Trump Executive Order Aims to Speed Flu Vaccine Development

Alicia Ault

September 20, 2019

President Donald J. Trump has issued an executive order that aims to encourage development of seasonal and pandemic influenza vaccines that are more effective and can be made more quickly than current vaccines.

The order also establishes a new task force charged with developing a solid plan to modernize US flu vaccine production, which has largely relied on a decades-old, egg-based method.

The executive order does not provide any new funding, nor does it direct Congress to appropriate any new money. But it "directs actions to reduce the United States' reliance on egg-based influenza vaccine production; to expand domestic capacity of alternative methods that allow more agile and rapid responses to emerging influenza viruses; to advance the development of new, broadly protective vaccine candidates that provide more effective and longer lasting immunities; and to support the promotion of increased influenza vaccine immunization across recommended populations."

The federal government and many private companies have already been working on these technologies, while also trying to develop a vaccine that would protect against a range of influenza viruses, including a pandemic strain. The National Institute of Allergy and Infectious Diseases (NIAID), for instance, began the first human trial of such a universal flu vaccine in April.

Two vaccines are currently approved for seasonal influenza that don't rely on eggs for manufacture: Flublok Quadrivalent, a recombinant vaccine; and the and cell-cultured Flucelvax Quadrivalent.

Deeming progress too slow, the White House issued the executive order to create a National Influenza Vaccine Task Force. The task force must, within 120 days, come up with a 5-year plan to "promote the use of more agile and scalable vaccine manufacturing technologies and to accelerate development of vaccines that protect against many or all influenza viruses."

In addition, the task force is required to submit a progress report every year on June 1.

The order also requires the US Department Health & Human Services (HHS) to give cost estimates on scaling up production and distribution of vaccines — including cell-based and recombinant vaccine manufacturing — especially in the case of a pandemic.

The savings from having a vaccine on hand could be massive, said the White House's Council of Economic Advisers (CEA) in a new report. Direct and indirect costs during a pandemic could range from $413 billion to $3.79 trillion, and estimates indicate the United States could see 500,000 deaths and 670,000 to 4.3 million hospitalizations. If vaccines could be available at the outset, however, the costs could be cut by $730 billion. Add if the vaccines have greater effectiveness, which the CEA estimates could be 30% better with new technologies, the savings could rise to $953 billion.

Pandemic vaccines have not been developed in part because they would be made and then stockpiled; there is little potential for profit until a pandemic occurs. Meanwhile, the chance of such an outbreak is rare — about 4% a year, according to the CEA.

Public-private partnerships have resulted in some acceleration of development and should continue to be encouraged, the CEA said. Other incentives, such as requiring the federal government to preferentially purchase vaccines produced with newer, faster technologies "may create more efficacious seasonal vaccines, especially for older people, [and] can promote additional cost-effective innovation and lessen the impact of future pandemics," the CEA report stated.

The executive order urges HHS to consider cost-sharing agreements with private vaccine makers, including an "agreed-upon pricing strategy during a pandemic." It also requires the Centers for Medicare & Medicaid Services to "examine the current legal, regulatory, and policy framework surrounding payment for influenza vaccines," in a bid to determine whether reimbursement could be used as an incentive.

"Faster methods of producing influenza vaccines will help keep Americans safer both from seasonal influenza, which kills tens of thousands of Americans each year, and from the potential of pandemic influenza, which is the single greatest biodefense threat our country faces," said HHS Secretary Alex Azar in a related statement.

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