Application of a Language Model Tool for COVID-19 Vaccine Adverse Event Monitoring Using Web and Social Media Content: Algorithm Development and Validation Study.

Background: Spontaneous pharmacovigilance reporting systems are the main data source for signal detection for vaccines. However, there is a large time lag between the occurrence of an adverse event (AE) and the availability for analysis. With global mass COVID-19 vaccination campaigns, social media, and web content, there is an opportunity for real-time, faster monitoring of AEs potentially related to COVID-19 vaccine use.

Background incidence rates of health outcomes of interest for COVID-19 vaccine safety monitoring in a US population: a claims database analysis.

Objective: To evaluate background incidence rates of 59 health outcomes of interest (HOI) in a diverse population, including important subpopulations, during the pre-COVID-19 era (1 January 2017-31 December 2019) and the COVID-19 era (1 March 2020-31 December 2020), before the introduction of COVID-19 vaccines.

Design: Observational retrospective cohort study. Annual incidence rates and 95% confidence intervals (CIs) of HOIs were estimated for each population of interest, stratified by: age, sex, age and sex and seasonality.

DTaP-IPV-HB-Hib vaccine (Hexaxim): an update 10 years after first licensure.

Introduction: Hexaxim® is fully liquid, hexavalent, combination vaccine that provides immunization against diphtheria, tetanus, pertussis (whooping cough), polio, hepatitis B, and invasive diseases caused by type b. Combination vaccines such as Hexaxim reduce the number of injections needed, improving both vaccination compliance and operational efficiency.

Areas Covered: Safety and immunogenicity data were reviewed from >25 clinical trials involving approximately 7200 infants/toddlers, identified using PubMed searches to April 2023.

Enhanced passive safety surveillance of a quadrivalent inactivated split virion influenza vaccine in Finland during the influenza season 2020/21.

Background: The European Medicines Agency (EMA) requires enhanced safety surveillance to be conducted for annual seasonal influenza vaccines with the aim of rapidly detecting any potential new safety concerns before the peak immunisation period of the vaccine in any given year. The aim of this study was to detect any clinically significant change in the frequency or severity of expected reactogenicity of the quadrivalent inactivated split-virion influenza vaccine (IIV4) during routine immunisation in Finland for the 2020/21 season. The primary objective was to investigate the frequency of suspected adverse drug reactions (ADRs) occurring within 7 days following vaccination.