scholarly journals The incidence of COVID-19 infection following emergency use authorization of BBIBP-CORV inactivated vaccine in frontline workers in the United Arab Emirates

2022 ◽  
Vol 12 (1) ◽  
Author(s):  
Nawal Al Kaabi ◽  
Abderrahim Oulhaj ◽  
Farida Ismail Al Hosani ◽  
Shamma Al Mazrouei ◽  
Omer Najim ◽  
...  
Keyword(s):  
Incidence Rate ◽  
United Arab Emirates ◽  
Absolute Risk ◽  
Seroconversion Rate ◽  
Severe Disease ◽  
Phase Iii ◽  
Inactivated Vaccine ◽  
Serious Adverse Events ◽  
Symptomatic Infection ◽  
Frontline Workers

AbstractBased 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.

scholarly journals Subcutaneous Abatacept for the Treatment of Rheumatoid Arthritis: Longterm Data from the ACQUIRE Trial

2014 ◽  
Vol 41 (4) ◽  
pp. 629-639 ◽  
Author(s):  
Mark C. Genovese ◽  
César Pacheco Tena ◽  
Arturo Covarrubias ◽  
Gustavo Leon ◽  
Eduardo Mysler ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Severe Disease ◽  
Incidence Rates ◽  
Phase Iii ◽  
Inadequate Response ◽  
Open Label ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Safety And Efficacy ◽  
Link Type

Objective.Assess longterm tolerability, safety, and efficacy of subcutaneous (SC) abatacept (ABA) in methotrexate-refractory patients with rheumatoid arthritis (RA).Methods.The phase III, multinational Abatacept Comparison of Sub[QU]cutaneous Versus Intravenous in Inadequate Responders to MethotrexatE (ACQUIRE) trial comprised a 6-month, randomized, double-blind (DB) period, in which patients received intravenous (IV) or SC ABA, plus MTX, followed by an open-label, longterm extension (LTE), in which patients received SC ABA, 125 mg/week. Safety and efficacy from the LTE (∼3.5 yrs of exposure) are reported.Results.Patients who completed the DB period (1372/1385, 99.1%) entered the LTE; 1134 patients (82.7%) kept taking the treatment at time of reporting. Mean (SD) was 31.9 months (6.8); median (range) exposure was 33.0 (8–44) months. Patients entering the LTE had longstanding, moderate-to-severe disease [mean 7.6 (7.9) yrs and DAS28 (C-reactive protein) 6.2 (0.9)]. Incidence rates (events/100 patient-yrs) were reported for serious adverse events (8.76, 95% CI 7.71, 9.95), infections (44.80, 95% CI 41.76, 48.01), serious infections (1.72, 95% CI 1.30, 2.27), malignancies (1.19, 95% CI 0.86, 1.66), and autoimmune events (1.31, 95% CI 0.95, 1.79). Twenty-seven patients (2%) experienced injection-site reactions; all except 1 were mild. American College of Rheumatology 20, 50, and 70 responses achieved during the DB period were maintained through the LTE, and on Day 981 were 80.2% (95% CI 77.2, 83.2), 63.5% (95% CI 58.2, 68.9), and 39.5% (95% CI 34.0, 44.9) for patients who kept taking SC ABA, and 80.0% (95% CI 77.0, 83.0), 63.2% (95% CI 57.8, 68.7), and 39.2% (95% CI 33.7, 44.7) for those who switched from IV to SC ABA.Conclusion.These findings support SC ABA as a well-tolerated and efficacious longterm treatment for patients with RA and inadequate response to MTX (ClinicalTrials.gov identifier NCT00559585).

scholarly journals Olokizumab, a monoclonal antibody against interleukin 6, in combination with methotrexate in patients with rheumatoid arthritis inadequately controlled by methotrexate: efficacy and safety results of a randomised controlled phase III study

2021 ◽  
pp. annrheumdis-2021-219876
Author(s):  
Evgeniy Nasonov ◽  
Saeed Fatenejad ◽  
Eugen Feist ◽  
Mariana Ivanova ◽  
Elena Korneva ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Activity Index ◽  
Disease Activity Index ◽  
Phase Iii ◽  
Double Blind Study ◽  
Efficacy And Safety ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Acr20 Response

