The COVID-19 pandemic revealed critical gaps in preparedness and response capacities globally. These gaps were evident in the Middle East and North Africa (MENA) region, as the region faces unique challenges due to ongoing humanitarian crises, political instability and large-scale religious gatherings, which further exacerbate the risk of spread of infectious diseases.In April 2024, a conference hosted by the US Centres for Disease Control and Prevention MENA Regional Office and National Institutes of Allergy and Infectious Diseases, in collaboration with the Mohammed Bin Rashid University of Medicine and Health Sciences, brought together 200 scientists and public health professionals from 16 countries to discuss lessons learnt from the COVID-19 pandemic and strategies to strengthen future preparedness and response. This report presents the key barriers to regional collaboration and data sharing identified during the conference, along with the proposed solutions, including establishing regional collaboration platforms, increasing public-private partnerships, operationalising the one health approach and leveraging technological advances.Reflections on the global pandemic response emphasise the need for improved communication, preparedness extending beyond the health sector and distribution of resources. The collective insights and recommendations in this report aim to provide a roadmap for strengthening emergency preparedness and response in the MENA region and globally, ensuring improved readiness for future public health emergencies.

Background: Despite the high prevalence of breast cancer, there is limited understanding of the psychosocial needs of cancer survivors in the United Arab Emirates (UAE). Methods: A survey was conducted to assess the psychosocial needs among 205 breast cancer survivors in the UAE and the association of various socio-demographics and clinical characteristics with the psychosocial needs were analysed. Results: The informational needs were the highest (mean - 27.99 ± 11.02) among the study participants compared to other psychosocial needs. Healthcare specialists were the most preferred source of information for all the psychosocial needs. Individuals currently receiving treatment (p-0.006) and who had longer years of survival (p-0.006) had significantly higher informational concerns. Social and financial concerns were significantly higher in expats (p<0.001), individuals currently receiving treatment (p<0.001) and individuals with longer years of survival (p<0.001). Conclusion: The study shows that there are unmet psychosocial needs among the breast cancer survivors in the UAE and the needs differ based on demographic and clinical characteristics.

Background:The coronavirus disease 2019 (COVID-19) significantly impacted the lifestyles of millions of people, with new challenges arising as the pandemic progresses. However, little attention has been given to issues like fertility intentions and pregnancy planning during COVID-19. Consequently, we aimed to investigate the influence of the pandemic on pregnancy and fertility decisions among the residents of the United Arab Emirates (UAE).Methods:We surveyed UAE residents of reproductive age between November 2021 to June 2022 via the Google Forms platform and collected data on demographics, associated health conditions, COVID-19 infections, as well as plans for pregnancy and fertility intentions. We presented data through descriptive statistics (frequencies and percentages) and used Pearson's χ2 test to compare the characteristics of participants who reported that the COVID-19 pandemic has influenced their fertility preferences with those who reported that it had not.Results:Overall, 564 participants completed the survey, of whom 115 (20.4%) stated that the COVID-19 pandemic had influenced their fertility preferences. Meanwhile, 234 (41.5%) reported previous history of COVID-19 infection; regarding post-COVID-19 infection symptoms, 53 (22.6%) reported decreased libido and 40 (17%) reported trouble in conceiving a baby. Participants who were ≤30 years of age were less likely to be influenced by the COVID-19 pandemic on their decision on fertility compared to those >30 years of age. Factors like education, income, chronic health conditions, and previous history of COVID-19 infection or vaccination did not have any significant effect on the COVID-19 pandemic influence on fertility preferences.Conclusions:The COVID-19 pandemic has brought in new challenges which could affect fertility and this needs to be studied further for planning effective measures.

AbstractThe United Arab Emirates (UAE) has cancer as the third leading cause of death. This chapter features clinical research in oncology, focusing on clinical trials in the UAE. Based on the last 10 years of data, the number of cancer-based clinical trials registered in the UAE is thin on the ground, which signifies the need for initiating clinical research on cancers specific to the Emirati population to strengthen evidence that can guide screening, diagnosis, and treatment policies.

