Executive order hopes to improve flu vaccine effectiveness, but funding is unclear.
This article was first published on Friday, September 20, 2019 in MedPage Today.
By Molly Walker, Associate Editor, MedPage Today.
President Donald Trump fired the first shot of the 2019-2020 flu season, with an executive order Thursday aiming to improve processes for manufacturing influenza vaccines, including greater effort toward a "universal" flu vaccine.
The order calls for reduced reliance on current egg-based flu vaccines, and an approach that hopes to modernize the process -- from expanding capacity for alternative flu vaccines, such as newer cell-based vaccine technology, to the development of newer, more broadly protective vaccine candidates that don't have to be reformulated every year.
However, the order did not indicate how this aggressive program would be funded, noting that its implementation would be "subject to the availability of appropriations."
Andrew Pavia, MD, co-chair of the Infectious Diseases Society of America (IDSA) Treatment Guidelines Panel, and chief of pediatric infectious diseases at the University of Utah, characterized the executive order as "an important and clear commitment to goals" for the prevention of influenza in the U.S.
"We are at a point where we can move to 'Generation 2' vaccines, such as cell-based and recombinant vaccines, but they are not being produced in large amounts or being preferred," Pavia told MedPage Today.
Indeed, a senior administration official in a "background" press call stated that there is a "lack of appropriate innovation incentives" for such vaccines "due in part to a misalignment between social and private returns."
Or, as Pavia noted, the government needs to "figure out what the incentives are for us to move away from egg-based vaccines."
He added that the government also "could act as a pull mechanism": because the government has so much vaccine purchasing power, with programs such as Vaccines for Children and Medicare Part D, that could help "move the commercial market at the same time."
In fact, the executive order included instructions to various agencies, including the Veterans Affairs system and the Department of Defense, to take steps toward buying flu vaccines produced with "faster, more scalable, and innovative technologies."
During the press call, an official cited a Council of Economic Advisors analysis estimating that treating influenza currently costs some $50 billion, a number that could reach $1.8 to $3.8 trillion in direct costs, lives lost and lost productivity in the event of an influenza pandemic.
"Moving to faster vaccine manufacturing technologies that would make a vaccine available near the outset of a pandemic would save over $730 billion, over an average pandemic," said the official, who spoke on condition of anonymity. "And if that new technology also includes vaccine effectiveness by 30% over the effectiveness seen in the most recent pandemic in 2009, it would save $953 billion, or roughly half the cost of an average pandemic."
The executive order creates a National Influenza Vaccine Task Force co-chaired by the secretaries of Defense and Health and Human Services. It will include input from public health agencies such as the NIH, CDC, FDA, Biomedical Research Development Authority, as well as the Veterans Affairs and Homeland Security departments.
The Task Force will have 120 days to develop a 5-year plan, with annual reports and updates.
Pavia said the new approach could speed seasonal vaccine selection ("so we don't have to decide in March what we have to use in September") and expand the CDC Vaccine Effectiveness Network. Ultimately, data collected this way could result in the CDC's Advisory Committee for Immunization Practices (ACIP) being able to recommend different vaccines for specific populations, such as older adults and children, Pavia noted.
He added that input from medical experts, such as IDSA, as well as industry would be important, especially for goals such as re-prioritizing the research agenda and developing incentives.
But ultimately, none of this will happen without appropriate funding, and according to a senior administration official, this will be "dependent on the evaluation of what is the current status of our seasonal and pandemic influenza abilities." But the executive order requires an estimate of the cost to improve vaccine production and redirect funds into more modern vaccine research and development.
This would include the longed for universal flu vaccine, but Pavia said that is still years away, even though it's "receiving a lot of attention and money."
"What this [executive order] does is very useful, spells out the steps that can be taken and makes it a national priority," Pavia noted. "But to make it happen, it's going to require money. That's the next step we need to hear about."
“What this [executive order] does is very useful, spells out the steps that can be taken and makes it a national priority. But to make it happen, it's going to require money. That's the next step we need to hear about.”
Andrew Pavia, MD, co-chair, Infectious Diseases Society of America
The executive order calls for reduced reliance on current egg-based flu vaccines, and for the development newer, more broadly protective vaccine candidates that don't have to be reformulated every year.
The National Influenza Vaccine Task Force will have 120 days to develop a 5-year plan, with annual reports and updates.
The order did not say how this aggressive program would be funded, noting that its implementation would be 'subject to the availability of appropriations.'