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

Works of the United States government are not entitled to domestic copyright protection under U.S. law and are therefore in the public domain.

Medium

document

Topics

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