Scientific Publications by FDA Staff

Biologicals 2018 May;53:30-8

Assessing the potency and immunogenicity of inactivated poliovirus vaccine after exposure to freezing temperatures.

White JA, Estrada M, Weldon WC, Chumakov K, Kouiavskaia D, Fournier-Caruana J, Stevens E, Gary HE Jr, Maes EF, Oberste MS, Snider CJ, Anand A, Chen D

According to manufacturers, inactivated poliovirus vaccines (IPVs) are freeze sensitive and require storage between 2°C and 8°C, whereas oral poliovirus vaccine requires storage at -20¿°C. Introducing IPV into ongoing immunization services might result in accidental exposure to freezing temperatures and potential loss of vaccine potency. To better understand the effect of freezing IPVs, samples of single-dose vaccine vials from Statens Serum Institut (VeroPol) and multi-dose vaccine vials from Sanofi Pasteur (IPOL) were exposed to freezing temperatures mimicking what a vaccine vial might encounter in the field. D-antigen content was measured to determine the in vitro potency by ELISA. Immunogenicity testing was conducted for a subset of exposed IPVs using the rat model. Freezing VeroPol had no detectable effect on in vitro potency (D-antigen content) in all exposures tested. Freezing of the IPOL vaccine for 7 days at -20¿°C showed statistically significant decreases in D-antigen content by ELISA in poliovirus type 1 (p¿<¿0.0001) and type 3 (p¿=¿0.048). Reduction of poliovirus type 2 potency also approached significance (p¿=¿0.062). The observed loss in D-antigen content did not affect immunogenicity in the rat model. Further work is required to determine the significance of the loss observed and the implications for vaccine handling policies and practices.