ObjectiveTo evaluate the efficacy and safety of olokizumab (OKZ) in patients with active rheumatoid arthritis despite treatment with methotrexate (MTX).MethodsIn this 24-week multicentre, placebo-controlled, double-blind study, patients were randomised 1:1:1 to receive subcutaneously administered OKZ 64 mg once every 2 weeks, OKZ 64 mg once every 4 weeks, or placebo plus MTX. The primary efficacy endpoint was the proportion of patients achieving an American College of Rheumatology 20% (ACR20) response at week 12. The secondary efficacy endpoints included percentage of subjects achieving Disease Activity Score 28-joint count based on C reactive protein <3.2, Health Assessment Questionnaire Disability Index at week 12, ACR50 response and Clinical Disease Activity Index ≤2.8 at week 24. Safety and immunogenicity were assessed throughout the study.ResultsA total of 428 patients were randomised. ACR20 responses were more frequent with OKZ every 2 weeks (63.6%) and OKZ every 4 weeks (70.4%) than placebo (25.9%) (p<0.0001 for both comparisons). There were significant differences in all secondary efficacy endpoints between OKZ-treated arms and placebo. Treatment-emergent serious adverse events (TESAEs) were reported by more patients in the OKZ groups compared with placebo. Infections were the most common TESAEs. No subjects developed neutralising antidrug antibodies.ConclusionsTreatment with OKZ was associated with significant improvement in signs, symptoms and physical function of rheumatoid arthritis without discernible differences between the two regimens. Safety was as expected for this class of agents. Low immunogenicity was observed.Trial registration numberNCT02760368.

scholarly journals Comparison of the Clinical Characteristics of Patients With COVID-19 in Suining and Wuhan

2020 ◽  
Author(s):  
Xiao-juan Wu ◽  
Chao-Ping Wang ◽  
Xiao-Bin Luo ◽  
Gao-Yan He ◽  
Bao-Lin Jia ◽  
...  
Keyword(s):  
Blood Glucose ◽  
Incidence Rate ◽  
Clinical Characteristics ◽  
Clinical Symptoms ◽  
Average Length ◽  
Severe Disease ◽  
Imaging Features ◽  
Lung Consolidation ◽  
Laboratory Test Results ◽  
D Dimer

Abstract Background Coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which was first identified in December 2019 in Wuhan. This study mainly analyzed the clinical characteristics, imaging features, and prognosis of patients with COVID-19 in Suining, one of China's fourth-tier cities, and Wuhan in 2019 and compared data between the 2 cities. Methods A retrospective analysis of the epidemiological history, clinical data, symptom presentation, laboratory test results, chest computed tomography (CT) imaging features, treatment measures and prognosis of 68 patients with COVID-19 diagnosed at Wuhan Red Cross Hospital and 17 patients with COVID-19 diagnosed at Suining Central Hospital from January 23, 2020, to February 27, 2020, was conducted. Results 1) The incidence rate of COVID-19 in Wuhan was 52.99‱, and the incidence rate in Suining was 0.04‱. The median age of patients with COVID-19 was 40.71 years old in Suining and 56.04 years old in Wuhan. The age of patients with COVID-19 in Wuhan was significantly older than that of patients with COVID-19 in Suining. Among the 68 patients with COVID-19 in Wuhan, 30 (44.1%) had hypertension, and 25 (36.8%) had diabetes. Three out of the 17 patients in Suining (17.6%) had hypertension, and 2 patients (11.8%) had diabetes. The proportion of patients with diabetes or hypertension in Wuhan was significantly higher than that in Suining (P<0.05). In the clinical classification, there were 1 (5.9%) and 23 (33.8%) patients with severe COVID-19 in Suining and Wuhan, respectively. The proportion of patients with severe COVID-19 in Wuhan was significantly higher than that in Suining (P<0.05).Fever and cough were the most common clinical symptoms, with 9 cases (52.9%) and 8 cases (47.1%) in Suining, respectively, and 54 cases (79.4%) and 42 cases (61.8%) in Wuhan, respectively. There was 1 patient (5.9%) with COVID-19 with dyspnea in Suining and 23 patients (33.8%) with COVID-19 with dyspnea in Wuhan; the difference was statistically significant (P<0.05). Chest CT showed that lung consolidation occurred in 2 (11.8%) and 26 (38.2%) patients with COVID-19 in Suining and Wuhan, respectively. The proportion of lung consolidation in patients in Wuhan was significantly higher than that in patients in Suining (P<0.05). The laboratory tests suggested that percentage ofelevated C-reactive protein (CRP) (58.8%), ALT (33.8%), blood glucose (45.6%), creatine kinase (CK) (33.8%) or D-dimer (47.1%) of patients in Wuhan were significantly increased than those in Suining (29.4%, 5.9%, 17.6%, 5.9%, and 17.7%, respectively). Moreover, the average length of hospital stay of patients in Wuhan was 17.49 days, which was significantly longer than that of patients in Suining (12.29 days). Conclusions The incidence of COVID-19 in fourth-tier cities, Suining, in China was significantly lower than that in Wuhan, and the disease severity was generally lower than that in Wuhan, with mostly good prognoses. Advanced age, diabetes, and hypertension are important factors that aggravate COVID-19, while elevated CRP, ALT, blood glucose, CK, and D-dimer levels are important indicators for severe disease.

