Should Bacillus Calmette–Guérin (BCG) vaccine be used in the prophylaxis of COVID-19?

2020 ◽  
Vol 54 ◽  
Author(s):  
Daisy O. Sanchez-Mostiero ◽  
Abigail F. Melicor
Keyword(s):  
Adverse Events ◽  
Police Officers ◽  
Cell Activity ◽  
Risk Groups ◽  
Bcg Vaccine ◽  
Bacillus Calmette Guerin ◽  
Efficacy And Safety ◽  
Insufficient Evidence ◽  
Bcg Vaccination ◽  
Cutaneous Reactions

At present, there is insufficient evidence to support the use of BCG vaccine as prophylaxis for COVID-19. Bacillus Calmette Guerin (BCG) vaccine is an attenuated microorganism derived from bovine tubercle bacillus and is being given to prevent severe tuberculosis. BCG vaccination may enhance production of antibodies and pro-inflammatory cytokines such as interleukin (IL)-1β and tumor necrosis factor (TNF). BCG may lead to increased CD4 and CD8 T-cell activity on subsequent viral infection. Ecological studies on the effect of BCG vaccination policy on COVID-19 outcomes have conflicting results and are prone to bias from confounders. There is insufficient evidence on the efficacy and safety of BCG vaccine for COVID-19 prophylaxis. Thirteen clinical trials are ongoing among high-risk groups (healthcare workers, elderly, police officers) to evaluate the efficacy and safety of BCG vaccine in preventing COVID-19 and its severe symptoms. WHO does not recommend the use of BCG vaccine as prophylaxis against COVID-19. Adverse events of BCG vaccine range from mild local cutaneous reactions to systemic adverse events such as abscess, lymphadenopathy and osteomyelitis.

scholarly journals BCG vaccine and post-BCG complications among infants in Gaza Strip, 1999

2001 ◽  
Vol 7 (1-2) ◽  
pp. 211-220
Author(s):  
R. Awad
Keyword(s):  
Health Services ◽  
Adverse Events ◽  
Surveillance System ◽  
Gaza Strip ◽  
Bcg Vaccine ◽  
Bcg Vaccination ◽  
Complications Rate ◽  
The Relationship ◽  
Single Batch

The relationship between post-BCG complications and the practices of administration and/or use of certain batches of BCG vaccine was investigated. A questionnaire were given to nurses administering BCG vaccination. An abstraction sheet was used to analyse cases with BCG complications among infants [n = 552] and schoolchildren [n = 97]. The rate of complications was 14.7/1000 among infants and 2.5/1000 among schoolchildren in 1997. The complications rate was 19.1/1000 at UNRWA and 8.3/1000 at governmental health services. It was found that a single batch of BCG 2611-11 combined with incorrect administering of the vaccine was responsible for this outbreak of complications. Therefore, the establishment of a surveillance system to monitor adverse events following immunization is needed.

Bacillus Calmette-Guérin (BCG) Vaccine Adverse Events in Victoria, Australia: Analysis of Reports to an Enhanced Passive Surveillance System

Drug Safety ◽  
2014 ◽  
Vol 38 (1) ◽  
pp. 79-86 ◽  
Author(s):  
Hazel J. Clothier ◽  
Laine Hosking ◽  
Nigel W. Crawford ◽  
Melissa Russell ◽  
Mee Lee Easton ◽  
...  
Keyword(s):  
Adverse Events ◽  
Surveillance System ◽  
Bcg Vaccine ◽  
Bacillus Calmette Guerin ◽  
Passive Surveillance ◽  
Passive Surveillance System

scholarly journals COVID-19 and BCG vaccine: is there a link?

