Background: Thailand’s fourth and fifth waves of coronavirus disease 19 (COVID-19) started in July and December 2021, respectively, and greatly overloaded the nation’s public health system. The massive imbalance between health resources and patient demand for services was one of the most significant challenges hampering the country’s response to the catastrophic COVID-19 pandemic. Hospital-based facilities were overwhelmed with an exponential rise in new patient numbers, with a rapidly growing backlog of patients with delayed care or even acceptance within the healthcare system. In response, “outpatient self-isolation” (SI), “home-based isolation” (HI), and “community-based isolation” (CI) strategies were adopted to stabilize COVID-19 cases with mild to moderate symptoms. We present the lessons learned from the system management of HI by drawing on the experiences gained at a university hospital that provided patient-to-professional remote support during the pandemic. The vast majority of patients were assigned to HI immediately after being diagnosed with COVID-19. This system enabled remote consultation, needed medications, and survival-kit supplies to be initiated and delivered to patients’ homes. Conclusion: Our investigation indicates that the HI teleconsultation system was a productive approach to COVID-19 management. It allowed a prompt response to patients’ needs and provided timely access to medical support, especially for patients with mild to moderate symptoms.

Introduction: During the early phase of the coronavirus disease 2019 (COVID-19), remdesivir was only approved for hospitalized patients. Our institution developed hospital-based, outpatient infusion centers for selected hospitalized patients with COVID-19 who had clinical improvement to allow for early dismissal. The outcomes of patients who transitioned to complete remdesivir in the outpatient setting were examined. Methods: Retrospective study of all hospitalized adult patients with COVID-19 who received at least one dose of remdesivir from 11/6/2020 to 11/5/2021 at one of the Mayo Clinic hospitals. Results: Among 3,029 hospitalized patients who received treatment with remdesivir for COVID-19, the majority (89.5%) completed the recommended the five-day course. Among them, 2,169 (80%) completed treatment during hospitalization, while 542 (20.0%) patients were dismissed to complete remdesivir in outpatient infusion centers. Patients who completed the treatment in the outpatient setting had lower odds of death within 28 days (aOR 0.14, 95% CI 0.06-0.32, p<0.001). However, their rate of subsequent hospital encounters within 30 days was higher (aHR 1.88, 95% CI 1.27-2.79, p=0.002). Among patients treated with remdesivir only in the inpatient setting, the adjusted odds of death within 28 days were significantly higher among those who did not complete the 5-day course of remdesivir (aOR 2.07, 95% CI 1.45-2.95, p<0.001). Conclusions: This study describes the clinical outcomes of a strategy of transitioning remdesivir therapy from inpatient to outpatient among selected patients. Mortality was lower among patients who completed the 5-day course of remdesivir.

BACKGROUND Severe acute respiratory syndrome corona virus (SARS-CoV-2) infection frequently causes severe and prolonged disease but only few specific treatments are available. We aimed to investigate safety and efficacy of a SARS-CoV-2-specific siRNA-peptide dendrimer formulation (MIR 19 ®) targeting a conserved sequence in known SARS-CoV-2 variants for treatment of COVID-19. METHODS We conducted an open-label, randomized controlled multicenter phase II trial (NCT05184127) evaluating safety and efficacy of inhaled MIR 19 ® (3.7mg and 11.1 mg/day: groups 1 and 2, respectively) in comparison with standard etiotropic drug treatment (group 3) in patients hospitalized with moderate COVID-19. The primary endpoint was the time to clinical improvement according to predefined criteria within 14 days of randomization. RESULTS Patients from group1 had a significantly reduced (median 6 days (95% confidence interval [CI]: 5-7, HR 1.75, P=0.0005) time to clinical improvement compared to patients from group 3 (8 days (95% CI: 7-10). Normalized oxygen saturation (SpO 2>94%) occurred quicker in the group 1 (median 5 days (95% CI: 4–5, HR 1.59, P=0.0033) than in the group 3 (6 days, 95% CI: 5–8). Treatment with MIR 19® was well tolerated and safe. CONCLUSIONS MIR 19 ®, a SARS-CoV-2-specific siRNA-peptide dendrimer formulation is safe and significantly reduces time to clinical improvement in hospitalized moderate COVID-19 patients compared to standard therapy in a randomized controlled trial. MIR 19 ® treatment targets a sequence which is identical in all SARS-CoV-2 variants known so far and hence should be applicable for all of them.