scholarly journals Barriers to the Use of Endari™ in an Urban Adult Sickle Cell Center

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 2287-2287
Author(s):  
Ugochi Olivia Ogu ◽  
Merin Thomas ◽  
Florence Chan ◽  
Gracy Sebastian ◽  
Caterina P. Minniti
Keyword(s):  
Side Effects ◽  
Sickle Cell ◽  
Patient Population ◽  
Severe Disease ◽  
High Rate ◽  
Phase Iii ◽  
Prior Authorization ◽  
Original Cohort ◽  
Fda Approval ◽  
Number Of Patients

Background In 2017, the US Food and Drug Administration (FDA) approved Endari (L-glutamine oral powder) for patients age five years and older with sickle cell disease (SCD) to reduce sickle cell-related acute pain events and hospitalizations1. This was applauded as the first medication approval for SCD in almost 20 years, following Hydroxyurea (HU) in 1998. We report our experience with barriers to accessibility to a new medication such as Endari, and patients' adherence in adults with SCD in an urban adult sickle cell center. Methods After prospectively establishing internal guidelines for the use of Endari, adult patients with SCD seen in clinic at a large urban adult SCD center were prescribed Endari via a local specialty pharmacy, over a 14 month period. Upon return to clinic, patients were asked about barriers to obtaining the medication and adherence to the twice a day dosing. Adherence was also evaluated by calculating the mean possession ratio (MPR) utilizing pharmacy records. Results 111 patients with SCD (57% females) were prescribed Endari over a 14 month period (Table 1): 83% with severe disease genotypes (Hb SS/Sβ0), 17% with "milder" genotypes (Hb SC/Sβ+). Mean age was 36 years old. 74% of patients were on concomitant HU and 1% on chronic transfusions (>6 months). At the end of the 14 month period, 21 patients (19%) were actively taking Endari, 47 (42%) had discontinued it, 39 (35%) never filled the prescription, and 4 (4%) had received but never initiated therapy. Of the 39 who never filled the initial prescription, barriers included denial of prior authorizations (38% of patients), high deductibles (21%), and inability of pharmacy to contact patient after approval was obtained (23%) (Table 2). Reasons for discontinuing Endari included poor adherence (36%), as defined by patients who did not refill after the initial/subsequent prescriptions (mean refill 1.79 times) and/or missed follow up appointments, side effects (13%), no perceived benefit (4%), and pregnancy/breastfeeding (4%) (Table 3). Average MPR for the 21 patients that are still taking Endari is 0.73, similar to the adherence reported in the landmark phase III trial (77.4%)1. Discussion This is the first study that addresses both acceptance of a new medication by the sickle cell population and the barriers to obtaining it. We identified significant barriers to the initiation of Endari in our urban adult SCD patient population and a high rate of self-discontinuation. Patients who discontinued Endari, did so after a median of 47 days after the initial prescription. The most common reasons for not initiating therapy, present in ~ 70% of the cases, were insurance-related issues, such as prior authorization denial or high deductible/co-pays. In 30% of the cases patients were not reachable or had other issues for not filling it, despite obtaining prior authorization, which may indicate a lack of interest on their part. A small number of patients (6) reported discontinuing due to side effects. After 14 months, only 21/111, ~20% of the original cohort of patients prescribed Endari, reported taking it. The MPR of the patients that were taking the medication was 0.73, similar to the adherence in the Endari study (77.4%)1. Prospective studies are needed to confirm if this pattern is reproducible in other patients' populations across the country and to investigate whether the introduction of a new drug affects adherence to HU. As experienced with HU, several years elapsed from initial FDA approval to its being more accepted and widely used, and adherence remains sub-optimal. From our report, it is critical to evaluate and mitigate barriers to initiation and adherence to Endari, to ensure it is available to and accepted by the patient population it gained approval and was intended for. 1. N Engl J Med.2018 Jul 19;379(3):226-235 Disclosures Ogu: Vertex Pharmaceuticals: Consultancy. Minniti:Doris Duke Foundation: Research Funding.

