FDA Test Warning, ‘Warp Speed’ Vaccine Project

What your doctor is reading on Medscape.com:

MAY 15, 2020 — Here are the coronavirus stories Medscape’s editors around the globe think you need to know about today: 

FDA Warning on Accuracy of Abbott ID NOW Rapid Test

Preliminary data suggest that Abbott Labs’ ID NOW rapid test for COVID-19, reportedly in use to screen White House staff, may give false-negative results, the US Food and Drug Administration (FDA) said in an alert late Thursday.

To date, the FDA has received 15 adverse event reports about the Abbott ID NOW test that suggest some users are receiving inaccurate negative results, the agency said, and some studies have identified accuracy issues with the test. The agency is investigating whether this could be due to the types of swabs or viral transport media used.

“This test can still be used and can correctly identify many positive cases in minutes. Negative results may need to be confirmed with a high-sensitivity authorized molecular test,” an FDA official said in the alert statement.

Details on ‘Operation Warp Speed’ Vaccine Project

Under an initiative called “Operation Warp Speed,” a group of federal officials, scientists, and drug companies have the challenge of developing a coronavirus vaccine by the end of the year.

The team includes leaders from the Centers for Disease Control and Prevention, the FDA, the National Institutes of Health, the Department of Health and Human Services (HHS), and the Department of Defense. President Donald Trump discussed details of the initiative during a press briefing Friday afternoon. 

Public health experts have predicted that a coronavirus vaccine could take 12 to 24 months to produce. Operation Warp Speed’s goal is to reduce that timeline by simultaneously preparing the manufacturing and distribution processes so drug companies can fill vaccine vials once the formula is ready. Under the directive, orders were placed this week for vaccine-related supplies like glass vials, needles, and syringes, said Alex Azar, HHS Secretary.

Stay-at-Home Orders Correlated With Slower Spread

Two studies suggest that government stay-at-home orders have had a significant impact on slowing the spread of COVID-19. One found a significant difference in the growth of COVID-19 cases between border counties in Illinois, which has a stay-at-home order, and Iowa, which does not. Another measured how much shelter-in-place orders have decreased the spread of the virus compared with other social distancing measures.