White House

• (New) Biden Administration Outlines Strategy to Manage the Omicron BA.5 Variant of COVID-19
  • On July 12th, 2022, the White House COVID-19 Team announced its strategy to manage BA.5, a subvariant of the Omicron lineage of COVID-19. The strategy relies on ensuring that Americans continue to have easy and convenient access to the vaccines, treatments, tests, and tools that protect against and treat COVID-19.
• (New) Biden–Harris Administration Releases Two New Reports on Long COVID to Support Patients and Further Research -  In April 2022, President Joe Biden issued a Memorandum on Addressing the Long-Term Effects of COVID-19, which called for the creation of two reports.
  • The National Research Action Plan on Long COVID details advances in current research and charts a course for future study to better understand prevention and treatment of Long COVID.
  • The Services and Supports for Longer-Term Impacts of COVID-19 report highlights resources for health care workers, and those affected by broader effects of COVID-19, including Long COVID, mental health disorders, substance use, and loss of caregivers and loved ones.

HHS

• (Update) On July 15, 2022, HHS Secretary Xavier Becerra renewed the COVID-19 public health emergency declaration to ensure that healthcare providers and state/territorial health departments have continued flexibility to respond to the pandemic.
  • HHS will provide states and territories with at least 60 days’ notice prior to the termination of the public health emergency declaration for COVID-19. Find the latest information on the COVID-19 public health emergency declaration renewal on the Administration for Strategic Preparedness and Response (ASPR) website.

CDC 

• (NEW)  Global COVID-19 Budget Factsheet - This webpage details CDC’s strategy for global response to COVID-19 along with budgeted amounts to support these objectives.
• (NEW)  Global Community Mitigation - This webpage describes actions that individuals, partners, and ministries of health can take to slow the spread of COVID-19
• (NEW)  Selected Adverse Events Reported after COVID-19 Vaccination - This webpage provides an update about adverse events after COVID-19 vaccination.  Specifically,
  • COVID-19 vaccines are safe and effective and severe reactions after vaccination are rare
  • The benefits of vaccination continue to outweigh any potential risks
  • Anaphylaxis after COVID-19 vaccination is rare with an estimated incidence of 5 cases per one million vaccine doses administered
  • Myocarditis and pericarditis after COVID-19 vaccination are rare
• (Update)  COVID Data Tracker Recent Updates
  • Displays June 2022 rates of COVID-19-associated hospitalization comparing people who are unvaccinated and those who received a primary vaccination series, either with or without additional or booster doses.
  • Includes data on second boosters for adults ages 50 years and older.
  • The risk of hospitalization increases with increasing age of the individual.
  • Displays data on second booster doses for people ages 50 years and older by age, sex, and race/ethnicity.
  • • The rates of laboratory-confirmed hospitalizations by vaccination status tab was updated
    • Unvaccinated people aged 5 years and older are at higher risk of COVID-19- associated hospitalizations compared to people who have received a primary vaccine series or a primary vaccine series and one or more booster doses.
    • The vaccination demographics and vaccination demographic trends tabs were updated
  • (NEW)  Operation Expanded Testing
    • CDC’s Operation Expanded Testing (OpET) program increases access to testing nationwide, especially for communities that have been disproportionately affected by the COVID-19 pandemic.  This webpage provides more information about the program, including how to sign up.
• (NEW) CDC Recommends Novavax for Adults
  • The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the Novavax COVID-19 Vaccine, for the prevention of COVID-19 in people 18 years of age and older. CDC endorsed the Advisory Committee on Immunization Practices’ (ACIP) recommendation that the Novavax COVID-19 vaccine be used as an option for adults as a primary vaccination series.
    • The vaccine is the first COVID-19 protein subunit vaccine recommended for use in the United States.
    • The vaccine is stable at standard vaccine refrigeration temperatures (2-8 degrees Celsius).
    • Novavax is available in 10-dose vials, 10 vials per carton, with a minimum order of 100 doses. Once opened, each vial must be used within 6 hours.
    • Ancillary supplies will be provided, including a variety of 1-inch and 1.5-inch needles and syringes to support administration of 100 vaccine doses.
    • The Novavax COVID-19 vaccine does not require a diluent.
  • See additional details on the CDC webpage Novavax COVID-19 Vaccine Overview and Safety and in the CDC Novavax COVID-19 Vaccine Operational Planning Guide. Novavax HCP Fact Sheet (fda.gov) contains important information for healthcare providers regarding this emergency use authorization.