scholarly journals Epidemiological Evidence of the Recent Surge in MS in Asia and Australia: A Systematic Review

2021 ◽  
Vol 25 (2) ◽  
Author(s):  
Sharareh Eskandarieh ◽  
Mohammad Ali Sahraian
Keyword(s):  
Multiple Sclerosis ◽  
New Zealand ◽  
Incidence Rate ◽  
United Arab Emirates ◽  
Literature Search ◽  
Systematic Literature Search ◽  
Epidemiological Evidence ◽  
Male Ratio ◽  
The World ◽  
Lower Incidence Rate

Context: Recently, the incidence and prevalence of multiple sclerosis (MS) have increased drastically in different regions of the world, including Asia. The present study aimed to systematically review the recent MS epidemiology in Asia, New Zealand, and Australia. Methods: A systematic literature search was performed in Medline and Embase databases to retrieve the available studies regarding MS epidemiology in Asia, New Zealand, and Australia. Results: Most of the studies were performed in hospital settings. The female-to-male ratio in the sample populations varied from 1.5:1 in Turkey to 5:1 in Malaysia. The total mean age at the onset of MS varied from the minimum of 28 years in Hong Kong to the maximum of 36 years in the United Arab Emirates. Among 16 pertinent studies in this regard, seven addressed the incidence rate of MS, and 13 addressed the prevalence of the disease. The highest prevalence rate was reported to be respectively 124.2 and 148.06 in Australia and Iran versus 2.73 in Malaysia (06 per 100,000 population), while a higher incidence rate was estimated at 6.88 and 6.7 per 100,000 population in Kuwait and Australia, respectively compared to the lower incidence rate per 100,000 population in China (0.2 in females, 0.12 in males). Conclusions: According to the results, the prevalence of MS has increased in Asia, while the prevalence of MS in this continent is lower compared to the rates reported in Australia, Europe, and North America.

scholarly journals Phase III double-blind study comparing the efficacy and safety of proposed biosimilar MYL-1402O and reference bevacizumab in stage IV non-small-cell lung cancer

2021 ◽  
Vol 13 ◽  
pp. 175883592110458
Author(s):  
Mark A. Socinski ◽  
Cornelius F. Waller ◽  
Tazeen Idris ◽  
Igor Bondarenko ◽  
Alexander Luft ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Adverse Events ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Small Cell ◽  
Phase Iii ◽  
European Medicines Agency ◽  
Small Cell Lung ◽  
Serious Adverse Events ◽  
Double Blind

