Sensitivity and specificity of in vitro diagnostic device used for influenza rapid test in Taiwan

The pandemic influenza A/H1N1 outbreak resulted in 18,449 deaths in over 214 countries. In Taiwan, the influenza rapid test, an in vitro diagnostic device (Flu-IVD), only requires documented reviews for market approval by the Taiwan Food and Drug Administration. The purpose of this study was to investigate the analytical sensitivity and specificity of Flu-IVDs used in Taiwan. Analytical sensitivity and specificity tests were performed for influenza antigens A/California/7/2009 (H1N1) virus, A/Victoria/210/2009 (H3N2) virus, B/Brisbane/60/08 virus, and human coronavirus OC43. A total of seven domestic and 31 imported Flu-IVD samples were collected, of which, 20 samples had inadequate labeling, including those with removed package inserts or incorrect insert information. The analytical sensitivity of Flu-IVDs for A/H1N1, A/H3N2, and Flu B was 500–1000 ng/mL, 1000 ng/mL, and 1000 ng/mL, respectively. For the 50% cell culture infective dose (CCID₅₀) label, the average A/H1N1 and A/H3N2 sensitivity for Flu-IVDs was log₁₀ 5.8 ± 0.5 and log₁₀ 6.6 ± 0.5 CCID₅₀/mL, respectively. As to the specificity test, no product cross-reacted with human coronavirus OC43. This study provides important information on the Flu-IVD regulation status and can thus help the government formulate policies for the regulation of in vitro diagnostic devices in Taiwan.     

Acute bronchiolitis during the COVID-19 pandemic

IntroductionThe autumn and winter bronchiolitis epidemics have virtually disappeared in the first year of the COVID-19 pandemic.Our objectives were characterised bronchiolitis during fourth quarter of 2020 and the role played by SARS-CoV-2.MethodsProspective multi-centre study performed in Madrid (Spain) between October and December 2020 including all children admitted with acute bronchiolitis. Clinical data were collected and multiplex PCR for respiratory viruses were performed.ResultsThirty-three patients were hospitalised with bronchiolitis during the study period: 28 corresponded to rhinovirus (RV), 4 to SARS-CoV-2, and 1 had both types of infection. SAR-CoV-2 bronchiolitis were comparable to RV bronchiolitis except for a shorter hospital stay. A significant decrease in the admission rate for bronchiolitis was found and no RSV was isolated.ConclusionSARS-CoV-2 infection rarely causes acute bronchiolitis and it is not associated with a severe clinical course. During COVID-19 pandemic period there was a marked decrease in bronchiolitis cases.     

Long term effectiveness of adjuvanted influenza A(H1N1)pdm09 vaccine in children

BackgroundImmunological studies have indicated that the effectiveness of AS03 adjuvanted monovalent influenza A(H1N1)pdm09 vaccine (Pandemrix^®) may be of longer duration than what is seen for non-adjuvanted seasonal influenza vaccines. Sixty-nine percent of children 6 months–18 years of age in Stockholm County received at least one dose of Pandemrix^® during the 2009 pandemic. We studied the effectiveness of the vaccine during the influenza seasons 2010–2011 and 2012–2013 in children hospitalized with virologically confirmed influenza. The season 2011–2012 was not included, since influenza A(H3N2) was the predominant circulating strain.MethodsIn a retrospective case-control study using a modified test-negative design we compared the percentage vaccinated with Pandemrix^® among children diagnosed with influenza A(H1N1)pdm09 (cases), with that of those diagnosed with influenza A(H3N2) or influenza B (controls) during the two seasons. We excluded children born after July 1, 2009, since only children who were 6 months of age or older received the pandemic vaccine in October–December 2009.ResultsDuring the 2010–2011 season, 3/16 (19%) of children diagnosed with influenza A(H1N1)pdm09, vs. 32/41 (78%) of those with influenza A(H3N2) or influenza B had been vaccinated with Pandemrix^® in 2009. The odds ratio, after adjustment for sex, age and underlying diseases, for becoming a case when vaccinated with Pandemrix^® was 0.083 (95%CI 0.014, 0.36), corresponding to a VE of 91.7%. During the season 2012–2013, there was no difference between the two groups; 59% of children diagnosed with influenza A(H3N2)/B and 60% of those with influenza A(H1N1)pdm09 had been vaccinated with Pandemrix^® in 2009.ConclusionThe AS03 adjuvanted monovalent influenza A(H1N1) pdm09 vaccine (Pandemrix^®) was effective in preventing hospital admission for influenza A(H1N1)pdm09 in children during at least two seasons.     

