Vaccines and Related Biological Products Advisory Committee October 22, 2020 Meeting Presentation

URL

https://www.fda.gov/media/143557/download

Authors

Steve Anderson

Published Date

October 22, 2020

Organization

Food and Drug Administration (FDA)

Event

VRBPAC Meeting

Key Excerpts

"FDA Safety Surveillance of COVID-19 Vaccines: DRAFT Working list of possible adverse event outcomes:

Guillain-Barré syndrome
Acute disseminated encephalomyelitis
Transverse myelitis
Encephalitis/myelitis/encephalomyelitis/meningoencephalitis/meningitis/encepholapathy
Convulsions/seizures
Stroke
Narcolepsy and cataplexy
Anaphylaxis
Acute myocardial infarction
Myocarditis/pericarditis
Autoimmune disease
Deaths
Pregnancy and birth outcomes
Other acute demyelinating diseases
Non-anaphylactic allergic reactions
Thrombocytopenia
Disseminated intravascular coagulation
Venous thromboembolism
Arthritis and arthralgia/joint pain
Kawasaki disease
Multisystem Inflammatory Syndrome in Children
Vaccine enhanced disease

Working list of possible adverse event outcomes for COVID-19 vaccines

Additional Information

Steve Anderson is the Director of the FDA's Office of Biostatistics and Epidemiology

Medium

document

Topics

adverse events,autoimmunity,COVID-19,heart disorders,immunodeficiency and immunopathological disorders,neurological disorders,reproductive system issues,vaccines,vascular system issues