were reported among (6.7%) of all studied participants, including mainly cardiovascular (2.5%, 0.15% with QTc prolongation), and gastrointestinal (2.4%). No Intensive Care Unit admission or death were reported among these patients. CONCLUSION: Our results show that hydroxychloroquine for COVID-19 patients in mild to moderate cases in an outpatient setting, within the protocol recommendation and inclusion/exclusion criteria, is safe, highly tolerable, and with minimum side effects.

Comorbidities and severity of coronavirus disease 2019 patients.

OBJECTIVES: To determine the association between comorbidities and the severity of the disease among COVID-19 patients. METHODS: We searched the Cochrane, Medline, Trip, and EMBASE databases from 2019. The review included all available studies of COVID-19 patients published in the English language and studied the clinical characteristics, comorbidities, and disease outcomes from the beginning of the pandemic.  Two authors extracted studies characteristics and the risk of bias. Odds ratio (OR) was used to analyze the data with 95% confidence interval (CI). RESULTS: The review included 1,885 COVID-19 patients from 7 observational studies with some degree of bias risk and substantial heterogeneity. A significant association was recorded between COVID-19 severity and the following variables: male (OR= 1.60, 95%CI= 1.05 - 2.43); current smoker (OR=2.06, 95%CI= 1.08 - 3.94); and the presence of comorbidities including hypertension (OR=2.05, 95%CI= 1.56 - 2.70), diabetes (OR=2.46, 95%CI= 1.53 - 3.96), coronary heart disease (OR=4.10, 95%CI= 2.36 - 7.12), chronic kidney disease (OR=4.06, 95%CI= 1.45 - 11.35), and cancer (OR=2.28, 95%CI= 1.08 - 4.81). CONCLUSIONS: Comorbidities among COVID-19 patients may contribute to increasing their susceptibility to severe illness. The identification of these potential risk factors could help reduce mortality by identifying patients with poor prognosis at an early stage.

The use of irradiated amnion dressing for the treatment of antibiotic-disinfected skin ulcer.

Skin ulcers are non-healed wounds caused by inflammation of epidermis up to the dermis, which causes pain and limits body movements, significantly reducing quality of life. Amniotic membrane is a placental collagenous biomaterial with many biological and mechanical properties important for tissue engineering and regenerative medicine. The aim of this work is to evaluate the efficacy of topical antibiotic washing followed with irradiated human amniotic membrane (iHAM) dressing for treating five different types of ulcers. The current study included 15 patients who were recruited from the outpatient clinic of the Egyptian Atomic Energy Authority. Follow up of all treated cases that completed the regimen was up to 3 months. The clinical progression of all treated ulcers was quantitatively evaluated by computerized estimation of the wound size reduction based on 3D image analysis. All cases in this study showed great outcomes within several weeks of treatment depending on wound infection, ulcer depth and size, period of healing disorder, age, blood glycemia, and other clinical criteria. Patients' questionnaires revealed that pain was controlled by the first time of treatment. After 1 week post-treatment, granulation tissue was generated and observed in all patients, and all microbial colonies have been eliminated from wounds with previous infection. The current study indicated that the dressing of ulcers with iHAM induces fast healing without complication.

Uses of gamma irradiated amniotic membrane as an alternative method in psoriasis treatment.

Psoriasis is a chronic inflammatory autoimmune disease with undefined etiology. It affects 2-3% of the worldwide population. The unsatisfactory outcome of variable treatments of the disease is partially due to the poor compliance of the present therapies with more or less side effects. As known, the human amniotic membrane is a popular intervention for many diseases. Amniotic membrane has been found recently to possess antimicrobial, anti-inflammatory and immunosuppressive properties. The irradiated amniotic membrane was used in this study as a topical application for 4 weeks on localized lesions in cases of mild psoriasis. The results presented herein provide a solid basis for the amniotic membrane to be used as a promising intervention for psoriasis treatment in the future.

Assessing of policies and practices for occupational exposure to blood-borne viral infections in Tanta University Hospitals, Egypt.

One of the best ways to investigate and improve the effectiveness of polices for prevention and control of infections is through systematic and rigorous evaluation of the structural, functional, and practical elements of these polices. To assess the policies for managing occupational exposure to blood-borne viral infections in Tanta University Hospitals. A cross-sectional survey was carried out. A checklist was used to collect data related to the hospital policy regarding occupational exposure to blood-borne viral infections which was filled by direct personal interviews with the members of infection control (IC) committee of Tanta University Hospitals where the percentage of those in compliance with specific occupational management policies were reported. All studied participants reported lack of access to written infection control manual and only 14.3 % reported that infection control policies and procedures are updated yearly. Only 32.5 % of studied healthcare workers (HCWs) were not aware by the availability of a needle injury clinic. Only 28.6 % of the members of IC committee reported that pre-placement screening of HCWs for baseline blood tests for HBV, HCV, or HIV was conducted; however, periodic screening for these infections was not conducted as reported by all of the members. Among the members of IC committee, 57.1 % recorded availability of post-exposure evaluation. Only 42.8 % of the members of IC committee reported ensuring HCWs' confidentiality when reporting their exposure incidents. Both exposure management policies and practices were not aligning with the national guidelines.