Acute respiratory distress syndrome (ARDS) as an adverse event following immunization: Case definition & guidelines for data collection, analysis, and presentation of immunization safety data.

This is a Brighton Collaboration Case Definition of the term "Acute Respiratory Distress Syndrome - ARDS" to be utilized in the evaluation of adverse events following immunization. The Case Definition was developed by a group of experts convened by the Coalition for Epidemic Preparedness Innovations (CEPI) in the context of active development of vaccines for SARS-CoV-2 vaccines and other emerging pathogens. The case definition format of the Brighton Collaboration was followed to develop a consensus definition and defined levels of certainty, after an exhaustive review of the literature and expert consultation. The document underwent peer review by the Brighton Collaboration Network and by selected Expert Reviewers prior to submission. The comments of the reviewers were taken into consideration and edits incorporated in this final manuscript.

Vaccination against SARS-CoV-2 and disease enhancement - knowns and unknowns.

INTRODUCTION: The world is currently fighting a COVID-19 pandemic, perhaps the most disruptive infectious disease outbreak since the 1918 Spanish influenza. Governments have taken drastic measures to curb the spread of SARS-CoV-2, and the development of safe and efficacious vaccine candidates is being accelerated. The possibility of vaccine-mediated disease enhancement with coronavirus vaccines has been flagged as a potential safety concern, and, despite the urgent need, should be thoroughly assessed as vaccines against SARS-CoV-2 are being tested. AREA COVERED: We review the in vivo evidence suggesting a theoretical risk of disease enhancement after vaccination with SARS-CoV and MERS-CoV vaccine candidates. We also identify knowledge gaps that need to be filled to maximize the chance of developing a safe vaccine and minimize the risk of encountering disease enhancement in vaccinated individuals after exposure to SARS-CoV-2. EXPERT OPINION: We compile and propose avenues to investigate the risk of vaccine-mediated disease enhancement both during pre-clinical and early clinical development. While the pressing need for a vaccine against COVID-19 (and future epidemic coronaviruses) cannot be ignored, we advocate to keep safety at the center of the debate. Protecting individuals with effective and safe vaccines should be a priority, even during extraordinary times like the COVID-19 pandemic.