Planning for COVID-19 vaccines safety surveillance
“Common adverse events that occur shortly after vaccination may be detected in the clinical trials, but rare adverse events, and those with delayed onset, are likely to be detected only once large populations are immunized. In addition, no DNA or RNA vaccines have been licensed in humans to date. Safety surveillance accompanying deployment will be critical. Historic example of real adverse reactions that are only detected after widespread vaccine use (Guillain-Barré syndrome (GBS)…” Link To Article | Image Source
CDC and FDA Warn that Johnson & Johnson COVID jab may Cause Guillain-Barre Syndrome
July 13, 2021 | CNBC | Need To Know News
“Johnson & Johnson’s COVID-19 injections may increase the risk of Guillain-Barre syndrome. Guillain-Barré syndrome is a rare and dangerous neurological condition. It can cause muscle weakness and paralysis. About 12.8-million people (about 8% of the fully vaccinated population in the US) got the J&J vaccine. Among these, 100 suspected cases of Guillain-Barré were identified by FDA officials. Almost all of them required hospitalization, and one person died. The cases were reported two weeks after vaccination and mostly in males aged 50 and above.”