On October 12, 2022, the U.S. Food and Drug Administration (FDA) authorized Moderna COVID-19 Vaccine, Bivalent and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent for use as a single booster dose in younger age groups.

On October 12, 2022, Dr. Rochelle Walensky (Director, Centers for Disease Control and Prevention (CDC)) released a statement and signed a decision memo recommending updated (bivalent) COVID-19 boosters for children aged five years and older. The updated COVID-19 boosters add Omicron BA.4 and BA.5 spike protein components to the mRNA COVID-19 vaccine composition, increasing protection against the currently circulating variants.

New updated booster options include:

• Pfizer-BioNTech bivalent COVID-19 booster for children aged 5 through 11 years old (previous authorization was 12 years and older) - Fact Sheet
• Moderna bivalent COVID-19 booster for children ages 6 through 17 years old (previous authorization was 18 years and older) - Fact Sheet
• MONOVALENT vaccines are NO LONGER authorized for booster doses

CDC recommends that everyone aged 6 months and older stay up to date with COVID-19 vaccination. A person is up to date if they have completed a primary vaccine series and received all CDC recommended booster doses. Vaccines are currently the best method  to protect people from serious illness, which might lead to hospitalization or death, due to COVID-19.

Clinical research has demonstrated the safety and effectiveness of updated bivalent COVID-19 vaccines. As for all vaccines—including COVID-19 vaccines—safety monitoring will continue.

Moderna COVID-19 Vaccine, Bivalent 

• Age:  6 years of age and older
• Administration:  Single booster dose administered at least 2 months after either:
  • Completion of primary vaccination series with any FDA-authorized or FDA-approved monovalent COVID-19 vaccine, or
  • Receipt of the most recent booster dose with any FDA-authorized or FDA-approved monovalent COVID-19 vaccine.
• Dose:
  • For individuals 6 years through 11 years of age, a single booster dose is 0.25mL
  • For individuals 12 years of age and older, a single booster dose is 0.5 mL
• How supplied:  Multiple-dose vial with a dark blue cap and a label with a gray border.  The vaccine is a suspension for intramuscular injection.
• Number of doses per vial:
  • 0.5mL doses yields 5 booster doses
  • 0.25mL doses yields 10 booster doses
  • Both 0.5mL doses and 0.25mL doses may be withdrawn from the same multiple-dose vial  - DO NOT pool vaccines from multiple vials

Pfizer BioNTech COVID-19 Vaccine, Bivalent

• Age:  5 through 11 years of age
• Administration:  Single booster dose administered at least 2 months after either:
  • Completion of primary vaccine series with any FDA-authorized or FDA-approved monovalent COVID-19 vaccine, or
  • Receipt of the most recent booster dose with any FDA-authorized or FDA-approved monovalent COVID-19 vaccine.
• Dose:  0.2mL (after dilution)
• How supplied:  Pfizer-BioNTech COVID-19 Vaccine for individuals 5 through 11 years of age, and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, for individuals 5 through 11 years of age are both supplied in multiple dose vials with orange caps and labels with orange borders. Dilute before using. The vaccine is a suspension for intramuscular injection.
• Number of doses per vial: 10 from a single vial - DO NOT pool vaccines from multiple vials
• Note:  the Pfizer BioNTech COVID-19 Vaccine, Bivalent supplied in vials with gray caps and labels with gray borders, SHOULD NOT be used in individuals 5 through 11 years of age. 

Familiarize yourself with the importance and considerations involving storage and handling of the different vaccines. You can start preparing today by reviewing the CDC Vaccine Storage and Handling Toolkit.

• National Network of STD Clinical Prevention Training Centers (NNPTC): Monkeypox Clinical Update Webinar - NNPTC faculty will provide a clinical update on monkeypox with time for a facilitated Q&A session.
  • November 7, 2022 12 PM - 1:15 PM ET 

Below is a list of resources and upcoming informational activities related to the recommendations.

• CDC Interim Clinical Considerations
• Vaccines.gov
• CDC COVID-19 booster tool
• Web resources for the public:
  • Stay Up to Date with Your COVID-19 Vaccines | CDC
  • COVID-19 Vaccines for People who are Moderately or Severely Immunocompromised | CDC
  • Overview of COVID-19 Vaccines
  • Frequently Asked Questions about COVID-19 Vaccination | CDC
  • COVID-19 Vaccination for Children and Teens with Disabilities | CDC
  • How Do I Find a COVID-19 Vaccine or Booster?
• Web resources for immunization partners:
  • Vaccinate with Confidence
  • Guidance for Vaccinating Older Adults and People with Disabilities: Ensuring Equitable COVID-19 Vaccine Access 
  • Vaccinating Older Adults and People with Disabilities at Vaccination Clinics
• MMWR: Interim Recommendations from the Advisory Committee on Immunization Practices for use of the bivalent COVID-19 boosters for people aged 5 years and older – United States – November 10, 2022
• Virginia Statewide COVID-19 Standing Order
• Mini-Webinars Regarding Bivalent COVID-19 Boosters
• CDC is offering a series of brief (15-20 minute) webinars addressing topics around COVID-19 vaccination. These interactive, web-based training modules offer a real-world perspective on different issues around COVID-19 vaccines. Topics range from routine clinical and vaccine safety information to guidance for on-site clinic vaccination activities and having conversations with vaccine recipients. Each webinar includes self-test practice questions and lists additional resources related to the topic discussed.
• The October 19 webinar will focus on the bivalent booster recommendations for children ages 5-11 in lieu of a COCA call.  It will be pre-recorded and posted on October 19 at: COVID-19 Vaccine Webinar Series | CDC.
• COVID-19 Bivalent Vaccine Inventory and Wastage Guidance
• When reporting wastage for bivalent boosters in children, always report wastage in full doses based on the volume identified on the label.  Never report wastage in half doses.  The link below is provided to assist with wastage reporting.  Additional information on the identification, disposal and reporting of wastage can be found at Identification, Disposal, and Reporting of COVID-19 Vaccine Wastage | CDC
• For questions about VaxMaX and its functionality, please visit the VaxMaX Help website, which includes reference guides and tutorial videos.

FDA

• FDA Authorizes Moderna and Pfizer-BioNTech Bivalent COVID-19 Boosters
  • On August 31, 2022, the U.S. Food and Drug Administration (FDA) amended the emergency use authorizations (EUAs) of the Moderna and Pfizer-BioNTech COVID-19 Vaccines to authorize bivalent formulations of the vaccines for use as a single-booster dose at least two months following primary or booster vaccination.
  • On September 1,2022, the Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) reviewed information about Pfizer’s and Moderna’s COVID-19 updated bivalent vaccines. They recommended that both be placed into general public use.
  • The Pfizer and Moderna bivalent COVID-19 vaccines contain components from the original SARS-CoV-2 virus and spike protein components from the Omicron BA.4 and BA.5 subvariants. These new booster vaccines are referred to as “updated boosters.”
  • Following ACIP’s meeting,  the CDC endorsed ACIP’s recommendations for the use of updated COVID-19 bivalent boosters. Pfizer-BioNTech’s bivalent booster is authorized for people aged 12 years and older and Moderna’s updated booster for people aged 18 years and older.
  • Per the updated EUAs, Pfizer’s and Moderna’s monovalent mRNA COVID-19 vaccines are no longer authorized for use as boosters in people ages 12 years and older.
  • The bivalent booster recommendation replaces previous booster recommendations for people aged 12 years and older. As a result, all existing appointments for monovalent Pfizer-BioNTech or Moderna boosters in people 12 years of age and older should be rescheduled for a date and time when locations have the bivalent booster vaccine available.
  • At this time, there are no changes to COVID-19 vaccination schedules for children ages 6 months through 11 years

• Novavax COVID-19 for Adolescents: Updated Recommendations
  • On August 22, 2022, CDC Director Dr. Walensky signed a decision memo that Novavax’s COVID-19 vaccine be used as another primary series option for adolescents aged 12 through 17 years. This recommendation follows FDA’s emergency use authorization of the Novavax vaccine for this age group.
  • Novavax’s COVID-19 vaccine, which is available now, is an important tool in the pandemic and provides a more familiar type of COVID-19 vaccine technology for adolescents. Having multiple types of vaccines offers more options and flexibility for the public, jurisdictions, and vaccine providers.
  • CDC’s Interim Clinical Considerations for Use of COVID-19 Vaccines has been updated with new guidance regarding adolescents and Novavax COVID-19 vaccine.

