FDA Commissioner Addresses Flu Response and Preparedness Efforts

In oral testimony before the US House Committee on Energy and Commerce Subcommittee on Oversight and Investigations, FDA Commissioner Scott Gottlieb, MD, urged immediate steps that can be taken to enhance the product of existing licensed influenza vaccines, and he noted that a universal flu vaccine remains years away.

The testimony was given hearing on US public health preparedness and response efforts to seasonal influenza.

Exploring alternatives to egg-based vaccines is one way to address strain drift or newly emerging strains that make existing vaccines less effective, Dr. Gottlieb said. Many manufacturers are continuing to produce egg-based vaccines, largely because more investment would be needed to fundamentally change manufacturing. Despite this, Dr. Gottlieb indicated that it is worth better understanding the potential of these alternative vaccines.

“Some studies have found that cell-based and recombinant vaccines are more efficacious, or could be more efficacious, than egg-based vaccines; but, more data and analyses are needed,” he said, adding that the FDA is looking at how to develop a more robust recombinant vaccine manufacturing process to increase yield while reducing cost. Additionally, the agency intends to help industry make investments in new manufacturing technologies and develop regulatory tools and guidances for these products.

Data presented at a recent FDA advisory committee meeting suggested that the strains selected for the 2017-2018 vaccine reasonably matched circulating strains, even the H3N2 strain. Past vaccines have also been less effective against H3N2, and Dr. Gottlieb stated that the FDA is trying to better understand why effectiveness tends to be lower against this strain.

Related Coverage: FDA Advisory Committee Discusses 2018-2019 Flu Vaccine Strains

Until then, Dr. Gottlieb noted that improving vaccine uptake and preventing shortages of flu treatments, such as antivirals and IV saline, remain essential.

“As we continue to invest in the future of manufacturing and vaccine technology, we also need to remember the importance of simply ensuring that more people are vaccinated with available vaccines each flu seasons,” he explained.

Reference

Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for oral testimony before the U.S. House Committee on Energy and Commerce Subcommittee on Oversight and Investigations hearing “Examining U.S. Public Health Preparedness for and Response Efforts to Seasonal Influenza.” [FDA Statement]. FDA’s website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm600244.htm?utm_campaign=03082018_Statement_Oral%20testimony%20flu&utm_medium=email&utm_source=Eloqua. Accessed March 8, 2018.