At the start of the SARS-CoV-2 pandemic, healthcare workers had an increased risk of acquiring coronavirus disease (COVID)-19. As tertiary care hospitals are critical for the treatment of severely ill patients, the University Hospital Erlangen offered BNT162b2 mRNA vaccination against COVID-19 to all employees when the vaccine became available in Germany. Here, we performed a survey to assess the age- and sex-dependent reactogenicity and safety of BNT162b2 in a real-life setting with a special emphasis on the rate of vaccine-related incapacity to work amongst the employees. All vaccinated employees were invited to participate in the survey and received access to an electronic questionnaire between 31 March and 14 June 2021, which allowed them to report local and systemic adverse effects after the first or second vaccine dose. A total of 2372 employees completed the survey. After both the first and second dose, women had a higher risk than men for vaccine-related systemic side effects (odds ratio (OR) 1.48 (1.24-1.77) and 1.49 (1.23-1.81), respectively) and for inability to work (OR 1.63 (1.14-2.34) and 1.85 (1.52-2.25), respectively). Compared to employees ≥ 56 years of age, younger vaccinated participants had a higher risk of systemic reactions after the first (OR 1.35 (1.07-1.70)) and second vaccination (OR 2.08 (1.64-2.63)) and were more often unable to work after dose 2 (OR 2.20 (1.67-2.88)). We also recorded four anaphylactic reactions and received two reports of severe adverse effects indicative of vaccine complications. After the first and second vaccination, 7.9% and 34.7% of the survey participants, respectively, were temporarily unable to work, which added up to 1700 days of sick leave in this cohort. These real-life data extend previous results on the reactogenicity and safety of BNT162b2. Loss of working time due to vaccine-related adverse effects was substantial, but was outweighed by the potential benefit of prevented cases of COVID-19.
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http://dx.doi.org/10.3390/vaccines10050650 | DOI Listing |
Background: A MenABCWY vaccine containing 4CMenB and MenACWY-CRM vaccine components has been developed to protect against the five meningococcal serogroups that cause most invasive disease cases.
Methods: In this phase 3 study (NCT04707391), healthy participants aged 15-25 years, who had received MenACWY vaccination ≥4 years previously, were randomized (1:1) to receive two MenABCWY doses six months apart or one MenACWY-CRM dose. Primary objectives were to demonstrate the non-inferiority of MenABCWY 1 month post-vaccination versus MenACWY-CRM, with a lower limit of 2-sided 95% confidence interval above -10% for group differences in 4-fold rise in human serum bactericidal antibody (hSBA) titers against serogroups ACWY, and to evaluate reactogenicity and safety.
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Department of Pediatrics, Emory University School of Medicine, Atlanta, GA, USA.
Filoviruses, including Ebola, Marburg, Sudan, and Taï Forest viruses, are zoonotic pathogens that can cause severe viral hemorrhagic fever and death. Developing vaccines that provide durable, broad immunity against multiple filoviruses is a high global health priority. In this Phase 1 trial, we enrolled 60 healthy U.
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National Centre for Immunisation Research and Surveillance, Westmead, New South Wales.
Despite widespread adoption of "high-dose" glucocorticoid definitions across international immunisation guidelines (i.e., prednisone-equivalent dosing >20 mg/day, or >2 mg/kg/day in children), the rationale remains unclear.
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December 2024
GSK, GSK Asia House, Singapore, Singapore.
Pertussis resurgence has been documented even in countries with high pediatric vaccine coverage. The proportion of isolates not expressing pertactin (PRN) has increased in several countries where acellular pertussis (aP) vaccines are used. We systematically reviewed published literature up to July 2023 on PRN-negative isolates in MEDLINE and Embase with no geographical limitations, complemented with a gray literature search.
View Article and Find Full Text PDFLancet Infect Dis
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Department of Biochemistry and Kavli Institute for Nanoscience Discovery and the NIHR Oxford Biomedical Research Centre, University of Oxford, Oxford, UK. Electronic address:
Background: Two pre-erythrocytic vaccines (R21/Matrix-M and RTS,S/AS01) are now approved for Plasmodium falciparum malaria. However, neither induces blood-stage immunity against parasites that break through from the liver. RH5.
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