• CDC - CDC Updates and Shortens Recommended Isolation and Quarantine Period for General Population
  • CDC is shortening the recommended time for isolation from 10 days to 5 days for people with COVID-19, if asymptomatic or symptoms are resolving, followed by 5 days of wearing a mask when around others.
  • CDC is also updating the recommended quarantine period for those exposed to someone with COVID-19:
    • For people who are unvaccinated or are more than six months out from their second mRNA dose (or more than 2 months after the J&J vaccine) and not yet boosted, CDC now recommends quarantine for 5 days followed by strict mask use for an additional 5 days. If a 5-day quarantine is not feasible, it is imperative that an exposed person wear a well-fitting mask at all times when around others for 10 days after exposure.
    • Individuals who have received their booster shot or who are within 6 months of receiving their second mRNA dose (or within 2 months of receiving their J&J vaccine) do not need to quarantine following an exposure, but should wear a mask for 10 days after the exposure.
    • For all those exposed, best practice would also include a test for SARS-CoV-2 at day 5 after exposure. If symptoms occur, individuals should immediately quarantine until a negative test confirms symptoms are not attributable to COVID-19.
• Potential rapid increase of Omicron variant. CDC has identified the potential for a rapid increase in infections of the new variant of SARS-CoV-2, the Omicron variant, in the United States. Plausible scenarios include steep epidemic trajectories that would require expedient public health action to prevent severe impacts on the health of individuals and the healthcare system. The CDC Center for Forecasting and Outbreak Analytics conducted scenario models to assess a range of plausible scenarios for the epidemic trajectory based on what is currently known about the Omicron variant. Recent case data of the Omicron variant from South Africa, Botswana, the United Kingdom and elsewhere are consistent with the faster growth scenarios that were modeled.
• Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States. CDC clinical considerations recommend the use of mRNA vaccines (Pfizer & Moderna) over the use of the Johnson & Johnson’sCOVID-19 vaccine in most situations, unless there are contraindications. These considerations include preference for mRNA COVID-19 vaccines for primary and booster doses.
• CDC - CDC endorses ACIP’s updated COVID-19 vaccine recommendations - CDC is endorsing updated recommendations made by the Advisory Committee on Immunization Practices (ACIP) for the prevention of COVID-19, expressing a clinical preference for individuals to receive an mRNA COVID-19 vaccine over Johnson & Johnson’s COVID-19 vaccine. ACIP’s unanimous recommendation followed a robust discussion of the latest evidence on vaccine effectiveness, vaccine safety and rare adverse events, and consideration of the U.S. vaccine supply. The U.S. supply of mRNA vaccines is abundant – with nearly 100 million doses in the field for immediate use. This updated CDC recommendation follows similar recommendations from other countries, including Canada and the United Kingdom. Given the current state of the pandemic both here and around the world, the ACIP reaffirmed that receiving any vaccine is better than being unvaccinated. Individuals who are unable or unwilling to receive an mRNA vaccine will continue to have access to Johnson & Johnson’s COVID-19 vaccine.
  • CDC added a banner across some of its pages that reads: "CDC has updated its recommendations for COVID-19 vaccines with a preference for people to receive an mRNA COVID-19 vaccine (Pfizer-BioNTech and Moderna). Read CDC’s media statement."
  • CDC updated its websites, including the  Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States and the Johnson & Johnson’s Janssen COVID-19 Vaccine Overview and Safety page.
• CDC - HAN Rapid Increase of Omicron Variant Infections in the United States: Management of Healthcare Personnel with SARS-CoV-2 Infection or Exposure - Due to the increased transmissibility of the SARS-CoV-2 Omicron variant and concerns about potential impacts on the healthcare system, CDC is updating recommendations to enhance protection for healthcare personnel, patients, and visitors, and ensure adequate staffing in healthcare facilities. The guidance is based on the limited information currently available about the Omicron variant and will be updated as needed as new information becomes available. Provides background, key points from the two guidance documents listed below, and recommendations for HCP and healthcare facilities and systems.
• CDC- Interim Guidance for Managing Healthcare Personnel with SARS-CoV-2 Infection or Exposure to SARS-CoV-2 and Strategies to Mitigate Healthcare Personnel Staffing Shortages CDC released updated guidance for isolation and quarantine for healthcare personnel (HCP), decreasing their isolation time after infection with COVID-19. CDC also released updated guidance for contingency and crisis management in the setting of significant healthcare worker shortages.
• FDA Authorizes Oral Antiviral Treatments for COVID-19
  • FDA Authorizes First Oral Antiviral for Treatment of COVID-19 - The FDA issued an emergency use authorization (EUA) for Pfizer’s Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms or about 88 pounds) with positive results of direct SARS-CoV-2 testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. Paxlovid is available by prescription only and should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset. Fact sheets for healthcare providers and patients and caregivers are available.
  • FDA Authorizes Additional Oral Antiviral for Treatment of COVID-19 in Certain Adults - The FDA issued an emergency use authorization (EUA) for Merck’s molnupiravir for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate. Molnupiravir is available by prescription only and should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset. Molnupiravir is not authorized for use in patients younger than 18 years of age because molnupiravir may affect bone and cartilage growth. Based on findings from animal reproduction studies, molnupiravir may cause fetal harm when administered to pregnant individuals. Therefore, molnupiravir is not recommended for use during pregnancy or while breastfeeding. Fact sheets for healthcare providers and patients and caregivers are available.
• CDC Encourages Healthcare Providers to Recommend COVID-19 Self-testing Before Holiday Gatherings. CDC is encouraging healthcare providers to recommend COVID-19 self-testing before the holidays and includes considerations such as when to to get tested, where to get a self-test, and how to interpret self-test results. People should consider self-testing before joining indoor gatherings with others who are not in your household, or if you live with someone at higher risk for severe COVID-19, regardless of vaccination status or if they are having symptoms. Self-tests are available over-the-counter at pharmacies, community health centers, and online. Positive results mean a person should isolate and negative results mean that a person may not be contagious. However, CDC recommends that they test again at least 24 hours later.
• President Biden Announces New Actions to Protect and Help Communities and Hospitals Battle Omicron. On December 21, President Biden announced new actions to protect Americans and help communities and hospitals battle Omicron, building on the robust plan he announced earlier this month to get people maximum protection ahead of the winter and prepare for rising cases driven by the new variant.
  • Increase support for hospitals, including deploying additional medical personnel, expanding hospital capacity, and providing critical supplies
  • Ensure robust access to free testing, including standing up new federal testing sites, distributing free rapid tests starting in January, and further accelerating production
  • Expand capacity to get shots in arms, including standing up new pop-up vaccination clinics, deploying additional vaccinators, allowing flexibility to surge pharmacy teams, and continuing to scale up pharmacy capacity