2020 ◽  
Vol 10 (3) ◽  
pp. 459-468
Author(s):  
I. V. Lyadova ◽  
A. A. Starikov
Keyword(s):  
Clinical Trials ◽  
Latent Tuberculosis Infection ◽  
Latent Tuberculosis ◽  
Risk Groups ◽  
Bcg Vaccine ◽  
Tuberculosis Infection ◽  
Antiviral Immune Response ◽  
Epidemiological Modeling ◽  
Bcg Vaccination ◽  
The Impact

The spread of the novel coronavirus infection (COVID-19) makes the search for new approaches to prevent the infection of great importance. As one of the relevant approaches, the vaccination of risk groups with BCG vaccine has recently been suggested. BCG (Mycobacterium bovis, Bacillus Calmette–Guérin) is a live vaccine for tuberculosis, which is used in many countries with a high tuberculosis prevalence and helps preventing childhood tuberculosis, primarily, military disease and tuberculosis meningitis. Whether BCG may be used to increase the protection against COVID-19 is currently a question of debates. The review considers scientific background underlying possible impact of BCG in increased protection against COVID-19. BCG is able of inducing the heterologous and trained immunity, and its capacity to stimulate antiviral immune response has been demonstrated in experimental animals and humans. Our comparison of the dynamics of COVID-19 morbidity and mortality in countries with different BCG vaccination policies has demonstrated a milder course of COVID-19 (i.e., a slower increase in disease cases and mortality) in countries where BCG vaccination is mandatory for all children. However, an association between BCG vaccination and a milder COVID-19 course is not obligatory direct. Other factors that may affect the association, such as the level of virus testing, the rigidity and the speed of quarantine implementation and others are discussed. An important argument against a role of BCG in the protection against COVID-19 is that BCG is given in childhood and may hardly induce long-lasting immunity. Because mandatory BCG vaccination is implemented in countries with high TB burden and because in these countries latent tuberculosis infection is widely spread, we suggest a hypothesis that latent tuberculosis infection may contribute to the maintenance of heterologous/trained antiviral immunity in countries with mandatory BCG vaccination. Four countries have recently initiated clinical trials to investigate whether BCG vaccination can increase the level of protection against COVID-19 in risk groups. The results of these studies, as well as COVID-19 epidemiological modeling will help understanding the impact of BCG in the level of the protection against COVID-19. Performing analogous clinical trials in Russia seems appropriate and scientifically sound.

scholarly journals BCG Vaccination and Mortality of COVID-19 across 173 Countries: An Ecological Study

2020 ◽  
Vol 17 (15) ◽  
pp. 5589 ◽  
Author(s):  
Mitsuyoshi Urashima ◽  
Katharina Otani ◽  
Yasutaka Hasegawa ◽  
Taisuke Akutsu
Keyword(s):  
Urban Population ◽  
Ecological Study ◽  
Randomized Clinical Trials ◽  
Vaccine Coverage ◽  
Bcg Vaccine ◽  
Bacillus Calmette Guerin ◽  
Ecological Studies ◽  
Bcg Vaccination ◽  
Insufficient Physical Activity ◽  
Pcr Test

Ecological studies have suggested fewer COVID-19 morbidities and mortalities in Bacillus Calmette–Guérin (BCG)-vaccinated countries than BCG-non-vaccinated countries. However, these studies obtained data during the early phase of the pandemic and did not adjust for potential confounders, including PCR-test numbers per population (PCR-tests). Currently—more than four months after declaration of the pandemic—the BCG-hypothesis needs reexamining. An ecological study was conducted by obtaining data of 61 factors in 173 countries, including BCG vaccine coverage (%), using morbidity and mortality as outcomes, obtained from open resources. ‘Urban population (%)’ and ‘insufficient physical activity (%)’ in each country was positively associated with morbidity, but not mortality, after adjustment for PCR-tests. On the other hand, recent BCG vaccine coverage (%) was negatively associated with mortality, but not morbidity, even with adjustment for percentage of the population ≥ 60 years of age, morbidity, PCR-tests and other factors. The results of this study generated a hypothesis that a national BCG vaccination program seems to be associated with reduced mortality of COVID-19, although this needs to be further examined and proved by randomized clinical trials.