• Moderna (Spikevax) COVID-19 Vaccine Available for Ordering
  • The Moderna (Spikevax) COVID-19 vaccine received FDA approval in January 2022, for administration to people ages 18 years and older. Similar to Comirnaty, Spikevax is licensed through the Biologics License Applications (BLA) process.
  • The FDA-authorized Moderna COVID-19 vaccine for individuals ages 18 years and older will now be marketed as Spikevax. Ordering for Spikevax began in August 2022.
  • The FDA-approved Spikevax and the EUA Moderna COVID-19 vaccine for people ages 12 years and older have the same formulation and can be used interchangeably

Significant Changes to CDC Guidance or Materials

• (Updated) Interim Clinical Considerations for use of COVID-19 Vaccines. CDC has updated its vaccination recommendations to include:
  • New booster recommendation for people aged 12 years and older to receive 1 bivalent mRNA booster after completion of a monovalent primary series; it replaces all prior booster recommendations for this age group.
    • Recommendations for use of a bivalent Moderna booster dose in people ages 18 years and older
    • Recommendations for use of a bivalent Pfizer-BioNTech booster dose in people aged 12 years and older
  • Updated guidance for observation periods following COVID-19 vaccination
  • Updated guidance on COVID-19 vaccination and Multi-system Inflammatory Syndrome in children (MIS-C) and adults (MIS-A)

VDH

• Revised COVID-19 Vaccine Standing Order which was updated on September 2, 2022
• VDH COVID-19 websites have now been updated to reflect current CDC guidance. VDH policy leaves masking as a personal choice in most circumstances; exceptions are high-risk settings, including healthcare delivery, and as part of an isolation protocol, where masking is still recommended.
• VDH Interim Guidance for COVID-19 Prevention for Students, Teachers, and Staff in Child Care, K-12 Schools, and Day Camp Settings

• Notable revisions to the updated Virginia guidance include:
  • Updated testing guidance for persons who test positive for COVID-19 and are unable or choose not to wear a mask through day 10. Recommendations to either isolate for 10 full days (including children under age 2) or use the CDC's test-based strategy that includes two negative tests 48 hours apart.
  • Updated testing guidance for persons who have had recent or suspected exposure to an infected person. Guidance for exposed persons is no longer based on vaccination status. Persons who have had recent exposure may consider testing for COVID-19 ≥5 days after exposure (or sooner, if they are symptomatic), regardless of their vaccination status. “Test to Stay” is no longer routinely recommended. Schools that choose to implement Test to Stay programs can contact VDH for more information on available testing resources and/or guidance.

• 2022-2023 Communicable Disease Reference Chart for School and Child Care Facility Personnel 
  • Major changes include the following: Now applies to both K-12 schools and child care and includes COVID-19 and Monkeypox

• Bivalent COVID-19 vaccine ordering is expected to be available in VaxMax as soon as 9/8/2022. At that time, providers will be able to request bivalent booster doses through the normal COVID-19 order process.
• Expiry Lookup Tools
  • Pfizer: https://lotexpiry.cvdvaccine.com
  • Moderna: https://eua.modernatx.com/covid19vaccine-eua/providers/vial-lookup
  • Novavax: https://us.novavaxcovidvaccine.com/hcp
  • Johnson and Johnson/Janssen: https://vaxcheck.jnj/

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

Check out our complete list of COVID-19 Vaccination Clinic Best Practices and our Lightning Learnings: Best Practices for Busy Providers!

• Monkeypox Webinars- These webinars will cover an overview of the current monkeypox situation, epidemiology of the virus, risk assessment/communication, infection prevention and control, testing, collaboration with public health officials, and medical countermeasure strategies, including an in depth overview of the JYNNOES vaccine and TPOXX therapeutic. There will also be an allotted time for questions.
  • Note: both sessions will present the same information/content.
  • Session 1: Friday September 9th at 12pm (noon) Registration Link -  https://us06web.zoom.us/webinar/register/WN_BCwWS11RQTSOMdI_9p2IrQ
  • Session 2: Tuesday, September 13th at 7pm Registration Link -  https://us06web.zoom.us/webinar/register/WN_3Zj_8VqpTOGpPIhKSI0paw

Refer to Previously posted resources

CDC

• (New) CDC Recommends Novavax for adolescents.
  • On August 22, 2022, CDC Director Rochelle Walensky signed a decision memo that Novavax’s COVID-19 vaccine be used as a primary series option for adolescents 12 through 17 years of age.
  • This recommendation follows FDA’s decision to grant emergency use authorization  for the vaccine in this age group. (FDA Updated Fact Sheet here.)
  • Novavax’s COVID-19 vaccine, which is available now, is an important tool in the pandemic and provides a more familiar type of COVID-19 vaccine technology.
  • Having multiple types of vaccines offers more options and flexibility for the public, jurisdictions, and vaccine providers.

• (New) CDC streamlines COVID-19 guidance to help the public better protect themselves and understand their risk.
  • On August 11, 2022, CDC updated its quarantine and isolation guidance.
  • Guidance for people who are not up to date with COVID-19 vaccines and are exposed to someone with COVID-19 is now consistent with existing guidance for people who are up to date with COVID-19 vaccines.
  • For people who were exposed to COVID-19, CDC now recommends that they wear a high-quality mask for 10 days and get tested on Day 5. Quarantine is no longer recommended.
  • Screening testing of asymptomatic people without known exposures will no longer be recommended in most community settings.
  • Physical distance is just one component of how to protect yourself and others. It is important to consider the risk in a particular setting, including local COVID-19 Community Levels and the important role of ventilation, when assessing the need to maintain physical distance.
  • Note: VDH is in the process of reviewing this guidance to determine if it will be adopted in Virginia.

• (Update) CDC web pages updated based on guidance above:
  • COVID-19 Testing Overview
  • Symptoms of Coronavirus
  • Operational Guidance for K-12 Schools and Early Care and Education Programs to Support Safe In-Person Learning
  • What to Do If You Were Exposed to COVID-19
  • Factors That Affect Your Risk of Getting Very Sick from COVID-19
  • Understanding Exposure Risks
  • Isolation and Precautions for People with COVID-19

FDA:

• (Update) At-Home COVID-19 Antigen Tests-Take Steps to Reduce Your Risk of False Negative Results- FDA Safety Communication - the FDA issued a safety communication advising people to perform repeat, or serial, testing following a negative result on any at-home COVID-19 antigen test. If repeat testing is not performed after a negative result, an infection may be missed and people may unknowingly spread the SARS-CoV-2 virus to others, especially if they are not experiencing symptoms. COVID-19 diagnostic testing remains a cornerstone of our nation’s fight against COVID-19. While not perfect, at-home COVID-19 antigen tests provide a fast, convenient, and inexpensive COVID-19 testing option.
• Free COVID-19 rapid antigen tests can be ordered from the federal government at www.covid.gov/tests.
• (New) FDA authorizes the emergency use of Novavax COVID-19 Vaccine, Adjuvanted for individuals 12 through 17 years of age.
  • On August 19, 2022, FDA authorized the emergency use of Novavax COVID-19 Vaccine, Adjuvanted for the prevention of COVID-19 caused by SARS-CoV-2 in individuals 12 through 17 years of age.
  • This authorization follows a rigorous analysis and evaluation of the safety and effectiveness data conducted by the FDA.
  • The agency previously authorized the vaccine for individuals 18 years and older.
  • Additional information is available on the FDA website

VDH

• COVID-19 Vaccine Standing Order and Summary of Legal Authorities has been updated

• • Vaccine Standing order
  • Summary of Legal Authorities for Pharmacists to Administer

• (New) Monkeypox

• • The website for monkeypox has been migrated to a new page with improved design and navigation.  At this time, the content has not been changed, but expect  more updates to come in the next few weeks. Note: If you bookmarked the previous monkeypox page, it will redirect you to the new webpage. Please share the new page in your communications materials. https://www.vdh.virginia.gov/monkeypox/
    • Training resources
      • VDH:https://www.vdh.virginia.gov/emergency-preparedness/emergency-preparedness/monkeypox-smallpox-vaccination/
      • CDC: https://www.cdc.gov/smallpox/clinicians/vaccination.html