We report two cases of previously healthy young men with COVID-19 infection who developed acute ischemic stroke due to large vessel occlusion followed by secondary events concerning for a further thromboembolic event. We hypothesize that the hypercoagulable state related to COVID-19 exacerbated the underlying hereditary thrombophilia due to MTHFR-gene mutation.

Objective: The causative virus of COVID-19 is SARS-CoV-2. The aim of the present study was to invastigate the in vivo virucidal activity of nasal irrigation with saline, nasal irrigation with Povidone-iodine (PVP-I) 1%, nasal irrigation with hypertonic alkaline and nasal irrigation with PVP-I 1% against SARS CoV- 2. Design: The present study was a prospective randomized clinical trial. Setting: A multicenter study involving tertiary care centers. Participants: The study included adult outpatients whose qualitative SARS-CoV-2 RT-PCR tests in nasopharyngeal swabs were positive. One hundred twenty patients divided into four equal groups. Standard COVID-19 treatment was given to group 1 (n=30), nasal irrigation containing isotonic solution was added to patients’ treatment in group 2 (n=30), nasal irrigation containing 1% PVP solution was added to patients’ treatment in group 3(n=30), and nasal irrigation containing 1% PVP solution and nasal irrigation containing hypertonic alkaline solution was added to patients’ treatment in group 4 (n=30). Main outcome measures: On the first day of diagnosis (day 0), nasopharyngeal swab samples were taken, on the 3rd and 5th days the nasopharyngeal viral load reduction in quantitative RT-PCR tests were calculated. Results: Between the 0-3rd Day and 0-5th days, the nasopharyngeal viral load reduction was significant in all groups (p< .05). In paired comparisons of groups, the nasopharyngeal viral load decrease in group 4 in first 3 days was significantly lower than all groups (p < .05). The nasopharyngeal viral load degrease in groups 3 and 4 in the first 5 days were significantly lower than group 1 (p < .05). Conclussion: This study was reveal that the use of hypertonic alkaline nasal irrigation together with 1% povidone-iodine was more effective in reducing viral load in the early period. The decreased nasopharyngeal viral load may reduce the carriage of infectious SARS-CoV-2 in patients. Our results suggest that 1% povidone-iodine and hypertonic alkaline nasal irrigation may be promising modality to prevent the COVID-19 epidemic.

As the COVID-19 continues to mutate, the number of infected people is increasing dramatically, and the vaccine is not enough to fight the mutated strain. In this paper, a SEIR-type fractional model with reinfection and vaccine inefficacy is proposed, which can successfully capture the mutated COVID-19 pandemic. The existence, uniqueness, boundedness and nonnegativeness of the fractional model are derived. Based on the basic reproduction number R 0 , locally stability and globally stability are analyzed. The sensitivity analysis evaluate the influence of each parameter on the R 0 and rank key epidemiological parameters. Finally, the necessary conditions for implementing fractional optimal control are obtained by Pontryagin's Maximum Principle, and the corresponding optimal solutions are derived for mitigation COVID-19 transmission. The numerical results show that humans will coexist with COVID-19 for a long time under the current control strategy. Furthermore, it is particularly important to develop new vaccines with higher protection rates.

Objective: SARS-COV-2 pandemic had a profound impact on acute bronchiolitis epidemiology, especially in RSV diffusion and the burden of disease with implications on the management of prophylaxis and health resources. We aimed to compare clinical and epidemiological characteristics of bronchiolitis before and during the SARS-CoV-2 pandemic.   Methods: We conducted an observational study involving children aged 0-2 years with bronchiolitis admitted to a tertiary children’s hospital during the last 5 years. Demographic, clinical, microbiological, and outcome data were collected. Comparison between pre- and post-pandemic period, RSV positive versus non-RSV patients, and SARS-CoV-2 positive vs negative patients were carried out.    Results: A total of 647 patients admitted for bronchiolitis were included (264 female,40.8%, median age 78 days). Molecular diagnostic tests were performed in 617 patients (95.4%) with RSV detected in 62.5% of patients. SARS-CoV-2 was found in 3.9% of hospitalized bronchiolitis (3.9%). We observed a progressive increase in bronchiolitis admissions and a statistically significant increase over the years in the need for respiratory support. Conversely, this was not true for mechanical ventilation, duration of respiratory support, ICU admission, and length of stay. During the pandemic period children with prematurity increased, although only 1 child had an indication for prophylaxis. Discussion: We confirm the stronger impact of bronchiolitis in the 2021-22 season, which is likely explained by the higher prevalence of RSV and the immunity debt theory. However, our findings were conflicting in terms of worsening clinical severity. The increase of children with prematurity and the inter-seasonal spread of RSV highlight the importance of epidemiological surveillance systems that monitor RSV circulation.

