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 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.

Moderna COVID-19 Vaccine (23-24 Formula): Recent Updates for Healthcare Providers

Spikevax® (COVID-19 Vaccine, mRNA) Is Now FDA Approved

COVID-19 is still evolving and emerging XBB subvariants have been found to be even more transmissible than some previous variants and can evade prior immunity from COVID-19 infection and vaccination.1-3

Spikevax® (COVID-19 Vaccine, mRNA), is now FDA approved for patients 12+. SPIKEVAX® has been updated to help protect against the COVID-19 subvariants recommended in the June 2023 FDA VRBPAC.

Spikevax® is available in 2 presentations - single-dose vials and pre-filled syringes.4 Pre-filled syringes are ready to ship.

Spikevax is ready-to-use with no deep-freeze storage required4

•Ready-to-use formulation, no need to reconstitute4. •Once thawed, Spikevax can be stored refrigerated between 2°C to 8°C (36°F to 46°F) for up to 30 days prior to use4

IMPORTANT SAFETY INFORMATION

Contraindications

Do not administer SPIKEVAX® to individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of SPIKEVAX®.

Warnings and Precautions

•Management of Acute Allergic Reactions: Appropriate medical treatment to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of SPIKEVAX®. •Myocarditis and Pericarditis: Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within the first week following vaccination. The observed risk is highest in males 18 through 24 years of age. •Syncope (fainting): May occur in association with administration of injectable vaccines, including SPIKEVAX®. Procedures should be in place to avoid injury from fainting. •Altered Immunocompetence: Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished immune response to SPIKEVAX®. •Limitations of Vaccine Effectiveness: SPIKEVAX® may not protect all vaccine recipients.

FDA Takes Action on Updated mRNA COVID-19 Vaccines to Better Protect Against Currently Circulating Variants

For Immediate Release:

September 11, 2023

On September 11, the U.S. Food and Drug Administration took action approving and authorizing for emergency use updated COVID-19 vaccines formulated to more closely target currently circulating variants and to provide better protection against serious consequences of COVID-19, including hospitalization and death. Today’s actions relate to updated mRNA vaccines for 2023-2024 manufactured by ModernaTX Inc. and Pfizer Inc. Consistent with the totality of the evidence and input from the FDA’s expert advisors, these vaccines have been updated to include a monovalent (single) component that corresponds to the Omicron variant XBB.1.5.

What You Need to Know

  • Individuals 5 years of age and older regardless of previous vaccination are eligible to receive a single dose of an updated mRNA COVID-19 vaccine at least 2 months since the last dose of any COVID-19 vaccine. 

  • Individuals 6 months through 4 years of age who have previously been vaccinated against COVID-19 are eligible to receive one or two doses of an updated mRNA COVID-19 vaccine (timing and number of doses to administer depends on the previous COVID-19 vaccine received). 

  • Unvaccinated individuals 6 months through 4 years of age are eligible to receive three doses of the updated authorized Pfizer-BioNTech COVID-19 Vaccine or two doses of the updated authorized Moderna COVID-19 Vaccine.

  • The FDA is confident in the safety and effectiveness of these updated vaccines and the agency’s benefit-risk assessment demonstrates that the benefits of these vaccines for individuals 6 months of age and older outweigh their risks.

  • Individuals who receive an updated mRNA COVID-19 vaccine may experience similar side effects as those reported by individuals who previously received mRNA COVID-19 vaccines as described in the respective prescribing information or fact sheets.

  • The updated vaccines are expected to provide good protection against COVID-19 from the currently circulating variants. Barring the emergence of a markedly more virulent variant, the FDA anticipates that the composition of COVID-19 vaccines may need to be updated annually, as is done for the seasonal influenza vaccine. 

  • The U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet tomorrow (Sept. 12), to discuss clinical recommendations on who should receive an updated vaccine, as well as further considerations for specific populations such as immunocompromised and older individuals. 

  • Manufacturers have publicly announced that the updated vaccines would be ready this fall, and the FDA anticipates that the updated vaccines will be available in the near future.

“Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality. We very much encourage those who are eligible to consider getting vaccinated.”

The updated mRNA vaccines are each approved for individuals 12 years of age and older and are authorized under emergency use for individuals 6 months through 11 years of age. As part of today’s actions, the bivalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States.

Data Supporting the Updated mRNA COVID-19 Vaccines (2023-2024 Formula)

The mRNA COVID-19 vaccines approved and authorized today are supported by the FDA’s evaluation of manufacturing data to support the change to the 2023-2024 formula and non-clinical immune response data on the updated formulations including the XBB.1.5 component. 

  • The updated mRNA vaccines are manufactured using a similar process as previous formulations. In studies that have been recently conducted, the extent of neutralization observed by the updated vaccines against currently circulating viral variants causing COVID-19, including EG.5 and BA.2.86, appears to be of a similar magnitude to the extent of neutralization observed with prior versions of the vaccines against corresponding prior variants against which they had been developed to provide protection. This suggests that the vaccines are a good match for protecting against the currently circulating COVID-19 variants.

  • The benefit-risk profile of previously authorized and approved mRNA COVID-19 vaccines is well understood as these vaccines have been administered to hundreds of millions of people in the United States. 

Based on an evaluation of the totality of the evidence, the benefit-risk profile is favorable for individuals 6 months of age and older to receive an updated COVID-19 mRNA vaccine. Although serious outcomes from COVID-19 are less common in younger individuals, they do occur, and it has been demonstrated that recently receiving a COVID-19 vaccine reduces the risk of such serious outcomes.

Additional Details on Today’s Actions

Specifically, today’s actions include:

  • Approval of Comirnaty (COVID-19 Vaccine, mRNA) to include the 2023-2024 formula, and a change to a single dose for individuals 12 years of age and older. Comirnaty was previously approved as a two-dose series for individuals 12 years of age and older. 

  • Approval of Spikevax (COVID-19 Vaccine, mRNA) to include the 2023-2024 formula, a change to a single dose for individuals 18 years of age and older, and approval of a single dose for individuals 12 through 17 years of age. Spikevax was previously approved as a two-dose series for individuals 18 years of age and older. 

  • Authorization of Moderna COVID-19 Vaccine for emergency use in individuals 6 months through 11 years of age to include the 2023-2024 formula and lower the age eligibility for receipt of a single dose from 6 years to 5 years of age. Additional doses are also authorized for certain immunocompromised individuals ages 6 months through 11 years, as described in the fact sheets.

  • Authorization of Pfizer-BioNTech COVID-19 Vaccine for emergency use in individuals 6 months through 11 years of age to include the 2023-2024 formula. Additional doses are also authorized for certain immunocompromised individuals ages 6 months through 11 years, as described in the fact sheets.

The approval of Comirnaty (COVID-19 Vaccine, mRNA) (2023-2024 Formula) was granted to BioNTech Manufacturing GmbH. The EUA amendment for the Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) was issued to Pfizer Inc.

The approval of Spikevax (COVID-19 Vaccine, mRNA) (2023-2024 Formula) was granted to ModernaTX Inc. and the EUA amendment for the Moderna COVID-19 Vaccine (2023-2024 Formula) was issued to ModernaTX Inc.

Related Information

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

FDA approves Beyfortus™ (nirsevimab-alip) to protect infants against RSV disease

On July 17, 2023, The U.S. Food and Drug Administration (FDA) approved Beyfortus™, a long-acting antibody for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in all infants born during or entering their first RSV season and in children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. Here is the full press release with additional information.