- FDA Safety Communication: Use and Store At-Home COVID-19 Tests Properly to Avoid Potential Harm
- On March 18, 2022, the U.S Food and Drug Administration (FDA) released a safety communication about the proper use and storage of at-home Covid-19 test materials. As noted in the communication, FDA has received reports of injuries caused by incorrect use of at-home test components. Reports include people accidentally using the small bottle of test reagent as eye drops, and people placing the nasal swabs into the liquid solution before swabbing their nose.
- FDA is alerting people that there is a potential for harm if FDA authorized at-home COVID-19 tests are not used according to the manufacturer’s test instructions. The FDA is also reminding people to keep the tests out of reach from children and pets.
- FDA has also provided recommendations to promote the safe use of at-home COVID-19 tests.
- Class I Recalls of COVID-19 Tests
- STANDARD Q COVID-19 Ag Home Tests by SD Biosensor: Class I Recall - Because Tests Are Not Authorized, Cleared, or Approved by the FDA and May Give False Results - SD Biosensor is recalling its STANDARD Q COVID-19 Ag Home Tests because these tests were distributed to U.S. customers without authorization, clearance, or approval from the FDA. As this test was not authorized, cleared, or approved by the FDA, there is not sufficient data demonstrating that the test's performance is accurate. This means there is a risk of both false-negative and false-positive test results. This recall does not apply to the SD Biosensor COVID-19 At-Home Test (also an antigen test), which was authorized by the FDA on December 24, 2021, and is distributed by Roche Diagnostics. For more information about this recall, refer to the announcement.
- Certain Celltrion DiaTrust COVID-19 Ag Rapid Tests by Celltrion USA: Class I Recall - Due to False Positive Test Results and Unauthorized Shelf Life - Celltrion USA is recalling specific lots of the DiaTrust COVID-19 Ag Rapid Test due to a high number of false positive reports. Additionally, the tests’ labeling for the affected products includes a shelf life of 18 months. However, the FDA’s emergency use authorization specifies these tests may only be used for 12 months. For more information about this recall, refer to the announcement.
- Please take 5 minutes to complete this anonymous survey conducted by ImmunizeVA and is designed to get your current thoughts and opinions regarding receiving the COVID-19 vaccine and recommending it to your patients. You may exit out of the survey at any time.
- The survey is divided into three sections:
- Demographic questions about you and your profession
- Questions about your thoughts, attitudes, and concerns regarding receiving the COVID-19 vaccine
- Questions about your thoughts, attitudes, and concerns regarding recommending the COVID-19 vaccine.
- If you have any questions about the survey, please email us at firstname.lastname@example.org.
- The survey is divided into three sections:
- Pfizer Purple Cap Inventory Update
- We continue to see a reduction of Pfizer Purple Cap in the field and appreciate your efforts to reduce this inventory.
- Please use the Pfizer Purple Cap before ordering the Gray Cap, when possible, and remember to keep your inventory of Purple and Gray Caps separate to avoid any confusion regarding diluent (Purple Cap uses diluent and Gray Cap does not).
- For questions about VaxMaX and its functionality, please visit the VaxMaX Help website, which includes reference guides and tutorial videos.
Best Practice Spotlight
- On Wednesday, March 30 at 12 pm, VDH's Healthcare-Associated Infections & Antimicrobial Resistance Program will host an infection prevention lunch and learn about Healthcare-Associated Infections Reporting and the National Healthcare Safety Network. To register, see the registration link. Questions on this topic are welcome before the webinar -- please email them to email@example.com.
- FDA has announced a virtual meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Wednesday, April 6, from 8:30 am to 5 pm to discuss considerations for future COVID-19 vaccine booster doses and the process for selecting specific strains of the SARS-CoV-2 virus for COVID-19 vaccines to address current and emerging variants. No vote is planned at this meeting and there will not be discussion of any product-specific applications. The meeting will be livestreamed for the public.