• (New) Polio

• • • A case of vaccine-derived poliovirus type 2 (VDPV2) was identified in late July in an unvaccinated individual in Rockland County, NY. Enhanced surveillance and detection of poliovirus in wastewater samples from Rockland and Orange Counties provided evidence of community transmission. Based on evidence from earlier polio outbreaks, health officials estimate that for every one case of paralytic polio observed, there may be hundreds of other people infected. The occurrence of this case, combined with the identification of poliovirus in wastewater, underscores the importance of maintaining high vaccination coverage to prevent paralytic polio in persons of all ages.
    • Providers should remain vigilant for polio, and continue to encourage on-time routine administration of inactivated polio vaccine (IPV). Providers should carefully assess any patient exhibiting unexplained acute flaccid weakness, including determining vaccination status and travel history. Polio may also present similarly to acute flaccid myelitis (AFM), which is expected to peak in late summer and early fall.
    • Polio is a serious and life-threatening disease. Spread from person-to-person, polio is very contagious, and an individual can transmit the virus even if they aren't sick. Those unvaccinated against poliovirus are most at-risk. Childhood vaccination schedules, which includes vaccination against polio, may have been interrupted by the COVID-19 pandemic, making children particularly vulnerable.  Parents who are uncertain about their child’s polio vaccination history should check with their child’s pediatrician, family physician, or medical provider.
    • Adults who have completed a routine series of poliovirus vaccine are considered to have lifelong immunity to poliomyelitis, but data on duration of immunity are lacking. As a precaution, adults 18 years of age or older who are traveling to areas where wild poliovirus or VDPV is actively circulating and who have received a routine series with either IPV or oral polio vaccine (OPV) in childhood should receive another dose of IPV before departure.
    • For adults, currently available data does not indicate the need for more than a single lifetime booster dose with IPV. Note: The World Health Organization recommends that countries affected by wild poliovirus or VDPV outbreaks require residents and long-term visitors (4 weeks or more) to show proof of polio vaccination before leaving the country. These recommendations are regularly reviewed and updated. Visit CDC's Travelers' Health site for current details about country-specific requirements (www.cdc.gov/travel/).
    • Public Health Response to a Case of Paralytic Poliomyelitis in an Unvaccinated Person and Detection of Poliovirus in Wastewater — New York, June–August 2022 | MMWR
    • Polio Elimination in the United States

• Beginning Thursday, August 18th, 2022, Moderna – Spikevax will be available to request in VaXMaX. Orders submitted before Monday, August 22 at 7:00 PM will be delivered Friday, August 26 or Monday, August 29.
  • CDC - Spikevax Information
  • FDA - Spikevax Information

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

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

Not aware of new announcements

Please refer to previous editions.

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.

FDA:

• New: FDA Authorizes Emergency Use of Novavax COVID-19 Vaccine
  • On July 13, 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 caused by SARS-CoV-2 in individuals 18 years of age and older.
    • The Novavax COVID-19 Vaccine is administered as a two-dose primary series, three weeks apart.
    • The vaccine contains the SARS-CoV-2 spike protein and Matrix-M adjuvant. Adjuvants are incorporated into some vaccines to enhance the immune response of the vaccinated individual.
    • Overall, the vaccine was 90.4% effective in preventing mild, moderate or severe COVID-19, with 17 cases of COVID-19 occurring in the vaccine group and 79 cases in the placebo group.
    • No cases of moderate or severe COVID-19 were reported in participants who received the vaccine, compared with 9 cases of moderate COVID-19 and 4 cases of severe COVID-19 reported in placebo recipients.
    • In the subset of participants 65 years of age and older, the vaccine was 78.6% effective.
    • The clinical trial was conducted prior to the emergence of delta and omicron variants.

CDC:

• New: CDC Recommends Novavax’s COVID-19 Vaccine for Adults On July 19, 2022, the Centers for Disease Control and Prevention (CDC) Director Rochelle P. Walensky, M.D., M.P.H., endorsed the CDC Advisory Committee on Immunization Practices’ (ACIP) recommendation that Novavax’s COVID-19 vaccine be used as another primary series option for adults aged 18 years and older. Novavax’s COVID-19 vaccine, which will be available in the coming weeks, is an important tool in the pandemic and provides a more familiar type of COVID-19 vaccine technology for adults. Having multiple types of vaccines offers more options and flexibility for the public, jurisdictions, and vaccine providers.
• Updated: Pfizer-BioNTech COVID-19 Vaccine Overview and Safety | CDC - Added that FDA approved the Pfizer COVID-19 (COMIRNATY) vaccine for individuals aged 12 years and older.
• Updated: As of July 18, 2022, CDC’s COVID-19 Program for Cruise Ships is no longer in effect and this page will no longer be updated. New guidance for cruise ships to mitigate and manage COVID-19 transmission will be available in the coming days. For more information, please see the cruise travel Frequently Asked Questions (FAQs).

VDH:

• Updated: Revised standing order authorizing dispensing and administering of the COVID-19 vaccine under Virginia code 54.1-3408(P) - July 26, 2022
  • Updated to include Novavax Vaccine
• Updated:  VDH COVID-19 Antigen Test Results - What do my results mean?  Updated links from CDC to VDH guidance, added links for site-specific guidance, and updated to reflect VDH updated quarantine guidance.
• Updated:  VDH Algorithm for Evaluating Non-Healthcare Workers for COVID-19 Symptoms or Exposures.  Updated quarantine recommendations to reflect the 6-month exception for previous COVID-19 infection (changed from 90-days), Updated definition of "close contact" to remove the K-12 exception language, Changed testing information from a CDC to a VDH link, and updated all isolation links to the VDH Isolation webpage.

• The recently approved Novavax vaccine will be available to order in VaXMaX beginning Thursday, August 4. Doses requested during this initial ordering window will be delivered on August 12 or August 15.
• For questions about VaxMaX and its functionality, please visit the VaxMaX Help website, which includes reference guides and tutorial videos.

Check out our complete list of COVID-19 Vaccination Clinic Best Practices and our Lightning Learnings: Best Practices for Busy Providers!

• CDC COCA Call: Recommendations for the Novavax COVID-19 Primary Series in Adults Ages 18 Years and Older 
  • Date: Thursday, July 28, 2022
  • Time: 2:00 PM – 3:00 PM ET
  • Webinar Link: https://www.zoomgov.com/j/1612728470
  • Passcode: 663869
  • Dial In: US: +1 669 254 5252

• CDC Office of Minority Health and Health Equity will host a webinar Protecting Our Children and Youth from COVID-19: Information for Parents, Caregivers, and Community Partners to provide accurate, timely, and trusted information about how to protect all children from COVID-19. Speakers include pediatric vaccine experts from HHS, CDC, and community partners leading vaccine efforts for children and youth.
  • Date: Friday, July 29, 2022
  • Time: 1:30–3:00 PM ET
  • Webinar Link
  • Passcode: COVID@19
  • Dial In: US: +1 669 254 5252

VDH External Web Updates

• (Updated) On K-12 Schools and Child Care Programs webpage
  • Updated the Template Letters for Daycare/School COVID-19 Exposure,   Daycare/School COVID-19 Case, and Daycare/School COVID-19 Outbreak to reflect new quarantine guidance. These are located under the “Resources for Schools and Child Care Programs section.
• Effective Tuesday, July 19, 2022, the COVID-19 Variant dashboard will be updated on a weekly basis (Mondays). It will feature more accurate and timely genomic sequencing data, but will no longer feature demographic or geographic information. What exactly is changing?
  • • VDH will no longer report demographic and location information.
    • VDH will move to reporting variant percentages on a weekly basis.
    • Variant infection percentages will now be shown together with case counts

Significant Changes to Federal Guidance

• (New) HHS 6/29/2022 Press Release: Biden-Harris Administration secures 105 million doses of Pfizer’s latest COVID-19 vaccine for fall vaccination campaign - The U.S. Department of Health and Human Services (HHS), in collaboration with the Department of Defense, announced an agreement to purchase 105 million doses of Pfizer’s COVID-19 vaccine for a fall vaccination campaign, with options for up to 300 million doses. The contract announcement follows a June 28, 2022 meeting of the U.S. Food and Drug Administration’s (FDA’s) Vaccines and Related Biological Products Advisory Committee meeting, which recommended the inclusion of an Omicron component for COVID-19 booster vaccines in the U.S.
• (New) FDA 6/30/2022 Press Release: Coronavirus (COVID-19) Update: FDA Recommends Inclusion of Omicron BA.4/5 Component for COVID-19 Vaccine Booster Doses - On Tuesday, June 28, 2022, the U.S. Food and Drug Administration’s independent experts on the Vaccines and Related Biological Products Advisory Committee met publicly to discuss whether a change to the current vaccine strain composition of COVID-19 vaccines for booster doses is necessary for the 2022 fall and winter seasons. “Following the vote, and striving to use the best available scientific evidence, we have advised manufacturers seeking to update their COVID-19 vaccines that they should develop modified vaccines that add an Omicron BA.4/5 spike protein component to the current vaccine composition to create a two component (bivalent) booster vaccine, so that the modified vaccines can potentially be used starting in early to mid-fall 2022. As we expect this coming year to be a transitional period when this modified booster vaccine may be introduced, we have not advised manufacturers to change the vaccine for primary vaccination, since a primary series with the FDA-authorized and approved COVID-19 vaccines provides a base of protection against serious outcomes of COVID-19 caused by circulating strains of SARS-CoV-2.”