FDA

• (New) North American Diagnostics Recalls Oral Rapid SARS-CoV-2 Rapid Antigen Test Kits That Are Not Authorized, Cleared, or Approved by the FDA These tests are being recalled because they were distributed to U.S. customers 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. This means there is a risk of potential false negative, false positive, or misinterpretation of results.
• (New) FDA Recommends Inclusion of Omicron BA.4/5 Component for New COVID-19 Booster As we move into the fall and winter, it is critical that safe and effective vaccine boosters that can provide protection against circulating and emerging variants to prevent the most severe consequences of COVID-19 be available. In June 2022,  FDA experts on the Vaccines and Related Biological Products Advisory Committee (VRBPAC) met and  voted in favor of including a SARS-CoV-2 Omicron component in COVID-19 vaccines that would be used for boosters in the U.S. in Fall 2022.
• (New) FDA Expands Approval of Comirnaty® to Include People Aged 12 years and Older In August 2021, the Pfizer-BioNTech COVID-19 vaccine was approved for use in people 16 years of age and older. The FDA has now approved the Pfizer-BioNTech COVID-19 vaccine for use as a primary series for immunization of individuals ages 12 through 15 years of age.  Comirnaty is now FDA approved for immunization of people aged 12 years and older against the SARS-CoV-2 virus.
  • No change was made to the vaccine’s formula.
  • The Pfizer-BioNTech COVID-19 vaccine label remains the same for children ages 6 months through 11 years as this vaccine is available through an EUA only and is not yet approved/licensed for these age groups.
  • See the Pfizer-BioNTech COVID-19 Vaccine Presentations.
• Moderna (Spikevax™) COVID-19 Vaccine Available for Ordering Soon! The Moderna (Spikevax™) COVID-19 vaccine received FDA approval in January 2022 for administration to people aged 18 years and older. .
  • No change has been made to the vaccine’s formula with the name change.
  • The name remains the same for Moderna COVID-19 vaccines approved for use in children and adolescents ages 6 months to 17 years since those vaccines are authorized (but not yet licensed/approved) for this age group.

 VDH

• (Update) The COVID-19 Outbreaks by Selected Settings Dashboard will be retired on August 10, 2022.
  • A note will be added to the dashboard when it is removed on August 10, 2022.
  • This change will be documented in the Website Change Log.
  • Initially, this dashboard was created to share information with the public about COVID-19 outbreaks in specific settings so decisions could be made about visitation and attendance.
  • Reporting this level of detail was also required by House Bill 5048 during a declaration of a public health emergency by the Governor. The emergency declaration for COVID-19 in Virginia ended on June 30, 2021.
  • Now that COVID-19 has spread throughout the state and has become part of our daily routine, there is little need to share specific information about outbreaks at every facility.
  • There are now other available resources for individuals and facilities to make informed decisions about community risk at this stage in the pandemic, including the CDC COVID-19 Community Levels and the CDC Community Transmission Rates.
  • A few notes to ease this transition:
• (Update) Health Professionals page
  • Added “New Hot Topics”
  • Removed MMWR Section (link to COVID MMWR page is in resource section)

• CDC opened ordering of Novavax COVID-19 vaccine in VTrckS on July 25, 2022 and began shipping on July 26, 2022.
  • Novavax vaccine is shipped by McKesson Specialty in the cold pack shipper with accompanying ancillary kits. You may opt out of Novavax ancillary kits using the same process that was used for Moderna and J&J COVID-19 vaccines. Instructions are available in the VTrckS library.

• Shelf-life & Expiry Date Look-up Reminders:

• • New Pfizer Expiry Date Look-up Tool Has been updated Pfizer is in the process of developing a new expiration date look-up tool and webpage for Pfizer COVID-19 vaccines, which we anticipate will be released by the end of July 2022. Notification will be sent when the page and tool are operational. Also see select details below for healthcare providers (HCP).
    • HCP navigates to website (lotexpiry.cvdvaccine.com)
    • Default Country is “United States of America”
    • HCP enters Lot # & clicks “submit” button
    • Pop-up appears with lot expiry information

• Pfizer Purple Cap and Expiry Dates
  • Most of the distributed Pfizer PURPLE Cap vaccine has expired, but small amounts of inventory remain on shelves. You are encouraged to transition to the Pfizer GREY Cap product by August 31, 2022, and to dispose of all expired PURPLE Cap COVID-19 vaccines according to state and local regulations. Contact your Project Officer or VDSO if you need assistance or have questions.

