| A stepwise multi-disciplinary investigation assessed a safety signal of solid organ transplant (SOT) rejection after immunisation with adjuvanted (AS03) A/H1N1 2009 pandemic vaccines. |
| Based on the overall findings supporting an acceptable safety profile in transplanted patients, the European Medicines Agency (EMA) closed the regulatory commitment to investigate in 2014, and SOT rejection as a potential risk was removed from the Risk Management Plan of adjuvanted (AS03) A/H1N1 pandemic influenza vaccines. |
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