In this review, we discuss the current state of population genome programs (PGPs) conducted in the Middle East and North African (MENA) region. This region has high prevalence of genetic diseases and significant health challenges as well as being a significantly underrepresented population in public genetic databases. The majority of ongoing PGPs represent regions in Europe, North and South America, South Asia, Australia, and Africa, with little to no descriptive information highlighted only on the MENA Region when it comes to genome programs databases, outcomes, or the challenges that MENA region countries may face establishing their own national programs. This review has identified 6 PGPs currently underway in the MENA region, namely in the Kingdom of Saudi Arabia, Qatar, Egypt, the United Arab Emirates, Bahrain, and Iran. Due to the rapidly growing involvement of the MENA region in national-scale genomic data collection, an increase in representation in public genetic databases is to be expected to occur in the near future. Whilst significant progress is being made in some MENA countries, future initiatives as well as ongoing programs will be facing several challenges related to collaboration, finance, infrastructure and institutional data access, data analysis, sustainability, health records, and biobanks. The review also reiterates the need for ensuring ethical and regulated genomic initiatives which can drive developments in personalized medicine treatments to improve patient prognosis and quality of life.

An ongoing randomized, double-blind, controlled phase 2 trial was conducted to evaluate the safety and immunogenicity of a mosaic-type recombinant vaccine candidate, named NVSI-06-09, as a booster dose in subjects aged 18 years and older from the United Arab Emirates (UAE), who had administered two or three doses of inactivated vaccine BBIBP-CorV at least 6 months prior to enrollment. The participants were randomly assigned with 1:1 to receive a booster dose of NVSI-06-09 or BBIBP-CorV. The primary outcomes were immunogenicity and safety against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Omicron variant, and the exploratory outcome was cross-immunogenicity against other circulating strains. Between May 25 and 30, 2022, 516 adults received booster vaccination with 260 in NVSI-06-09 group and 256 in BBIBP-CorV group. Interim results showed a similar safety profile between two booster groups, with low incidence of adverse reactions of grade 1 or 2. For immunogenicity, by day 14 post-booster, the fold rises in neutralizing antibody geometric mean titers (GMTs) from baseline elicited by NVSI-06-09 were remarkably higher than those by BBIBP-CorV against the prototype strain (19.67 vs 4.47-fold), Omicron BA.1.1 (42.35 vs 3.78-fold), BA.2 (25.09 vs 2.91-fold), BA.4 (22.42 vs 2.69-fold), and BA.5 variants (27.06 vs 4.73-fold). Similarly, the neutralizing GMTs boosted by NVSI-06-09 against Beta and Delta variants were also 6.60-fold and 7.17-fold higher than those by BBIBP-CorV. Our findings indicated that a booster dose of NVSI-06-09 was well-tolerated and elicited broad-spectrum neutralizing responses against divergent SARS-CoV-2 variants, including Omicron and its sub-lineages.

Background Breast cancer is the most common cancer among women in the United Arab Emirates; yet there is little known about the psychosocial concerns of the survivors. Research shows that meeting the psychosocial needs significantly contributes to cancer survivor’s wellbeing and potentially elevates the quality of the patient’s life. Therefore the study aims to understand the psychosocial needs of breast cancer survivors through a qualitative approach. Methods A qualitative study was conducted using semi structured in-depth interviews among ten breast cancer survivors. The recorded texts were coded and salient themes were generated using an inductive approach. Thematic analysis of the interviews was done observing for meaning, repeating phrases and keywords. Results Analysis yielded three major themes which included survivors’ living experience with breast cancer, concerns of breast cancer survivors and the survivors’ expectations of healthcare delivery or support needed. The breast cancer survivors had psychosocial concerns that are not well understood and addressed by the healthcare. The experiences, concerns and expectations differ from individuals and through the continuum of survivorship. Conclusion Understanding the unmet psychosocial concerns of the cancer survivors is essential to design a structured survivorship program and offer timely and effective interventions. This would improve survivorship care in the country and offers opportunities to redesign cancer services towards patient-centred care.