- The Virginia Department of Health Office of Emergency Preparedness partnered with the Virginia Department of Behavioral Health & Development Services, and Virginia Hospital & Healthcare Association to conduct a virtual Community Based Emergency Response Seminar (CBERS) in April 2022. This year’s topic will be Mental Health Wellness and the Rippling Effects of COVID-19. Please join us as we discussed the different mental health issues that can affect us as we tackle responding and caring for others during this pandemic. Participants will learn about the various types of stress caused by providing care to others during COVID, the difference between burnout and compassion fatigue, self-care, and coping strategies.
- Target Audience: General Public Workers, Healthcare Workers, Emergency Management Workers, Disaster Shelter Workers, EMS/Fire Workers, Law Enforcement, Local Health Districts, VDH Staff, Clergy, Educators, Volunteers, Contractors, and Retail Workers- Anyone working during COVID-19 and feel they have been affected by the pandemic.
- A webinar connection link will be sent before those who register for this live webinar. For more information: https://www.vdh.virginia.gov/emergency-preparedness/cbers-2022-mental-health-the-rippling-effects-of-covid-19/ or contact Adreania Tolliver at firstname.lastname@example.org.
- Webinar Dates:
- Registration: Registration is required for each attendee. Please only register for one date to attend.
- Cost: Free
- CEUs: None offered at this time.
- Project Firstline is excited to announce the availability of their newest suite of infection control educational resources and training materials. These new resources are designed to help all healthcare workers gain a foundational understanding of infection control, so they can recognize the risk for germs to spread throughout the workday, and take action to protect patients and themselves – no matter the situation.
- March 18 Morbidity and Mortality Weekly Report (MMWR) COVID-19 Reports
- Early Release: Effectiveness of mRNA Vaccination in Preventing COVID-19–Associated Invasive Mechanical Ventilation and Death — United States, March 2021–January 2022
- Early Release: COVID-19–Associated Hospitalizations Among Adults During SARS-CoV-2 Delta and Omicron Variant Predominance, by Race/Ethnicity and Vaccination Status — COVID-NET, 14 States, July 2021–January 2022
- Effectiveness of 2-Dose BNT162b2 (Pfizer BioNTech) mRNA Vaccine in Preventing SARS-CoV-2 Infection Among Children Aged 5–11 Years and Adolescents Aged 12–15 Years — PROTECT Cohort, July 2021–February 2022
- Updated: Vaccination FAQs: A new FAQ addresses revaccination for certain individuals who received cancer chemotherapy or radiation. Updated FAQs involve the following topics:
- status of vaccines for younger children
- studies on breakthrough cases and further transmission of COVID-19
- immunize.org FAQs for healthcare providers who want additional information
- studies on vaccine effectiveness in children and adolescents.
- Updated: On the Isolation and Quarantine Calculator website under Step 1. Isolate and monitor your symptoms, added wording that people at higher risk of severe COVID-19 should contact their healthcare provider to see if they are eligible for treatment.
Health Resources & Services Administration (HRSA)
- New: These 2 HRSA websites provide details on information mentioned in the 3/15 White House Fact Sheet: Consequences of Lack of Funding for Efforts to Combat COVID-19 if Congress Does Not Act (section: Providers No Longer Able to Submit Claims for Testing, Treating, and Vaccinating the Uninsured).
- COVID-19 Claims Reimbursement to Health Care Providers and Facilities for Testing, Treatment, and Vaccine Administration for the Uninsured - On March 22, 2022 at 11:59 pm ET, the Uninsured Program will stop accepting claims for testing and treatment due to lack of sufficient funds. On April 5, 2022 at 11:59 pm ET, the Uninsured Program will also stop accepting vaccination claims due to a lack of sufficient funds. Submitted claims will be paid subject to the availability of funds. For additional information, see Frequently Asked Questions.
- COVID-19 Coverage Assistance Fund - On April 5, 2022 at 11:59 pm ET, the Coverage Assistance Fund will stop accepting vaccination claims due to a lack of sufficient funds. Submitted claims will be paid subject to the availability of funds. For additional information, see Frequently Asked Questions.
Information about the COVID-19 vaccination program is changing frequently. This newsletter will offer regular updates to providers who have submitted an intent to vaccinate or signed the CDC provider agreement within Virginia.