Accounting for personal and professional choices for pandemic influenza vaccination amongst English healthcare workers

BackgroundHealthcare workers (HCWs) are encouraged to get vaccinated during influenza pandemics to reduce their own, and patients’, risk of infection, and to encourage their patients to get immunised. Despite extensive research on HCWs’ receipt of vaccination, little is known about how HCWs articulate pandemic influenza vaccination advice to patients.AimsTo explore HCWs’ uptake of the A/H1N1 vaccine during the pandemic of 2009–2010, their recommendations to patients at the time, and their anticipated choices around influenza vaccination under different pandemic scenarios.MethodWe conducted semi-structured interviews and focus groups with eight vaccinated and seventeen non-vaccinated HCWs from primary care practices in England. The data was analysed using thematic analysis.ResultsThe HCWs constructed their receipt of vaccination as a personal choice informed by personal health history and perceptions of vaccine safety, while they viewed patients’ vaccination as choices made following informed consent and medical guidelines. Some HCWs received the A/H1N1 vaccine under the influence of their local practice organizational norms and values. While non-vaccinated HCWs regarded patients’ vaccination as patients’ choice, some vaccinated HCWs saw it also as a public health issue. The non-vaccinated HCWs emphasised that they would not allow their personal choices to influence the advice they gave to patients, whereas some vaccinated HCWs believed that by getting vaccinated themselves they could provide a reassuring example to patients, particularly those who have concerns about influenza vaccination. All HCWs indicated they would accept vaccination under the severe pandemic scenario. However, most non-vaccinated HCWs expressed reticence to vaccinate under the mild pandemic scenario.ConclusionsProviding evidence-based arguments about the safety of new vaccines and the priority of public health over personal choice, and creating strong social norms for influenza vaccination as part of the organizational culture, should increase uptake of influenza vaccination among primary care HCWs and their patients.     

Nurses’ stories from Beirut: The 2020 explosive disaster on top of a pandemic and economic crises

The World Health Organization designated last year as the International Year of the Nurse and the Midwife. And as we know worldwide, 2020 became an unforgettable year as nurses and midwives everywhere confronted the COVID‐19 pandemic. To be a nurse in 2020 was challenging and heroic, but being a nurse in 2020 in Beirut, Lebanon was so extraordinarily charged with adversity. The country witnessed in a one‐year series of tragedies of epic dimensions – laying a heavy toll on front‐line nurses. We present our stories as eight Lebanese nurses, giving voice to our incredible experiences and our ongoing resilience in the face of these adversities. We served in the emergency department of a Beirut city hospital after a catastrophic explosion occurred in the capital on the 4th of August 2020. We reported for duty during a disaster of immense magnitude and are now coping with the aftermath of trauma. As nurses, we have faced many traumas in our country that has experienced through war and terrorism for decades. Arising from this disaster and challenges of the pandemic, we give policy recommendations that deserve urgent attention in Lebanon and underscore the need for disaster preparation, funding, education and importantly mental health care for nurses and other health professionals with help and support of the international community.     

H5N1 vaccines in humans

The spread of highly pathogenic avian H5N1 influenza viruses since 1997 and their virulence for poultry and humans has raised concerns about their potential to cause an influenza pandemic. Vaccines offer the most viable means to combat a pandemic threat. However, it will be a challenge to produce, distribute and implement a new vaccine if a pandemic spreads rapidly. Therefore, efforts are being undertaken to develop pandemic vaccines that use less antigen and induce cross-protective and long-lasting responses, that can be administered as soon as a pandemic is declared or possibly even before, in order to prime the population and allow for a rapid and protective antibody response. In the last few years, several vaccine manufacturers have developed candidate pandemic and pre-pandemic vaccines, based on reverse genetics and have improved the immunogenicity by formulating these vaccines with different adjuvants. Some of the important and consistent observations from clinical studies with H5N1 vaccines are as follows: two doses of inactivated vaccine are generally necessary to elicit the level of immunity required to meet licensure criteria, less antigen can be used if an oil-in-water adjuvant is included, in general antibody titers decline rapidly but can be boosted with additional doses of vaccine and if high titers of antibody are elicited, cross-reactivity against other clades is observed. Prime-boost strategies elicit a more robust immune response. In this review, we discuss data from clinical trials with a variety of H5N1 influenza vaccines. We also describe studies conducted in animal models to explore the possibility of reassortment between pandemic live attenuated vaccine candidates and seasonal influenza viruses, since this is an important consideration for the use of live vaccines in a pandemic setting.