Industry Highlights Issues With EU HTA Regulation’s PICO Framework For Vaccines

Vaccine developers should be aware that the framework underpinning the new EU Health Technology Assessment (HTA) Regulation might not be suitable for immunizations, but actions from policymakers and industry could help mitigate some issues, a senior figure from GSK says.

The PICO framework used for EU-level HTA assessments might be unsuitable for vaccines (Shutterstock)
Key Takeaways
  • The framework used to evaluate products under the EU Health Technology Assessment (HTA) Regulation might pose unique challenges for vaccines, industry warns.

EU-level joint clinical assessments (JCAs) will apply for vaccines under the HTA Regulation from 2030, but manufacturers are concerned that...

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