EMA lists rare spinal condition as side effect of AstraZeneca’s COVID-19 shot -Breaking
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© Reuters. FILE PHOTO A healthcare worker holds an AstraZeneca/Oxford University COVID-19 vaccination vial at Pentland Medical Practice, Currie, Scotland. January 7, 2021. REUTERS/Russell Cheyne/Pool(Reuters) -The European Drug Regulator’s safety panel recommended Friday that transverse myelitis, a rare form of spinal inflammation, be added to the side effects of AstraZeneca’s COVID-19 vaccine.
The vaccine faced many setbacks including delays in production and probes from regulators after rare instances of serious side effects like blood clots or low platelets. This led to many countries stopping their use.
The European Medicines Agency’s safety committee also reiterated its recommendation of a similar warning to be included for Johnson & Johnson (NYSE:)’s one-shot vaccine.
After reviewing the data, the committee concluded that there is at most a possibility of a causal link between transverse myelitis and these vaccines.
Added to that, the benefits-risk profiles of both vaccines remain unchanged.
Reports of the serious neurological illness was also at the heart of trial halts in the early stages of development for both AstraZeneca and J&J’s shots, which are based on similar technology.
AstraZeneca also suggested updating AstraZeneca’s product information regarding the rare blood clots that occurred after the initial shot.
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