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FDA
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New: FDA Authorizes First COVID-19 Diagnostic Test Using Breath Samples - the U.S. Food and Drug Administration (FDA) granted an emergency use authorization (EUA) to the InspectIR COVID-19 Breathalyzer test made by InspectIR Systems LLC. This is the first COVID-19 diagnostic test that detects chemical compounds associated with a SARS-CoV-2 infection in a breath sample. The test can be performed in environments where the patient specimen is both collected and analyzed, such as doctor’s offices, hospitals and mobile testing sites using an instrument about the size of a piece of carry-on luggage. The test is performed by a qualified, trained operator under the supervision of a health care provider licensed or authorized by state law to prescribe tests and can provide results in less than three minutes.
- Note: Further information will be forthcoming and testing instruments are not readily available at this time.
CDC
- National Infant Immunization Week starts April 24. This week highlights the importance of protecting infants from vaccine-preventable diseases and celebrates the achievements of immunization partners. This year, it’s important to ensure that families get back on track for routine checkups and vaccinations following disruptions from the COVID-19 pandemic.
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Updated: Frequently Asked Questions About COVID-19 Vaccination - The answer to the following question was updated: Does the definition of "up to date" include a booster?
- It depends. Everyone aged 12 years and older is considered up to date until the time they are eligible for their first booster — which is 5 months after the second dose of Pfizer-BioNTech and Moderna vaccines, or two months after the J&J/Janssen vaccine. After this time period, they need to get 1 booster dose to be considered up to date. Getting a second booster dose is not necessary to be considered up to date at this time.
HHS
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- The FDA has approved an amendment to the EUA for Pfizer-BioNTech COVID-19 Vaccine (tris-sucrose formulation)extending the shelf-life of the following Pfizer product formulations from 9 to 12 months:
- Pfizer-BioNTech Pediatric COVID-19 Vaccine (tris-sucrose formulation) (Orange Cap for ages 5 through 11 years, with diluent)
- Pfizer-BioNTech Adult COVID-19 Vaccine (tris-sucrose formulation) (Gray Cap for ages 12+ years, no diluent)
- Vials stored consistently in an ultra-low temperature freezer at -90oC to -60oC (-130oF to -76oF) may remain in use for up to 12 months beyond the date of manufacture printed on the vials and cartons. Vials stored in refrigerated vials (2oC to 8oC) are NOT eligible for extension, regardless of the expiration date. Additional information on Pfizer storage and handling may be found at Administration Overview for Pfizer-BioNTech COVID-19 Vaccine | CDC.
- Pfizer Orange and Gray Cap Vaccine expiry dates based on 12 months from the date of the manufacture are shown at Expiry Information for Pfizer COVID-19 Vaccines
- No changes have been made to the vaccine itself to enable extension of expiry dating. This change is based on stability data submitted by the manufacturer to the FDA.
- Reminders:
- Do not use Pfizer COVID-19 vaccines (tris-sucrose formulation) beyond 12 months from manufacture date.
- Expiration dates for the Pfizer COVID-19 vaccines (tris-sucrose formulation)are NOT printed on the vaccine cartons or vials.
- Do not store Pfizer vials at -25°C to -15°C (-13°F to 5°F). Once vials are thawed, they should not be refrozen.
- For more information, please review the updated FDA Factsheets:
- COVID-19 vaccines authorized under an EUA do not have fixed expiration dates, and expiration dates may be extended as more stability data is collected.
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For questions about VaxMaX and its functionality, please visit the VaxMaX Help website, which includes reference guides and tutorial videos.
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- To obtain the most up-to-date expiration dates for the Pfizer COVID-19 vaccines you have in inventory.
- Vaccine Expiration Date Lookup & Reference Information:
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Upcoming Events
- The Advisory Committee on Immunization Practices (ACIP) will be meeting on April 20, 2022, from 11:00 am to 4:00 pm, EDT. They will be discussing the safety and effectiveness of COVID-19 booster doses and the framework for future COVID-19 doses. The meeting will be available via webcast. No registration is required.
- Project Firstline Training Sessions - Join Virginia Department of Health’s (VDH) Project Firstline (PFL) team for an educational watch party session on personal protection equipment (PPE) on Thursday, April 21 at 1:00 pm-1:30 pm. Registration is required.
- The VDH Office of Emergency Preparedness is partnering with the Virginia Department of Behavioral Health & Development Services and the Virginia Hospital & Healthcare Association to conduct a virtual Community Based Emergency Response Seminar (CBERS) this month. This year’s topic will be Mental Health Wellness and the Rippling Effects of COVID-19. Please join us as we discuss the different mental health issues that can affect us as we respond to and care 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.
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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, Retail Workers, and anyone working during COVID-19 who feels they have been affected by the pandemic.
- For those who register for the live webinar, a link will be sent before the program. For more information, see: https://www.vdh.virginia.gov/emergency-preparedness/cbers-2022-mental-health-the-rippling-effects-of-covid-19/ or contact Adreania Tolliver at adreania.tolliver@vdh.virginia.gov.
- Webinar Dates:
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Registration: Registration is required for each attendee. Please only register for one date to attend.
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Cost: Free
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CEUs: None offered at this time.
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CDC
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Updated: CDC Realigns Travel Health Notice System
- Effective April 18, CDC’s January 29, 2021 Order requiring masks on public transportation conveyances and at transportation hubs is no longer in effect. CDC will no longer enforce the Order. CDC continues to recommend that people wear masks in indoor public transportation settings.
- On April 18, CDC updated its Travel Health Notice system for international destinations. To help the public understand when the highest level of concern is most urgent, this new system now reserves Level 4 travel health notices for special circumstances, such as rapidly escalating case trajectory or extremely high case counts, emergence of a new variant of concern, or healthcare infrastructure collapse. Levels 3, 2, and 1 will continue to be primarily determined by 28-day incidence or case counts.
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Health Professionals - Added most recent MMWR
- Updated Home Health and Hospice link to National Association for Home Care & Hospice.
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Vaccination FAQs - Updated questions on protection from a booster dose in individuals previously infected with COVID-19
- Myocarditis risk from vaccination compared to COVID-19 illness
- FDA’s Vaccines and Related Biological Products Advisory Committee meeting about second boosters
- Updated the Healthcare Providers section regarding Pfizer vaccine expiration date and returning Pfizer shipping containers
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Overnight Camps- Refreshed guidance for 2022 camp season. Included latest American Camp Association and CDC recommendations and information on diagnostic and screening testing options.
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Facts About COVID-19 - Updated the following sections: Facts: COVID-19, Facts: COVID-19 Vaccines, Facts:
- Food & Alcohol, Facts: Medications and Substances, and Other Facts.
- Renamed Facts: Masks and Staying at home section to Facts: Masks.
- Other sections were updated to include relevant information about immunity
- Omicron and its BA.2 subvariant
- normal and expected reactions to COVID-19 vaccines, protection that comes from COVID-19 vaccination
CDC
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Updated: The table at the top of the Vaccinations in the US tab and the bar charts at the bottom of the Vaccinations in the US tab were updated to indicate that they refer to the first booster dose.
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Updated: The Wastewater Surveillance tab now displays data showing levels of SARS-CoV-2 in wastewater in participating communities across the United States. The current SARS-CoV-2 levels for each site are shown as a comparison to past levels at that site, and for each site, a graph of the SARS-CoV-2 levels for the past 4 months will be displayed. These two new visuals enable users to compare current and previous SARS-CoV-2 wastewater levels.
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