Upcoming Webinar: Protecting Kids from COVID-19

Many caregivers feel there’s no serious COVID-19 risk for their children, but hospitalizations and deaths persist in this age group, even without comorbidities.

Please join Moderna along with a panel of national experts on Tuesday, December 5, 2023 at 12:00 p.m. EST for a live, virtual event discussing COVID-19 and kids.

Topics will include:

• The burden of pediatric COVID-19

• Factors associated with severe outcomes

• Past versus current vaccination uptake

• Pediatric-specific risks and benefits

• Common caregiver questions

In order to receive a webinar replay link, you must be registered for the event.

COVID-19 Remains a Leading Health Burden in Pediatrics

Pediatric COVID-19 Vaccinations: A Step-by-Step Guide from Moderna

Amid Modern’s ongoing efforts to safeguard children's health against COVID-19, they are reaching out to all customers to clarify the dosage and administration instructions for the COVID-19 Vaccine (2023-2024 Formula) authorized for ages 6 months through 11 years of age. Moderna‘s COVID-19 Vaccine (2023-2024 Formula) for ages 6 months through 11 years is supplied in single dose vials. A single dose for this age group is 0.25 mL. The single dose vials contain notably more than 0.25 mL of vaccine. Only a single 0.25 mL dose should be withdrawn from the vial. Discard the vial and excess volume after extracting a single dose.

To further support HCP education on our pediatric vials, please see the resources referenced below to all relevant constituents:

• “Dear HCP Letter” attached provides a thorough explanation of the dosing and administration guidance for our pediatric vials

• Training Video provides a step-by-step guide for accurately drawing and administering the pediatric COVID-19 vaccine from our vials, ensuring each child receives the proper dose.

Pfizer COVID-19 Vaccine NDC Notification

Updated COVID-19 vaccines from BioNTech and Pfizer are available. Here is a brief update on the market landscape:

• Pfizer has substantial supply of 2023-2024 Formula COVID-19 vaccines and does not have any shortages at this time. 

• Following FDA approval and emergency use authorization, the CDC issued recommendations the week of September 11, 2023.

• Pfizer has shipped and delivered several million doses of 2023-2024 Formula COVID-19 vaccines. We continue to fulfill orders and anticipate delivering millions of additional doses each week.

• Pfizer is actively working with our Wholesaler and Distributors partners and customers to help ensure access by shipping product directly to customers when and where needed.

Regarding reimbursement, there may be confusion related to reimbursement for COVID-19 vaccines and out of pocket costs to patients.  Under Section 3203 of the CARES Act and subsequent U.S. government guidance, most commercial health plans (excluding ACA grandfathered plans), must cover updated ACIP-recommended COVID-19 vaccines and their administration with no patient cost-sharing immediately upon approval or authorization for emergency use. As a result, commercial health plans must cover and reimburse claims for the updated Pfizer-BioNTech COVID-10 vaccines (2023-24 formula) as of the date of FDA approval and emergency use authorization on September 11, 2023.

In July 2023, HHS issued guidance to payors to prepare to cover COVID-19 vaccination with the onset of the COVID-19 vaccine Commercialization. To review this letter click on the attached link Letter from HHS Secretary on COVID-19 Vaccine Coverage | HHS.gov

 Click here to request a call from a Pfizer Vaccines Representative for information about updated COVID-19 vaccines from BioNTech and Pfizer or contact Tina Clark, your local Pfizer Vaccines Representative.

Vaccinate Against RSV this Respiratory Season

There are options to help prevent RSV and its potential serious consequences on infants and older adults this respiratory season.  ABRYSVOTM (Respiratory Syncytial Virus Vaccine) from Pfizer is the only FDA-approved and ACIP-recommended RSV vaccine to help protect both older adults and infants (via maternal immunization) from RSV.

RSV can lead to serious outcomes in older adults (annual data)

• 2.2 million symptomatic illnesses

• 60,000-160,000 hospitalizations

• 6000-10,000 deaths

RSV is the leading cause of hospitalization in infants aged <1 year

• Hospitalization burden is greatest in infants under 6 months of age, peaking between 1 and 2 months of age 3

• In severe cases, RSV may result in acute respiratory failure, hypoxia and carbon dioxide retention, apnea, and death

Please review the Indications and Important Safety Information for ABRYSVO™ below.

ABRYSVO™ is ACIP recommended

• The CDC’s ACIP recommends ABRYSVO™ for adults 60 years and older based on shared clinical decision making.6 The recommendation was published in the July 21, 2023, issue of MMWR, and is available here.