Importance: The protective efficacy of COVID-19 vaccinations has declined over time such that booster doses are required. Objective: To evaluate the efficacy and adverse events of booster doses of two inactivated COVID-19 vaccines. Design: This is a double-blind, randomized, placebo-controlled phase 3 trial aiming to evaluate the protective efficacy, safety, and immunogenicity of inactivated SARS-CoV-2 vaccine (Vero cells) after inoculation with booster doses of inactivated COVID-19 vaccine. Setting: Healthy volunteers were recruited in an earlier phase 3 trial of two doses of inactivated vaccine. The participants in Abu Dhabi maintained the blind state of the trial and received a booster dose of vaccine or placebo at least six months after the primary immunization. Participants: Adults aged 18 and older with no history of SARS-CoV, SARS-CoV-2, or Middle East respiratory syndrome infection (via onsite inquiry) were screened for eligibility. Interventions: A total of 9370 volunteers were screened and randomly allocated, of which 61 voluntarily withdrew from the screening stage without booster inoculation; 9309 received the booster vaccination, with 3083 in the WIV04 group, 3150 in the HB02 group, and 3076 in the alum-only group. Further, 5μg and 4μg of inactivated SARS-CoV-2 virion was adsorbed into aluminum hydroxide in a 0.5 mL aqueous suspension for WIV04 and HB02 vaccines. Main Outcomes and Measures: The primary efficacy outcome was the prevention of PCR-confirmed symptomatic COVID-19 from 14 days after the booster vaccine in the per-protocol population. A safety analysis was performed in the intention-to-treat population. Results: Symptomatic COVID-19 was identified in 36 participants in the WIV04 group (9.9 [95% CI, 7.2–13.8] per 1000 person-years), 28 in the HB02 group (7.6 [95% CI, 5.2–11.0] per 1000 person-years), and 193 in the alum-only group (55.2 [95% CI, 47.9–63.5] per 1000 person-years), resulting in a vaccine efficacy of 82.0% (95% CI, 74.2–87.8%) for WIV04 and 86.3% (95% CI, 79.6–91.1%) for HB02. One severe case of COVID-19 occurred in the alum-only group, and none occurred in the vaccine groups. Adverse reactions within seven days after vaccination occurred in 29.4% to 34.3% of participants in the three groups. Serious adverse events were rare and not related to vaccines (WIV04: 17 [0.5%]; HB02: 11 [0.4%]; alum only: 40 [1.3%]). Conclusions and Relevance: This study evaluated the safety of the booster dose, which was well tolerated by participants. Booster doses given over six months after the completion of primary immunization can help to provide more-effective protection against COVID-19 in healthy people 18 years of age or older. At the same time, the anti-SARS-CoV-2 antibodies produced by the two groups of experimental vaccines exhibited extensive cross-neutralization against representative SARS-CoV-2 variants. Trial Registration: This study is registered on ClinicalTrials.gov (NCT04510207).

NVSI-06-08 is a potential broad-spectrum recombinant COVID-19 vaccine that integrates the antigens from multiple SARS-CoV-2 strains into a single immunogen. Here, we evaluate the safety and immunogenicity of NVSI-06-08 as a heterologous booster dose in BBIBP-CorV recipients in a randomized, double-blind, controlled, phase 2 trial conducted in the United Arab Emirates (NCT05069129). Three groups of healthy adults over 18 years of age (600 participants per group) who have administered two doses of BBIBP-CorV 4-6-month, 7-9-month and >9-month earlier, respectively, are randomized 1:1 to receive either a homologous booster of BBIBP-CorV or a heterologous booster of NVSI-06-08. The incidence of adverse reactions is low, and the overall safety profile is quite similar between two booster regimens. Both Neutralizing and IgG antibodies elicited by NVSI-06-08 booster are significantly higher than those by BBIBP-CorV booster against not only SARS-CoV-2 prototype strain but also multiple variants of concerns (VOCs). Especially, the neutralizing antibody GMT against Omicron variant induced by heterologous NVSI-06-08 booster reaches 367.67, which is substantially greater than that boosted by BBIBP-CorV (GMT: 45.03). In summary, NVSI-06-08 is safe and immunogenic as a booster dose following two doses of BBIBP-CorV, which is immunogenically superior to the homologous boost with another dose of BBIBP-CorV.

ABSTRACT BACKGROUND The rising breakthrough infections caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants, especially Omicron and its sub-lineages, have raised an urgent need to develop broad-spectrum vaccines against coronavirus disease 2019 (COVID-19) . We have developed a mosaic-type recombinant vaccine candidate, named NVSI-06-09, having immune potentials against a broad range of SARS-CoV-2 variants. METHODS An ongoing randomized, double-blind, controlled phase 2 trial was conducted to evaluate the safety and immunogenicity of NVSI-06-09 as a booster dose in subjects aged 18 years and older from the United Arab Emirates (UAE), who had completed two or three doses of BBIBP-CorV vaccinations at least 6 months prior to the enrollment. The participants were randomly assigned with 1:1 to receive a booster dose of NVSI-06-09 or BBIBP-CorV. The primary outcomes were immunogenicity and safety against SARS-CoV-2 Omicron variant, and the exploratory outcome was cross-immunogenicity against other circulating strains. RESULTS A total of 516 participants received booster vaccination. Interim results showed a similar safety profile between NVSI-06-09 and BBIBP-CorV booster groups, with low incidence of adverse reactions of grade 1 or 2. For immunogenicity, by day 14 after the booster vaccination, the fold rises in neutralizing antibody geometric mean titers (GMTs) from baseline level elicited by NVSI-06-09 were remarkably higher than those by BBIBP-CorV against the prototype strain (19.67 vs 4.47-fold), Omicron BA.1.1 (42.35 vs 3.78-fold), BA.2 (25.09 vs 2.91-fold), BA.4 (22.42 vs 2.69-fold), and BA.5 variants (27.06 vs 4.73-fold). Similarly, the neutralizing GMTs boosted by NVSI-06-09 against Beta and Delta variants were also 6.60-fold and 7.17-fold higher than those boosted by BBIBP-CorV. CONCLUSIONS A booster dose of NVSI-06-09 was well-tolerated and elicited broad-spectrum neutralizing responses against SARS-CoV-2 prototype strain and immune-evasive variants, including Omicron and its sub-lineages. The immunogenicity of NVSI-06-09 as a booster vaccine was superior to that of BBIBP-CorV. (Funded by LIBP and BIBP of Sinopharm; ClinicalTrials.gov number, NCT05293548 ).

