An adapted version of the Brighton Collaboration priority list was used to evaluate serious adverse events (SAE) of special interest observed in mRNA Covid-19 vaccine trials. In December of 2020, reviewers searched journal publications and trial data on the FDA’s and Health Canada’s websites to locate SAE results tables for these trials. For each trial, blinded SAE tables were prepared. Using these blinded SAE tables, two clinician reviewers judged whether each SAE type was an adverse event of special interest (AESI). Risk ratios and risk differences between vaccine and placebo groups were calculated for the incidence of AESIs and SAEs.
This study investigates multiple vaccine strategies to enhance immunogenicity and protection against SARS-CoV-2 in aged mice. The study aims to determine the effect of a booster dose, with an emphasis on older age. Female three and eleven-month-old BALB/c mice were studied over the course of 38 weeks. Mice received BNT162b2 SARS-CoV-2 spike mRNA vaccine series, primary vaccination series, and mock Phosphate-buffered saline (PBS) injections. Single mouse experiments aimed to include 20 mice per group. Sample size and age criteria were chosen empirically based on the results of previous studies. Mice were randomly assigned to different treatment groups.
Due to constraints in vaccine supply, this agent-based model of COVID-19 transmission was developed to compare the impact of two vaccination strategies: 1) vaccinate more individuals with the first dose of available vaccines and delay the second dose or 2) to continue with the recommended 2-dose series as tested in clinical trials. Model population was stratified into 6 age groups of 0 to 4, 5 to 19, 20 to 49, 50 to 64, 65 to 79, and 80+ years based on United States census data.