• The CDC's ACIP recommends ABRYSVO for pregnant people as a one-time dose at 32 weeks and zero days’ through 36 weeks and 6 days’ gestation using seasonal administration (meaning September–January in most of the continental United States) for prevention of RSV-associated LRTI in infants aged <6 months.  The recommendation was published in the October 6, 2023, issue of MMWR, and is available here.

ABRYSVO™ is ACOG recommended

• The American College of Obstetricians and Gynecologists (ACOG) recommends a single dose of maternal RSV vaccination for pregnant individuals 32 through 36 weeks gestation*, using seasonal administration, to prevent RSV lower respiratory tract infection in infants.

* Beginning on the first day of the 32nd week through the last day of the 36th week

Moderna Resources for PRN Members

Moderna is striving to support every entity as best as possible to make this COVID season as easy as possible from our end.  Click here to access a live, hyperlinked PDF where healthcare professionals can find a library of resources for their education as well as for patient use. 

Click here to see the CPT codes developed to describe the Moderna COVID-19 2023-24 vaccine formula.

Information for Ordering Select Updated COVID-19 Vaccines

As you may know, updated COVID-19 vaccines from BioNTech and Pfizer are now available. These vaccines target an XBB.1.5 lineage of the Omicron variant.

Eligible HCPs can continue to prepare for patient needs by placing an order for updated COVID-19 vaccines through Pfizer Prime or by contacting their wholesaler for additional options.

UPDATE: The minimum order quantity for 12 years of age and older (30 mcg) single dose vial has been lowered from 100 doses to 50 doses. If placing an order, it is recommended to order 6-8 business days prior to when you would like it delivered. If you have any questions, please let me know.

Pfizer and BioNTech offer a flexible return policy on COVID-19 vaccine orders subject to the Pfizer Terms of Sale/Return Goods Policy, which is available on Pfizer Prime and may be updated by Pfizer at any time. Billing occurs at the time of shipping. If you are an HCP, and do not currently have a direct account, I can walk you through an additional ordering process to set up a Pfizer Prime account and place a direct order.

Please click here for additional information on ordering and don’t hesitate to contact me with any questions you may have.

Updated 2023 MMMR Pneumococcal Vaccine Recommendations in Children

The CDC has published its Morbidity and Mortality Weekly Report (MMWR)—ACIP Updates: Recommendations for the Use of 20-Valent Pneumococcal Conjugate Vaccine in Children ― United States, 2023.

 A link to this report is available on the CDC website and can be found here. 

Updated Terms of Sale/Return Goods Policy for COVID-19 vaccines from BioNTech and Pfizer

Pfizer has updated its Terms of Sale/Return Goods Policy for the 6 months through 4 years of age yellow cap presentation of Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula). Credit will be issued for returned expired or discontinued units of COVID-19 vaccine presentation for ages 6 months to <5y, three (3) dose Vial, (10 pack) 59267-4315-for 100% of the total doses purchased during the “Season” (as defined by the Policy). Please review the updated Policy linked below for complete terms.

Important Prescribing Information from Moderna

 On September 11, 2023, the U.S. Food and Drug Administration:

• authorized Moderna COVID-19 Vaccine (2023-2024 Formula) for Emergency Use in individuals 6 months through 11 years of age.

• approved SPIKEVAX (COVID-19 Vaccine, mRNA) (2023-2024 Formula) for use in individuals 12 years of age and older.

• removed authorization for use of Moderna COVID-19 Vaccine, Bivalent for use in the U.S.

The COVID-19 vaccines (2023-2024 Formula) are monovalent and encode the spike protein of SARS-CoV-2 Omicron variant lineage XBB.1.5.

Moderna COVID-19 Vaccine (2023-2024 Formula) authorized for ages 6 months through 11 years is supplied in single dose vials. SPIKEVAX (2023-2024) Formula approved for ages 12 years and older is supplied in single dose vials and single dose pre-filled syringes (see table below).

Should you have any questions about the use of Moderna COVID-19 Vaccine (2023-2024 Formula) or SPIKEVAX (COVID-19 Vaccine, mRNA) (2023-2024 Formula), you can either contact your PRN Administrator or you can contact the Moderna Medical Information Contact Center at 1-866-MODERNA (1-866-663-3762) or visit www.modernatx.com/covid19vaccine-eua or www.spikevax.com or for additional resources.