• Moderna Shelf Life Extension
  • Moderna COVID-19 vaccines are once again receiving a shelf-life extension by lot number. It is important to monitor expiration dates regularly of all vaccines as dates are subject to change. Moderna vaccine vials have a QR code that, when scanned, provides the up-to-date expiration date from the manufacturer website. Check your Moderna lot number expiration dates regularly at Vial Expiration Date Lookup | Moderna COVID-19 Vaccine (EUA) (modernatx.com) and – as always – properly dispose of expired vaccine according to state and local regulations.

• Novavax Expiry Date Page Now Available!
  • An Expiry Date Page is now available for the new Novavax COVID-19 Vaccine recently authorized for emergency use by the FDA. Novavax was authorized for a 9-month refrigerated shelf life, and all Novavax vaccine purchased by the United States Government (USG) currently expires February 2023. Should this date be extended, the Novavax Expiry Date Page will contain current expiration date information.

• Johnson and Johnson/Janssen COVID-19 Vaccine
  • A large quantity of J&J COVID-19 vaccine expires in August 2022. We would like to remind you to check expiration dates at Janssen COVID-19 Vaccine Expiry Checker (vaxcheck.jnj). Dispose of all expired vaccine in accordance with state and local regulations.

• Ancillary Supply Kit - Opt Summary
  • You may (CAN) opt-out of ancillary supply kits for COVID-19 vaccines for adults. You can also opt-out of ancillary supply kits for COVID-19 vaccines for children that do not require diluent; however, you may not (CANNOT) opt-out of kits for vaccines for children that do require diluent. This means:
    • You CANNOT opt-out of ancillary kits for COVID-19 vaccines that require diluent:
      • Pfizer ORANGE Cap (ages 5 through 11 years)
      • Pfizer MAROON (ages 6 months through 5 years)
    • You MAY opt out of ancillary kits for COVID-19 vaccines as follows:
      • Pfizer GRAY Cap – ages 12+ (EUA and BLA labeled)
      • Moderna – all products
      • Johnson & Johnson
      • Novavax
      • For Awardees
        • Opt-out instructions can be found in the VTrckS library at: https://vtrcks-library.cdc.gov/gm/folder-1.11.17315

• Vaccination Record Cards for many recipients of COVID-19 vaccines are now full. This is especially true for those over 50 years of age or immunocompromised individuals seeking additional boosters. In these instances, providers and jurisdictions are raising questions about the proper procedure for issuing new Vaccination Record Cards.
  • As a reminder, the ancillary kits that accompany every COVID-19 vaccine order include Vaccination Record Cards for every dose. If a vaccination card is full, the CDC recommends that a second card be completed, and the two cards stapled together. Encourage the patient to photograph both cards in case the two become separated, if possible. Both cards should be presented when vaccination history is required for travel, employment, or any other purpose requiring official, universally recognized documentation. Patients should bring both cards to future vaccination appointments for verification of vaccination history.
  • Some providers have the option to provide the immunization record from the jurisdiction’s immunization information system (IIS) that would list the patient’s received doses. However, for travel, employment, or any other purpose that requires official, universally recognized documentation, the IIS record may not be acceptable.
  • When a Vaccination Record Card is Full:
    • Complete a new card for the patient
    • Staple both cards together
    • Encourage the patient to photograph both cards in case they become separated
    • Bring both cards to future vaccination appointments

• For questions about VaxMaX and its functionality, please visit the VaxMaX Help website, which includes reference guides and tutorial videos.

Strategies to Limit COVID-19 Vaccine Wastage

• It is important for providers to take every opportunity to vaccinate all eligible persons so they remain up to date on COVID-19 vaccines. As the rate of vaccine administration slows, the likelihood of leaving unused doses in a vial may increase. While we want to continue to follow best practices to use every dose possible, jurisdictions should continue efforts to make COVID-19 vaccine accessible to those who would like to receive it.
• We want to encourage jurisdictions to maintain distribution strategies that strategically place inventory to minimize vaccine loss. However, they should not miss any opportunities to vaccinate every eligible person who requests a COVID-19 vaccination, even if it means puncturing a multidose vial without options to use all doses in each vial.
• CDC provides guidance to help jurisdictions minimize wastage. We recognize that multi-dose vials are not optimal, but we are optimistic that single dose vials may become available as manufacturers adapt to vaccines moving into the commercial market. Please reinforce the message to “turn no-one away”; the USG  provides vaccine, ancillary supplies, and technical assistance free of charge and wastage numbers do not reflect negatively on your program.
• Check out our complete list of COVID-19 Vaccination Clinic Best Practices and our Lightning Learnings: Best Practices for Busy Providers!