SummaryBackgroundThe increased coronavirus disease 2019 (COVID-19) breakthrough cases pose the need of booster vaccinations. In this study, we reported the safety and immunogenicity of a heterologous boost with a recombinant COVID-19 vaccine (CHO cells), named NVSI-06-07, as a third dose in participants who have previously received two doses of the inactivated vaccine (BBIBP-CorV) at pre-specified time intervals. Using homologous boost with BBIBP-CorV as control, the safety and immunogenicity of the heterologous boost with NVSI-06-07 against various SARS-CoV-2 strains, including Omicron, were characterized.MethodsThis study is a single-center, randomised, double-blinded, controlled phase 2 trial for heterologous boost of NVSI-06-07 in BBIBP-CorV recipients from the United Arab Emirates (UAE). Healthy adults (aged ≥18 years) were enrolled and grouped by the specified prior vaccination interval of BBIBP-CorV, i.e., 1-3 months, 4-6 months or ≥6 months, respectively, with 600 individuals per group. For each group, participants were randomly assigned at 1:1 ratio to receive either a heterologous boost of NVSI-06-07 or a homologous booster dose of BBIBP-CorV. The primary outcome was to comparatively assess the immunogenicity between heterologous and homologous boosts at 14 and 28 days post-boosting immunization, by evaluation of the geometric mean titers (GMTs) of IgG and neutralizing antibodies as well as the corresponding seroconversion rate (≥4-fold rise in antibody titers). The secondary outcomes were the safety profile of the boosting strategies within 30 days post vaccination. The exploratory outcome was the immune efficacy against Omicron and other variants of concern (VOCs) of SARS-CoV-2. This trial is registered with ClinicalTrials.gov, NCT05033847.FindingsA total of 1800 individuals who have received two doses of BBIBP-CorV were enrolled, of which 899 participants received a heterologous boost of NVSI-06-07 and 901 received a homologous boost for comparison. No vaccine-related serious adverse event (SAE) and no adverse events of special interest (AESI) were reported. 184 (20·47%) participants in the heterologous boost groups and 177 (19·64%) in the homologous boost groups reported at least one adverse reaction within 30 days. Most of the local and systemic adverse reactions reported were grades 1 (mild) or 2 (moderate), and there was no significant difference in the overall safety between heterologous and homologous boosts. Immunogenicity assays showed that the seroconversion rates in neutralizing antibodies against prototype SARS-CoV-2 elicited by heterologous boost were 89·96% - 97·52% on day 28 post-boosting vaccination, which was much higher than what was induced by homologous boost (36·80% - 81·75%). Similarly, in heterologous NVSI-06-07 booster groups, the neutralizing geometric mean titers (GMTs) against the prototype strain increased by 21·01 - 63·85 folds from baseline to 28 days post-boosting vaccination, whereas only 4·20 - 16·78 folds of increases were observed in homologous BBIBP-CorV booster group. For Omicron variant, the neutralizing antibody GMT elicited by the homologous boost of BBIBP-CorV was 37·91 (95%CI, 30·35-47·35), however, a significantly higher level of neutralizing antibodies with GMT 292·53 (95%CI, 222·81-384·07) was induced by the heterologous boost of NVSI-06-07, suggesting that it may serve as an effective boosting strategy combating the pandemic of Omicron. The similar results were obtained for other VOCs, including Alpha, Beta and Delta, in which the neutralizing response elicited by the heterologous boost was also significantly greater than that of the homologous boost. In the participants primed with BBIBP-CorV over 6 months, the largest increase in the neutralizing GMTs was obtained both in the heterologous and homologous boost groups, and thus the booster vaccination with over 6 months intervals was optimal.InterpretationOur findings indicated that the heterologous boost with NVSI-06-07 was safe, well-tolerated and immunogenic in adults primed with a full regimen of BBIBP-CorV. Compared to homologous boost with a third dose of BBIBP-CorV, incremental increases in immune responses were achieved by the heterologous boost with NVSI-06-07 against SARS-CoV-2 prototype strain, Omicron variant, and other VOCs. The heterologous BBIBP-CorV/NVSI-06-07 prime-boosting vaccination may be valuable in preventing the pandemic of Omicron. The optimal booster strategy was the heterologous boost with NVSI-06-07 over 6 months after a priming with two doses of BBIBP-CorV.Research in contextEvidence before this studyWe searched PubMed for clinical trials or prospective/cohort studies involving heterologous booster vaccination in non-immunocompromised population published up to Dec 25, 2021, using the term “(COVID) AND (vaccin*) AND (clinical trial OR cohort OR prospective) AND (heterologous) AND (booster OR prime-boost OR third dose)” with no language restrictions. Nine studies of heterologous prime-boost vaccinations with adenovirus-vector vaccines (ChAdOx1 nCov-19, Oxford-AstraZeneca, Ad26.COV2.S, Janssen) and mRNA vaccines (BNT162b2, Pfizer-BioNtech; mRNA1273, Moderna) were identified. The adenovirus-vector and mRNA heterologous prime-boost vaccination was found to be well tolerated and immunogenic. In individuals primed with adenovirus-vector vaccine, mRNA booster vaccination led to greater immune response than homologous boost. However, varied results were obtained on whether heterologous boost was immunogenically superior to the homologous mRNA prime-boost vaccination. Besides that, A preprint trial in population previously immunized with inactivated vaccines (CoronaVac, Sinovac Biotech) showed that the heterologous boost with adenovirus-vector vaccine (Convidecia, CanSino Biologicals) was safe and induced higher level of live-virus neutralizing antibodies than by the homogeneous boost. A pilot study reported that boosting with BNT162b2 in individuals primed with two doses of inactivated vaccines (BBIBP-CorV) was significantly more immunogenic than homologous vaccination with two-dose of BNT162b2. In addition, a preprint paper demonstrated that heterologous boost of ZF2001, a recombinant protein subunit vaccine, after CoronaVac or BBIBP-CorV vaccination potently improved the immunogenicity. But only a small size of samples was tested in this study and the live-virus neutralization was not detected. Till now, it is still lacking a formal clinical trial to evaluate the immunogenicity and safety of the heterologous prime-boost vaccination with an inactivated vaccine followed by a recombinant protein subunit-based vaccine.Added value of this studyTo our knowledge, this is the first reported result of a large-scale randomised, controlled clinical trial of heterologous prime-boost vaccination with an inactivated vaccine followed by a recombinant protein subunit vaccine. This trial demonstrated that the heterologous prime-booster vaccination with BBIBP-CorV/NVSI-06-07 is safe and immunogenic. Its immunoreactivity is similar to that of homologous vaccination with BBIBP-CorV. Compared to homologous boost, heterologous boost with NVSI-06-07 in BBIBP-CorV recipients elicited significantly higher immunogenicity not only against the SARS-CoV-2 prototype strain but also against Omicron and other variants of concern (VOCs).Implications of all the available evidenceBooster vaccination is considered an effective strategy to improve the protection efficacy of COVID-19 vaccines and control the epidemic waves of SARS-CoV-2. Data from our trial suggested that the booster vaccination of NVSI-06-07 in BBIBP-CorV recipients significantly improved the immune responses against various SARS-CoV-2 strains, including Omicron. Due to no Omicron-specific vaccine available currently, the BBIBP-CorV/NVSI-06-07 heterologous prime-boost might serve as an effective strategy combating Omicron variant. Besides that, BBIBP-CorV has been widely inoculated in population, and thus further boosting vaccination with NVSI-06-07 is valuable in preventing the COVID-19 pandemic. But further studies are needed to assess the long-term protection of BBIBP-CorV/NVSI-06-07 prime-booster vaccination.

The emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants with immune escape ability raises the urgent need for developing cross-neutralizing vaccines against the virus. NVSI-06-08 is a potential broad-spectrum recombinant COVID-19 vaccine that integrates the antigens from multiple SARS-CoV-2 strains into a single immunogen. Here, we evaluated the safety and immunogenicity of NVSI-06-08 as a heterologous booster dose in adults previously vaccinated with the inactivated vaccine BBIBP-CorV in a randomized, double-blind, controlled, phase 2 trial conducted in the United Arab Emirates ( NCT05069129 ). Three groups of healthy adults over 18 years of age (600 participants per group) who had administered two doses of BBIBP-CorV 4-6-month, 7-9-month and >9-month earlier, respectively, were vaccinated with either a homologous booster of BBIBP-CorV or a heterologous booster of NVSI-06-08. The primary outcome was immunogenicity and safety of booster vaccinations. The exploratory outcome was cross-reactive immunogenicity against multiple SARS-CoV-2 variants of concerns (VOCs). The incidence of adverse reactions was low in both booster vaccinations, and the overall safety profile of heterologous boost was quite similar to that of homologous boost. Heterologous NVSI-06-08 booster was immunogenically superior to homologous booster of BBIBP-CorV. Both Neutralizing and IgG antibodies elicited by NVSI-06-08 booster were significantly higher than by the booster of BBIBP-CorV against not only SARS-CoV-2 prototype strain but also multiple VOCs. Especially, the neutralizing activity induced by NVSI-06-08 booster against the immune-evasive Beta variant was no less than that against the prototype strain, and a considerable level of neutralizing antibodies against Omicron (GMT: 367.67; 95%CI, 295.50-457.47) was induced by heterologous booster, which was substantially higher than that boosted by BBIBP-CorV (GMT: 45.03; 95%CI, 36.37-55.74). Our findings showed that NVSI-06-08 was safe and immunogenic as a booster dose following two doses of BBIBP-CorV, which was immunogenically superior to homologous boost with another dose of BBIBP-CorV. Our study also indicated that the design of hybrid antigen may provide an effective strategy for broad-spectrum vaccine developments.