CDC

• Statement 6/24/2022 - CDC Recommends Moderna COVID-19 Vaccine (Spikevax) for Children and Adolescents Ages 6 through 17 Years - CDC Director Rochelle P. Walensky, M.D., M.P.H., endorsed the CDC Advisory Committee on Immunization Practices’ (ACIP) recommendation that Moderna’s COVID-19 vaccine be used as an option for children ages 6 through 17 years, in addition to its already recommended use in children 6 months through 5 years and adults 18 years and older. This recommendation reinforces the use of Moderna’s COVID-19 vaccine as an important tool in the pandemic and provides another vaccine option for children and adolescents. The ACIP recommendation comes after a thorough review of the scientific evidence demonstrating safety and efficacy, and supports the use of the vaccine among those 6 through 17 years of age.

FDA:

• Press release 7/6/2022 - FDA Authorizes Pharmacists to Prescribe Paxlovid with Certain Limitations - the U.S. Food and Drug Administration 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.“The FDA recognizes the important role pharmacists have played and continue to play in combatting this pandemic,” said Patrizia Cavazzoni, M.D., director for the FDA’s Center for Drug Evaluation and Research. “Since Paxlovid must be taken within five days after symptoms begin, authorizing state-licensed pharmacists to prescribe Paxlovid could expand access to timely treatment for some patients who are eligible to receive this drug for the treatment of COVID-19.”

• How to Order Moderna Vaccine for children aged 6-11 years in VaXMaX

The recently released Moderna Blue Cap/Purple Label vial has been approved for primary series administration to children aged 6-11 years old AND as a booster for adults aged 18+ years. This vaccine is currently available for order in VaXMaX and appears in the system as Moderna - Booster Only.

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

Check out our complete list of COVID-19 Vaccination Clinic Best Practices and our Lightning Learnings: Best Practices for Busy Providers!

CDC National Center for Immunization and Respiratory Diseases (NCIRD)

With COVID vaccines now available across the lifespan, meeting schedules have been  streamlined. The changes are intended to balance consistent COVID-19 information sharing with summer schedules, and hopefully allow more flexibility for taking some much needed rest.

Beginning in July the meeting schedule will be:

• First Wednesday of the month – Vaccine Finder/Vaccines.gov Office Hours. 3:30 – 4:00 ET
• Second Wednesday of the month – Distribution Officer Hours. 3:30 – 4:00 ET
• Third Wednesday of the month – All Awardee Call. 3:30 – 4:45 ET
• Fourth Wednesday of the month – The Reader (formerly The Weekly Reader)

Please note: all calls will begin at 3:30 pm ET and meeting invitations will be updated shortly

We will still be available for answering questions or ad hoc calls. Please work with your Project Officer if you do have questions.

Pediatric Pfizer Training: https://www.pfizermedicalinformation.com/en-us/medical-updates 

VDH External Web Updates

• (Updated) For the resource When to End Isolation or Quarantine that was last updated on 6/15/2022, posted the translations for Spanish, Arabic, Chinese, Korean, Tagalog. These are available on multiple sites:
  • VDH Resources and Support website (under Exposure or Illness)
  • What to do if you were potentially exposed to coronavirus disease (COVID-19)? (under For More Information)
  • Health Professionals website (under Print Resources)
  • K-12 Education (under General Resources for Parents)
  • Institutions of Higher Education website (under Resources for Students)
  • Testing and Laboratory website (under Resources for Patients tab)
• (Updated) Vaccination FAQs -
  • Updated the availability of Moderna COVID-19 vaccines for children and adolescents 6 years through 17 years
  • FDA recommendations for COVID-19 vaccine booster formulations for the fall
  • information for children on the cusp of an age group for which a different Pfizer or Moderna formulation is recommended

Vaccine schedules resources

• Vaccine schedules at a glance
• Interim COVID-19 Immunization Schedule for 6 Months of Age and Older 

COCA Call Videos

• What Clinicians Need to know About Available Therapeutic Options for COVID-19 - June 16, 2022

• Monkeypox: Updates about Clinical Diagnosis and Treatment - June 29, 2022

Information on Monkeypox can be found at: https://www.vdh.virginia.gov/surveillance-and-investigation/monkeypox/

Significant Changes to CDC Guidance

• Following CDC's new recommendation last week for the Moderna COVID-19 Vaccine in children and adolescents aged 6–17 years, multiple vaccine-related guidance documents, reference materials, or websites were updated or added regarding this product. This Moderna vaccine comes in two formulations–one for children aged 6 through 11 years; the other for adolescents and teens aged 12 through 17 years.
  • (Updated) Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States
  • (Updated) Summary Document for Interim Clinical Considerations
  • (Updated) Interim COVID-19 Immunization Schedule
  • (Updated) Information about the Moderna COVID-19 Vaccine
  • (Updated) COVID-19 Vaccine Recommendations for Children and Teens
  • (Updated) Stay Up to Date with Your COVID-19 Vaccines
  • (Updated) COVID-19 Vaccine Booster Shots
  • (Updated) COVID-19 Vaccines for Moderately to Severely Immunocompromised People
  • (New) At-A-Glance COVID-19 Vaccination Schedule
  • (New) Moderna COVID-19 Vaccine for Children who Transition from a Younger to Older Age Group
  • (New) Pfizer-BioNTech for Children who Transition from a Younger to Older Age Group

FDA

• On June 28, the FDA and HHS/ASPR announced the authorization of an extension to the shelf-life from 18 months to 24 months for specific lots of the refrigerated AstraZeneca monoclonal antibody, Evusheld (tixagevimab co-packaged with cilgavimab), which is currently authorized for emergency use for pre-exposure prophylaxis of COVID-19 in certain adults and pediatric individuals. The agency granted this extension following a thorough review of data submitted by AstraZeneca. As a result of this extension, some batches may be stored for an additional 6 months from the labeled date of expiry. This extension applies to all unopened vials of Evusheld that have been held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers and the EUA Letter of Authorization for Evusheld. As required by the emergency use authorization for Evusheld, unopened vials of Evusheld (150 mg/1.5 mL of tixagevimab and 150 mg/1.5 mL of cilgavimab), must be stored under refrigerated temperature at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.
• On June 27, the FDA authorized an extension to the shelf-life from 24 months to 30 months for specific lots of the refrigerated Regeneron monoclonal antibodies, casirivimab and imdevimab, administered together or REGEN-COV. Due to the high frequency of the Omicron variant and its subvariants, REGEN-COV is not currently authorized in any U.S. region. Therefore, REGEN-COV may not be administered for treatment or post-exposure prevention of COVID-19 under the Emergency Use Authorization until further notice by the Agency. However, it is the recommendation of the U.S. Government that product be retained in the event that future SARS-CoV-2 variants, which may be susceptible to REGEN-COV, emerge and become prevalent in the U.S.

• On Thursday, June 23, 2022, Pfizer Pediatric Vaccine (under 5 years of age), Moderna Pediatric Vaccine (under 6 years of age), and Comirnaty became available to order in VaxMaX.
• Doses requested will be delivered Friday, July 1, 2022, Tuesday, July 5, 2022, or Wednesday, July 6, 2022.
• How to Order 6 year - 11 year Moderna in VaXMaX: The recently released Moderna Blue Cap/Purple Label vial has been approved for primary series administration to children aged 6 - 11 years old AND as a booster for adults ages 18+. This vaccine is currently available for order in VaXMaX and appears in the system as Moderna - Booster Only

Independence Day 2022 Holiday Ordering and Shipping Schedule

• NO ORDERS WILL BE DELIVERED MONDAY, JULY 4, 2022 – INDEPENDENCE DAY
• McKesson Specialty (Moderna and J&J/Janssen) will not deliver vaccine orders on July 5, 2022.
• Pfizer-BioNTech Vaccines
  • No vaccine deliveries will occur on Saturday, July 2 through Monday, July 4, 2022.
  • Pfizer will be closed for the holiday weekend, and no orders will be processed on July 4-5, 2022.
  • Orders placed on Friday, July 1 will be delivered on Tuesday, July 5, 2022.
  • If you would like to hold delivery on Tuesday, July 5, 2022, contact Pfizer by Wednesday, June 29, 2022 at 9:00 p.m. EST via email at cvgovernment@pfizer.com.
• Moderna and J&J/Janssen Vaccines
  • No vaccine deliveries will occur on Saturday July 2 through Tuesday, July 5, 2022.
  • McKesson will be closed for the holiday weekend. No orders will be processed on July 4 or 5, 2022.
  • Orders placed by 12:00 p.m. EST on Friday, July 1, 2022 will be delivered on Wednesday, July 6, 2022.
  • McKesson Specialty customer service is reaching out to awardee and partner ordering points of contact to determine if order holds are requested. If you have not already spoken with McKesson Specialty customer service and want to request a hold for your orders on Friday, July 1, 2022, please call 1-833-343-2703 or email COVIDVaccineSupport@McKesson.com by 12:00 p.m. EST on Wednesday June 29, 2022.
• For questions about VaxMaX and its functionality, please visit the VaxMaX Help website, which includes reference guides and tutorial videos.