Purpose: This phase III study compared the efficacy and safety of proposed biosimilar MYL-1402O with reference bevacizumab (BEV), as first-line treatment for patients with stage IV non-squamous non-small-cell lung cancer. Patients and methods: Patients were randomly assigned (1:1) to receive MYL-1402O or bevacizumab with carboplatin-paclitaxel up to 18 weeks (6 cycles), followed by up to 24 weeks (8 cycles) of bevacizumab monotherapy. The primary objective was comparison of overall response rate (ORR), based on independently reviewed best tumor responses as assessed during the first 18 weeks. ORR was analyzed per US Food and Drug Administration (ratio of ORR) and European Medicines Agency (difference in ORRs) requirements for equivalence evaluation. Secondary end points included progression-free survival, disease control rate, duration of response, overall survival, safety, and immunogenicity over a period of 42 weeks, and pharmacokinetics (up to 18 weeks). Results: A total of 671 patients were included in the intent-to-treat population. The ratio of ORR was 0.96 [confidence interval (CI) 0.83, 1.12] and the difference in ORR was −1.6 (CI −9.0, 5.9) between treatment arms; CIs were within the predefined equivalence margins. Overall, the incidence of treatment-emergent adverse events and serious adverse events was comparable. Treatment-emergent anti-drug antibody (ADA) positivity was transient, with no notable differences between treatment arms (6.5% versus 4.8% ADA positivity rate in MYL-1402O versus BEV, respectively). The incidence of neutralizing antibody post-baseline was lower in the MYL-1402O arm (0.6%) compared to the bevacizumab arm (2.5%). Conclusions: MYL-1402O is therapeutically equivalent to bevacizumab, based on the ORR analyses, with comparable secondary endpoints. Trial Registry Information EU Clinical Trials Register, Registration # EudraCT no. 2015-005141-32 https://www.clinicaltrialsregister.eu/ctr-search/search?query=2015-005141-32 Plain language summary Previous studies established bioequivalence of the proposed bevacizumab biosimilar MYL-1402O to reference bevacizumab. In this randomized, double-blind, phase III trial, MYL-1402O ( n = 337) demonstrated comparable efficacy to bevacizumab ( n = 334) in treating advanced non-squamous non-small-cell lung cancer per Food and Drug Administration and European Medicines Agency requirements for equivalence; the ratio of objective response rate (ORR) was 0.96 [90% confidence interval (CI) 0.83, 1.12] and the difference in ORR (MYL-1402O:bevacizumab) was −1.6 (95% CI −9.0, 5.9). Median progression-free survival at 42 weeks was comparable: 7.6 (7.0, 9.5) with MYL-1402O versus 9.0 (7.2, 9.7) months ( p = 0.0906) with bevacizumab, by independent review. Treatment-emergent adverse events leading to death (2.4% vs 1.5%), serious adverse events (17.6% vs 16.7%), and antidrug antibodies (6.5% vs 4.8%), were comparable in the MYL-1402O vs bevacizumab arms, respectively. The incidence of neutralizing antibody post-baseline was lower with MYL-1402O (0.6%) than with bevacizumab (2.5%). These findings confirm therapeutic equivalence of MYL-1402O to bevacizumab, providing opportunities for improving access to bevacizumab.

scholarly journals Durability analysis of the highly effective BNT162b2 vaccine against COVID-19

2021 ◽  
Author(s):  
Arjun Puranik ◽  
Patrick J. Lenehan ◽  
John C. O’Horo ◽  
Michiel J.M. Niesen ◽  
Abinash Virk ◽  
...  
Keyword(s):  
Conditional Logistic Regression ◽  
Severe Disease ◽  
Negative Control ◽  
Calendar Time ◽  
Symptomatic Infection ◽  
National Medical ◽  
Early Signal ◽  
Durability Analysis ◽  
Negative Case ◽  
Nonpharmaceutical Interventions

