FDA’s SARS-CoV-2 vaccine review needs major dose of transparency

As the federal government’s “Operation Warp Speed” works to quickly deliver a safe, effective vaccine to protect against SARS-CoV-2 infection, the AMA is calling for a big boost in the transparency of the process.

“With COVID-19 vaccine development moving at a rapid pace, it is critical that we ensure physicians are continuously informed of the U.S. Food and Drug Administration’s (FDA) plans for review and that they are provided with the utmost level of transparency regarding the process for authorization or licensure, standards for review, and safety and efficacy data as soon as possible,” AMA Executive Vice President and CEO James L. Madara, MD, wrote in a letter or FDA Commissioner Stephen Hahn, MD.

My latest for the AMA. The whole shebang.

With supplies short, COVID-19 tests should go where most needed

Continuing shortages of reagents, viral transport media, pipettes and other supplies means 2020 will continue to negatively affect the nation’s COVID-19 polymerase chain reaction testing capacity. Given that sobering fact, the AMA and other organizations with expertise in medical testing are urging Health and Human Services Secretary Alex Azar to ensure the nation’s limited testing resources go to patients with medically identified needs or to public health surveillance efforts.

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Also check out this other new story on a California bill to allow nurse practitioners to practice without physician supervision.

Dr. Fauci outlines 5 ways to blunt COVID-19 pandemic’s resurgence

The U.S. remains “right in the middle of the first wave” of the COVID-19 pandemic, with national case counts hovering around 50,000–60,000 per day and more than 1,000 people dying daily, Anthony S. Fauci, MD, explained during a JAMA Network™ livestreamed video interview.

“We’ve got to get those numbers down,” stressed Dr. Fauci, a member of the White House coronavirus task force and director of the National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID). “If we don’t get them down, we’re going to have a really bad situation in the fall … as you get indoors and you get the complications of influenza season.”

The goal is to get the daily nationwide caseload below 10,000 before September. In the interview with JAMA Editor-in-Chief Howard Bauchner, MD, Dr. Fauci detailed these five keys physicians should be stressing with patients to protect themselves, their families and their communities from the deadly, contagious respiratory illness.

My lede. The whole shebang.