Background Sarajevo Canton in the Federation of Bosnia and Herzegovina has recorded several waves of high SARS-CoV-2 transmission and has struggled to reach adequate vaccination coverage. We describe the evolution of infection- and vaccine-induced SARS-CoV-2 antibody response and persistence. Methods We conducted repeated cross-sectional analyses of blood donors aged 18-65 years in Sarajevo Canton in November-December 2020 and 2021. We analyzed serum samples for anti-nucleocapsid (anti-N) and anti-spike (anti-S) antibodies. To assess immune durability, we conducted longitudinal analyses of seropositive participants at 6 and 12 months. Results 1015 participants were included in Phase 1 (November-December 2020), and 1152 in Phase 2 (November-December 2021). Seroprevalence increased significantly from 19.2% (95% CI: 17.2-21.4%) in Phase 1 to 91.6% (95% CI: 89.8-93.1%) in Phase 2. Anti-S IgG titers were significantly higher among vaccinated (58.5%) than unvaccinated infected participants across vaccine products (p<0.001), though highest among those who received an mRNA vaccine. At 6 months, 78/82 (95.1%) participants maintained anti-spike seropositivity; at 12 months, 58/58 (100.0%) participants were seropositive and 33 (56.9%) had completed the primary vaccine series within 6 months. Among 11 unvaccinated participants who were not reinfected at 12 months, anti-S IgG declined from median 770.1 (IQR 615.0-1321.7) to 290.8 (IQR 175.7-400.3). Anti-N IgG antibodies waned earlier; from 35.4% seropositive at 6 months to 24.1% at 12 months. Conclusions SARS-CoV-2 seroprevalence increased significantly over 12 months from end of 2020 to end of 2021. Although individuals with previous infection may have residual protection, COVID-19 vaccination is vital to strengthening population immunity.

Background: Measures introduced during the COVID-19 pandemic intended to address the spread of SARS-CoV-2 may also influence the incidence of other common seasonal respiratory viruses (SRV). This evaluation reports laboratory confirmed cases of common SRV in a well-defined region of central Canada to address this issue. Methods: Surveillance data for common non-SARS-CoV-2 SRV in the Ottawa, Canada region was provided by the Eastern Ontario Regional Laboratory Association (EORLA) reference virology lab. Weekly reports of the number of positive tests and proportion that yielded positive results was analyzed from August 26, 2018 to January 2, 2022. Results: A drastic reduction in influenza and other common SRV was observed during the 2020-2021 influenza season in the Ottawa region. Influenza was virtually undetected post SARS-CoV-2 emergence. Rhinoviruses and enteroviruses were the only viruses that remained relatively unaffected during this period. Conclusions: We speculated that the introduction of non-pharmaceutical measures including masking to prevent SARS-CoV-2 transmission contributed to the near absence of SRV in the Ottawa region. These measures should remain a key component in addressing spikes in SRV activity and future pandemics.

Objective: To determine SARS-CoV-2 seroprevalence in a UK pregnancy cohort and assess associations with demographic factors and vaccination timing. Design: Observational cohort study. Setting: UK inner-city maternity centre. Sample: 960 pregnant women attending nuchal scans from July 2020-January 2022. Methods: Blood samples were tested for IgG antibodies against SARS-CoV-2 nucleocapsid (N) and spike (S) proteins. Self-reported demographics, vaccination status and previous Covid-19 infection were extracted from health records. Multivariable regression models determined factors associated with seroprevalence and antibody titers. Main outcome measures: IgG N- and S-protein antibody titers. Results: 196/960 (20.4%) women were SARS-CoV-2 seropositive from previous infection. Of these, 70 (35.7%) self-reported previous infection. Amongst unvaccinated women, black women were most likely to be SARS-CoV-2 seropositive (aRR 1.88 [95% CI, 1.35-2.61], P < 0.001). Women from black and mixed ethnic backgrounds were least likely to have a history of vaccination with seropositivity to S-protein (aRR 0.58 [95% CI, 0.40-0.84], P = 0.004 and aRR 0.56 [95% CI, 0.34-0.92], P = 0.021 respectively). Double vaccinated, previously infected women had higher IgG S-protein antibody titers than unvaccinated, previously infected women (mean difference: 4.76, 95% CI = [2.65, 6.86], P < 0.001). Vaccination timing before vs during pregnancy did not significantly affect IgG S antibody titers (F(1, 77) = [0.07], P = 0.785). Conclusions: This inner-city pregnancy cohort demonstrates high rates of asymptomatic SARS-CoV-2 infection with women of black ethnicity having higher infection risk and lower vaccine uptake. SARS-CoV-2 antibody titers were highest among double vaccinated, previously infected women.