BACKGROUND:Booster doses for COVID-19 vaccinations are currently recommended and approved in many countries. However, we need more evidence on the immune response of individuals to booster doses of inactivated vaccines and the neutralizing effect against the variants of concerns of SARS-CoV-2.OBJECTIVE:To compare the fold reduction in antibody titers against the variants of concerns of SARS-CoV-2 between the primary doses and booster dose vaccine cohorts of inactivated BBIBP-CorV vaccine.STUDY DESIGN:In this observational study Plaque Reduction Neutralization Test (PRNT) assay was done on pooled serum samples of the recipients of primary two doses of inactivated BBIBP-CorV and on the pooled serum samples of recipients of a booster dose of inactive BBIBP-CorV. The neutralizing antibody titers against the wild (Wuhan) strain and the variants of concern (alpha, beta and delta) were compared.RESULTS:The serum sample pool from the booster cohort had high neutralizing antibody titers against the SARS-CoV-2 variants compared to the pooled serum samples of the recipients of primary two doses of inactivated BBIBP-CorV and the difference was statistically significant. The observed fold reduction in antibody titers from the serum pool of recipients of two doses of BBIBP-CorV vaccine were 3.7-fold, 14.6-fold and 10.4-fold compared to 1.8 -fold, 6.5-fold and 3.8-fold reduction against the alpha, beta and delta lineages respectively in the serum pool of recipient of a booster dose (three doses of BBIBP-CorV).CONCLUSION:Booster doses of inactive BBIBP-CORV offered better protection against the variants of concern of SARS-CoV-2.

Clinical evidence suggests that some patients diagnosed with coronavirus disease 2019 (COVID-19) experience a variety of complications associated with significant morbidity, especially in severe cases during the initial spread of the pandemic. To support early interventions, we propose a machine learning system that predicts the risk of developing multiple complications. We processed data collected from 3,352 patient encounters admitted to 18 facilities between April 1 and April 30, 2020, in Abu Dhabi (AD), United Arab Emirates. Using data collected during the first 24 h of admission, we trained machine learning models to predict the risk of developing any of three complications after 24 h of admission. The complications include Secondary Bacterial Infection (SBI), Acute Kidney Injury (AKI), and Acute Respiratory Distress Syndrome (ARDS). The hospitals were grouped based on geographical proximity to assess the proposed system's learning generalizability, AD Middle region and AD Western & Eastern regions, A and B, respectively. The overall system includes a data filtering criterion, hyperparameter tuning, and model selection. In test set A, consisting of 587 patient encounters (mean age: 45.5), the system achieved a good area under the receiver operating curve (AUROC) for the prediction of SBI (0.902 AUROC), AKI (0.906 AUROC), and ARDS (0.854 AUROC). Similarly, in test set B, consisting of 225 patient encounters (mean age: 42.7), the system performed well for the prediction of SBI (0.859 AUROC), AKI (0.891 AUROC), and ARDS (0.827 AUROC). The performance results and feature importance analysis highlight the system's generalizability and interpretability. The findings illustrate how machine learning models can achieve a strong performance even when using a limited set of routine input variables. Since our proposed system is data-driven, we believe it can be easily repurposed for different outcomes considering the changes in COVID-19 variants over time.

