EMA Recommends Change in Storage Conditions for Pfizer/BioNTech Vaccine

BioPharm International Editors

The agency’s human medicines committee has recommended extending the approved storage period of unopened thawed vials at 2–8 0C from five days to 31 days.

The European Medicines Agency (EMA) announced on May 17, 2021 that its human medicines committee (CHMP) has recommended changing the approved storage conditions for Pfizer/BioNTech’s COVID-19 vaccine, Comirnaty. The recommendation extends the approved storage period of the unopened thawed vial at 2–8 oC from five days to 31 days.

The change follows EMA’s assessment of additional stability data, and the agency expects it to have an impact on planning and logistics for the rollout of the vaccine to member states in the European Union. The change will be implemented in updated product labeling.

Source: EMA