SARS-CoV-2 infection can manifest many rashes. However, thrombotic retiform purpura rarely occurs during COVID-19 illness. Aggressive anti-COVID-19 therapy with a high-dose steroid regimen led to rapid recovery. This immuno-thrombotic phenomenon likely represents a poor type 1 interferon response and complement activation on the endothelial surface in response to acute infection.

Cases of bullous pemphigoid following Covid-19 vaccines have been recently reported. We describe herein an atypical case of acral bullous pemphigoid after Pfizer BionTech vaccine. Clinicians should be aware of this reaction and encourage full vaccination as the disease displays a rapid improvement treatment.

Reactivation of the scar resulting from intracutaneous injection of Bacillus Calmette-Guérin (BCG) is a common specific reaction in Kawasaki’s Disease. It has also sporadically been associated with viral infections, Multisystem Inflammatory Syndrome in Children, influenza vaccination and mRNA COVID-19 vaccination. Since the start of the COVID-19 vaccination campaign in January 2021, the Netherlands Pharmacovigilance Centre Lareb has received 22 case reports of BCG reactivation after vaccination with a COVID-19 vaccine. In 20 case reports it concerned mRNA COVID-19 vaccines Moderna (14) and Pfizer (6). In 2 case reports the viral vector COVID-19 vaccine AstraZeneca was administered. Erythema and pain were the most frequently reported symptoms and the size of the inflammation was between 1.5 to 5 cm. BCG reactivation occurred with a median time to onset of 2 days after the second or booster COVID-19 vaccination, whereas the median time to onset was 7 days after the first COVID-19 vaccination. None of the BCG reactivations were treated. The exact mechanism of the occurrence of this specific reaction remains unknown, however involvement of heat shock protein 65 is suggested. BCG reactivation is a non-serious, self-limiting reaction that can occur after vaccination with both mRNA and viral vector COVID-19 vaccines.

Background Respiratory syncytial virus (RSV) seasonality is dependent on the local climate. We assessed the stability of RSV seasonality prior to the SARS-CoV-2 pandemic in Western Australia (WA), a state spanning temperate and tropical regions. Method RSV laboratory testing data were collected from January 2012 to December 2019. WA was divided into three regions determined by population density and climate; Metropolitan, Northern and Southern. Season threshold was calculated per region at 1.2% annual cases, with onset the first of ≥2 weeks above this threshold and offset as the last week before ≥2 weeks below. Results The incidence of RSV in WA was 6.3/10,000. The Northern region had the highest incidence (15/10,000), more than 2.5 times the Metropolitan region (IRR 2.7; 95% CI, 2.6-2.9). Test percentage positive was similar in the Metropolitan (8.6%) and Southern (8.7%) regions, with the lowest in the Northern region (8.1%). RSV seasons in the Metropolitan and Southern regions occurred annually, with a single peak and had consistent timing and intensity. The Northern tropical region did not experience a distinct season. Proportion of RSV A to RSV B in the Northern region differed from the Metropolitan region in 5 of the 8 years studied. Conclusions Incidence of RSV in WA is high, especially in the Northern region, where climate, an expanded at-risk population, and increased testing may have contributed to greater numbers. Before the SARS-CoV-2 pandemic, RSV seasonality WA was consistent in timing and intensity for the Metropolitan and Southern regions.

Studies have shown that fluvoxamine can be useful in preventing the spread of Covid-19 disease (in the early stages of the disease) by strengthening the body’s immune system. For this purpose, in this work, the structural and electronic properties of fluvoxamine drug were investigated using quantum theory of atom in molecule (QTAIM) and Density-functional theory (DFT) at B3LYP-DFT/6-311G+ (at presence of water as solvent and the CPCM model) computational level. Also, in order to improve the electronic/pharmaceutical properties, the effect of electron donor/acceptor groups of NO2 and NH2 on fluvoxamine was studied. According to the results, electronic properties changed significantly in the presence of the NO2 group. So that (in the presence of NO2) cohesive energy, energy gap, dipole moment, adsorption energy, antioxidant properties, and recovery time improved by 20%, 70%, 84%, 48%, 48%, and 46% respectively. Although the electronic properties were improved in the presence of the NH2 group, the effect of the NO2 functional group was more noticeable. Therefore, it is expected that the presence of the NO2 electron-acceptor electron group will improve its medicinal function by changing the electronic properties of the drug fluvoxamine.

