Effectiveness of the WHO-Authorized COVID-19 Vaccines: A Rapid Review of Global Reports till 30 June 2021

Large clinical trials have proven the efficacy of the COVID-19 vaccine, and the number of studies about the effectiveness rapidly grew in the first half of the year after mass vaccination was administrated globally. This rapid review aims to provide evidence syntheses as a means to complement the current evidence on the vaccine effectiveness (VE) against various outcomes in real-world settings. Databases (PubMed, EMBASE, and MedRxiv) were searched up to 30 June 2021, (PROSPERO ID: 266866). A total of 39 studies were included, covering over 15 million participants from 11 nations. Among the general population being fully vaccinated, the VE against symptomatic SARS-CoV-2 infection was estimated at 89–97%, 92% (95% CI, 78–97%), and 94% (95% CI, 86–97%) for BNT162b2, ChAdOx1, and mRNA-1273, respectively. As for the protective effects against B.1.617.2-related symptomatic infection, the VE was 88% (95% CI, 85.3–90.1%) by BNT162b2 and 67.0% (95% CI, 61.3–71.8%) by ChAdOx1 after full vaccination. This review revealed a consistently high effectiveness of certain vaccines among the general population in real-world settings. However, scarce data on the major variants of SARS-CoV-2 and the shortness of the study time may limit the conclusions to the mRNA vaccines and ChAdOx1.

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Effectiveness of the WHO-authorized Covid-19 Vaccines: a Rapid Review of Global Reports till June 30, 2021

10.1101/2021.08.23.21262500 ◽

2021 ◽

Author(s):

Chang-Jie Cheng ◽

Chun-Yi Lu ◽

Ya-Hui Chang ◽

Yu Sun ◽

Hai-Jui Chu ◽

...

Keyword(s):

Clinical Trials ◽

General Population ◽

Quality Assessment ◽

Real World ◽

Rapid Review ◽

Current Evidence ◽

Protective Effects ◽

Symptomatic Infection ◽

High Effectiveness ◽

Duration Of Protection

Objective: Large clinical trials have proved the efficacy of Covid-19 vaccine, and the number of literature about the effectiveness is rapidly growing in the first half of year after mass vaccination was administrated globally. This rapid review aims to provide evidence syntheses as a means to complement the current evidence on the vaccine effectiveness (VE) against various outcomes in real-world settings. Methods: This review is conducted based on the updated guideline of PRISMA 2020. Databases (PubMed, EMBASE, and MedRxiv) were searched up to 30 June 2021, (PROSPERO ID: 266866). The studies that assessed the VE of the 6 WHO-authorized vaccines (BNT162b2, ChAdOx1, Ad26.COV2.S, mRNA-1273, BBIBP-CorV, and CoronaVac) were eligible to be included. Quality assessment was performed based on ROBINS-I by 2 independent reviewers. Findings: A total of 39 studies were included, covering over 15 million of participants from 11 nations. Among the general population after 2 doses of vaccination, the VE against symptomatic SARS-CoV-2 infection was estimated at 89%-97%, 92% (95% CI, 78%-97%) and 94% (95% CI, 86%-97%) for BNT162b2, ChAdOx1 and mRNA-1273, respectively. As for the protective effects against B.1.617.2 related symptomatic infection, the VE was 88% (95% CI, 85.3%-90.1%) by BNT162b2 and 67.0% (95% CI, 61.3%-71.8%) by ChAdOx1 after fully vaccination. Conclusion: This review revealed a consistently high effectiveness of vaccines among the general population in real-world settings. Further studies are needed to provide the information on different races/ethnicity, the effects against SARS-CoV-2 variants, and the duration of protection with longer study time.

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Recombinant Zoster Vaccine (Shingrix) real-world effectiveness in the first two years post-licensure

Clinical Infectious Diseases ◽

10.1093/cid/ciab125 ◽

2021 ◽

Author(s):

Hector S Izurieta ◽

Xiyuan Wu ◽

Richard Forshee ◽

Yun Lu ◽

Heng-Ming Sung ◽

...

