EMA’s PRAC Requests Additional Data on Guillain-Barré Syndrome in COVID-19 Vaccine
EMA’s Pharmacovigilance Risk Assessment Committee has requested more data for its evaluation of reports of Guillain-Barré syndrome after vaccination.
The European Medicines Agency (EMA) announced on August 6, 2021 that its Pharmacovigilance Risk Assessment Committee (PRAC) is requesting additional data from AstraZeneca regarding reports of Guillain-Barré syndrome after vaccination with the company’s COVID-19 vaccine, Vaxzevria. PRAC is analyzing data about the rare immune system disorder, which causes nerve inflammation, to determine if updates to the product’s information and risk management plan are necessary. The request follows the committee’s recommendation to include a warning about Guillain-Barré syndrome in the product information.
EMA stated in a press release that, “People taking the vaccine are advised to seek immediate medical attention if they develop weakness and paralysis in the extremities that can progress to the chest and face. These side effects are very rare, and the benefit-risk balance of the vaccine remains unchanged.”
Source: EMA
Guidance on Quality Culture Standards
June 3rd 2025Matt Cushing, VP of Quality and Science, Nelson Labs, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company, discuss PDA/ANSI Standard 06-2025: Assessment of Quality Culture Guidance Documents, Models, and Tools, which was published in February 2025.