• FDA has approved a shelf-life extension for the Pfizer Pediatric vaccine (Orange cap, 5-11 year old, diluent required) and the soon to be available Adol/Adult Tris (Gray Cap, age 12+ years, no diluent). This approval may be found at Healthcare Providers for 5-11 years of age, orange cap (must dilute) (fda.gov) ; Healthcare Providers for 12 years of age and older, gray cap (no dilution) (fda.gov) ) and takes effect immediately. This extension applies to frozen (ULT) inventories only.
  • As you are aware, the date printed on the Pfizer Pediatric (orange cap, 5-11 year old) and Adult/Adolescent (gray cap, 12+ years, no diluent) vaccine vials indicate the manufacture date and NOT the expiration date.  Originally, the expiration date was 6 months from the manufacture date.  The expiration date for Pfizer orange and gray cap vaccine has now been extended to 9 months (while held at ULT frozen.)  The Fact Sheets for both orange and gray cap vials provided by the FDA now read, “regardless of storage conditions, vaccines should not be used after 9 months from the date of manufacture printed on the vial and cartons”.  The updated expiry dates for both the orange and gray cap vials based on 9 months from the date of manufacture are provided below.

• Printed Manufacturing date : 9-Month Expiry Date

• • • 06/2021   : 02/28/2022
    • 07/2021   : 03/31/2022
    • 08/2021   : 04/30/2022
    • 09/2021   : 05/31/2022
    • 10/2021   : 06/30/2022
    • 11/2021   : 07/31/2022
    • 12/2021   : 08/31/2022
    • 01/2021   : 09/30/2022
    • 02/2021   : 10/31/2022

• The QR code provided on the Pfizer Pediatric Vaccine carton provides a link to the EUA but does not provide information on expiration dates.