Check out our complete list of COVID-19 Vaccination Clinic Best Practices and our Lightning Learnings: Best Practices for Busy Providers!

Pfizer Webinars for Healthcare Providers

• Pfizer has expanded its training sessions to address questions about currently recommended COVID-19 vaccine products as well as vaccines for children that are anticipated to be approved through an EUA.
• The COVID-19 vaccine medical updates and site training webinars aim to educate providers and immunization staff on the proper use of the Pfizer-BioNTech COVID-19 vaccines.
• For details, see dates and links for upcoming training sessions.
  • The trainings will include presentations on COVID-19 vaccines with a MAROON cap for individuals 6 months through 4 years of age.
  • Daily trainings (Monday through Friday) will continue through July 8, 2022 (with no training on July 4th).

VDH External Web Updates 

• If You are Sick page - Updated to reflect current VDH isolation and quarantine guidance. Moved the "Steps to take if you are sick" section to the top of the page and moved the "Get Tested for COVID-19" section below.
• VDH When to End Isolation or Quarantine:
  • On page two, the time frame for when quarantine and testing are not required if you have recently had COVID-19 was extended from 90 days to 6 months.
  • The recommendation for masking and testing for close contacts who are not required to quarantine was removed.
  • Previously, children aged 12-17 years who had not yet received a booster dose (and were therefore not considered “up to date” on COVID-19 vaccinations) were granted an exception and not required to quarantine after an exposure. This grace period has ended, and children aged 12-17 years who are not up to date on vaccinations must follow quarantine guidance. Currently, children aged 5-11 years who have not received a booster may still be considered “up to date” on COVID-19 vaccinations until the start of the 2022-2023 school year.
  • On page three, updated wording for up-to-date close contacts from “should get tested at least 5 days after” to “can consider getting tested”.
  • Updated the link to CDC Quarantine Guidance to VDH Quarantine Guidance.

• Interim Guidance for Child Care Facility Collaboration with the Local Health Department -
  • Updated VDH guidance that those who have recovered from confirmed COVID-19 within the past six months (changed from CDC recommendation of 90 days) do not need to quarantine or wear a mask after a close contact.
  • Added CDC updates regarding prevention strategies that should be considered at different COVID-19 Community Levels.
  • Updated facility reporting requirement to: "may voluntarily report suspected outbreaks of COVID-19 using the online reporting portal."

• VDH Flowchart for K-12 and Child Care Parents: If my Child is Ill or Exposed to COVID-19 -
  • Removed recommendation that even if quarantine is not required, testing is recommended on Day 5, and that masks should be worn around others for a full 10 days.
  • Added links to CDC Guidance for definition of “up to date” with COVID-19 vaccinations, updated footnote to reflect this.
  • Removed guidance that students ages 12-17 years who completed their COVID-19 primary vaccine series but have not yet received a booster can forgo quarantine.
  • Included guidance that students ages 5-11 who have received the primary series but not a booster dose may forgo quarantine at this time, until the start of the 2022-2023 academic school year.
  • Updated time frame of recovery from COVID-19 infection from 90 days to 6 months; those who have recovered from COVID-19 in the last 6 months are not required to quarantine after a close contact exposure to an individual with COVID-19.
  • Updated “COVID-19 Symptoms” to link to CDC’s guidance on symptoms of COVID-19.
  • Added guidance that children <2 years of age and those who cannot mask should quarantine or isolate at home for the full 10 day period.

Resources for vaccinating young children (6 months through 6 years of age)

Less than 11 months of age: anterolateral thigh:  https://www.cdc.gov/vaccines/hcp/admin/downloads/IM-Injection-Infants-508.pdf

1-2 years of age: anterolateral thigh: https://www.cdc.gov/vaccines/hcp/admin/downloads/IM-Injection-1-2-Years-508.pdf

3-6 years of age: deltoid muscle: https://www.cdc.gov/vaccines/hcp/admin/downloads/IM-Injection-3-6-Years.pdf

Needle gauge guide: https://www.cdc.gov/vaccines/hcp/admin/downloads/vaccine-administration-needle-length.pdf

CDC IM injection video: deltoid and anterolateral thigh: https://youtu.be/PqSuCPnPeYE

White House

• 6/21/2022:  Remarks by President Biden on COVID-⁠19 Vaccines for Children Under Five - The United States is now the first country in the world to offer safe and effective COVID-19 vaccines for children as young as six months old. In the first time in our fight against this pandemic, nearly every American can now have access to lifesaving vaccines. And we’re ready. Parents will soon be able to start scheduling an appointment and addressing vaccines at pediatricians’ offices,[and] children’s hospitals. And starting today, you can go to Vaccines.gov and find information and appointments near you. More and more locations will be ramping up, and more vaccines are delivered to providers in your areas every day.

VDH

• Revised Standing order authorizing dispensing and administering of the covid-19 vaccine under Virginia Code 54.1-3408(P) 
  • Legal summary of legal authorities for Pharmacists to administer COVID Vaccines
• CDC Guidance or Materials
  • New - 6/24/2022:   Moderna COVID-19 vaccine recommended for children and adolescents  [Media Statement]. CDC endorsed the Advisory Committee on Immunization Practices’ (ACIP) recommendation that children aged 6 through 17 years of age can receive the Moderna COVID-19 vaccine for a primary series. Children and adolescents who receive the Moderna COVID-19 vaccine will need two doses separated by at least 28 days for their primary series. There are separate Moderna products for children 6 through 11 years of age and adolescents 12 through 17 years of age.  CDC will provide additional guidance in its Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States.
• New - 6/18/2022: CDC Recommends COVID-19 Vaccines for Young Children [Media Statement]. CDC endorsed the Advisory Committee on Immunization Practices’ (ACIP) recommendation that all children 6 months through 5 years of age should receive a COVID-19 vaccine. This expands eligibility for vaccination to nearly 20 million additional children and means that all Americans ages 6 months and older are now eligible for vaccination. More information can be found in CDC’s Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States.
• Updated - 6/21/2022: Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY): Overview and Safety. CDC recommends Pfizer COVID-19 vaccines for children ages 6 months through 4 years. The primary series consists of 3 doses. For immunocompetent children, the first and second doses are separated by three to eight weeks and the second and third doses are separated by at least eight weeks. For people who are moderately or severely immunocompromised (have a weakened immune system), the first and second doses are separated by three weeks, and the second and third doses are separated by at least eight weeks. Boosters are currently not authorized for children in this age group.
• Updated - 6/19/2022: Moderna COVID-19 Vaccine (also known as Spikevax): Overview and Safety. CDC recommends Moderna COVID-19 vaccine for children aged 6 months through 5 years. For children with a normal immune system, the primary series is 2 doses, with the second dose given 4-8 weeks after the first dose.  For children who are moderately or severely immunocompromised (have a weakened immune system), the primary series consists of three doses. An interval of 4 weeks is recommended between the first and second doses, and the second and third doses should be separated by at least 4 weeks.
• Updated - 6/19/2022: Myocarditis and Pericarditis After mRNA COVID-19 Vaccination. CDC continues to recommend that everyone ages 6 months and older get vaccinated for COVID-19. The known risks of COVID-19 illness and its related, possibly severe complications, such as long-term health problems, hospitalization, and even death, far outweigh the potential risks of having a rare adverse reaction to vaccination, including the possible risk of myocarditis or pericarditis.
• Updated - 6/19/2022: COVID-19 Vaccines for People who are Moderately or Severely Immunocompromised. Children aged 6 months through 11 years who are moderately or severely immunocompromised should receive primary series doses – and boosters, if eligible – as shown on the linked page.
• Updated - 6/19/2022: COVID-19 Vaccine Side Effects in Children and Teens. Common COVID-19 vaccine side effects that children aged 4 and older may experience after their second dose include: Pain, swelling, and redness at the injection site, , fever (usually low grade), tiredness, headache, chills, muscle or joint pain, and swollen lymph nodes. For children aged 3 years and younger, common side effects can include: Mild pain and redness at the injection site,  swollen lymph nodes, irritability or crying, sleepiness, and loss of appetite.

