President Donald Trump called on his administration to boost its efforts to make a better flu vaccine but did not ask Congress for more government funding, nor did he provide any incentives for industry.
The work that Trump wants pursued involves research and development programs that have long been underway — most of them in progress before he entered the White House.
|
His requests came in a Sept. 19 executive order, which has been expected since mid-July, when officials in his administration confirmed it was being prepared.
In his order, Trump told federal agencies to "modernize the domestic influenza vaccine enterprise to be highly responsive, flexible, scalable and more effective at preventing the spread of influenza viruses."
He called on the U.S. to reduce its reliance on egg-based influenza vaccine production and to expand domestic capacity of alternative methods that allow more agile and rapid responses to emerging flu viruses — an effort the U.S. National Institutes of Health and the Biomedical Advanced Research and Development Authority have been focused on over a number of years.
The NIH is the U.S. government's biomedical research agency — the largest organization of its kind in the world. BARDA supports the transition of medical countermeasure candidates from the early stages of development to the advanced phase and toward U.S. approval and potential procurement by the government.
Both agencies have worked for years to get biopharmaceutical companies to adopt newer techniques, like cell-based and recombinant technologies, in which vaccines can be made much quicker and can provide more flexibility to rapidly shift to keep pace with changes in the flu virus.
At a March 8, 2018, hearing on Capitol Hill, Anthony Fauci, director of the NIH's National Institute of Allergy and Infectious Diseases, urged drugmakers to move away from the 70-year-old antiquated egg-based process of developing a flu vaccine and "graduate to the 21st century."
So far, however, only a few companies have done so.
|
CSL Ltd. unit Seqirus Inc. produces a cell-based product, Flucelvax, while Sanofi subsidiary Protein Sciences Corp. makes a recombinant protein-based vaccine Flublok.
But sales of Flublok have been slow, which one senior Trump administration official attributed to its pricing and poor reimbursement.
Incentives need more study
Trump did not outline what types of incentives the government could provide to drive more companies to pursue newer vaccines or engage in public-private partnerships for that endeavor.
Instead, he called on the assistant secretary for preparedness and response at the U.S. Department of Health and Human Services and the head of BARDA to evaluate such incentives.
Trump told those two agencies to work with the NIH, U.S. Department of Defense and the Department of Veterans Affairs to support a suite of clinical studies, though he did not call on Congress to provide additional funds to support those activities.
A senior administration official told reporters that federal agencies needed to first complete their evaluation of the current status of the nation's seasonal and pandemic influenza abilities before Trump would seek additional funds.
In his last three budget requests to Congress, Trump has actually sought cuts to the vaccine programs run by the NIH and the Centers for Disease Control and Prevention.
Lawmakers, however, are poised to boost those agencies' budgets for fiscal 2020.
Task force
In his order, Trump also called for the creation of a National Influenza Vaccine Task Force consisting of senior officials from a number federal agencies.
That panel would be charged with submitting a report to the White House within 120 days outlining a five-year national plan aimed at promoting the use of more agile and scalable manufacturing technologies and accelerating development of products that protect against many or all influenza viruses — a universal vaccine.
The NIH has been working for a number of years on a universal vaccine. In February 2018, Fauci and his colleagues unveiled the agency's research agenda for speeding the U.S. efforts on a universal flu vaccine.
The biomedical agency had conducted trials on BiondVax Pharmaceuticals Ltd.'s M-001 and the NIH's own product, known as H1ssF_3928.
Trump is not the first president to form an influenza task force or special panel to evaluate the nation's vaccine capabilities.
Presidents George W. Bush and Barack Obama each had their own panels of internal and external experts evaluating the situation and providing advice on modernizing the flu vaccine — suggestions that led to the NIH's current pursuit of developing a universal flu vaccine.
Officials, however, said Trump's executive order would fortify those efforts.

President Donald Trump
Anthony Fauci