 

• Please follow EUA recommendations for storage:
  • Pfizer 5 through 11 years of age formulation
    • If not previously thawed at 2ºC to 8ºC (35ºF to 46ºF), allow vials to thaw at room temperature [up to 25ºC (77ºF)] for 30 minutes.
    • Pfizer-BioNTech COVID-19 Vaccine multiple dose vials with orange caps and labels with orange borders may be stored at room temperature [8°C to 25°C (46°F to 77°F)] for a total of 12 hours prior to dilution.
    • After dilution, the vial should be held between 2ºC to 25°C (35°F to 77°F). Vials should be discarded 12 hours after dilution.
  • Pfizer 12 years and older formulation.
    • Frozen vials may be stored in an ultra-low temperature freezer at -90ºC to -60ºC (-130ºF to -76ºF). Do not store vials at -25°C to -15°C (-13°F to 5°F). Once vials are thawed they should not be refrozen.
    • Vials may be transferred to the refrigerator [2ºC to 8ºC (35ºF to 46ºF)], thawed and stored for up to 10 weeks. The 10-week refrigerated expiry date should be recorded on the carton at the time of transfer. A carton of 10 vials may take up to 6 hours to thaw at this temperature.
  • Regardless of storage condition, vaccines should not be used after 9 months from the date of manufacture printed on the vial and cartons.
• Small Shipment Redistribution Program (SSRP) Reminder: Important Updates
• Due to the holidays, SRRP will have a limited window to send all deliveries. Because of this, we are asking that providers only place an SSRP request if it is absolutely necessary to meet the demand for your facility over the next few weeks.
  • Orders placed December 30-31 will be shipped as normal on January 3
• New Year Holiday Cadence
  • NO ORDERS WILL BE DELIVERED THURSDAY, DECEMBER 30 THROUGH TUESDAY, JANUARY 4.
  • Pfizer -New Year Holiday

• • • No vaccine deliveries will occur Thursday, December 30 through Tuesday, January 4.
  • Moderna and J&J- New Year Holiday
    • No vaccine deliveries will occur Thursday, December 30 through Tuesday, January 4.

• 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!

Upcoming Events

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Webinar: How to Talk to a Science Denier on Tuesday, January 18, 2022 from 11:00 am–12:00 pm ET - In this webinar, hosted by the Kresge Foundation and the Emerging Leaders in Public Health National Program Office, Dr. Lee McIntyre, research fellow at the Center for Philosophy and History of Science at Boston University, instructor in ethics at Harvard Extension School, and author of the recent book, How to Talk to a Science Denier, will share his thoughts and recommendations on how to communicate with and potentially change the minds of those who reject scientific evidence. Register now.

• The Immunization Services Division is excited to announce a new resource developed by some of our partners -- the Vaccine Resource Hub (www.vaccineresourcehub.org) – which was created by the CDC Foundation as a part of the Partnering for Vaccine Equity program. The hope is that this public site will be a helpful tool as immunization program awardees continue their important work related to vaccine equity. You can also feel free to share it with any of your partners.
  • The site provides diverse and culturally relevant materials that all partners, including large national organizations, local health departments, and the general public, can use to educate and inform their community members about vaccinations for COVID-19 and influenza. Resources include infographics, toolkits, videos, unbranded digital assets, messaging, and much more. All materials hosted on the Hub have been assessed for accuracy and relevance, and they are free and available for download and sharing.
  • Please note, the Hub is being launched in two phases. During Phase One (now) the site already has many features, links, and content that you can search and download. In Phase Two (early 2022), the site will have even more content, pages, stories, webinars, and links. There is also a recorded training on how to use the site which is available on the home page of the Hub.  If you have questions about the Resource Hub, you may send them to info@vaccineresourcehub.org.
• VDH - COVID-19 Update for Virginia - December 20. VDH's Clinician Letter details the CDC's preference of mRNA vaccines over Janssen vaccines. Providers will also have to start reporting immunizations to the Virginia Immunization Information System beginning in January 2022.
• VDH - Health Professionals - Added a new Hot Topic about CDC's preference of mRNA COVID-19 vaccines over the Johson & Johnson vaccine and linked to CDC's updated clinical considerations
• VDH - Vaccination HCP web page under Resources for Vaccine Clinics: Updated the COVID-19 Vaccine Dosage and Scheduling Table to include the recommendation of a Pfizer booster for 16 and 17 year olds