The use of the nasopharyngeal swab as a diagnostic procedure for CoVID-19 infection has become widespread. It is generally accepted as a safe procedure with few data on complications. We describe the case of a patient who developed a CSF fistula after nasal swabbing.

A 57-year-old man suffered chest pain during the COVID-19 pandemic, but he delayed medical treatment due to fear of infection. Four months later, symptoms chest tightness and shortness of breath appeared. Electrocardiogram (ECG) revealed old myocardial infarction; color sonography and myocardial CT revealed apical myocardial defect. He refused surgery and percutaneous transcatheter closure, and follow-up observation. After 22 months, the symptoms of chest tightness and shortness of breath aggravated. He recovered after percutaneous transcatheter closure, and was discharged. This case shows delayed closure is one of the possible options for the patients without severe organ dysfunction or hemodynamic disturbance.

Background. Prior to the introduction of vaccines, COVID-19 hospitalizations of non-institutionalized persons in Connecticut disproportionately affected communities of color and individuals of low socioeconomic status (SES). Whether the magnitude of these disparities changed 7-9 months after vaccine rollout during the Delta wave is not well documented. Methods. All initially hospitalized patients with laboratory-confirmed COVID-19 during July-September 2021, were obtained from the Connecticut COVID-NET database, including patients’ geocoded residential addresses. Census tract measures of poverty and crowding were determined by linking geocoded residential addresses to the 2014-2018 American Community Survey. Age-adjusted incidence and relative rates of COVID-19 hospitalization were calculated and compared to those from July-December 2020. Vaccination levels by age and race/ethnicity at the beginning and end of the study period were obtained from Connecticut’s COVID vaccine registry and age-adjusted average values were determined. Results. There were 708 COVID-19 hospitalizations among community residents of the two counties, July-September 2021. Age-adjusted incidence was highest among non-Hispanic Blacks and Hispanic/Latinx compared to non-Hispanic Whites ((RR 4.10 (95% CI 3.41-4.94) and 3.47 (95% CI 2.89-4.16)). While RR decreased significantly among Hispanic/Latinx and among the lowest SES groups, it increased among non-Hispanic Blacks (from RR 3.1 (95% CI 2.83-3.32) to RR 4.10). Average age-adjusted vaccination rates among those >12 years were lowest among non-Hispanic Blacks compared to Hispanic/Latinx and non-Hispanic Whites (50.6% vs 64.7% and 66.6%). Conclusions. While racial/ethnic and SES disparities in COVID-19 hospitalization have mostly decreased over time, disparities among non-Hispanic Blacks increased, possibly due to differences in vaccination rates.

Coronavirus (COVID-19) infection exposes patients with heart failure to a higher risk of morbidity and mortality. In LVAD patients, one of the key problems that can lead to life-threatening low-flow or pump malfunction due to thrombus development in the inflow cannula, device body, or outflow graft, implicating hemodynamic instability, hemolysis, renal or hepatic failure, or cerebral or peripheral thromboembolism. [Endothelial protein C receptor and thrombomodulin levels are elevated along with procoagulants such as factor VIII, P-selectin, and von Willebrand factor and downregulated along with thrombomodulin as a result of the cytokine storm released by endothelial and immune cells. In general ,](#ref-0013) LVAD thrombosis has been found to occur in 2–13% of adult patients who use current continuous-flow devices. However, LVAD thrombosis due to COVID-19 is underreported and a few cases presented. We present a case of accelerated LVAD outflow thrombosis in the setting of COVID-19 infection with multiorgan failure.