The effectiveness of the inactivated BBIBP-CorV vaccine against severe COVID-19 outcomes (hospitalization, critical care admission and death due to COVID-19) and its long-term effectiveness have not been well characterized among the general population. We conducted a retrospective cohort study using electronic health records of 3,147,869 adults, of which 1,099,886 vaccinated individuals were matched, in a 1:1 ratio to 1,099,886 unvaccinated persons. A Cox-proportional hazard model with time varying coefficients was used to assess the vaccine effectiveness adjusting for age, sex, comorbidity, ethnicity, and the calendar month of entry into the study. Our analysis showed that the effectiveness was 79.6% (95% CI, 77.7 to 81.3) against hospitalization, 86% (95% CI, 82.2 to 89.0) against critical care admission, and 84.1% (95% CI, 70.8 to 91.3) against death due to COVID-19. The effectiveness against these severe outcomes declined over time indicating the need for booster doses to increase protection against severe COVID-19 outcomes.

Background: This is a community-based retrospective cohort study conducted to determine effectiveness of the BBIBP-CorV inactivated vaccine in the real-world setting against hospital admissions and death.Methods: Study participants were chosen from 214,940 PCR-positive cases of COVID-19 reported to the Department of Health, Abu Dhabi Emirate, United Arab Emirates (UAE) between September 01, 2020 and May 1, 2021. Of these, 176,640 individuals were included in the study who were aged ≥15 years with confirmed COVID-19 positive status who had records linked to their vaccination status. Those with incomplete or missing records were excluded (n = 38,300). Study participants were divided into three groups depending upon their vaccination status: fully vaccinated (two doses), partially vaccinated (single dose), and non-vaccinated. Study outcomes included COVID-19-related admissions to hospital general and critical care wards and death. Vaccine effectiveness for each outcome was based on the incidence density per 1000 person-years.Findings: The fully-, partially- and non-vaccinated group included 62,931, 21,768 and 91,941 individuals, respectively. Based on the incidence rate ratios, the vaccine effectiveness in fully vaccinated individuals was 80%, 92%, and 97% in preventing COVID-19-related hospital admissions, critical care admissions, and death, respectively, when compared to the non-vaccinated group. No protection was observed for any of these outcomes for the partially vaccinated group.Interpretation: In a COVID-19 pandemic, use of the Sinopharm BBIBP-CorV inactivated vaccine is effective in preventing severe disease and death in a two-dose regimen. Lack of protection with the single dose may be explained by behavioral and biological factors.Funding Information: This study was not funded.Declaration of Interests: No conflict of interest.Ethics Approval Statement: This study was approved by the Abu Dhabi Health Research and Technology Ethics Committee (approval numbers DOH/CVDC/2021/994 and DOH/CVDC/2021/994) of the UAE Ministry of Health and Prevention.

COVID-19 vaccines have proven to be very safe in the clinical trials, however, there is less evidence comparing the safety of these vaccines in real-world settings. Therefore, we aim to investigate the nature and severity of the adverse effects reported and the differences based on the type of vaccine received. A survey was conducted among 1,878 adult (≥18 years) COVID-19 vaccine recipients through online survey platforms and telephonic interviews during March to September 2021. The factors potentially associated with the reported side effects like age, gender, ethnicity, comorbidities, and previous COVID-19 infection were analyzed based on the type of vaccine received. Differences in adverse events and the severity were compared between inactivated and mRNA vaccine recipients. The major adverse effects reported by the COVID-19 vaccine recipients were pain at the site of injection, fatigue and drowsiness, and headache followed by joint/muscle pain. The adverse effects were more common among recipients of mRNA Pfizer-BioNTech vaccine than among recipients of inactive Sinopharm vaccine with the odds ratio of 1.39 (95% CI 1.14–1.68). The average number of adverse effects reported between individuals who had received Sinopharm and Pfizer-BioNTech vaccines was 1.61 ± 2.08 and 2.20 ± 2.58, respectively, and the difference was statistically significant ( p <0.001). Severe adverse effects after COVID-19 vaccinations were rare and 95% of the adverse effects reported after either an inactivated or mRNA vaccine were mild requiring no or home-based treatment. The study found that individuals less than 55 years of age, female gender, with history of one or more comorbid conditions, who had received mRNA Pfizer- BioNTech vaccine, and with history of COVID-19 infections are at higher odds of developing an adverse effect post COVID-19 vaccination compared to the others.

