Key points
- ÐÇ¿ÕÓéÀÖ¹ÙÍø is working with other federal agencies and the private sector to improve flu vaccine technologies.
- These improvements to flu vaccine technologies have expanded vaccine supply and improved vaccine effectiveness.
Background
For more than a decade, collaborative efforts in the United States across the federal government and the private sector have led to improved influenza (flu) vaccine technologies. These technologies have expanded vaccine supply and/or improved vaccine effectiveness.
To further support improvement of flu vaccines, the White House issued Executive Order (EO) 13887: Modernizing Influenza Vaccines in the United States to Promote National Security and Public Health on September 19, 2019. The EO established a National Influenza Vaccine Task Force, which ÐÇ¿ÕÓéÀÖ¹ÙÍø is a member of. It calls for the modernization of flu vaccines and vaccine manufacturing along with increased national flu vaccination.
Roles of ÐÇ¿ÕÓéÀÖ¹ÙÍø and the other federal agencies in flu vaccine improvements
As the nation's leading public health agency, ÐÇ¿ÕÓéÀÖ¹ÙÍø is part of a broad inter-agency government effort to improve flu vaccines. One of ÐÇ¿ÕÓéÀÖ¹ÙÍø's primary roles in this effort is to provide recommendations for the best public health use of existing flu vaccines. ÐÇ¿ÕÓéÀÖ¹ÙÍø also plays a leading role in conducting year-round global influenza virus surveillance, supporting the selection and in some cases production of viruses used in flu vaccines. The agency also supports the development of new and better vaccines. For example, ÐÇ¿ÕÓéÀÖ¹ÙÍø's Influenza Division is using next generation sequencing and genomic technologies to develop better flu candidate vaccine viruses (CVVs). A CVV is an influenza virus that has been prepared by ÐÇ¿ÕÓéÀÖ¹ÙÍø (or another public health partner) that can be used by vaccine manufacturers to produce a flu vaccine. ÐÇ¿ÕÓéÀÖ¹ÙÍø is working to produce better CVVs to make flu vaccines that provide the best possible immune response following vaccination. In addition, ÐÇ¿ÕÓéÀÖ¹ÙÍø monitors and reports on the effectiveness of existing flu vaccines.
Much of the work to improve flu vaccine technology over the past decade has taken place as part of efforts associated with flu pandemic preparedness planning which is led by the U.S. Department of Health and Human Services' . is charged with the development and procurement of medical and non-pharmaceutical countermeasures for pandemic flu preparedness and response, including flu vaccines. ÐÇ¿ÕÓéÀÖ¹ÙÍø, the , and the are partners in this broad inter-agency government effort. FDA is the federal regulatory agency responsible for assuring the safety, effectiveness, quality, and security of drugs, vaccines, and other biological products and medical devices. NIH is the nation's medical research agency, a role which includes conducting clinical trials for vaccines.
Recent advances with flu vaccines
- A high dose vaccine that is designed specifically for people 65 and older to create a stronger antibody response.
- A flu vaccine made with adjuvant (an ingredient added to vaccine that helps create a stronger immune response in the patient's body) was approved for people 65 years of age and older.
- A U.S.-approved cell culture-based flu vaccine, which can be made more quickly than traditional egg-based vaccines and does not require eggs for production.
- ÐÇ¿ÕÓéÀÖ¹ÙÍø has established good laboratory practice (GLP) laboratories and procedures to isolate candidate vaccine viruses (CVVs) in qualified manufacturing cell lines that serve as seeds for cell-based vaccine manufacturing.
- ÐÇ¿ÕÓéÀÖ¹ÙÍø performs two-way antigenic testing of cell CVVs, which is required for them to serve as a vaccine virus.
- ÐÇ¿ÕÓéÀÖ¹ÙÍø has established good laboratory practice (GLP) laboratories and procedures to isolate candidate vaccine viruses (CVVs) in qualified manufacturing cell lines that serve as seeds for cell-based vaccine manufacturing.
- The first recombinant influenza vaccines require neither an egg-grown vaccine virus nor eggs in production.
- Developing live attenuated influenza vaccines (LAIV): ÐÇ¿ÕÓéÀÖ¹ÙÍø Influenza Division's Virology, Surveillance, and Diagnosis Branch (VSDB) develops LAIV vaccines that are distributed globally via World Health Organization. VSDB recently developed methods to stabilize the vaccine to eliminate the cold chain.
Long-term goals to improve flu vaccines
One long-term goal is to reduce reliance on egg-based methods of flu vaccine manufacturing and to embrace newer vaccine manufacturing technologies that can be used to more quickly respond to novel flu outbreaks and pandemics. Another long-term goal is the development of a single flu vaccine that would provide safe, effective, and long-lasting immunity (i.e., immunity lasting multiple flu seasons) against a broad spectrum of influenza viruses, both seasonal and novel. A flu vaccine with these qualities is often referred to as a “universal flu vaccine.”
How ÐÇ¿ÕÓéÀÖ¹ÙÍø is currently supporting the development of a universal flu vaccine
At this time, ÐÇ¿ÕÓéÀÖ¹ÙÍø is participating in a broad that supports the advanced development of new and better flu vaccines. These efforts already have yielded important successes. Part of this effort is the eventual development of a "universal vaccine" that would offer better, broader, and longer-lasting protection against seasonal influenza viruses as well as novel influenza viruses. This task poses an enormous scientific and programmatic challenge, but a number of government agencies and private companies already have begun work to advance development of a universal flu vaccine.