Vaccine Updates: Moderna Life Span Approval, Training and Resources & July 4th Deliveries

• Moderna 6-11 Years: A two-dose Moderna COVID-19 vaccines series (50ug) is recommended for children ages 6-11 years, under the EUA issued by FDA.
  • Ordering for this product, Dark Blue Cap/Purple Border, will open next week in Philavax on the 29th. Monday.com ordering will open the following week.
• Moderna 12-17 Years: A two-dose Moderna COVID-19 vaccines series (100ug) is recommended for children ages 12-17 years, under the EUA issued by FDA.

Training and Resources

• Vial Wallchart – Moderna COVID-19 Vaccines (see also this version)
• Vial for Peds 6mths-5years – Moderna Peds COVID-19 Vaccines 
• What to Expect – HCP Letter – Moderna Peds COVID-19 Vaccines  
• Videos – Dosing and Administration Moderna Peds COVID-19 Vaccines
• Dear Healthcare Provider Letter – Moderna 6-11 COVID-19 Vaccine
• LOA – Moderna 6mths – 17yrs COVID Vaccines

• Tuesday, June 28 at 3 pm ET (2 pm CT / 12 pm PT)
• Thursday, July 7 at 12 pm ET (11 am CT / 9 am PT)
• Tuesday, July 12 at 2 pm ET (1 pm CT / 11 am PT)
• Tuesday, July 19 at 12 pm ET (11 am CT / 9 am PT)

• Trainings now include presentations on COVID-19 vaccines with a MAROON Cap for individuals 6 months through 4 years of age.
• For details, see dates and links for upcoming training sessions.
• Daily trainings (Monday through Friday) will begin Monday, June 20, 2022, and continue at least through July 8, 2022 (with no training on July 4th).

Fourth of July Deliveries

• No vaccine deliveries will occur Saturday July 2 through Tuesday, July 5, 2022.

• No vaccine deliveries will occur on Saturday, July 2 through Monday, July 4, 2022.

Key Messages for Younger Pediatric COVID-19 Vaccination

KEY DATES

• If you placed an order in Philavax before 6/8/22 at 5pm, your order will be arriving between the 21st and 24th.
• If you placed an order in Philavax between 6/8/22 – 6/22/22 at 5pm, your order will most likely be arriving the week of the 27th (exact delivery TBD).
• If you placed an order via Monday.com before 6/22/22 at 5pm, your order will be arriving 6/28/22.
• ACIP will be meeting to discuss recommendations for the recently authorized Moderna COVID-19 Vaccine for ages 6-17 years on June 23rd.

KEY MESSAGES   

• Parents make decisions every day to protect their children, and now COVID-19 vaccines are available to protect all children 6 months and older.
• Both the Moderna and Pfizer-BioNTech COVID0-19 vaccines have been approved for children ages 6 months through 5 years.
• The Moderna vaccine for children ages 6 months through 5 years will be a two-dose primary series.
• The Pfizer-BioNTech vaccine for children ages 6 months through 4 years will be a three-dose primary series.

• Thousands of children were part of robust clinical trials to evaluate the safety of the COVID-19 vaccines and how well they worked.
• Parents and caregivers are encouraged to register their children for v-safe to share how their child is feeling after vaccination. V-safe uses confidential text messaging and web surveys to provide personalized health check-ins following COVID-19 vaccination.
• To help enroll more children in v-safe, providers are encouraged to give families information on v-safe (and why it is important and beneficial) at the time of vaccination.
• Children and teens can get a COVID-19 vaccine and other routinely recommended vaccines, including a flu vaccine, at the same visit.

• To find COVID-19 vaccines for children, parents and caregivers can talk to a doctor, nurse, pharmacist, visit vaccines.gov.
  • VaccineFinder should be updated to search for under five vaccines on WED/THUR.

• Reported side effects tend to be mild and temporary. Some children have no side effects.​
• Serious health events, like myocarditis, after COVID-19 vaccination in children are rare. When they are reported, side effects occur most frequently within a few days after vaccination.

RESOURCES

• Interim Clinical Considerations for Use of COVID-19 Vaccines
• Planning COVID-19 Vaccination for Children | CDC
  • Updated Pediatric COVID-19 Vaccination Operational Planning Guide-Information for Vaccine for Children 6 Months through 4 Years, and Children 6 Months through 5 Years Old (cdc.gov)
• Resources to Promote the COVID-19 Vaccine for Children & Teens | CDC
• Equity in Childhood COVID-19 Vaccination (cdc.gov)
• CDC COVID Data Tracker
• Ways Health Departments Can Help Increase COVID-19 Vaccinations | CDC
• What to Consider When Planning to Operate a COVID-19 Vaccine Clinic
• How Schools and Early Care and Education (ECE) Programs Can Support COVID-19 Vaccination
  • Hosting Vaccination Clinics: Best Practices for School Districts and Early Care and Education (ECE) Programs
  • Customizable Content for School and Childcare-Located Vaccination Clinics
  • Considerations for Planning School-Located Vaccination Clinics