 

FDA

• New: FDA Authorizes Moderna and Pfizer-BioNTech COVID-19 Vaccines for Children Down to 6 Months of Age - On June 17, the U.S. Food and Drug Administration (FDA)authorized emergency use of the Moderna and Pfizer-BioNTech (Pfizer) COVID-19 Vaccines  for the prevention of COVID-19.  For the Moderna COVID-19 Vaccine, the FDA amended the emergency use authorization (EUA) to include use of the product in individuals 6 months through 17 years of age.  For the Pfizer COVID-19 Vaccine, the FDA amended the EUA to include use of the vaccine in individuals 6 months through 4 years of age. The FDA’s evaluation and analysis of the safety, effectiveness and manufacturing data of these vaccines was rigorous and comprehensive, supporting the EUAs.The agency determined that the known and potential benefits of the Moderna and Pfizer COVID-19 vaccines outweigh the known and potential risks in the pediatric populations for whom these vaccines are now authorized for use. Prior to making the decision to authorize these vaccines for the respective pediatric populations, the FDA’s independent Vaccines and Related Biological Products Advisory Committee was consulted and voted in support of the authorizations.
• Updated - 6/21/2022: Pulse Oximeter Accuracy and Limitations: FDA Safety Communication. With the advent of the Covid-19 pandemic, pulse oximetry has been used more to measure blood oxygen levels in patients. Per the NIH Clinical Spectrum of SARS-CoV-2 Infection, a pulse ox value can help determine if someone has ‘moderate’ or ‘severe’ Covid-19 illness. This has implications in determining whether a patient with Covid-19 can be treated as an outpatient or needs hospitalization. At least one study (from Sjoding and others) suggests that pulse oximetry may lack accuracy in black patients. In its update, FDA notes it will convene a meeting of the Medical Devices Advisory Committee later in 2022 to examine this in more detail.

• On Thursday, June 23, 2022, Pfizer Pediatric Vaccine (under 5 years of age), Moderna Pediatric Vaccine (under 6 years of age), and Comirnaty will be available to order in VaxMaX.

 

• Doses requested June 23rd through June 27th will be delivered Friday - July 1st, Tuesday - July 5th, or Wednesday - July 6th.

 

• The VDH Vaccine Unit Allocation Team is working to make Moderna (blue cap/purple label) available for ordering. Additional information regarding the process for initial orders will be provided by EOD 6/27/2022.

 

Independence Day 2022 Holiday Ordering and Shipping Schedule

• NO ORDERS WILL BE DELIVERED MONDAY, July 4, 2022 – INDEPENDENCE DAY

 

• McKesson Specialty (Moderna and Janssen) will not deliver vaccine orders on July 5, 2022.

 

• Pfizer-BioNTech Vaccines
  • No vaccine deliveries will occur on Saturday, July 2 through Monday, July 4, 2022.
  • Pfizer will be closed for the holiday weekend, and no orders will be processed July 4-5, 2022.
  • Orders placed on Friday, July 1 will be delivered on Tuesday, July 5, 2022.
  • If you would like to hold delivery for Friday, July 1, contact Pfizer by Tuesday, June 28, 9:00 p.m. EST via email at cvgovernment@pfizer.com.
  • If you would like to hold delivery for Tuesday, July 5, contact Pfizer by Wednesday, June 29, 9:00 p.m. EST via email at cvgovernment@pfizer.com.

• Moderna and J&J/Janssen Vaccines
  • No vaccine deliveries will occur Saturday July 2 through Tuesday, July 5, 2022.
  • McKesson will be closed for the holiday weekend. No orders will be processed July 4 or 5, 2022.
  • Orders placed by 12:00 p.m. EST on Friday, July 1 will be delivered on Wednesday, July 6, 2022.
  • McKesson Specialty customer service is reaching out to awardee and partner ordering points of contact to determine if order holds are requested. If you have not already spoken with McKesson Specialty customer service and want to request a hold for your orders for Friday, July 1, please call 1-833-343-2703 or email COVIDVaccineSupport@McKesson.com by 12:00 p.m. EST on Wednesday June 29, 2022.

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

Check out our complete list of COVID-19 Vaccination Clinic Best Practices and our Lightning Learnings: Best Practices for Busy Providers!

Pfizer Webinars for Healthcare Providers

• Pfizer has expanded its training sessions to address questions about currently recommended COVID-19 vaccine products as well as vaccines for children that are anticipated to be approved through an EUA.
• The COVID-19 vaccine medical updates and site training webinars aim to educate providers and immunization staff on the proper use of the Pfizer-BioNTech COVID-19 vaccines.
• For details, see dates and links for upcoming training sessions.
  • The trainings will include presentations on COVID-19 vaccines with a MAROON cap for individuals 6 months through 4 years of age.
  • Daily trainings (Monday through Friday) will continue through July 8, 2022 (with no training on July 4th).
  • While current trainings follow a Tuesday, Wednesday, Thursday schedule, future trainings will be offered 5 days per week as the pediatric vaccines roll out

VDH External Web Updates 

• If You are Sick page - Updated to reflect current VDH isolation and quarantine guidance. Moved the "Steps to take if you are sick" section to the top of the page and moved the "Get Tested for COVID-19" section below.
• VDH When to End Isolation or Quarantine:
  • On page two, the time frame for when quarantine and testing are not required if you have recently had COVID-19 was extended from 90 days to 6 months.
  • The recommendation for masking and testing for close contacts who are not required to quarantine was removed.
  • Previously, children aged 12-17 years who had not yet received a booster dose (and were therefore not considered “up to date” on COVID-19 vaccinations) were granted an exception and not required to quarantine after an exposure. This grace period has ended, and children aged 12-17 years who are not up to date on vaccinations must follow quarantine guidance. Currently, children aged 5-11 years who have not received a booster may still be considered “up to date” on COVID-19 vaccinations until the start of the 2022-2023 school year.
  • On page three, updated wording for up-to-date close contacts from “should get tested at least 5 days after” to “can consider getting tested”.
  • Updated the link to CDC Quarantine Guidance to VDH Quarantine Guidance.

• Interim Guidance for Child Care Facility Collaboration with the Local Health Department -
  • Updated VDH guidance that those who have recovered from confirmed COVID-19 within the past six months (changed from CDC recommendation of 90 days) do not need to quarantine or wear a mask after a close contact.
  • Added CDC updates regarding prevention strategies that should be considered at different COVID-19 Community Levels.
  • Updated facility reporting requirement to: "may voluntarily report suspected outbreaks of COVID-19 using the online reporting portal."

• VDH Flowchart for K-12 and Child Care Parents: If my Child is Ill or Exposed to COVID-19 -
  • Removed recommendation that even if quarantine is not required, testing is recommended on Day 5, and that masks should be worn around others for a full 10 days.
  • Added links to CDC Guidance for definition of “up to date” with COVID-19 vaccinations, updated footnote to reflect this.
  • Removed guidance that students ages 12-17 years who completed their COVID-19 primary vaccine series but have not yet received a booster can forgo quarantine.
  • Included guidance that students ages 5-11 who have received the primary series but not a booster dose may forgo quarantine at this time, until the start of the 2022-2023 academic school year.
  • Updated time frame of recovery from COVID-19 infection from 90 days to 6 months; those who have recovered from COVID-19 in the last 6 months are not required to quarantine after a close contact exposure to an individual with COVID-19.
  • Updated “COVID-19 Symptoms” to link to CDC’s guidance on symptoms of COVID-19.
  • Added guidance that children <2 years of age and those who cannot mask should quarantine or isolate at home for the full 10 day period.

