COVID-19 vaccines and adverse events of special interest: A multinational Global Vaccine Data Network (GVDN) cohort study of 99 million vaccinated individuals.

BACKGROUND: The Global COVID Vaccine Safety (GCoVS) Project, established in 2021 under the multinational Global Vaccine Data Network™ (GVDN®), facilitates comprehensive assessment of vaccine safety. This study aimed to evaluate the risk of adverse events of special interest (AESI) following COVID-19 vaccination from 10 sites across eight countries. METHODS: Using a common protocol, this observational cohort study compared observed with expected rates of 13 selected AESI across neurological, haematological, and cardiac outcomes. Expected rates were obtained by participating sites using pre-COVID-19 vaccination healthcare data stratified by age and sex. Observed rates were reported from the same healthcare datasets since COVID-19 vaccination program rollout. AESI occurring up to 42 days following vaccination with mRNA (BNT162b2 and mRNA-1273) and adenovirus-vector (ChAdOx1) vaccines were included in the primary analysis. Risks were assessed using observed versus expected (OE) ratios with 95 % confidence intervals. Prioritised potential safety signals were those with lower bound of the 95 % confidence interval (LBCI) greater than 1.5. RESULTS: Participants included 99,068,901 vaccinated individuals. In total, 183,559,462 doses of BNT162b2, 36,178,442 doses of mRNA-1273, and 23,093,399 doses of ChAdOx1 were administered across participating sites in the study period. Risk periods following homologous vaccination schedules contributed 23,168,335 person-years of follow-up. OE ratios with LBCI > 1.5 were observed for Guillain-Barré syndrome (2.49, 95 % CI: 2.15, 2.87) and cerebral venous sinus thrombosis (3.23, 95 % CI: 2.51, 4.09) following the first dose of ChAdOx1 vaccine. Acute disseminated encephalomyelitis showed an OE ratio of 3.78 (95 % CI: 1.52, 7.78) following the first dose of mRNA-1273 vaccine. The OE ratios for myocarditis and pericarditis following BNT162b2, mRNA-1273, and ChAdOx1 were significantly increased with LBCIs > 1.5. CONCLUSION: This multi-country analysis confirmed pre-established safety signals for myocarditis, pericarditis, Guillain-Barré syndrome, and cerebral venous sinus thrombosis. Other potential safety signals that require further investigation were identified.

Background rates of adverse events of special interest for COVID-19 vaccines: A multinational Global Vaccine Data Network (GVDN) analysis.

BACKGROUND: The Global COVID Vaccine Safety (GCoVS) project was established in 2021 under the multinational Global Vaccine Data Network (GVDN) consortium to facilitate the rapid assessment of the safety of newly introduced vaccines. This study analyzed data from GVDN member sites on the background incidence rates of conditions designated as adverse events of special interest (AESI) for COVID-19 vaccine safety monitoring. METHODS: Eleven GVDN global sites obtained data from national or regional healthcare databases using standardized methods. Incident events of 13 pre-defined AESI were included for a pre-pandemic period (2015-19) and the first pandemic year (2020). Background incidence rates (IR) and 95% confidence intervals (CI) were calculated for inpatient and emergency department encounters, stratified by age and sex, and compared between pre-pandemic and pandemic periods using incidence rate ratios. RESULTS: An estimated 197 million people contributed 1,189,652,926 person-years of follow-up time. Among inpatients in the pre-pandemic period (2015-19), generalized seizures were the most common neurological AESI (IR ranged from 22.15 [95% CI 19.01-25.65] to 278.82 [278.20-279.44] per 100,000 person-years); acute disseminated encephalomyelitis was the least common (<0.5 per 100,000 person-years at most sites). Pulmonary embolism was the most common thrombotic event (IR 45.34 [95% CI 44.85-45.84] to 93.77 [95% CI 93.46-94.08] per 100,000 person-years). The IR of myocarditis ranged from 1.60 [(95% CI 1.45-1.76) to 7.76 (95% CI 7.46-8.08) per 100,000 person-years. The IR of several AESI varied by site, healthcare setting, age and sex. The IR of some AESI were notably different in 2020 compared to 2015-19. CONCLUSION: Background incidence of AESIs exhibited some variability across study sites and between pre-pandemic and pandemic periods. These findings will contribute to global vaccine safety surveillance and research.

Estimation of the real burden of invasive meningococcal disease in Argentina.

Among the different existing types of bacterial meningitis, the one caused by Neisseria meningitidis is the main presentation of invasive meningococcal disease (IMD). IMD is a significant public health concern and has a reported incidence rate in Argentina of 0.44 cases per 100 000 inhabitants in 2015. However, the actual incidence is thought to be higher as passive surveillance systems neither report nor identify 100% of all cases. The aim of this study is to develop an estimation of the burden of IMD in Argentina closer to reality by adjusting/correcting several limitations observed in the surveillance data available. A retrospective observational study has been performed using four Argentinean national databases recording the number of IMD cases and deaths, serogroups of N. meningitidis and ages, between 2007 to 2016. The reported data were adjusted to account for underreporting and to also integrate the cases missed due to well-known limitations associated with the diagnosis of N. meningitidis detection methods. Data were further analysed by serogroups of N. meningitidis and by age groups. After these adjustments, the potential numbers of IMD cases and IMD-related deaths are estimated to be 3.1 and 1.9 higher than reported, respectively. The study corrects the previous underestimation of the disease burden and provides expectedly more robust estimates aligned with international evidence and highlights the importance of active surveillance, with high-quality methods, for a better definition of preventive strategies against IMD in Argentina.

