Public Policy Updates

The CDC recently updated its COVID-19 testing guidance to recommend that if someone has had exposure to a person with COVID-19 and is asymptomatic, but has had COVID-19 within the past 30 days, testing to identify a new infection is generally not recommended. If someone has become newly symptomatic after having had COVID-19 within the … Continued

North American Diagnostics is recalling Oral Rapid SARS-CoV-2 Rapid Antigen Test Kits because they were distributed without authorization, clearance, or approval from the FDA. North American Diagnostics did not provide the FDA with adequate validation data to show that the test’s performance is accurate. Use of these test kits may cause serious adverse health consequences … Continued

CDC update 8/22/22 — The CDC will hold a webinar to update public health partners on its monkeypox response on Thursday, August 25 at 1:00 – 1:45 pm ET. Click here for Zoom link.  The CDC is also continually updating its monkeypox guidance. Click here for CDC’s key messages on monkeypox. In addition, here are links to recently … Continued

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.