The coronavirus pandemic has exposed gaps in U.S. medical manufacturing and distribution. Cheap foreign materials and “just in time” shipping have made it tough to meet the sudden demand for cleaning agents, protective gear, and ventilators — even as sick patients are filling hospital ICUs.
And yet U.S. companies that make vaccines — the kind of low-priced, one-dose commodity product that drugmakers often leave to foreigners — have stepped up.
Last Friday, President Donald Trump signed the $2 trillion CARES Act, including $27 billion for vaccines and protective gear. On Monday, drug giant Johnson & Johnson said it was joining the CARES-enriched Biomedical Advanced Research and Development Authority (BARDA) to spend more than $1 billion developing anti-coronavirus vaccines.
J&J said the first “emergency” shots should be available on a “not-for-profit” basis early next year — well in advance of the usual five- to seven-year timetable — and an eventual billion doses will be made in a new U.S. factory at an unnamed location.
J&J’s Janssen unit, which includes the company’s vaccines business, has labs in Belgium, central New Jersey, and Horsham.
The Philadelphia area is the historic center of vaccine science. Maurice Hilleman’s labs at Merck developed preventives for measles, mumps, meningitis, hepatitis, pneumonia, and flu, among others. Hilary Koprowski and colleagues at the Wistar Institute on the Penn campus developed vaccines against polio, rabies, and more. Scientists at Merck and GlaxoSmithKline labs in the western suburbs and start-ups in University City remain focused on new generations of vaccines.
And specialized firms such as Fort Washington-based Inovio Pharmaceuticals have lately announced accelerated coronavirus vaccine schedules, also armed with federal funding — from the U.S. military, in Inovio’s case.
The fact that U.S. vaccine capability hasn’t withered along with other commodities once made here is no accident, but a result of steady lobbying, medical initiative, and government foresight, advocates say.
Washington has funded vaccine development and other pandemic preparation in uneven doses. But the framework of a national vaccine policy has endured between crises and into periods of neglect — and will now be flush with new anti-coronavirus billions.
“We are very pleased to see the government’s increased appreciation for vaccines, which save both lives and substantial costs to the U.S.,” said Amy Pisani, executive director of Vaccinate Your Family, a Washington-based advocacy network backed by the CDC, vaccine makers, and charitable groups.
“Our country has an amazing brain trust of scientists who are aware of the potential threats to the world from future viruses,” but they need R&D funding, as well as support from better public health education. “There are still some who believe coronavirus is a conspiracy,” Pisani added.
In the emergency preparedness climate that followed the 2001 terrorist attacks on Washington and New York, the federal government rolled out Project BioShield, a $5.6 billion pandemic preparedness program funding testing and vaccines, initially designed to run from 2003 to 2013.
When the H5N1 flu hit hard in early 2005, President George W. Bush, joined by the CDC’s top infectious disease expert, Anthony Fauci, summoned executives from Baxter, GSK, Wyeth, and other vaccine makers to the White House.
“Bush said, ‘Where’s the flu vaccine? This should make you a lot of money,’” recalls Berwyn lawyer Frank Rapoport, who prepped the GSK executives for the meeting. “And they said, ‘Sir, we won’t make money, but we will get sued.’”
Bush and Congress responded with the federal PREP Act, which extended legal protections from plaintiff lawsuits to vaccine, testing, and antiviral makers building medicines for pandemics, said John Clerici, a founder of pharma consulting firm Tiber Creek Partners in Washington.
Clerici worked to draft PREP with then-Republican Senate aide Robert Kadlec, whom Trump in 2017 named assistant secretary for preparedness and response, overseeing BARDA and its vaccine funding, and the Strategic National Stockpile of medical supplies — making Kadlec a key leader in the coronavirus fight.
Without legal liability protections, Clerici says companies such as J&J would be “100%” against developing vaccines in the U.S.
In 2013, when the original BioShield funding ran out, Congress began a series of annual appropriations totaling about $1.5 billion a year to fund BARDA vaccine development efforts and to build up the emergency medical stockpile. A special $5 billion was appropriated for the multinational Ebola virus fight in 2015.
But flu planning has been stuck at about $250 million a year in each of the last three federal budgets — “extremely underfunded,” in Clerici’s view.
The CARES Act has multiplied those resources, splitting $27 billion between rebuilding the depleted medical stockpile and BARDA vaccine funding — on top of $6 billion appropriated for those purposes in the first anti-coronavirus bills last winter.
Clerici said BARDA also has the power to bypass “very burdensome” federal purchasing regulations, and speed vaccine development by paying companies for mass-producing vaccines and antivirals while their clinical trials are not yet concluded, even if they end up proving unsuitable.
He said the agency has remained “very conservative” about using such powers, preferring the “National Institutes of Health style” of sequencing development, then animal, and finally human trials, rather than the more expensive but faster approach of attempting different stages at the same time.
Pisani says this new attention to vaccines should lead to permanent higher funding. She’d like to see higher appropriations for the CDC and state, city, and tribal health departments, as well as higher vaccine and antiviral R&D spending.