Keyword(s):

Clinical Trials ◽

Herpes Zoster ◽

Real World ◽

Postherpetic Neuralgia ◽

Vaccine Effectiveness ◽

Community Dwelling ◽

Zoster Vaccine ◽

Post Market ◽

Recombinant Zoster Vaccine ◽

Dose Vaccine

Abstract Background Shingrix™ (recombinant zoster vaccine) was licensed to prevent herpes zoster, dispensed as two doses given 2–6 months apart, among adults ages ≥50 years. Clinical trials yielded efficacy of >90% for confirmed herpes zoster,but post-market vaccine performance has not been evaluated. Efficacy of a single dose, delayed second dose, or among persons with autoimmune or general immunosuppressive conditions have also not been studied. We aimed to assess post-market vaccine effectiveness of Shingrix. Methods We conducted a cohort study among vaccinated and unvaccinated Medicare Part D community dwelling beneficiaries ages >65 years. Herpes zoster was identified using a medical office visit diagnosis with treatment, and postherpetic neuralgia using a validated algorithm. We used inverse probability of treatment weighting to improve cohort balance, and marginal structural models to estimate hazard ratios. Results We found a vaccine effectiveness of 70.1% (95% CI, 68.6–71.5) and 56.9% (95% CI, 55.0–58.8) for two and one doses, respectively. The two-dose vaccine effectiveness was not significantly lower for beneficiaries 80+ years, for second doses received at ≥180 days, or for individuals with autoimmune conditions. The vaccine was also effective among individuals with immunosuppressive conditions. Two-dose vaccine effectiveness against postherpetic neuralgia was 76.0% (95% CI, 68.4-81.8). Conclusions This large real-world observational study of effectiveness of Shingrix demonstrates the benefit of completing the two-dose regimen. Second doses administered beyond the recommended 6 months did not impair vaccine effectiveness.Our effectiveness estimates were lower than the clinical trials estimates, likely due to differences in outcome specificity.

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Should chloroquine and hydroxychloroquine be used to treat COVID-19? A rapid review

BJGP Open ◽

10.3399/bjgpopen20x101069 ◽

2020 ◽

Vol 4 (2) ◽

pp. bjgpopen20X101069 ◽

Cited By ~ 35

Author(s):

Kome Gbinigie ◽

Kerstin Frie

Keyword(s):

Clinical Trials ◽

Relevant Literature ◽

Safety Data ◽

World Health ◽

Rapid Review ◽

Current Evidence ◽

Long Term Follow Up

BackgroundOn the 11 March 2020, the World Health Organization (WHO) declared that COVID-19 was a pandemic. To date, there are no medical treatments for COVID-19 with proven effectiveness. Novel treatments and/or vaccines will take time to be developed and distributed to patients. In light of this, there has been growing interest in the use of existing medications, such as chloroquine (CQ) and hydroxychloroquine (HCQ), as potential treatments of this disease.AimTo establish the current evidence for the effectiveness of CQ and HCQ in treating COVID-19.Design & settingA rapid review of the literature was conducted.MethodElectronic searches in PubMed and Google Scholar were conducted on 21 March 2020. A further search was conducted in Google for relevant literature on 28 March 2020.ResultsThere is limited evidence of in vitro activity of CQ/HCQ against SARS-CoV-2. A number of in vivo clinical trials are underway. The empirical data available from two of these trials reveal conflicting results. Both trials are characterised by small numbers of participants (n = 30 and n = 36) and suffer methodological limitations. No medium or long-term follow-up data is available.ConclusionAt present, there is insufficient evidence to determine whether CQ/HCQ are safe and effective treatments for COVID-19. High quality, adequately powered randomised clinical trials in primary and secondary care settings are urgently required to guide policymakers and clinicians. These studies should report medium- and long-term follow-up results, and safety data.