Background and Aim An essential issue for Kawasaki Disease (KD) is the development of coronary artery disease. We decided to investigate (VEGF) subtype gene expression in KD due to the proangiogenic nature of Vasoactive Endothelial Growth Factor A (VEGF). VEGF-A is a known angiogenic molecule with pro-inflammatory effects, whereas the role of VEGFB has been less defined. Method KD Microarray and RNA-seq datasets were selected using a comprehensive search strategy of the NCBI GEO Dataset, which resulted in eight studies from whole blood. This included three extensive studies in KD (KD1-KD3). Further, one study dataset from coronary artery tissue, the Coronary Artery Dataset (CAD), was also included to appreciate end-stage KD. Results In CAD, cases of KD versus controls, VEGF-B was up-regulated (p = 4.932e-02). KD1, KD Acute versus convalescent samples, VEGF-A is up-regulated (p=1.258e-07) and VEGF-B was down-regulated (p=1.42e-28). Similar up regulation of VEGF-A and down regulation of VEGF-B was seen in KD2 (p=1.140e-04; p=1.746e-02) and KD3 (p=1.140e-04; p=1.746e-02), both are KD Versus Controls. VEGF-A up-regulated (p=1.140e-04), VEGF-B down-regulated (p=1.746e-02).KD3, KD versus Control; VEGF-A up-regulated (p=1.140e-04), VEGF-B down regulated (p=1.746e-02). Conclusions In acute KD VEGF-A up-regulation, with VEGFB being down-regulated, the reverse being true of the convalescent situation. This suggests a temporal inverse relationship between VEGF-A and VEGF-B may have biomarker implications. Moreover, a dual therapeutic strategy, enhancing VEGFB while minimizing VEGFA effects, could be a possible advancement over current KD related-therapies. Further work defining the relationship of VEGF-A to VEGF-B in KD-related angiogenesis is suggested.

Based on the findings from the Phase III clinical trials of inactivated SARS COV-2 Vaccine, (BBIBP-CORV) emergency use authorization (EUA) was granted for the vaccine to frontline workers in the UAE. A prospective cohort study was conducted among frontline workers to estimate the incidence rate and risk of symptomatic COVID-19 infection 14 days after the second dose of inoculation with BBIBP-CORV inactivated vaccine. Those who received two doses of the BBIBP-CORV vaccine in the period from 14th of September 2020 (first dose) to 21st of December 2020 (second dose) were followed up for COVID-19 infections. 11,322 individuals who received the two-dose BBIBP-CORV vaccine were included and were followed up post the second dose plus fourteen days. The incidence rate of symptomatic infection was 0.08 per 1000-person days (95% CI 0.07, 0.10). The estimated absolute risk of developing symptomatic infection was 0.97% (95% CI 0.77%, 1.17%). The confirmed seroconversion rate was 92.8%. There were no serious adverse events reported and no individuals suffered from severe disease. Our findings show that vaccinated individuals are likely to remain protected against symptomatic infection or becoming PCR positive for SARS COV 2 following the second dose of the vaccination.

Background Breakthrough infections post-COVID-19 vaccination occur with the emerging variants of the SARS-CoV virus which might be either due to the newer variants escaping immune response or the waning of antibodies over time. However, there is lack of long-term follow-up evidence on the waning of immune response following inactivated COVID-19 vaccine. Methods A retrospective, observational study was conducted on serum samples of individuals who had received two doses of BBIBP-CorV vaccine. Individual's antibody responses were evaluated based on IgG anti-S and neutralizing antibodies measurements. Antibody samples were categorized into four groups, defined by the time interval from the individual's receipt of the BBIBP-CorV vaccine: <30 days, 30-90 days, 91-180 days and >180 days. Results A total of 6668 serum samples from inactivated BBIBP-CorV vaccine recipients were analyzed for IgG anti-S and neutralizing antibodies. 571 (8.6%) samples were tested during the first 29 days interval post vaccination, 3642 (54.6%) were tested during 30-90 days interval, 2173 (32.6%) samples were tested during 91 to 180 days interval and 282(4.2%) were tested at >180 days interval post vaccination. We found that more than 50% of the individuals had antibody titers below the average cut-off range at the 91-180 days interval post vaccination. Older age (>60 years), male gender, chronic kidney disease, hypertension, immunodeficiencies and increased interval post vaccination emerged as independent risk factors associated with lower immune response. Conclusion Inactivated BBIBP-CorV vaccine recipients, based on age, gender and associated comorbid conditions might need booster doses at an earlier interval than the currently followed six months interval.