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How ‘Emergency Use’ Can Help Roll Out a Covid Vaccine

Scott Gottlieb, M.D.
 

By Scott Gottlieb and Mark McClellan (original source The Wall Street Journal)

“A vaccine for Covid-19 could emerge in the next several months. But first, clinical trials need to reach completion showing that the vaccines reduce Covid. The data must undergo multiple layers of scientific review to weigh risks against benefits. This includes careful analysis by career experts at the Food and Drug Administration, independent safety monitors, scientists who work for the vaccine manufacturer, and outside experts who advise the FDA.

In a highly politicized environment, many Americans are understandably concerned about cutting corners. But the FDA’s career experts have publicly and clearly affirmed their commitment to the gold standard for review. As former FDA commissioners, we are confident in the FDA’s career scientists to oversee vaccine development rigorously.

If a Covid vaccine clears this process, it could be made available initially to specific groups of people through an Emergency Use Authorization. This emergency authority enables the FDA to make products available before a full application is approved by the agency. Congress created the emergency-use pathway as part of the Project BioShield Act of 2004, which provided for the development of medical countermeasures against chemical, biological, radiological and nuclear threats. Following 9/11 and anthrax, lawmakers expected an urgent need for such defenses.

After the 2009 swine flu, Congress expanded this pathway in the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013, a bipartisan measure aimed at preparing the country to weather a pandemic. The law streamlined the application process for emergency use, expanded the classes of drugs eligible, and broadened the testing the FDA could require.”

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