Why Shingrix Requires Refrigeration
Shingrix must be refrigerated because it is a lyophilized (freeze-dried) vaccine that requires cold storage to maintain potency, and once reconstituted, it must be stored between 2°C and 8°C (36°F and 46°F) and used within 6 hours to prevent loss of vaccine effectiveness. 1
Storage Requirements for Unreconstituted Shingrix
The evidence provided does not specify the exact storage temperature for unreconstituted Shingrix components, but the FDA label clearly states that after reconstitution, the vaccine must be either administered immediately or refrigerated. 1 This refrigeration requirement exists because:
Biological vaccines are temperature-sensitive products that lose potency when exposed to temperatures outside recommended ranges, which can reduce protection against vaccine-preventable diseases. 2
The cold chain must be maintained to ensure vaccine effectiveness from manufacturer to administration, typically requiring storage between 2°C and 8°C for most vaccines. 3
Post-Reconstitution Storage: Critical Time Window
Once reconstituted, Shingrix has a strict 6-hour window during which it must be used or discarded. 1 During this period:
The vaccine must be stored refrigerated between 2°C and 8°C (36°F and 46°F) if not administered immediately. 1
Any reconstituted vaccine not used within 6 hours must be discarded, as potency cannot be guaranteed beyond this timeframe. 1
Key Distinction from Live Vaccines
It's important to note that Shingrix is fundamentally different from live attenuated zoster vaccines (like Zostavax):
Live varicella-containing vaccines require frozen storage at temperatures below -15°C to maintain viability. 2
Shingrix is a recombinant subunit vaccine (not live virus), which has different stability characteristics and storage requirements. 4, 5
The recombinant nature makes it safe for immunocompromised individuals, unlike live vaccines. 4, 5
Clinical Implications and Common Pitfalls
Critical practice points to avoid vaccine wastage:
Reconstitute only when ready to administer, as the 6-hour window is non-negotiable. 1
Monitor refrigerator temperatures carefully, as exposure to improper temperatures can irreversibly reduce vaccine potency. 2
Do not freeze reconstituted vaccine, as freezing can damage the adjuvant system and antigen components. 2
Use only the supplied AS01B adjuvant suspension component for reconstitution—no substitutions are permitted. 1