• The U.S. Food and Drug Administration (FDA) has announced two upcoming meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to discuss newly available data regarding the three approved COVID-19 vaccines in the U.S.
  • VRBPAC is meeting on October 14 to15 to discuss booster doses of the Moderna and Johnson &Johnson/Janssen (J&J) COVID-19 vaccines. Given the timeline of previous decisions around COVID-19 vaccines, we are preparing for CDC guidance for the Moderna and J&J booster doses the week of October 18.
  • The committee will also hear presentations and discuss available data on the use of a booster of a different vaccine than the one used for the primary series of an authorized or approved COVID-19 vaccine (heterologous or “mix and match” booster).
  • VRBPAC will also meet on October 26 to discuss amending Pfizer-BioNTech’s Emergency Use Authorization (EUA) to include the use of its Pfizer COVID-19  vaccine among children aged 5 to 11years . We are preparing for CDC guidance for this age group to occur the week of November 1.
  • For more information, please refer to the FDA's press release here.
• NEW:  CDC Health Alert Network - COVID-19 Vaccination for Pregnant People to Prevent Serious Illness, Deaths, and Adverse Pregnancy Outcomes from COVID-19 - The Centers for Disease Control and Prevention (CDC) recommends urgent action to increase COVID-19 vaccination among people who are pregnant, recently pregnant (including those who are lactating), who are trying to become pregnant now, or who might become pregnant in the future. CDC strongly recommends COVID-19 vaccination either before or during pregnancy because the benefits of vaccination outweigh known or potential risks. As of September 27, 2021, more than 125,000 laboratory-confirmed COVID-19 cases have been reported in pregnant people, including more than 22,000 hospitalized cases and 161 deaths. Media Statement here.
• FDA: Press Release: FDA to Hold Advisory Committee Meetings to Discuss Emergency Use Authorization for Booster Doses and COVID-19 Vaccines for Younger Children On October 14 and 15, the advisory committee will meet to discuss the use of booster doses of the Moderna COVID-19 Vaccine and the Janssen COVID-19 Vaccine. Both vaccines are currently authorized for emergency use to prevent COVID-19 in individuals 18 years of age and older.  The FDA anticipates receiving a request from Pfizer to amend its emergency use authorization to allow the use of its COVID-19 vaccine in children 5 through 11 years of age. In anticipation of the request, the FDA is moving forward with scheduling an advisory committee meeting on October 26 to inform the agency’s decision-making.
• UPDATE: On October 1, the U.S. Department of Health and Human Services (HHS) made a technical amendment to the current COVID-19 Public Readiness and Emergency Preparedness (PREP) Act declaration. The amendment will clarify that liability immunity and Countermeasures Injury Compensation Program eligibility applies to any COVID-19 vaccine recommendation by CDC (including those adopted from ACIP recommendations). The updated declaration is available here.
• Vaccination FAQs
  • New: Doses of booster shot; examples of high-risk occupations or settings; booster guidance for HCPs; booster guidance for LTCFs
  • Updated: vaccination numbers; risk of reinfection after vaccination; updated fact sheets for Pfizer-BioNTech vaccine recipients and vaccine providers; duration of protection and booster doses; myocarditis and booster doses; pregnant people and booster doses; status of COVID-19 vaccines for children; definition of fully vaccinated; mobile units.

• Moderna Shelf Life Extension- We are being told that a shelf life extension is very likely to come through for Lots of Moderna currently in circulation, as long as they have been kept at frozen conditions. Please check at the site listed below to see if your Lots are subject to this extension. It may also take a few days to update on their site, so even if the doses don't register immediately please check again in a few days.
  • https://www.modernatx.com/covid19vaccine-eua/providers/vial-lookup

• Monoclonal Antibody Ordering Integration Into Vaxmax
  • Starting next Tuesday, mAB ordering will be available through your Vaxmax portal to alleviate having to place orders for different treatments in different places. To place an order you must already be enrolled with AmerisourceBergen as a supplier. We are going to keep the current REDCap request survey open through at least the end of next week to allow for continuity with our current process, but we ask that you place your request in one location or the other but not both.
  • If you're not currently an mAB provider but are interested in becoming one please reach out to our mAB inbox at mabs_requests@vdh.virginia.gov.
• For questions about VaxMaX and its functionality, please visit the VaxMaX Help website, which includes reference guides and tutorial videos.

• Now is the best time to encourage patients to receive their seasonal influenza vaccine if they haven't already. We support and encourage coadministration of the COVID-19 vaccine with other non-live vaccines, such as influenza (with the exception of Flumist). If multiple vaccines are administered at the same time, remember to administer each vaccine at a different injection site, at least 1 inch apart, or in separate arms. With the recent approval of Pfizer COVID-19 boosters, educate and encourage patients to get their booster and flu shot together!  For more information on coadministration, please refer to Interim Clinical Considerations for Use of COVID-19 Vaccines 
• Check out our complete list of COVID-19 Vaccination Clinic Best Practices and our Lightning Learnings: Best Practices for Busy Providers!

Upcoming Events

• NEW: CDC has developed a toolkit, “Festivals and Other Multi-Day Large Gatherings: COVID-19 Planning Toolkit for Health Departments”, to help health departments prevent the spread of COVID-19 at multi-day events that are expected to draw large numbers of people. It includes checklists, resources, and a case study that state and local health departments, event planners, vendors, and other partners can use to anticipate and plan for some of the challenges they could encounter.  Please click here  for more information.
• Disparities in COVID-19 Vaccination Status, Intent, and Perceived Access for Noninstitutionalized Adults, by Disability Status — National Immunization Survey Adult COVID Module, United States, May 30–June 26, 2021 - Compared with adults without a disability, those with a disability had a lower likelihood of having received COVID-19 vaccination, despite being less hesitant about getting vaccinated. Adults with a disability also reported more difficulties obtaining a COVID-19 vaccine than did persons without a disability. CDC resources for individuals with disabilities and their providers include: Toolkit for People with Disabilities and COVID-19 Accessible Resources Home | Center for Inclusive Design and Innovation.
• Counterfeit or fake vaccination cards should be reported to the HHS Office of the Inspector at 1-800-HHS-TIPS or www.oig.hhs.gov and the FBI at tips.fbi.gov.