MedImmune gets approval for flu vaccine production technology

MedImmune will apply the technology to its intranasal FluMist product and its next-generation, refrigerator-stable formulation, CAIV-T.

Creation of new vaccine strains is the first step in the influenza vaccine manufacturing process. Use of reverse genetics, also known as ‘plasmid rescue,’ technology enhances the safety, specificity, reliability and efficiency with which new vaccine strains can be produced.

“Reverse genetics represents an important breakthrough in commercial influenza vaccine processes by improving the efficiency of producing new influenza vaccine strains on an annual basis,” said Dr George Kemble, vice president of vaccines R&D at MedImmune. “This technology enables scientists to replace cumbersome seasonal vaccine strain development methods that were created in the 1960s with modern techniques, which should allow us to accelerate the availability of influenza vaccines to the public.”

The company has already begun applying its plasmid rescue technology to pandemic research efforts. In June, the US National Institutes of Health (NIH) began enrolling participants in a phase I study of an intranasal H5N1 influenza vaccine candidate based on MedImmune’s live, attenuated vaccine technology, which also utilized reverse genetics technology.

Investigators at MedImmune and Johns Hopkins Bloomberg School of Public Health Center for Immunization Research, where the study is being conducted, are hopeful that a live, attenuated intranasal influenza vaccine would be as effective against potential pandemic A strains as it has been shown to be against seasonal matched and mismatched A strains of influenza.

Most influenza vaccine manufacturing companies and governmental agencies are now using reverse genetics technology in their development of pandemic vaccine candidates because it allows them to avoid working directly with the infectious, circulating pandemic strains.