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.

Australian immunisation registers: established foundations and opportunities for improvement.

The National Immunisation Program Schedule in Australia is formulated and funded nationally under the population-wide Medicare system. The policy is implemented by the eight state and territory jurisdictions. The national immunisation registers consist of the Australian Childhood Immunisation Register (ACIR), and, more recently, the National Human Papillomavirus (HPV) Vaccination Program Register. Moreover, a variety of jurisdiction-based registers and primary care practice software systems exist, which interact with the national registers. General practitioners can obtain reports listing patients under seven years attending their practice and recorded as 'not fully immunised', and immunisation coverage rates for their practice linked to government incentives through Medicare. A 2011 report documents national coverage of 91.8% fully immunised at 12 months, and 92.6% at 24 months. The HPV register provides information on vaccination coverage with the potential to link with a register of cervical cancer screening results. Limitations of current national register include inability to easily access immunisation histories beyond seven years of age, and issues of underreporting and timeliness, which impact significantly the immunisation coverage estimates. The linkage of these registers with healthcare outcome data will further enhance public health outcomes by enabling rapid, population-level vaccine safety and effectiveness investigations in a nation with a track record as an 'early adopter' of new childhood vaccines.

Multiresistant Pseudomonas aeruginosa outbreak in a pediatric oncology ward related to bath toys.

BACKGROUND: Nosocomial outbreaks of Pseudomonas aeruginosa in pediatric hospitals frequently involve neonates and immunosuppressed patients and can cause significant morbidity and mortality. OBJECTIVE: To describe the investigation of a multidrug-resistant P. aeruginosa outbreak in a pediatric oncology ward at the Royal Children's Hospital, Melbourne, Australia. DESIGN AND METHODS: Specimens were collected from infected patients and the ward environment. Bacterial isolates were characterized by antibiotic susceptibility patterns and bacterial DNA fingerprinting performed by pulsed-field gel electrophoresis (PFGE). A case-control study was carried out to assess possible risk factors for infection. RESULTS: Eight patients had clinical illnesses including bacteremia (n = 5) and infections of skin (n = 2), central venous catheter site (n = 1) and urinary tract (n = 1). The environmental ward survey yielded isolates of multiresistant P. aeruginosa from a toy box containing water-retaining bath toys, as well as from three of these toys. Pulsed-field gel electrophoresis of bacterial DNA demonstrated identical band patterns of the isolates from patients, toys and toy box water. A case-control study involving the 8 cases and 24 disease-matched controls demonstrated a significant association between P. aeruginosa infection and use of bath toys (P = 0.004), use of bubble bath (P = 0.014), duration of stay (P = 0.007) and previous antibiotic exposure (P = 0.026). Cultures from the bubble bath liquid were negative. CONCLUSION: This is the first description of a nosocomial outbreak associated with toys. We caution against the use of water-retaining bath toys in wards treating immunocompromised children.

Stability of the CK-MB isoenzyme on routine storage.

Unlike earlier studies on the stability of the CK-MB isoenzyme carried out on control sera and on semi-purified and purified CK isoenzymes, we have studied the stability of CK-MB measured electrophoretically in patient sera under different laboratory storage conditions. The values obtained if the test was done immediately were significantly higher than those done on stored samples. There was no difference between specimens stored at -20 degrees C overnight or kept at room temperature (RT) for a few hours, but values were significantly lower (p less than 0.005) in specimens left at RT for 6 h and then stored overnight at 4 degrees C. To determine the effects of longer storage, further specimens stored either at -20 degrees C or at 4 degrees C for up to 4 days were also tested for CK-MB stability by electrophoresis and by immunoinhibition and immunoenzymetric methods. The immunological methods were included in the study to assess method dependency of CK-MB stability. CK-MB was stable at -20 degrees C by all methods, but at 4 degrees C, CK-MB was stable only by immunological and not by electrophoretic (p less than 0.005) measurement. Specimens stored under adverse conditions (4-6 days at RT) showed 50% deterioration of CK-MB when measured electrophoretically but only about 20% when measured immunologically.

A sensitive method of screening for urinary porphobilinogen.

In this screening method for urinary porphobilinogen (PBG), urine is added to Dowex 2 resin under alkaline conditions in a test tube and mixed. The supernate is removed and the adsorbed PBG is eluted with acid and reacted with Ehrlich's reagent. We compared results with those by the Watson-Schwartz screening method, using urine samples from normal people with and without added PBG. At a PBG concentration of about five times the upper limit of normal, the resin method gave a sensitivity of 100%; the Watson-Schwartz method gave a sensitivity of 51%. At lower PBG concentrations of just over and twice the upper limit of normal, the sensitivity by the resin method was respectively 97% and 100%. With normal urine samples, the resin method gave negative results for all samples (100% specificity) and the Watson-Schwartz had 95% specificity. Our data indicate that the resin method is sensitive, specific, and reliable and is superior to the Watson-Schwartz method.

Colorimetric measurement of plasma lactate.

A rapid and simple enzymatic method for plasma lactate is proposed using stable reagents to produce the formazan color. This method agrees well with a reference kit method, r = 0.955 and the regression equation is y = 0.99x + 0.09. The over-all recovery averages 100%, with a precision ranging from 0.6 to 3.3%. No interferences have been shown with the formazan reaction. The proposed method is inexpensive, ideal for batch analyses, and is an attractive method for the busy clinical laboratory.