COVID-19 Vaccine Providers Newsletter 06.29.2022

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.

Upcoming Events

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