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Current Evidence on the Antimicrobial Treatment and Chemoprophylaxis of Human Leptospirosis: A Meta-Analysis

Pathogens ◽

10.3390/pathogens10091125 ◽

2021 ◽

Vol 10 (9) ◽

pp. 1125

Author(s):

Marta Guzmán Pérez ◽

José Javier Blanch Sancho ◽

Juan Carlos Segura Luque ◽

Fernando Mateos Rodriguez ◽

Elisa Martínez Alfaro ◽

...

Keyword(s):

Clinical Trials ◽

Hospital Stay ◽

Antibiotic Treatment ◽

Treatment Time ◽

Meta Analysis ◽

Antimicrobial Treatment ◽

The Other ◽

Current Evidence ◽

Weekly Dose ◽

Symptomatic Infection

Background: Leptospirosis is a worldwide zoonotic infection, and its management needs to be refined. This study aims to discern which antibiotic would be the best option to treat leptospirosis disease and analyze the efficacy of chemoprophylaxis regimens to prevent this illness. Methods: systematic review and meta-analysis on the efficacy of antibiotic treatment and chemoprophylaxis of leptospirosis in humans. Results: Ten clinical trials compared an antibiotic treatment with placebo or other antibiotic treatments in leptospirosis (the most recent one was published in 2007). The meta-analysis shows no effect of penicillin treatment on mortality compared to placebo (OR 1.65; 95% CI 0.76–3.57; p = 0.21). There are no differences between penicillin and cephalosporins or doxycycline. Penicillin does not reduce the time of defervescence (MD-0.16; 95% CI (−1.4) –1.08; p = 0.80) nor hospital stay (MD 0.15; 95% CI (−0.75)–1.06; p = 0.74). Besides, the data did not demonstrate any effectiveness of the use of penicillin in terms of the incidence of oliguria/anuria, the need for dialysis treatment, time to creatinine normalization, incidence of jaundice, or the liver function normalization time. Eight trials have assessed prophylactic treatment against leptospirosis with different strategies. A weekly dose of 200 mg of doxycycline does not show benefit versus placebo regarding the number of new cases of symptomatic leptospirosis (OR 0.20; 95% CI 0.02–1.87; p = 0.16). A single dose of doxycycline at exposure to flood water could have a beneficial effect (OR 0.23; 95% CI 0.07–0.77; p = 0.02). None of the other chemoprophylaxis regimens tested have shown a statistically significant effect on the number of new symptomatic cases. Conclusion: There is no evidence that antibiotics are a better treatment than placebo regarding mortality, shortening of fever, liver and kidney function, or reduction in the hospital stay. On the other hand, neither doxycycline nor penicillin, nor azithromycin have shown statistically significant differences in preventing symptomatic infection. Well-designed clinical trials, including other antibiotics such as quinolones or aminoglycosides, are urgently needed to improve our understanding of the treatment for this infection, which continues to be a neglected disease.

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Mirabegron, alone and in combination, in the treatment of overactive bladder: real-world evidence and experience

Therapeutic Advances in Urology ◽

10.1177/1756287218801282 ◽

2018 ◽

Vol 10 (12) ◽

pp. 411-419 ◽

Cited By ~ 2

Author(s):

Sara J. Allison ◽

William Gibson

Keyword(s):

General Population ◽

Overactive Bladder ◽

Real World ◽

Adrenergic Receptor ◽

Current Evidence ◽

Urgency Incontinence ◽

Antimuscarinic Agents ◽

Selective Agonist ◽

Real World Evidence ◽

High Prevalence

Overactive bladder (OAB), the syndrome characterized by urgency, with or without urgency incontinence, usually with frequency and nocturia, in the absence of infection or other pathology, is a common, distressing and often debilitating condition with a high prevalence in the general population. For many years, the only available pharmacological treatment for OAB were the antimuscarinic agents. More recently, mirabegron, a selective agonist of the β3 adrenergic receptor, has become available. In this article we review the current evidence and experience of its use.