scholarly journals Exercising caution in correlating COVID-19 incidence and mortality rates with BCG vaccination policies due to variable rates of SARS CoV-2 testing

2020 ◽  
Author(s):  
Janine Hensel ◽  
Kathleen M. McAndrews ◽  
Daniel J. McGrail ◽  
Dara P. Dowlatshahi ◽  
Valerie S. LeBleu ◽  
...  
Keyword(s):  
Mortality Rates ◽  
Bcg Vaccine ◽  
The Novel ◽  
Bacillus Calmette Guerin ◽  
Vaccination Policy ◽  
Bcg Vaccination ◽  
The Past ◽  
Incidence And Mortality ◽  
Novel Coronavirus ◽  
A Current

ABSTRACTThe Bacillus Calmette-Guerin (BCG) vaccine provides protection against tuberculosis (TB), and is proposed to provide protection to non-TB infectious diseases. The COVID-19 outbreak results from infection with the novel coronavirus SARS-CoV-2 (CoV-2) and was declared a pandemic on March 11th, 2020. We queried whether the BCG vaccine offers protection against CoV-2 infection. We observed that countries with a current universal BCG vaccination policy have a significantly lower COVID-19 incidence than countries which never had a universal BCG policy or had one in the past. However, population density, median age, TB incidence, urban population, and, most significantly, CoV-2 testing rate, were also connected with BCG policy and could potentially confound the analysis. By limiting the analysis to countries with high CoV-2 testing rates, defined as greater than 2,500 tests per million inhabitants, these parameters were no longer statistically associated with BCG policy. When analyzing only countries with high testing rates, there was no longer a significant association between the number of COVID-19 cases per million inhabitants and the BCG vaccination policy. Although preliminary, our analyses indicate that the BCG vaccination may not offer protection against CoV-2 infection. While reporting biases may confound our observations, our findings support exercising caution in determining potential correlation between BCG vaccination and COVID-19 incidence, in part due significantly lower rates of CoV-2 testing per million inhabitants in countries with current universal BCG vaccination policy.

scholarly journals Relationship between Bacillus Calmette Guerin Vaccination Policy and Coronavirus Disease-2019 (COVID-19) Incidence

2021 ◽  
Author(s):  
Soheila Alyasin ◽  
Zahra Kanannejad ◽  
Hossein Esmaeilzadeh ◽  
Hesamedin Nabavizadeh ◽  
Mohammad Amin Ghatee ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Large Scale ◽  
Mortality Rates ◽  
Epidemiological Studies ◽  
Bcg Vaccine ◽  
Confounding Factors ◽  
Protective Effects ◽  
Bacillus Calmette Guerin ◽  
Vaccination Policy ◽  
Bcg Vaccination

Bacillus Calmette Guerin (BCG) was designed for protecting children against tuberculosis. Also, it can protect against other infectious diseases through the induction of trained immunity. Due to its heterologous protective effects, the BCG vaccine has been proposed as a treatment option for coronavirus disease-2019 (COVID-19). Epidemiological studies have found that countries without BCG vaccination policy have experienced higher mortality rates related to COVID-19 infection than those with BCG vaccination policy. However, there are some confounding factors such as age, population intensity, immigration, the pandemic phase, and data accuracy that may affect these results. Therefore, this hypothesis should be evaluated by clinical trial studies. Large-scale clinical trials are in progress to investigate if the BCG vaccine could be used as a useful tool for protection against COVID-19 infection.

scholarly journals The influence of vaccination against tuberculosis with the Bacillus-Calmette-Guérin(BCG) vaccine on COVID-19 incidence and mortality – review of the literature

