Policy Updates

8/11/22 — The FDA is advising people to perform repeat, or serial, testing following a negative result on any at-home COVID-19 antigen test, to reduce the risk an infection may be missed (false negative result) and to help prevent people from unknowingly spreading the SARS-CoV-2 virus to others. The FDA recommends repeat testing following a negative … Continued

8/9/22 — Haimen Shengbang Laboratory Equipment is recalling Viral Transport Media Containers because these products were distributed to U.S. customers without authorization, clearance, or approval from the FDA. This means there is a risk for false negative, false positive, or misinterpretation of results if these products are used to detect SARS-CoV-2. Use of these products may … Continued

8/10/22 – The FDA issued an emergency use authorization (EUA) for the JYNNEOS monkeypox vaccine, allowing healthcare providers to administer the vaccine by intradermal injection for individuals ages 18 years and older who are at high risk for monkeypox infection. This will result in a five-fold increase in the total number of doses available for use. … Continued

8/9/22 – FDA launched a new Rumor Control web page to provide facts in response to the growing spread of rumors, misinformation, and disinformation about science and medicine that is putting patients and consumers at risk.

8/12/22 – Working closely with the CDC and other federal and international agencies to monitor spread of the monkeypox virus, FDA issued a safety communication for blood establishments. FDA notes that there have been no reports of monkeypox transmission through blood transfusion. FDA believe that the robust existing safeguards for blood safety and donor screening … Continued

7/13/22 — The FDA issued emergency use authorization for the Novavax COVID-19 vaccine, adjuvanted for prevention of COVID-19 in individuals 18 years of age and older. Novavax is administered as a primary series in two doses, three weeks apart. Read more.

7/15/22 — The U.S. Secretary of Health and Human Services (HHS)has renewed the COVID-19 public health emergency (PHE), effective July 15. The PHE declaration, first issued January 2020, must be renewed every 90 days. HHS will provide states at least 60 days’ notice prior to termination of the PHE. Read the secretary’s declaration.

7/6/22 — The FDA revised the Emergency Use Authorization (EUA) for Paxlovid (nirmatrelvir and ritonavir), to authorize state-licensed pharmacists to prescribe Paxlovid to eligible patients, with certain limitations to ensure appropriate patient assessment and prescribing of Paxlovid for treatment of COVID-19. Read more. 

7/12/22 — The U.S. lost progress combating antimicrobial resistance (AR) in 2020 due, in large part, to effects of the COVID-19 pandemic, according to the newly released CDC report “COVID-19: U.S. Impact on Antimicrobial Resistance, Special Report 2022.” CDC’s 2019 AR Threats Report showed deaths from AR infections had decreased by 18 percent from 2012 through 2017. However, … Continued