AbstractSARS-CoV-2 breakthrough infections have been increasingly reported in fully vaccinated individuals. We conducted a test-negative case-control study to assess the durability of protection after full vaccination with BNT162b2, defined as 14 days after the second dose, against polymerase chain reaction (PCR)-confirmed symptomatic SARS-CoV-2 infection, in a national medical practice between February 1, 2021 and August 22, 2021. We fit conditional logistic regression (CLR) models stratified on residential county and calendar time of testing to assess the association between time elapsed since vaccination and the odds of symptomatic infection or non-COVID-19 hospitalization (negative control), adjusted for several covariates. The primary population included 652 individuals who had a positive symptomatic test after full vaccination with BNT162b2 (cases) and 5,946 individuals with at least one negative symptomatic test after full vaccination (controls). The adjusted odds of symptomatic infection were higher 120 days after full vaccination versus at the date of full vaccination (Odds Ratio [OR]: 3.21, 95% confidence interval [CI]: 1.33-7.74). Importantly, the odds of infection were still lower 150 days after the first BNT162b2 dose as compared to 4 days after the first dose (OR: 0.3, 95% CI: 0.19-0.45), when immune protection approximates the unvaccinated status. Low rates of COVID-19 associated hospitalization or death in this cohort precluded analyses of these severe outcomes. The odds of experiencing a non-COVID-19 hospitalization decreased with time since vaccination, suggesting a possible underestimation of waning protection by this approach due to confounding factors. Taken together, these data constitute an early signal for waning protection against symptomatic illness while also providing reassurance that BNT162b2 continues to protect against symptomatic SARS-CoV-2 infection several months after full vaccination. Continued surveillance of COVID-19 vaccine durability, particularly against severe disease, is critical to guide effective and equitable strategies to respond to the pandemic, including distribution of booster doses, development of new vaccines, and implementation of both pharmaceutical and nonpharmaceutical interventions.

scholarly journals The ‘Vero Cell’ COVID-19 vaccine rollout in Nepal: What we know about the Chinese vaccine development and access?

2021 ◽  
Vol 8 (1) ◽  
pp. 1-8
Author(s):  
Jay Narayan Shah
Keyword(s):  
Clinical Trial ◽  
United Arab Emirates ◽  
Science And Technology ◽  
Modern Science ◽  
Phase Iii ◽  
Phase 3 ◽  
Pharmaceutical Group ◽  
Fda Approval ◽  
The Usa ◽  
The Impact

The world has changed dramatically from the impact of the COVID-19. It has impacted the normality of daily life, highlighting the failure of rich and poor nations alike, which is evident from the high number of human lives lost in rich and powerful countries like the USA with total deaths of 32,735,704 and Europe with 43,708,958 until April 24, 2021, as per Worldometer. The COVID-19 pandemic has shown that all of us ‘have and have-not’, no one can escape from the effects of the lockdowns, disruption of normal life including education, businesses, etc. reminding all of us that equitable access to vaccines is the best possible choice not to further exacerbate the challenges because ‘no country is safe until every country is safe’. It is a remarkable scientific achievement that within a year of the identification of the virus, we have COVID-19 vaccines, albeit available mostly in rich countries. The benefit of research is possible only with solidarity, by sharing the available resources, vaccine included, for the control of the ongoing COVID-19 pandemic. Modern science and technology, including the development and marketing of COVID-19 vaccines, have been focused in the USA and Europe. China joined this club of elites of science following the Chinese FDA approval of Sinopharm (the subsidiary of state-owned China National Pharmaceutical Group- CNPG), first COVID-19 vaccine (inactivated Sars-Cov-2) based on the results of the phase-3 clinical trial in UAE and Bahrain showing up to 86% efficacy of the vaccine in preventing COVID-19. Detail of trials of Sinopharm inactivated COVID-19 vaccines (Vero Cells) available on two early trials in China (Phase I/II ChiCTR2000031809, enrollment 1,456) and later 4 trials outside China (phase III, NCT04510207 Bahrain, Egypt, Jordan, United Arab Emirates- enrollment of 45,000; ChiCTR2000034780 United Arab Emirates, enrollment of 15,000; NCT04612972 Peru, enrollment of 6,000) show the progress of research and approval in China and UAE. Modern science and technology, including the development and marketing of COVID-19 vaccines, have been focused in the USA and Europe. China joined this club of elites of science following the Chinese FDA approval of Sinopharm (the subsidiary of state-owned China National Pharmaceutical Group- CNPG) first COVID-19 vaccine (inactivated Sars-Cov-2) based on the results of the phase-3 clinical trial in UAE and Bahrain showing up to 86% efficacy of the vaccine in preventing COVID-19.3

Immunogenicity and Safety Analysis of Inactivated Virus Vaccine against SARS-CoV-2: A Systematic Review of Phase 1/2 Clinical Trials