2020 ◽  
pp. 290-302 ◽  
Author(s):  
Gabriela Ręka ◽  
Anna Korzeniowska ◽  
Halina Piecewicz-Szczęsna
Keyword(s):  
Respiratory Infections ◽  
Epidemiological Data ◽  
Bcg Vaccine ◽  
Bacillus Calmette Guerin ◽  
Review Of The Literature ◽  
Bcg Vaccination ◽  
Incidence And Mortality ◽  
Mortality Review ◽  
The Moment ◽  
Mandatory Vaccination

THE AIM OF THE STUDY. Is to present the state of knowledge from April and May 2020 about the influence of Bacillus-Calmette-Guérin vaccination against tuberculosis on incidence and mortality due to COVID-19. MATERIAL AND METHODS. A review of the latest literature till 9 May 2020 has been made. PubMed and ResearchGate databases and WHO reports were used. RESULTS. Immunomodulatory properties of the tuberculosis vaccine which protects against severe cases of tuberculosis and partly against other infections are indicated, including viral and respiratory infections. The BCG vaccine induces heterologous immunity and trained innate immunity. It was noted that in countries which maintain obligatory BCG vaccination COVID-19 incidence and mortality are lower than in countries that have stopped or never introduced BCG as mandatory vaccination. Most analysis confirmed this relationship, but they indicated the possible impact of other factors, such as genetics in the population, the type of strain from BCG vaccine, the level of health care and the wealth of a nation, the structure of migration, co-morbidities and a policy of introducing social distance. CONCLUSIONS. At the moment, we do not have enough evidence to support or deny the hypothesis of COVID-19 reduction in incidence and mortality in countries maintaining obligatory BCG vaccination. Other factors that might affect the results should be considered in further analysis. The results of clinical trials will provide more reliable proofs than analysis of epidemiological data. WHO does not recommend BCG vaccination to prevent COVID-19 and recommends it to newborns from areas with a higher incidence of tuberculosis.

scholarly journals BCG vaccination as protection from COVID-19: epidemiological and molecular biological aspects

2020 ◽  
Vol 98 (5) ◽  
pp. 6-14
Author(s):  
Ya. Sh. Shvartz ◽  
N. V. Stavitskaya ◽  
D. A. Kudlay
Keyword(s):  
High Risk ◽  
National Policy ◽  
Risk Groups ◽  
Bcg Vaccine ◽  
Antiviral Action ◽  
Bcg Vaccination ◽  
Pros And Cons ◽  
Biological Aspects ◽  
The Moment

The article presents a review of the recent hypothesis that the national policy of BCG-vaccination affects the spread of COVID-19 in different countries. It contains the information from 70 publications with epidemiological indicators, providing pros and cons of this hypothesis, with the description of possible mechanisms of non-specific antiviral action of BCG vaccine. It is concluded that there are not enough data to verify or refute the hypothesis, and at the moment the use of BCG vaccine to prevent the spread of the infection even in high-risk groups would be unreasonable.

Efficacy and Safety of Antigen-specific Immunotherapy in the Treatment of Patients with Non-small-cell Lung Cancer: A Systematic Review and Meta-analysis

2019 ◽  
Vol 19 (3) ◽  
pp. 199-209 ◽  
Author(s):  
Bing-Di Yan ◽  
Xiao-Feng Cong ◽  
Sha-Sha Zhao ◽  
Meng Ren ◽  
Zi-Ling Liu ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Systematic Review ◽  
Adverse Events ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Specific Immunotherapy ◽  
Meta Analysis ◽  
Small Cell ◽  
Efficacy And Safety ◽  
Small Cell Lung