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Diet and lifestyle

10.1093/med/9780198766452.003.0003 ◽

2016 ◽

Author(s):

David Levy

Keyword(s):

General Population ◽

Alcohol Intake ◽

Microvascular Complications ◽

Current Evidence ◽

Protective Effects ◽

Carbohydrate Counting ◽

Micronutrient Intake ◽

Moderate Alcohol Intake ◽

Diet And Lifestyle

Macro- and micronutrient intake in Type 1 patients is outlined, and is similar to that of the general population. Carbohydrate counting programmes (flexible intensive insulin therapy, FIIT, for example DAFNE) is increasingly advocated; mandatory for pump patients, it is not suitable for all patients. The 2015 USA guidelines on diet are reviewed in relation to Type 1 diabetes. There is increasing evidence for the protective effects of regular exercise on microvascular complications, and current evidence on the physiology of different forms of exercise are reviewed. Endurance events should not be discouraged. Cigarette smoking is as frequent in Type 1 patients as in the general population, and increased efforts to encourage smoking cessation are needed. Moderate alcohol intake is probably beneficial, but binge drinking is harmful and prevalent.

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All-cause mortality among patients treated with repurposed antivirals and antibiotics for COVID-19 in Mexico City: A Real-World Observational Study

10.1101/2020.10.13.20211797 ◽

2020 ◽

Author(s):

Javier Mancilla-Galindo ◽

Jorge Óscar García-Méndez ◽

Jessica Márquez-Sánchez ◽

Rodrigo Estefano Reyes-Casarrubias ◽

Eduardo Aguirre-Aguilar ◽

...

Keyword(s):

Clinical Trials ◽

General Population ◽

Observational Study ◽

Mexico City ◽

Mortality Risk ◽

Real World ◽

List Type ◽

Risk Of Death ◽

All Cause Mortality ◽

Critical Patients

ABSTRACTAimTo evaluate all-cause mortality risk in patients with laboratory-confirmed COVID-19 in Mexico City treated with repurposed antivirals and antibiotics.MethodsThis real-world retrospective cohort study contemplated 395,343 patients evaluated for suspected COVID-19 between February 24 and September 14, 2020 in 688 primary-to-tertiary medical units in Mexico City. Patients were included with a positive RT-PCR for SARS-CoV-2; those receiving unspecified antivirals, excluded; and antivirals prescribed in <30 patients, eliminated. Survival and mortality risks were determined for patients receiving antivirals, antibiotics, both, or none.Results136,855 patients were analyzed; mean age 44.2 (SD:16.8) years; 51.3% were men. 16.6% received antivirals (3%), antibiotics (10%), or both (3.6%). Antivirals studied were Oseltamivir (n=8414), Amantadine (n=319), Lopinavir-Ritonavir (n=100), Rimantadine (n=61), Zanamivir (n=39), and Acyclovir (n=36). Survival with antivirals (73.7%, p<0.0001) and antibiotics (85.8%, p<0.0001) was lower than no antiviral/antibiotic (93.6%). After multivariable adjustment, increased risk of death occurred with antivirals (HR=1.72, 95%CI:1.61-1.84) in ambulatory (HR=4.7, 95%CI:3.94-5.62) and non-critical (HR=2.03, 95%CI:1.86-2.21) patients. Oseltamivir increased mortality risk in the general population (HR=1.72, 95%CI:1.61-1.84), ambulatory (HR=4.79, 95%CI:4.01-5.75), non-critical (HR=2.05, 95%CI:1.88-2.23), and pregnancy (HR=8.35, 95%CI:1.77-39.30); as well as hospitalized (HR=1.13, 95%CI:1.01-1.26) and critical patients (HR:1.22, 95%CI:1.05-1.43) after propensity score-matching. Antibiotics were a risk factor in general population (HR=1.13, 95%CI:1.08-1.19) and pediatrics (HR=4.22, 95%CI:2.01-8.86), but a protective factor in hospitalized (HR=0.81, 95%CI:0.77-0.86) and critical patients (HR=0.67, 95%CI:0.63-0.72).ConclusionsNo significant benefit for repurposed antivirals was observed; oseltamivir was associated with increased mortality. Antibiotics increased mortality risk in the general population but may increase survival in hospitalized and critical patients.WHAT IS ALREADY KNOWNCurrent recommendations for using repurposed antivirals and antibiotics for COVID-19 are conflicting.Few antivirals (i.e. lopinavir-ritonavir) have been shown to provide no additional benefit for COVID-19 in clinical trials; other antivirals may be having widespread use in real-world settings without formal assessment in clinical trials.Real-world use of repurposed antivirals and antibiotics for COVID-19 in population-based studies have not been performed; important populations have been left largely understudied (ambulatory patients, pregnant women, and pediatrics).WHAT THIS STUDY ADDSThis is the first real-world observational study evaluating amantadine, rimantadine, zanamivir, and acyclovir for COVID-19; no registered studies to evaluate these drugs exist. Only one study has evaluated risk of death for oseltamivir. Lopinavir-ritonavir have been previously evaluated in clinical trials.Repurposed antivirals and antibiotics were commonly prescribed in 688 ambulatory units and hospitals of Mexico City despite unclear recommendations for their use out of clinical trials.Oseltamivir was associated with increased mortality risk; other repurposed antivirals (zanamivir, amantadine, rimantadine, and acyclovir) had no significant and consistent impact on mortality. Antibiotics were associated with increased mortality risk in the general population but may increase survival in hospitalized and critical patients.

