Abstract: The present disclosure relates to methods of enhancing self-amplifying mRNA molecules (SAMs) encapsulated within lipid nanoparticles (LNPs). Specifically, enhancement of the stability, potency, and/or shelf-life of SAM/LNPs formulated in the presence of reducing agents is discussed.

Abstract: Currently, the steps performed prior to release of influenza strains to vaccine manufacturers involve passaging influenza virus through eggs. The invention aims to provide procedures useful in manufacturing influenza vaccines, in which the use of eggs is reduced, and preferably is avoided altogether. For instance, rather than use chicken eggs for influenza vaccine isolation, MDCK cells (Madin Darby canine kidney cells) may be used e.g. growing in suspension, growing in a serum-free medium, growing in a protein-free medium, being non-tumorigenic, grown in the absence of an overlay medium, etc.

Abstract: Disclosed herein are methods for increasing protein yield and cellular productivity. Chemical agents facilitate host cell production of biological molecules to increase product yield.

Abstract: Compared to an unadjuvanted vaccine, an adjuvanted influenza vaccine can reduce by almost a quarter the risk of hospitalization for respiratory illness (e.g. influenza and pneumonia) in elderly recipients. Thus the invention provides a method for immunizing an elderly subject by administering an adjuvanted influenza vaccine, whereby the subject's risk of hospitalization for respiratory illness (e.g. influenza and pneumonia) is reduced relative to an elderly subject who receives an unadjuvanted influenza vaccine.

Abstract: An immunogenic composition comprising: (i) a non-virion influenza virus antigen, prepared from a virus grown in cell culture; and (ii) an adjuvant. Preferred adjuvants comprise oil-in-water emulsions.

Abstract: The present invention relates to vaccine products for the treatment or prevention of viral infections. Further provided are methods of reducing contaminants associated with the preparation of cell culture vaccines. Residual functional cell culture DNA is degraded by treatment with a DNA alkylating agent, such as ?-propiolactone (BPL), thereby providing a vaccine comprising immunogenic proteins derived from a virus propagated on cell culture, substantially free of residual functional cell culture DNA.

Abstract: Disclosed herein are methods for enhancing immune responses to a vaccine in immunocompromised individuals, including those receiving a statin therapy. Related products are also provided.

Abstract: Influenza vaccines include hemagglutinin from at least one influenza A virus strain and at least one influenza B virus strain. They also include an oil-in-water emulsion adjuvant with submicron oil droplets, comprising squalene. In some embodiments the hemagglutinin concentration is >12 ?g/ml per strain. In some embodiments the squalene concentration is <19 mg/ml. In some embodiments the vaccine is mercury-free. In some embodiments the vaccine has a unit dose volume between 0.2-0.3 mL. In some embodiments the squalene concentration is 9.75 mg/mL or 4.88 mg/mL. In some embodiments the vaccine includes antigens from two influenza A virus strains and two influenza B virus strains.

Abstract: The present application discloses stability-indicating potency assays for influenza vaccines.

Abstract: Disclosed herein are influenza vaccine compositions, related preparations and intermediates, formulations, production methods, immunization methods, and use thereof, for achieving improved immune-protection in human subjects. More specifically, non-egg-based influenza vaccines are described, which provide improved antigenic match.

Abstract: A number of improvements for preparing vaccine antigens from disintegrated influenza viruses are disclosed. A splitting step can be followed by detergent exchange. Splitting can take place in the presence of a buffer with a higher ionic strength and/or in the presence of phosphate buffer.

Abstract: New influenza donor strains for the production of reassortant influenza B viruses are provided.

Abstract: An immunogenic composition comprising (i) a non-virion influenza virus antigen prepared from a virus grown in cell culture; and (ii) an adjuvant. Preferred adjuvants comprise oil-in-water emulsions.

Abstract: Disclosed herein are methods for enhancing immune responses to a vaccine in immunocompromised individuals, including those receiving a statin therapy. Related products are also provided.

Abstract: New influenza donor strains for the production of reassortant influenza B viruses are provided.

Abstract: Improved methods for the production of reassortant influenza viruses are provided.

Abstract: The present invention relates to vaccine products for the treatment or prevention of viral infections. Further provided are methods of reducing contaminants associated with the preparation of cell culture vaccines. Residual functional cell culture DNA is degraded by treatment with a DNA alkylating agent, such as ?-propiolactone (BPL), thereby providing a vaccine comprising immunogenic proteins derived from a virus propagated on cell culture, substantially free of residual functional cell culture DNA.

Abstract: The invention provides various reverse genetics systems for producing segmented RNA viruses, wherein the systems do not require bacteria for propagation of all of their expression constructs.

Abstract: New influenza donor strains for the production of reassortant influenza A viruses are provided.

Abstract: New influenza donor strains for the production of reassortant influenza A viruses are provided.