Resources for vaccinating young children (6 months through 6 years of age)

Less than 11 months of age: anterolateral thigh:  https://www.cdc.gov/vaccines/hcp/admin/downloads/IM-Injection-Infants-508.pdf

1-2 years of age: anterolateral thigh: https://www.cdc.gov/vaccines/hcp/admin/downloads/IM-Injection-1-2-Years-508.pdf

3-6 years of age: deltoid muscle: https://www.cdc.gov/vaccines/hcp/admin/downloads/IM-Injection-3-6-Years.pdf

Needle gauge guide: https://www.cdc.gov/vaccines/hcp/admin/downloads/vaccine-administration-needle-length.pdf

CDC IM injection video: deltoid and anterolateral thigh: https://youtu.be/PqSuCPnPeYE

CDC

• Significant Changes to CDC Guidance or Materials
  • Updated: COVID Data Tracker is CDC’s home for COVID-19 data. It combines county, state, national, and global data from across the response in a series of interactive dashboards. Recent COVID Data Tracker releases and updates include:
    • The June 3,2022 COVID Data Tracker Weekly Review Interpretative Summary focuses on CDC’s updated booster guidance and booster uptake among children ages 5 through 11 years old.
    • On June 2, 2022, the Wastewater Surveillance tab was updated to display a national stacked bar chart showing how much virus levels have changed (increased and decreased) over time at wastewater sites across the United States. It shows the percent of total sites over time in each category of the percent change metric.
    • On June 2, 2022, a link to the ASPR COVID-19 Therapeutics website was added to the Additional COVID-related Data tab. This site provides current information on COVID-19 therapeutics thresholds, orders, and replenishment by jurisdiction.
    • On May 26, 2022, the Vaccination Trends tab was updated to display vaccination trends among people ages 50 years and older who received a second booster dose.
• New: CDC Rescinds Order Requiring Negative Pre-Departure COVID-19 Test Prior to Flight to the U.S. - the Order requiring persons to show a negative COVID-19 test result or documentation of recovery from COVID-19 before boarding a flight to the United States was rescinded effective on June 12, 2022 at 12:01AM ET. Airline passengers do not need to show documentation of a negative COVID-19 test result or documentation of recovery from COVID-19 prior to boarding a flight to the United States.
  • This change impacts multiple CDC pages including: Travel, International Travel during COVID-19, Non-U.S. citizen, Non-U.S. immigrants: Air Travel to the United States.

FDA 

• FDA Announces Tentative Advisory Committee Meeting Schedule Regarding COVID-19 Vaccines - On May 23, 2022, the Food and Drug Administration (FDA) revised the dates of the upcoming Vaccines and Related Biological Products Advisory Committee meetings due to new data from vaccine sponsors and expected submissions of emergency use authorization (EUA) requests. The new dates are as follows:
  • June 15, 2022 will be the new meeting date to discuss the Moderna COVID-19 vaccine EUA request for children 6 months through 5 years of age and Pfizer-BioNTech’s COVID-19 vaccine EUA request for children 6 months through 4 years of age, based on expected completion of an EUA submission.
  • Information on how to view the meetings can be found here: Vaccines and Related Biological Products Advisory Committee June 14-15, 2022 Meeting Announcement 
• On June 3, 2022, the FDA provided additional guidance to help prescribers evaluate potential drug-drug interactions when using Paxlovid for the treatment of COVID-19. Prescribers should review each patient’s complete medication list (including ALL prescription AND non-prescription medications such as vitamins, supplements, etc.) and use resources to evaluate for potential drug-drug interactions.  Current resources include the Paxlovid EUA Fact Sheet, the Paxlovid Patient Eligibility Screening Checklist Tool for Prescribers, and the University of Liverpool COVID-19 Drug Interactions Checker.

• McKesson Specialty (Moderna and Janssen) will not be delivering orders on July 5, 2022.
• Pfizer Centrally Distributed Vaccines
• • No vaccine deliveries will occur on Saturday, July 2 through Monday, July 4, 2022.
  • Pfizer will be closed for the holiday weekend, and no orders will be processed July 4-5, 2022.
  • Orders placed on Friday, July 1, 2022 will be delivered on Tuesday, July 5, 2022.
  • If you would like to hold delivery for Friday, July 1, 2022, contact Pfizer by Tuesday, June 28, 2022 at 9:00 p.m. EST via email at cvgovernment@pfizer.com.
  • If you would like to hold delivery for Tuesday, July 5, 2022, contact Pfizer by Wednesday, June 29, 2022 at 9:00 p.m. EST via email at cvgovernment@pfizer.com.
• Moderna and J&J/Janssen Centrally Distributed Vaccines
• • No vaccine deliveries will occur Saturday July 2 through Tuesday, July 5, 2022.
  • McKesson will be closed for the holiday weekend. No orders will be processed on July 4 or 5, 2022.
  • Orders placed by 12:00 p.m. EST on Friday, July 1, 2022 will be delivered on Wednesday, July 6, 2022.
  • McKesson Specialty customer service is reaching out to awardee and partner ordering points of contact to determine if order holds are requested. If you have not already spoken with McKesson Specialty customer service and want to request a hold for your orders for Friday, July 1, 2022, please call 1-833-343-2703 or email COVIDVaccineSupport@McKesson.com by 12:00 pm EST on Wednesday June 29, 2022.
• For questions about VaxMaX and its functionality, please visit the VaxMaX Help website, which includes reference guides and tutorial videos.

Check out our complete list of COVID-19 Vaccination Clinic Best Practices and our Lightning Learnings: Best Practices for Busy Providers!

• What Clinicians Need to Know About Available Therapeutic Options for COVID-19

• • Date: Thursday, June 16, 2022
  • Time: 2:00 PM – 3:00 PM ET
  • A few minutes before the webinar starts, please click on the Zoom link below to join: https://www.zoomgov.com/j/1603960029?pwd=Z0x1SE1mR3ZNUXFSK3hBckw3aFIyUT09
  • Passcode: 308026
  • Telephone: US: +1 669 254 5252
• Advisory Committee on Immunization Practices (ACIP) Meetings: Friday, June 17, 2022, 10 AM - 3:30 PM  and Saturday, June 18, 2022, 10 AM - 4 PM
  • Following the VRBPAC meeting, ACIP will discuss vaccination for children and recommendations on how the vaccines should be used.
  • Access these meetings here

Pfizer Webinars for Healthcare Providers

• Pfizer has expanded its training sessions to address questions about currently recommended COVID-19 vaccine products as well as vaccines for children that are anticipated to be approved through an EUA.
• The COVID-19 vaccine medical updates and site training webinars aim to educate providers and immunization staff on the proper use of the Pfizer-BioNTech COVID-19 vaccines.
• For details, see dates and links for upcoming training sessions.
  • The trainings will include presentations on COVID-19 vaccines with a MAROON Cap for individuals 6 months through 4 years of age.
  • Daily trainings (Monday through Friday) will begin Monday, June 20, 2022, and continue through July 8, 2022 (with no training on July 4th).
  • While current trainings follow a Tuesday, Wednesday, Thursday schedule, future trainings will be offered 5 days per week as the pediatric vaccines roll out (Please note, the COVID-19 vaccine has NOT yet been authorized or approved for use in individuals younger than 5 years of age)

AAP/ VDH Webinar

• In partnership with the Virginia Department of Health (VDH), the Virginia Chapter of the American Academy of Pediatrics (AAP) invites you to the upcoming webinar on June 20th from 12:15-1PM ET regarding the anticipated Pfizer and Moderna COVID-19 Vaccines for the 6-month to under 5-year population.
• During this webinar, we will hear about the COVID-19 vaccine efforts in Virginia to date, the impact of COVID-19 on the pediatric population, clinical information specific to the Pfizer and Moderna pediatric vaccines, and how to address vaccine hesitancy. We invite all pediatric providers to join us.
  • Webinar Information: 
    • Date: Monday, June 20, 2022
    • Time: 12:15PM – 1PM (ET)
    • Registration Link: Click here

VDH External Web Updates 

• External webpages are being updated to reflect the adjustments to quarantine recommendations released by VDH on June 10, 2022: Effective immediately, VDH will be revising its quarantine guidance for COVID-19. Specifically, for non-high risk situations, if a person is exposed to COVID-19, but has (1) tested positive for and recovered from COVID-19 within the last 6 months, or (2) is up to date on vaccines, or both, that person will no longer be recommended to quarantine, but rather should monitor for symptoms and follow isolation protocols should they appear. Note that this varies slightly from CDC guidance, which defines the post-infection immunity period as 90 days.
  • This change will apply to the general public, including but not limited to settings such as K-12 schools and early childhood education settings. Out of an abundance of caution, we will retain the 90-day standard for higher-risk situations, including healthcare workers, staff and residents of long-term care facilities, correctional facilities, and homeless shelters.
  • This change only pertains to quarantine recommendations for individuals and will not impact our case surveillance/case classification process for purposes of reporting probable or confirmed cases to CDC.
  • The recommendations for isolation with active disease or asymptomatic positive testing remain unchanged

• COVID-19 Vaccination Training Programs and Reference Materials for Healthcare Professionals
  • https://www.cdc.gov/vaccines/covid-19/downloads/COVID-19-Clinical-Training-and-Resources-for-HCPs.pdf

• Updated COVID-19 Vaccination FAQs
  • New questions were added to address the Novavax COVID-19 vaccine. Information was updated on the status of vaccines for children 6 months through 4 and 5 years of age and guidance for people vaccinated with COVID-19 vaccines not authorized in the United States. Information was consolidated in the Vaccination: Records section.