Background and Objective: We performed this systematic review and meta-analysis to assess the efficacy and safety of antigen-specific immunotherapy (Belagenpumatucel-L, MAGE-A3, L-BLP25, and TG4010) in the treatment of patients with non-small-cell lung cancer (NSCLC). </P><P> Methods: A comprehensive literature search on PubMed, Embase, and Web of Science was conducted. Eligible studies were clinical trials of patients with NSCLC who received the antigenspecific immunotherapy. Pooled hazard ratios (HRs) with 95% confidence intervals (95%CIs) were calculated for overall survival (OS), progression-free survival (PFS). Pooled risk ratios (RRs) were calculated for overall response rate (ORR) and the incidence of adverse events. </P><P> Results: In total, six randomized controlled trials (RCTs) with 4,806 patients were included. Pooled results showed that, antigen-specific immunotherapy did not significantly prolong OS (HR=0.92, 95%CI: 0.83, 1.01; P=0.087) and PFS (HR=0.93, 95%CI: 0.85, 1.01; P=0.088), but improved ORR (RR=1.72, 95%CI: 1.11, 2.68; P=0.016). Subgroup analysis based on treatment agents showed that, tecemotide was associated with a significant improvement in OS (HR=0.85, 95%CI: 0.74, 0.99; P=0.03) and PFS (HR=0.70, 95%CI: 0.49, 0.99, P=0.044); TG4010 was associated with an improvement in PFS (HR=0.87, 95%CI: 0.75, 1.00, P=0.058). In addition, NSCLC patients who were treated with antigen-specific immunotherapy exhibited a significantly higher incidence of adverse events than those treated with other treatments (RR=1.11, 95%CI: 1.00, 1.24; P=0.046). </P><P> Conclusion: Our study demonstrated the clinical survival benefits of tecemotide and TG4010 in the treatment of NSCLC. However, these evidence might be limited by potential biases. Therefore, further well-conducted, large-scale RCTs are needed to verify our findings.

Crizotinib Versus Chemotherapy on ALK-positive NSCLC: A Systematic Review of Efficacy and Safety

2018 ◽  
Vol 19 (1) ◽  
pp. 41-49 ◽  
Author(s):  
Mingxia Wang ◽  
Guanqi Wang ◽  
Haiyan Ma ◽  
Baoen Shan
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Adverse Events ◽  
Objective Response Rate ◽  
Retrospective Studies ◽  
Response Rate ◽  
Objective Response ◽  
Treated Group ◽  
Efficacy And Safety ◽  
Alk Positive

Introduction: Crizotinib was approved to treat anaplastic lymphoma kinase (ALK)- positive non-small cell lung cancer (NSCLC) by the Food and Drug Administration in 2011.We conducted a systematic review of clinical trials and retrospective studies to compare the efficacy and safety of crizotinib with chemotherapy. </P><P> Methods: We searched electronic databases from inception to Dec. 2016. Clinical trials and retrospective studies regarding crizotinib and crizotinib versus chemotherapy in treatment of NSCLC were eligible. The primary outcomes were the objective response rate (ORR) and disease control rate (DCR). Results: Nine studies (five clinical trials and four retrospective studies) including 729 patients met the inclusion criteria. Crizotinib treatment revealed 1-year OS of 77.1% and PFS of 9.17 months. And crizotinib had a better performance than chemotherapy in ORR (OR: 4.97, 95%CI: 3.16 to 7.83, P<0.00001, I2=35%). DCR revealed superiority with crizotinib than chemotherapy (OR: 3.42, 95% CI: 2.33 to 5.01, P<0.00001, I2=0%). PR (partial response) were significant superior to that of chemotherapy through direct systematic review. No statistically significant difference in CR (complete response) was found between crizotinib-treated group and chemotherapy-treated group. Regarding SD (stable disease), chemotherapy-treated group had a better performance than crizotinib-treated group. Common adverse events associated with crizotinib were visual disorder, gastrointestinal side effects, and elevated liver aminotransferase levels, whereas common adverse events with chemotherapy were fatigue, nausea, and hematologic toxicity. This systematic review revealed improved objective response rate and increased disease control rate in crizotinib group comparing with chemotherapy group. Crizotinib treatment would be a favorable treatment option for patients with ALK-positive NSCLC. ALK inhibitors may have future potential applications in other cancers driven by ALK or c-MET gene mutations.

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