PEI communications to marketing authorization holders of COVID-19 vaccines due to insufficient data

Summary

Original text of the question(s):<br /> <br /> Did the Paul Ehrlich Institute (PEI) send communications to approval holders of COVID-19 vaccines, in particular BioNTech, Moderna, AstraZeneca or Janssen, in the years 2021 to 2023, in which the institute pointed out that the data situation was insufficient in accordance with Section 13 Paragraph 5 of the Infection Protection Act or as part of the SafeVac 2.0 study, and if not, in the specified period Have corresponding inquiries been received from the PEI or the Federal Ministry of Health from the above-mentioned or other approval holders?

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Timeline

1. 15 August 2025

   Schriftliche Frage/Schriftliche Antwort

   PEI communications to marketing authorization holders of COVID-19 vaccines due to insufficient data

   Source: BT

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