• Updated Health Professionals Page
  • Added links to two recent MMWR articles
  • Added resource link for Healthcare Provider FAQs

CDC

• Updated: 
  • Updated CDC Pediatric COVID-19 Vaccination Operational Planning Guide — Information for the COVID-19 Vaccine for Children 6 Months through 4 Years Old and/or COVID-19 Vaccine for Children 6 Months through 5 Years Old - 
    • The Planning Guide was updated to include details about the anticipated Pfizer-BioNTech vaccine for children ages 6 months through 4 years, the Moderna vaccine for children ages 6 months through 5 years, as well as the pre-order process and related assumptions. Additional information is available at COVID-19 Vaccination for Children | CDC.
    • New information and updates on ordering and vaccine products have been bolded throughout the document.

• New: HAN Health Advisory: COVID-19 Rebound After Paxlovid Treatment
  • On May 24, 2022, the Centers for Disease Control and Prevention (CDC) issued a Health Alert Network (HAN) Health Advisory to update healthcare providers, public health departments, and the public on the potential for recurrence of COVID-19 or “COVID-19 rebound.” Paxlovid (nirmatrelvir with ritonavir) continues to be recommended for early-stage treatment of mild to moderate COVID-19 among persons at high risk for progression to severe disease.
  • COVID-19 rebound has been reported to occur between 2 and 8 days after initial recovery and is characterized by a recurrence of COVID-19 symptoms or a new positive viral test after having tested negative. A brief return of symptoms may be part of the natural history of SARS-CoV-2 (the virus that causes COVID-19) infection in some persons, independent of treatment with Paxlovid, and regardless of vaccination status.
  • Limited information currently available from case reports suggests that persons treated with Paxlovid who experience COVID-19 rebound have had mild illness; there are no reports of severe disease. There is currently no evidence that additional treatment is needed with Paxlovid or other anti-SARS-CoV-2 therapies in cases where COVID-19 rebound is suspected.
  • Regardless of whether the patient has been treated with an antiviral agent, risk of transmission during COVID-19 rebound can be managed by following CDC’s guidance on isolation, including taking other precautions such as masking.
• Updated:
  • Stay Up to Date with Your COVID-19 Vaccines
    • Updated with booster recommendations for children ages 5-11 years.
  • COVID-19 Vaccines for People who are Moderately or Severely Immunocompromised
    • Children ages 5 through 11 years who are moderately or severely immunocompromised should receive a total of 4 doses of Pfizer-BioNTech COVID-19 vaccine to stay up to date. The 4 doses include a primary series of 3 doses, plus 1 booster (4th dose).
    • People ages 12 years and older who are moderately or severely immunocompromised should receive a total of 5 doses of mRNA COVID-19 vaccine to stay up to date. The 5 doses include a primary series of 3 doses of Pfizer-BioNTech or Moderna COVID-19 vaccine, plus 2 boosters of Pfizer-BioNTech or Moderna COVID-19 vaccine. Note that Pfizer-BioNTech COVID-19 vaccine is the only vaccine currently available for teens aged 12–17 years.
  • COVID-19 Vaccine Boosters
    • The “Getting Your COVID-19 Booster” tool was updated with booster recommendations for 5 to 11 year olds and stronger second booster recommendations for people aged 12 years and older who are immunocompromised and people aged 50 years and older.
  • COVID-19 Vaccines for People Vaccinated Outside the United States
    • The updated guidance includes recommendations for people who received COVID-19 vaccines outside of the United States. CDC recommends that people who received a COVID-19 vaccine that FDA has not authorized or approved, or that WHO does not list for emergency use, start COVID-19 vaccination over with an FDA-authorized or approved COVID-19 vaccine. Before receiving an FDA-authorized or approved COVID-19 vaccine, wait at least 28 days after the last dose of the non-FDA-authorized or approved vaccine.

FDA 

• Novavax

• • Yesterday FDA's independent committee of scientists, VRBPAC, met to discuss and vote on whether Novavax should receive Emergency Use Authorization (EUA).
    • This vaccine uses a protein adjuvant provided in 2 doses 21 days apart to people 18 years of age and up.
    • The committee voted 21-0 (1 abstention) that it receive the EUA to ensure an alternative to existing vaccines available in the US for multiple reasons (allergy, hesitancy).
    • The recorded session can be found here and the meeting documents can be found here.
    • Our federal partners confirmed yesterday that the US government will purchase this vaccine and there will be a small allocation available in the future but it is likely not until August 2022 that this vaccine will be able to be distributed. 
    • The FDA Commissioner will take action next but we do not have a timeline for this.
    • If EUA is issued, we expect ACIP to still meet to discuss this vaccine recommendation and the CDC Director to make final recommendations. There is no timeline posted for these actions.
    • In the meantime VDH is posting a "banner" on the  https://www.vdh.virginia.gov/covid-19-vaccine/ to let the public know VDH is aware of Novavax and will update as more information becomes available.
• FDA Announces Tentative Advisory Committee Meeting Schedule Regarding COVID-19 Vaccines - On May 23, 2022, the Food and Drug Administration (FDA) revised the dates of the upcoming Vaccines and Related Biological Products Advisory Committee meetings due to new data from sponsors and expected submissions of emergency use authorization (EUA) requests. The new dates are as follows:
  • June 14 will be the new meeting date for the FDA and its advisory committee of external experts to discuss Moderna’s COVID-19 vaccine EUA request for 6 years through 17 years of age.
  • June 15 will be the new meeting date for the Moderna COVID-19 vaccine EUA request for 6 months through 5 years of age and Pfizer-BioNTech’s COVID-19 vaccine EUA request for 6 months through 4 years of age, based on expected completion of an EUA submission.
  • Information on how to view the meetings can be found here: Vaccines and Related Biological Products Advisory Committee June 14-15, 2022 Meeting Announcement 

VDH

• Pediatric (6m - under 5 years of age)

• • We have received several inquiries from parents who have called their pediatrician and local health department to ask questions about the upcoming 6mo - under 5 years of age vaccine rollout. We understand that access to, and the consistency of, information plays a critical role in a successful response, so we're sharing the linked talking points. In particular, it will be important to reiterate that we are in close coordination with our provider partners and that all children seeking the vaccine will have access within a few weeks of its approval and release. VDH is also posting a "banner" on the  https://www.vdh.virginia.gov/covid-19-vaccine/ to let the public know VDH is working through the distribution of these vaccines and that parents should contact their child's pediatrician and keep checking the VDH websites as more information becomes available.  

• Preordering for the second threshold of the Pfizer (under 5 years of age) and Moderna (under 6 years of age) COVID-19 vaccines for younger children closes at 12 PM on June 10, 2022. If you would like to request vaccine, please work with the allocation lead for your health district.
  • Vaccine requested from threshold 1 is scheduled to arrive on June 20, 2022 (Juneteenth observed). If your facility has requested vaccine from threshold 1, please ensure someone will be on-site to receive the shipment.
  • Vaccine requested from threshold 2 is scheduled to arrive on June 23, 2022 or later.

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

• Check out our complete list of COVID-19 Vaccination Clinic Best Practices and our Lightning Learnings: Best Practices for Busy Providers!

• Building a Village: Community Linkages for COVID-19 Vaccines and Beyond
  • Ahead of a potential Emergency Use Authorization of the COVID-19 vaccine for children under 5 years of age, please join the Health Resources and Services Administration (HRSA) for a special Town Hall event to identify partnership opportunities and provide a more comprehensive system of services and care for childhood COVID-19 vaccines and beyond. The event will feature panelists from HRSA’s Maternal and Child Health Bureau, Bureau of Primary Health Care, and Health Systems Bureau.
  • The special town hall event will be held on Thursday, June 9, 3-4:30 p.m. ET.
  • Registration can be found here.

VDH External Web Updates

• Updated: Health Professionals page - Added new first vaccine booster recommendations for 5 to 11 year old children and (separately) strengthened ("should" vs "may") second booster recommendations for immunocompromised people ages 12 years and older and those 50 years and older
• Facts About COVID-19 page - Updated section about vaccines with "more than a million people have died of COVID-19", and general language edits.
• Health Professionals page - Added 2 new topics to "Hot Topics" section: "COVID-19 rebound after Paxlovid treatment" & "COVID-19 vaccine first booster dose recommendations extended to include 5-11 year old children". Added 1 new MMWR: "Frequency of Long COVID conditions among U.S. COVID-19 patients".
• Vaccination FAQs -
  • Updated vaccine dashboard with recent changes
  • Updated factsheets for Pfizer-BioNtech COVID-19 vaccines
  • Updated status of COVID-19 vaccines for younger children and booster recommendations for children aged 5-11 years
  • Incorporated recent changes strengthening second booster recommendations for certain individuals and the definition of “up to date.”