Stability of undiluted and diluted vaccine
Once an undiluted vial is removed from the fridge and stored at room temperature it must be diluted within 2 hours. The vaccine should then be used within 6 hours after dilution. The MHRA Information for Healthcare Professionals (section 4.2) provides information about temperature requirements for different stages of preparation.
Interpreting expiry times for undiluted and diluted vaccine
The MHRA Public Assessment Report (pages 12-13) states that after removal from frozen storage, the undiluted vaccine can be stored for up to 120 hours at 2°C to 8°C. In addition to the 120 hour period at 2° to 8°C, an undiluted vial can be stored for a further 2 hours at up to 25°C.
After dilution, the vaccine is stored at 2°C to 25°C and should be used as soon as is practically possible and within 6 hours of dilution as recommended by WHO guidance. Once the stopper has first been punctured on addition of the diluent, the 6 hour expiry reflects the fact the vaccine does not contain a preservative. After 6 hours, any unused vaccine left in the vial should be discarded.
Change title amended to "Using Pfizer-BioNTech Vaccine within an appropriate time"
Thawing information moved to page "Issues to consider when defrosting the Pfizer-BioNTech COVID-19 vacccine". "Light conditions for storage and handling" removed
"Thawing at room temperature" reference changed to The Green Book (Chapter 14a).