Coronavirus (COVID-19) Update: June 8, 2021

FDA News Release

• For Immediate Release: June 08, 2021

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

• The White House, the U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response and the U.S. Food and Drug Administration (FDA) today released a series of policy recommendations to address the vulnerabilities in U.S. pharmaceutical supply chains. Led by HHS, the White House report and its recommendations have been accepted by President Biden.
  
  "Last year the American people experienced a widespread and significant shortage of N95 respirators for healthcare workers and masks to protect essential workers and others, and year after year we see shortages of medicines and medical supplies like saline,” said FDA Acting Commissioner Janet Woodcock. “Pharmaceutical supply chains are essential for the national and health security and economic prosperity of the United States, yet the COVID-19 pandemic revealed just how vulnerable the supply chain is in this country. Now is the right time to take action to keep the U.S. drug supply chain secure and resilient.”
• As part of the FDA’s effort to protect consumers, on May 24, 2021, the agency issued warning letters jointly with the Federal Trade Commission to Beauty & Spa Concepts, DBA Beenefits and to Everything Health LLC for selling unapproved products with unproven COVID-19 claims. Consumers concerned about COVID-19 should consult with their health care provider.
• A Wisconsin man was sentenced today to three years in prison, followed by three years of supervised release, for purposefully tampering with and attempting to spoil COVID vaccine doses at the hospital where he worked. The matter was investigated by the Food and Drug Administration’s Office of Criminal Investigations.
  
  “The FDA has ensured that the Moderna COVID-19 vaccine meets the agency’s rigorous standards for safety, effectiveness and manufacturing quality. Those who knowingly tamper with this vaccine place American patients’ health at risk,” said FDA Assistant Commissioner for Criminal Investigations Catherine A. Hermsen. “Today’s announcement should serve as a reminder that this kind of illicit tampering activity will not be tolerated.”
• Testing updates:
  • As of today, 384 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 275 molecular tests and sample collection devices, 81 antibody and other immune response tests and 28 antigen tests. There are 52 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one molecular prescription at-home test, three antigen prescription at-home tests, five antigen over-the-counter (OTC) at-home tests and two molecular OTC at-home tests.
  • The FDA has authorized 11 antigen tests and three molecular tests for serial screening programs. The FDA has also authorized 529 revisions to EUA authorizations.