Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared - Tucson News Now

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 Effo

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SOURCE U.S. Food and Drug Administration

SILVER SPRING, Md., March 8, 2018 /PRNewswire-USNewswire/ -- Good Morning, Chairman Harper, Ranking Member DeGette, and members of the subcommittee. Thank you for the invitation to testify on our response to the 2017-2018 seasonal flu.

U.S. Food and Drug Administration (FDA) logo (PRNewsfoto/FDA)

This flu season has been particularly hard.

I agree with my colleagues that investing in -- and working toward -- the universal flu vaccine is crucial. Unfortunately, given where we are today in the development process, that reality is still many years off.

While we should continue to focus on the discovery of a new breakthrough vaccine, we also must consider what immediate and intermediate steps we can take to enhance the production of existing licensed vaccines. And what should be done to invest in advanced domestic manufacturing to ensure new and existing technologies are scalable so that manufacturers can meet domestic and global demand.

There have been successes in developing alternatives to egg-based vaccines, such as cell-based and recombinant technologies, in part because of the collaborations and work by BARDA. However, despite these advances in vaccine development, the majority of manufacturers are continuing to produce egg-based vaccines.

There are reasons for this. The egg-based process works. And the vaccines are safe and effective. But even more so, it would require an enormous investment to fundamentally change manufacturing.

However, we believe it's worth better understanding the potential of cell-based and recombinant alternatives.

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. 

As one step to better understand the differences between egg-based and cell-based technologies, we're using CMS data to compare Medicare patients that received a cell-based vaccine to those who received an egg-based vaccine to determine which vaccine was more effective in that population. 

As we consider greater investment in alternative vaccine development processes, it's important to note, however, that there are also challenges with these newer cell-based approaches.

To help address these challenges, FDA is working to help develop more effective cell lines that can be better scaled through continuous manufacturing.

We're also looking at how we develop a more robust recombinant vaccine manufacturing process to increase yield, while reducing cost.

Continuous manufacturing holds great promise for both cell-based and recombinant vaccines, because supply could be more easily ramped up on short notice.

This would allow us to more rapidly address newly emerging strains or strain drift. Getting all the necessary preparatory work done is one of the limiting steps of egg-based technologies.

The FDA can help industry make investments in these new manufacturing technologies, and facilitate such a transition.

We need to develop a science-based framework that includes the regulatory tools and guidances for products developed in these systems to be evaluated. Ultimately, our investment will provide regulatory clarity for this kind of new technology.

That regulatory framework can increase the efficiency and reduce the cost of transitioning to this kind of new cell-based and recombinant product development and manufacturing.

More immediately, as we prepare for next year's flu season and analyze the data from this year, we're trying to better understand why this year's vaccines were less effective against the H3N2 strain.

At FDA's recent advisory committee meeting, the data presented continued to suggest that the strains selected for the 2017-2018 vaccines and used by manufacturers reasonably matched the circulating strains.  This includes the H3N2 strain.

Although adapting circulating virus strains for manufacture can lead to differences between the circulating strains and the ones used for manufacturing; and although those changes could affect vaccine effectiveness, the case this year, is likely more complex.

And this year is not the first time we've seen vaccines be less effective against H3N2. Recent flu vaccines have proven on average only about 33 percent effective against H3N2 viruses.

Given this, we're looking at several factors to better understand why effectiveness tends to be lower against this strain.

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 season.  And we also must work hard to ensure that products used to treat the flu – including antivirals and IV saline -- are available, and that we take steps to prevent and address shortages. 

As always, FDA remains committed to communicating and sharing updates with the public about all aspects of our flu response. I look forward to answering your questions today. Thank you.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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