Laboratory Colonization of Anopheles (Nyssorhynchus) marajoara (Diptera: Culicidae) by Induced Copulation.

Malaria is a serious public health problem, the control of which involves actions directed against its vector, mosquitoes of the genus Anopheles Meigan, 1818. The study of insect biology, ecology, and behavior is simplified when these insects are maintained at the laboratory. However, many of the species are eurygamic and require induced mating. Females of Anopheles marajoara Galvão e Damasceno, 1942 were collected at Mazagão county, State of Amapá, Brazil. F1 eggs were obtained through forced oviposition and raised until mosquito emergence. Around 300 mosquitoes were maintained in each cage and were fed with a 10% sugar solution. Induced mating was made to obtain the other generations. Females had their spermathecae examined for the presence of sperm. The efficacy of coupling in each generation was evaluated. The viability of a sample of generations F5, F9, F12, and F14 was followed from larvae to adult. Two free mating attempts were done. The results demonstrate adaptation of An. marajoara to laboratory conditions over 21 generations, with viability rates temporally increasing. There was no evidence of adaptation to free mating.

Temporal trends in diarrhea-related hospitalizations and deaths in children under age 5 before and after the introduction of the rotavirus vaccine in four Latin American countries.

INTRODUCTION: Rotavirus infection mainly affects children under 5 years of age and causes 453,000 deaths annually throughout the world. Several countries in Latin America have introduced the rotavirus vaccine and the majority have epidemiological data to measure impact following vaccine introduction. OBJECTIVE: To assess the impact of rotavirus immunization on the number of all-cause diarrhea-related deaths and hospitalizations in children under 1 and 5 years of age in Bolivia, El Salvador, Honduras and Venezuela. METHODS: Interrupted time-series analyzed with the integral method and the projection method to evaluate the pre and post-vaccine introduction trend in diarrheal disease compared to Argentina as the control country. The analysis period was from 2002 to 2010, including 2 to 4 post-vaccine years depending on the country. Information sources included records from PAHO, the Ministry of Health, public hospitals, social security, the private health system, the Expanded Programme on Immunization and UNPop 2008. RESULTS: Over the period studied, reductions were observed in trends of diarrhea-related deaths and hospitalizations in children under five. In diarrhea-related deaths, under the integral method, the range of reduction was between 15.7% (13.5-17.9) and 56.8% (56.0-57.5) while with the projection method was between 19.9% (4.9-34.8) and 63.7%(56.1-71.4). In diarrhea-related hospitalizations, under the integral method was 5.6% (4.1-6.7) and 17.9% (16.7-19.1)) while with the projection method was between 5.1%(1.7-8.7) and 11.1% (5.8-16.3) CONCLUSIONS: A decrease was observed in the number of diarrhea related deaths and hospitalizations in all countries under study following introduction of the rotavirus vaccine as opposed to the control country. The impact on reduction of deaths was greater than hospitalization.

Procedures used to prepare and administer intramuscular injections: a study of infertility nurses.

OBJECTIVE: To describe the procedures infertility nurses use to prepare and administer intramuscular injections of fertility medications. DESIGN: Descriptive survey. PARTICIPANTS: Nurses listed as members of the Nurses Professional Group of the American Society for Reproductive Medicine (N = 645) were surveyed. Completed questionnaires were returned by 219 of the nurses. MAIN OUTCOME MEASURES: Volume of diluent, needle selection, site selection, internal rotation of the extremity distal to the injection site, and use of the z-track technique. RESULTS: There was wide variation in the gauge and length of needles used to administer the medications, with most nurses using a 22 g, 1-1/2-in needle for all medications. Most nurses changed the needle between preparing and administering medications; however, filter needles were seldom used. There was wide variation in the volume of diluent used to reconstitute medications. Most of the nurses used the dorsogluteal site for injections. Although almost all of the nurses indicated that they routinely rotated injection sites, they infrequently used sites other that the dorsogluteal site. Most nurses did not rotate the extremity distal to the injection site when administering injections and even fewer used the z-track technique. CONCLUSIONS: This study demonstrated wide variation in the procedures used by infertility nurses to prepare and administer intramuscular injections of fertility medications. Many nurses did not use procedures that can reduce the pain and tissue trauma associated with intramuscular injections.

Valor de la punción abdominal con aguja de Chiba guiada por ecografia en un caso de linfoma abdominal

The intraabdominal punction tecnique is harmless and causes very little disturvance to the patient. It gives the pathologist enough adequate material for his diagnosis. The abdominal punction using a chiba needle also permits one to evaluate the extension of the illness. Medical literature only states a few complications such as peritonitis in pancreatic punctions. The diagnosis of no-Hodking Lymphoma based on the monomorphism and the sizes and the nuclear clefts, does no ofter many difficulties, nervertheless, the obtained material does not allow one to differenciate between nodular and diffuse lymphoma and therapeutic datum. It this sense, Histology surpasses Cytology

[Value of abdominal puncture with Chiba needle guided by echography in a case of abdominal lymphoma]. / Valor de la punción abdominal con aguja de Chiba guiada por ecografía en un caso de linfoma abdominal.

The intraabdominal punction technique is harmless and causes very little disturbance to the patient. It gives the pathologist enough adequate material for his diagnosis. The abdominal punction using a Chiba needle also permits one to evaluate the extension of the illness. Medical literature only states a few complications such as peritonitis in pancreatic functions. The diagnosis of non-Hodgkin's Lymphoma based on the monomorphism and the sizes and the nuclear clefts, does not offer many difficulties, nevertheless, the obtained material does not allow one to differentiate between nodular and diffuse lymphoma, this being a very important prognostic and therapeutic datum. In this sense, Histology surpasses Cytology.