The VDH COVID-19 Testing Team is offering a Back-to-School information session for K-12 School partners in preparation for the upcoming school year. During this session, it will review updated COVID-19 testing resources and guidance for schools and answer any questions you may have. The slide deck and a recording of the session will be posted online after the second session for those who are unable to join. Please note that in July 2022, VDH released updated COVID-19 guidance for K-12 Schools, including the COVID-19 Isolation and Quarantine Guidance for K-12 Schools, Child Care, and Day Camp Settings, VDH K-12 COVID-19 Parent Flow Chart, and the Test to Stay Protocol. If possible, please review these documents before attending the session.

• Register in advance for the Tuesday, Aug 16, 2022 11:00 AM session:https://vdh.zoom.us/meeting/register/tJYkcu2hqjopGdHSyq7P9m485O_mJv00cJcQ

PREP ACT FAQ -The Public Readiness and Emergency Preparedness (PREP) Act: 

• Q: Can kids under 5 get vaccinated at a pharmacy?
  A: Yes. Some pharmacies provide COVID-19 vaccinations for kids under 5. CDC recommends using Vaccines.gov to find a local pharmacy or other provider to make an appointment. Under the PREP Act declaration, pharmacists, pharmacy interns and pharmacy technicians can administer COVID-19 vaccine to children ages 3 and older. Check state law to determine whether those staff are authorized in a particular state to administer COVID-19 vaccine to children younger than 3 years old. In some cases, a pharmacy has a clinical space where healthcare providers other than pharmacists can vaccinate younger  children.

• Q: What age ranges can pharmacists vaccinate?
  A: Under the federal PREP Act declaration, pharmacists, pharmacy technicians, and pharmacy interns can administer COVID-19 vaccines to children aged 3 years and older notwithstanding narrower state laws. Some state laws may permit pharmacists, pharmacy technicians and pharmacy interns to vaccinate children younger than 3 years old.

• Q: Does the PREP Act vary by state?
  A: No, authorization under the PREP Act does not vary by state. However, some state laws (not Virginia) may permit pharmacists, pharmacy technicians and pharmacy interns to vaccinate children younger than 3 years old.

• Q: Are prescriptions required to vaccinate this age group?

  A: The COVID-19 PREP Act declaration authorizes pharmacists to directly order (prescribe) childhood vaccines, including COVID-19 vaccine, for children aged 3 years and older without need for a separate prescription from a physician and also permits certain additional non-traditional licensed healthcare providers, recently retired providers, and healthcare profession students to prescribe, dispense and administer COVID-19 vaccines to anyone for whom administration is authorized under the EUA notwithstanding narrower state laws. COVID-19 vaccines are prescription drugs and therefore there must be a prescription for a recipient to receive a COVID-19 vaccine that is FDA authorized or approved. For more information about a pharmacist’s ability to order and administer COVID-19 vaccines, see VDH SUMMARY OF AUTHORITIES FOR PHARMACISTS TO ADMINISTER COVID-19 VACCINE.

• Q: If a prescribing physician writes a prescription, can a pharmacist administer the vaccine to a child less than 3 years old?
  A: Varies depending on state law. Under the PREP Act declaration, pharmacists can only administer childhood vaccines, including COVID-19 vaccine, to children ages 3 years and older. That PREP Act declaration allows pharmacists to directly order (and administer) these vaccines to children ages 3 years and older, without a separate physician prescription. Check state law to determine whether pharmacists are authorized in a particular state to order/administer COVID-19 vaccine to children younger than 3 years of age. For more information about a pharmacist’s ability to order and administer COVID-19 vaccines, see VDH SUMMARY OF AUTHORITIES FOR PHARMACISTS TO ADMINISTER COVID-19 VACCINE.

• Q: Can pharmacies hire nurses to administer the vaccine to children less than 3 years of age?

  A: Applicable state law in each jurisdiction will determine the circumstances under which a nurse can administer the vaccine to a child under 3 years of age. Nurses must follow the State laws and regulations and the Board of Nursing; VDH cannot provide legal guidance on what they can and can’t do within their Scope of Practice. Please see the PREP Act Declaration for additional information.

  Pharmacies may hire nurses, or any other healthcare professional, as needed to suit their needs (i.e., vaccinating children younger than 3 years old).

• Q: Does the PREP Act offer liability protection for vaccination of all age groups?
  A: Yes. The PREP Act liability protections cover providers authorized under the declaration and providers authorized under state law. For more information, see PREP Act Immunity from Liability for COVID-19 Vaccinators.

• Q: Can EMTs or Paramedics administer COVID-19 vaccine to children aged 6 months-5 years?
  A: Yes, the PREP Act declaration provides that if those healthcare providers are licensed healthcare professionals, they can administer COVID-19 vaccine to any age.