• COVID-19 Vaccines for Children and Teens | CDC
• Frequently Asked Questions about COVID-19 Vaccination in Children | CDC
• 6 Things to Know about COVID-19 Vaccination for Children | CDC
• V-safe After Vaccination Health Checker | CDC

• Spikevax and Moderna COVID-19 Vaccine | FDA
• Comirnaty and Pfizer-BioNTech COVID-19 Vaccine | FDA

Upcoming Under 5 Vaccine Info Sessions

Pfizer and Moderna under 5 vaccines are tentatively scheduled for delivery between the 21st to 24th. As these dates are quickly approaching, PDPH will be offering provider information sessions next week (dates below). These sessions will cover what we currently know about the under 5 vaccines. It will also provide resources and links where providers can go to access additional information, updates, and tools. Pfizer is also offering info sessions next week (dates below as well). Moderna will begin offering info sessions once their vaccine is approved.

PREP Act: Pharmacists Cannot Vaccinate Children Under Age 3

In preparation for the rollout of under 5 vaccines, we wanted to reminder COVID-19 vaccine providers about the PREP Act, its coverage, and limitations. While many pharmacies are planning for a COVID-19 vaccination program for children under 5 years and have also been critical in the distribution of COVID-19 vaccines for other age groups, their ability to vaccinate these children (under 5) may be limited for various reasons (i.e., PREP Act Declaration authorizations).

The Public Readiness and Emergency Preparedness (PREP) Act and the PREP Act Declaration issued by the Secretary of the U.S. Department of Health and Human Services (HHS) authorize and provide liability protections to licensed providers and others identified in the declaration to administer COVID-19 vaccines authorized or approved by FDA, including COVID-19 vaccines authorized for administration to children. Subject to certain requirements, the recent PREP Act Declaration Third Amendment and HHS guidance authorize licensed pharmacists to order and administer ACIP-recommended vaccines to children ages 3 through 18. Due to this specification, children under the age of 3 are unable to be vaccinated by pharmacists/at pharmacies. It is recommended that pharmacists direct parents of children in this age group to vaccines.gov to find a provider who can offer them vaccination services.

For providers with additional questions regarding the PREP act, please see the following PREP Act guidance.

Pre-Ordering for Under 5 Vaccines Now Open in Philavax

Pfizer-BioNTech and Moderna are conducting clinical trials and data collection for COVID-19 vaccines for children ages 6 months through 4 years and 6 months through 5 years, respectively. Both companies have submitted data for review to the FDA. The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) is tentatively scheduled to meet on June 15, 2022, to discuss both the Pfizer-BioNTech vaccine for children aged 6m–4 years and the Moderna vaccine for children aged 6m–5 years. The CDC’s Advisory Committee on Immunization Practices (ACIP) is anticipated to meet within several days of VRBPAC, to make official recommendations.

In anticipation of the vaccine rollout, pre-ordering for both of these formulations (Moderna and Pfizer) is now open in Philavax. Between now and Wednesday, the 8th, at 5pm, COVID-19 vaccine providers can place a pre-order for the under 5 vaccines. Submission of both a temperature log and a reconciliation is also required to process provider orders. While both formulations (Moderna and Pfizer) will be available for ordering in the system, providers are strongly encouraged to order and stick with one under 5 vaccine product/manufacturer in order to prevent administration and handling errors.

Shipment of Pfizer-BioNTech COVID-19 vaccine for ages 6m–4 years and/or Moderna COVID-19 vaccine for ages 6m–5 years is planned to begin once FDA issues the EUA(s), tentatively arriving between the 23rd-29th. However, vaccine administration can only begin following the CDC/ACIP recommendation(s).

Here’s what we know about both vaccines so far (which could change pending FDA review):

CDC Expands Eligibility for COVID-19 Booster Shots

Following yesterday’s meeting of the Advisory Committee on Immunization Practices, CDC is expanding eligibility of COVID-19 vaccine booster doses to everyone 5 years of age and older. CDC now recommends that children ages 5 through 11 years should receive a booster shot 5 months after their initial Pfizer-BioNTech vaccination series.

Since the pandemic began, more than 4.8 million children ages 5 through 11 have been diagnosed with COVID-19, 15,000 have been hospitalized and, tragically, over 180 have died. As cases increase across the country, a booster dose will safely help restore and enhance protection against severe disease.

Weekly Reporting Beginning May 1

UPDATE: As of May 1, 2022, providers are only required to report COVID-19 vaccine supply levels at least weekly by close of business on Fridays. Daily reporting of inventory to VaccineFinder is no longer required. All other requirements regarding data reporting, to the IIS for example, remain unchanged.

We appreciate your efforts to update data in VaccineFinder. If your site does not have access to VaccineFiner or needs to change the primary or backup contact for VaccineFinder, please reach out to covidproviders@phila.gov. Please note that only two individuals can receive registration links for VaccineFinder. In some instances, sites may only be able to have one individual reporting to VaccineFinder depending on how the account was initially setup.