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Coronavirus Has Created a New Golden Age for Vaccines, and Philly Is at the Heart of It

The Philadelphia Inquirer

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.

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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.

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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.

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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.

“COVID-19 Funding Bill Doesn’t Give Govt. More Power over Drug Prices Coronavirus Has Created a New Golden Age for Vaccines, and Philly Is at the Heart of It,” by Joseph N. DiStefano, was published in The Philadelphia Inquirer on April 3, 2020.