Since late 2021, the highly transmissible SARS-CoV-2 Omicron variant has driven a new surge of infections across the world. We used a case-ascertained study to determine the features of household transmission of SARS-CoV-2 Omicron variant in Shanghai, China. We collected detailed information on 323 pediatric cases and their 951 household members, all received consecutively intensive RT-PCR testing. We estimated the transmission parameters. Both secondary infection attack rates (SARI) and secondary clinical attack rates (SARC) among adult household contacts were computed, through which the transmission heterogeneities in infectivity and susceptibility were characterized and the vaccine effectiveness were estimated. The mean incubation period and serial interval of Omicron variant were estimated to be 4.6±2.1 days and 3.9±3.7 days. The overall SARI and SARC among adult household contacts were 77.11% (95% confidence interval [CI]: 73.58%-80.63%) and 67.03% (63.09%-70.98%). We found higher household susceptibility in females, while infectivity was not significantly different in primary cases by age, sex, vaccination status and clinical severity. Full vaccination and booster vaccination of inactivated vaccines were 14.8% (5.8%-22.9%) and 18.9% (9.0%-27.7%) effective against Omicron infection and 21.5% (10.4%-31.2%) and 24.3% (12.3%-34.7%) effective against symptomatic disease. Overall, we found high household transmission during the Omicron wave in Shanghai due to asymptomatic and pre-symptomatic transmission in the context of city-wide lockdown, indicating the importance of early detection and timely isolation of SARS-CoV-2 infections and quarantine of close contacts. Marginal effectiveness of inactivated vaccines against Omicron infection poses great challenge for prevention and control of the SARS-CoV-2 Omicron variant.

COVID-19 can lead to pneumonia or acute respiratory distress syndrome. Non-respiratory manifestations of COVID-19 include venous and arterial thrombosis. The disease can affect kidneys and lead to renal vein thrombosis leading to symptoms such as flank pain, hematuria, or acute kidney damage.

Background: Acute lower respiratory tract infections (ALRI) are one leading cause of morbidity and mortality among people of all ages worldwide, particularly in low- and middle-income countries (LMICs). The purpose of this study was to determine epidemiological characteristics of respiratory viruses in ARI patients during the SARS-CoV-2 pandemic in Yaoundé, Cameroon. Methods: Patients were monitored for respiratory symptoms as part of surveillance of SARS-CoV-2 and other respiratory viral infections. Patients of all ages with respiratory symptoms less than 5 days were considered. Sociodemographic and clinical data as well as nasopharyngeal samples was collected from patients. Nasopharyngeal samples were tested for SARS-CoV-2, Influenza and Respiratory Syncytial Virus (RSV) using real-time reverse-transcription polymerase chain reaction methods. Virus distribution and demographic data were analyzed with R version 2.15.1. Results: From July 2020 to October 2021, 1120 patients were included. The overall viral detection rate was 32.5%, including 9.5 % for RSV (Respiratory Syncytial Virus), 12.6 % for influenza virus and 12.8 % for SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2). Co-infections were detected in 6.9% of positive cases. While RSV and influenza virus showed seasonal trends, SARS-CoV-2 was detected throughout the study period. Conclusion: We found that during SARS-CoV-2 pandemic, respiratory viruses play an important role in aetiology of influenza-like illness in Cameroon, and this observation was true for patients of all ages.

TITLE PAGE Title: Letter to the Editor: Early experience of aortic surgery during the COVID-19 pandemic in the United Kingdom: A multicenter studyArticle type: Letter to the editorCorrespondence : 1. Sara AlzagloolContact: +962797244907 Email: Sarah97.zg@hotmail.comInstitute: Al-Bashir HospitalAddress: Al Bashir Hospital، Ossamah Ben Zeid St. 261, Amman, JordanCo-authors : 2. Osama Al-JaiuossiContact: +962788003306 Email: Osamaeyad@ymail.comInstitute: Al-Bashir HospitalAddress: Al Bashir Hospital، Ossamah Ben Zeid St. 261, Amman, JordanWords count: 480Conflict of interest: NoneFunding: NoneAcknowledgement: NoneDeclaration: None

The European Medicines Agency (EMA) started operating under its new legal mandate on 1 April 2022. The mandate brings new responsibilities to the Agency in three different areas: • Reinforcement of the role and activities of the EMA pandemic Task Force(which is now known as the Emergency Task Force (ETF)). • A stronger role of EMA in the monitoring of shortages of critical medicines, medical devices and in-vitro diagnostics, both in anticipation of and during a crisis. • A more coordinated mechanism of European Union (EU) experts advice on medical devices classified as high-risk (class IIa and III or class D (1)) and in-vitro diagnostic medical devices. Here we consider the impact of the COVID-19 pandemic on the operations of EMA and the European medicines regulatory network, and how EMA’s new mandate will strengthen the Agency’s and the Network’s ability to face crises. EMA’s extended mandate brings clear benefits in terms of response to public health emergencies at EU level, which ranges from improvements in crisis management to avoiding medicine shortages and improving access to diagnostics and medical devices that are safe and conform to their expected function.