2021 ◽  
Vol 9 (1) ◽  
Author(s):  
Muhammad Mikail Athif Zhafir Asyura ◽  
Angelina Patricia Chandra ◽  
Achmad Agussalim ◽  
Garry Soloan
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Virus Vaccine ◽  
Seroconversion Rate ◽  
Phase 1 ◽  
Safety Analysis ◽  
Inactivated Vaccine ◽  
Online Databases ◽  
Dependent Relation ◽  
Tract Infections

Introduction: The lingering Severe Acute Respiratory System-Coronavirus-2 (SARS-CoV-2) pandemic worldwide has called scientists to accelerate vaccine production and reduce the spread of the virus. The inactivated virus vaccine has been administered widely due to its potency. Following its recent public use, we aim to summarize the efficacy and safety of the inactivated vaccine, especially following Indonesia’s settlement on the SinoVac vaccine. Materials and Methods: A systematic review was performed, searching for randomized controlled trials, according to the PRISMA statement throughout four online databases with studies published up to 2 February 2021. Critical appraisal was further conducted utilizing the Cochrane Risk of Bias Tool 2.0. Results and Discussions: The search yielded six phase ½ clinical trials with a total of 3251 subjects. The outcome was obtained in seroconversion rates (%) after two doses of vaccine. Four studies administered the CoronaVac inactivated vaccine and resulted in a high seroconversion rate, ranging from 89—90%. The other two studies administered the BBV152 and BBIBP-CorV inactivated vaccine and showed similar results. Furthermore, a dose dependent relation is shown with higher doses showing higher seroconversion rates. The safety analysis reported injection site pain as an insignificant but most prevalent local adverse reaction, with other adverse reactions being mild to moderate respiratory tract infections Conclusion: The inactivated vaccine’s efficacy has been proven to stimulate antibody response regardless of dosage, period of administration, and age, with insignificant adverse effects. Further phase 3 clinical trials and widespread administration with the help of non-governmental and medical student organizations are recommended

scholarly journals Incidence and risk factors for recurrent cardiovascular disease in middle-eastern adults: a retrospective study

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Romona D. Govender ◽  
Saif Al-Shamsi ◽  
Elpidoforos S. Soteriades ◽  
Dybesh Regmi
Keyword(s):  
Diabetes Mellitus ◽  
Risk Factors ◽  
Cardiovascular Disease ◽  
Incidence Rate ◽  
United Arab Emirates ◽  
Cox Proportional Hazards ◽  
Cvd Risk ◽  
Female Sex ◽  
Increased Risk ◽  
History Of

Abstract Background Individuals with established cardiovascular disease (CVD) and risk factors such as age, smoking, hypertension, and diabetes mellitus are at an increased risk of recurrent cardiovascular events and death. The incidence rate of recurrent CVD events varies between countries and populations. The United Arab Emirates (UAE) has one of the highest age-standardized death rates for CVD worldwide. The aim of our study was to estimate the incidence rates and determine the predictors of recurrent CVD events among UAE nationals. Methods We investigated an outpatient-based cohort of patients with a history of CVD visiting Tawam Hospital between April 1, 2008 and December 31, 2008. They were followed-up until July 31, 2018. Univariable and multivariable Cox proportional hazards regression models were used to determine the association between major CVD risk factors and the risk of CVD recurrence. Results A total of 216 patients (167 males, 49 females) with a history of CVD were included. They were followed for a median (interquartile range) of 8.1 (5.5–9.3) years, with a total of 1184 patient-years of follow-up. The overall incidence rate of recurrent CVD events was 92.1 per 1000 patient-years. The 8-year cumulative incidence was 73.7%. Age, female sex, and diabetes mellitus were significant predictors of recurrent CVD events, where females had a 1.96 times higher risk of recurrent CVD events than males. Conclusion Significant predictors of recurrent CVD events are older age, female sex, and diabetes mellitus. The incidence rate of recurrent CVD events was 92.1 per 1000 patient-years. Preventive measures, based on international guidelines for CVD management, may improve CVD morbidity and mortality in the UAE population.

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