Evaluation of a recombinant human gelatin as a substitute for a hydrolyzed porcine gelatin in a refrigerator-stable Oka/Merck live varicella vaccine

Table 1 The combined potency loss rate estimates of VZV (Oka/Merck) in both, hydrolyzed porcine gelatin (SOL-U-PRO), as well as recombinant human gelatin (FG-5001) stabilized, experimental refrigerator-stable varicella vaccine formulations stored at -15°C and 2–8°C for 24 months, and at 15°C for 12 months, respectively. The potency loss rates are in log₁₀ PFU per month.

	Potency Loss Rate Estimates (95%CI)
Storage Temperature	SOL-U-PRO	FG-5001	Combined
-15°C	0.000 (-0.004,0.005)	0.000 (0.005, 0.005)	0.000 (-0.003, 0.004)
2–8°C	0.005 (0.000, 0.010)	0.005 (0.000, 0.010)	0.005 (0.001, 0.009)
15°C	0.033 (0.017, 0.049)	0.033 (0.017, 0.048)	0.033 (0.022, 0.044)