Results 121 to 130 of about 183,149 (258)

Editorial: Pandemic preparedness in vaccine safety and regulation. [PDF]

Front Drug Saf Regul
Younus MM, van Hunsel F.
europepmc   +1 more source

Safety of pentavalent vaccines [PDF]

Indian Pediatrics, 2013
openaire   +2 more sources

Increasing the reporting of adverse drug reaction‐related hospitalizations using an ICD‐10‐based identification workflow: A multicentre study from Switzerland

British Journal of Clinical Pharmacology, EarlyView.
Background Reporting adverse drug reactions (ADRs) is essential for drug safety. In Switzerland, healthcare professionals are legally required to report serious and unlabelled ADRs, yet under‐reporting remains widespread. We tested a novel method to increase reporting of ADR‐related hospitalizations.
Georgia Anita Weber, Sophie‐Charlotte Bartel, Michael Boch, Christoph Rosen, Michael Bodmer, Balthasar Luzius Hug, Thomas Stammschulte, Patrick E. Beeler   +7 more
wiley   +1 more source

Development and psychometric testing of a parental knowledge, attitude, and practices questionnaire on pentavalent vaccine safety. [PDF]

Indian J Med Res
Fathima F, Nosenoor MM.
europepmc   +1 more source

Decoding RNA regulation: Challenges and opportunities for RNA‐based therapies in Europe

British Journal of Clinical Pharmacology, EarlyView.
Abstract RNA‐based medicinal products represent a promising frontier in personalised medicine, offering sequence‐specific disease targeting at various molecular levels, yet their clinical translation in the European Union (EU) may be hindered by regulatory uncertainty around definitions and evidence requirements; this study therefore aims to identify ...
Olivia C. Lewis, Christine Leopold, Joyce M. Hoek, Raymond M. Schiffelers, Marie L. De Bruin   +4 more
wiley   +1 more source

Retrospective cohort study of mRNA COVID-19 vaccine-associated enhanced disease in the Vaccine Safety Datalink, 2021-23. [PDF]

Hum Vaccin Immunother
Belongia EA, Kieke BA, Hanson KE, McClure DL, Boyce TG, Daley MF, DeSilva MB, Hurley LP, Irving SA, Jackson LA, Duffy J, McNeil MM, Sundaram ME.   +12 more
europepmc   +1 more source

Evaluating the (comparative) safety profile of the novel oral polio vaccine type 2 using individual case safety reports in VigiBase

British Journal of Clinical Pharmacology, EarlyView.
Aim Novel oral polio vaccine type 2 (nOPV2) was used under the WHO emergency use listing for circulating vaccine‐derived polio virus (cVDPV) outbreaks from 2021 to 2023. We assessed nOPV2 adverse events following immunization (AEFIs) and compared its safety profile to other vaccines using VigiBase.
Comfort Kunak Ogar, Malede Mequanent Sisay, Leonardo Roque‐Pereira, Christine Leopold, Patrick C. Souverein, Aukje K. Mantel‐Teeuwisse, Marie L. De Bruin   +6 more
wiley   +1 more source

Post-licensure safety of nirsevimab from the Canadian National Vaccine Safety (CANVAS) network. [PDF]

Hum Vaccin Immunother
Viñeta Paramo M, Kiely M, Valiquette L, Muller MP, McGeer A, Isenor JE, Sadarangani M, Kellner JD, Vanderkooi OG, Marty K, Lavoie PM, Bettinger JA.   +11 more
europepmc   +1 more source

A phase 1 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PF‐07261271 in healthy participants

British Journal of Clinical Pharmacology, EarlyView.
Aim There is an unmet need for more effective therapies in inflammatory bowel disease (IBD). A single drug that blocks multiple distinct pathogenic pathways may offer therapeutic benefit superior to current monotherapies. PF‐07261271, a bispecific antibody targeting both the p40 subunit of interleukin‐12/23 and tumour necrosis factor‐like cytokine 1A ...
Srividya Neelakantan, Christopher Banfield, Kenneth Hung, Anna Sapone, Vivek Pradhan, Yuxi Zhao, Dana Parsons‐Rich, Grace Lee, Bryce G. Johnson, Elena Peeva, Michael S. Vincent, Valerie M. Clerin   +11 more
wiley   +1 more source

Bivalent RSVpreF Subunit Vaccine Safety and Immunogenicity in Seropositive 2-<18 Year Olds. [PDF]

Vaccines (Basel)
Glanternik J, Paulsen GC, Senders S, Smith M, Shittu E, Pahud BA, Pereira L, Chen L, Maddalena Lino M, Kalinina EV, Baranova D, Kalina WV, Needle E, Murillo M, Leech JM, Cooper D, Swanson KA, Anderson AS, Gurtman A, Munjal I.   +19 more
europepmc   +1 more source