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COVID-19 in older people: a rapid clinical review

Age and Ageing ◽

10.1093/ageing/afaa093 ◽

2020 ◽

Vol 49 (4) ◽

pp. 501-515 ◽

Cited By ~ 31

Author(s):

Fiona E Lithander ◽

Sandra Neumann ◽

Emma Tenison ◽

Katherine Lloyd ◽

Tomas J Welsh ◽

...

Keyword(s):

Clinical Trials ◽

Older People ◽

English Language ◽

Extended Period ◽

Rapid Review ◽

Current Evidence ◽

Negative Consequences ◽

Radiological Findings ◽

Polymerase Chain ◽

Future Work

Abstract Introduction the COVID-19 pandemic poses a high risk to older people. The aim of this article is to provide a rapid overview of the COVID-19 literature, with a specific focus on older adults. We frame our findings within an overview of the disease and have also evaluated the inclusion of older people within forthcoming clinical trials. Methods we searched PubMed and bioRxiv/medRxiv to identify English language papers describing the testing, treatment and prognosis of COVID-19. PubMed and bioRxiv/medRxiv searches took place on 20 and 24 March 2020, respectively. Results screening of over 1,100 peer-reviewed and pre-print papers yielded n = 22 on COVID-19 testing, n = 15 on treatment and n = 13 on prognosis. Viral polymerase chain reaction (PCR) and serology are the mainstays of testing, but a positive diagnosis may be increasingly supported by radiological findings. The current evidence for the effectiveness of antiviral, corticosteroid and immunotherapies is inconclusive, although trial data are largely based on younger people. In addition to age, male gender and comorbidities, specific laboratory and radiology findings are important prognostic factors. Evidence suggests that social distancing policies could have important negative consequences, particularly if in place for an extended period. Conclusion given the established association between increasing age and poor prognosis in COVID-19, we anticipate that this rapid review of the current and emergent evidence might form a basis on which future work can be established. Exclusion of older people, particularly those with comorbidities, from clinical trials is well recognised and is potentially being perpetuated in the field of current COVID-19 research.

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