Thimerosal in Sanofi’s Fluzone Multi-Dose Vials Update

On July 23, 2025, the U.S. Department of Health and Human Services (HHS) officially adopted the Advisory Committee on Immunization Practices (ACIP) recommendation to remove thimerosal—a mercury-based preservative—from all influenza vaccines distributed in the United States.

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How Does this Recommendation Relate to the Multi-Dose Vials of Sanofi’s Fluzone?

The multi-dose vials of Sanofi’s Fluzone contain a small amount of thimerosal, and as such, fall under the recommendation to remove thimerosal from all U.S. influenza vaccines.

Considering the recommendation change, Sanofi will NOT ship your MDV Fluzone without confirmation of your original order OR a change to another product selection.

• Confirming your order of MDV Fluzone: Those who would like to receive their order of MDV Fluzone to administer this flu season MUST confirm your order by calling Sanofi’s customer service department at 1-800-822-2463.
  • Remember: Sanofi will NOT ship any doses of Fluzone multi-dose vials without a confirmation from your office.
    
• Changing your order of MDV Fluzone to a different product: If you have purchased MDV Fluzone and would like to change to a different product selection, please call Sanofi’s customer service department at 1-800-822-2463.
  • Should you prefer thimerosal-free prefilled syringes (FPS) of Fluzone* for the coming 2025-2026 season, Sanofi has ample supply to accommodate a modification to your order. (There is an additional cost for the Fluzone in PFS)

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In conclusion, the recent HHS adoption of ACIP’s recommendation to eliminate thimerosal from all U.S. influenza vaccines, providers who prebooked Sanofi’s Fluzone multi-dose vials must take action. If you intend to keep your MDV order or switch to a thimerosal-free alternative, please contact Sanofi Customer Service at 1-800-822-2463. No MDV orders will be shipped without confirmation. Be sure to review your options and respond promptly to ensure your flu vaccine supply for the 2025–26 season.

More Resources:

Pfizer’s Comirnaty Shipping Timeline for 2025-26

As we head into the upcoming flu and COVID-19 season, it’s essential to stay informed and prepared. Pfizer has shared important updates regarding the 2025–26 shipping schedule for its Comirnaty COVID-19 vaccines. This includes critical information on shipment timing, product availability, storage guidelines, and regulatory updates across all eligible age groups.

We encourage all members to review these details closely to ensure timely planning and to make any necessary adjustments to your Pfizer Prime reservations. Staying ahead of these logistics will help support a smooth and effective vaccination season.

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Pfizer Prime Reservation Shipping Schedule for COMIRNATY ADULT (65y and older and 12y-64y at risk for severe COVID-19)

All dates are subject to change pending FDA action and approval timing

Pfizer plans to ship 35% of reserved COMIRNATY 12y+ doses in the week following 2025-26 FDA approval. For example, if FDA approval is received AUG 21, Pfizer anticipates starting to ship these doses the week of AUG 25.  

• No action is needed if you would like to receive your initial shipment on this schedule.
• If you would like to delay your initial shipment, you may do so by going to Pfizer Prime – changes must be made between WED AUG 20 – MON AUG 25.
• After MON AUG 25, if no change is made, the initial shipment will proceed as planned.
• As a reminder, reservations for 10 boxes or fewer will ship in full in the initial shipment.

As you are preparing for the upcoming shipments, we wanted to remind you that COMIRNATY 12y+ doses ship as a glass pre-filled syringe at refrigerator temperatures. Also, the 2025-26 formula COMIRNATY 12y+ product has a 12-month shelf life from the date of manufacture.

Pfizer Prime Reservation Shipping Schedule for COMIRNATY PEDIATRIC (5y-11y at risk for severe COVID-19)

All dates are subject to change pending FDA action and approval timing

Pfizer plans to ship reserved COMIRNATY 5y -11y doses upon ACIP recommendation, anticipated mid-September. All dates are subject to change pending regulatory approval and ACIP timing.

If you would like to receive reserved 5y-11y doses in advance of ACIP upon FDA approval, please contact Pfizer Vaccines Customer Service at 1-800-879-3477 to schedule an earlier date. Supply is not an anticipated constraint.

As a reminder, Pfizer’s 5y-11y COVID vaccines are a single dose vial stored at ultra-low temperatures.  Once converted to refrigerated temperatures, the product has a 10-week shelf life.

Pfizer Prime Reservation Plan for 6 months through 4 years, 2025-26 Formula COVID-19 Vaccine from BioNTech and Pfizer

As you may be aware, the FDA has recently communicated to Pfizer the intent to potentially not renew the EUA for COVID-19 Pediatric Vaccines, which would affect Pfizer’s vaccine for individuals aged 6 months through 4 years for the 2025-26 Season.

• If the FDA does not grant a 2025-26 EUA for Pfizer’s 6m -4y formulation, Pfizer will cancel all reservations that were placed for the 6m -4y product and of course, no doses would ship.
• If you would like to cancel your 6m – 4y product reservation as well as diluent reservation, call customer service at 1-800-879-3477.

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In conclusion, we ask our members to please review their current Pfizer Prime reservations and make any necessary changes before the stated deadlines. No action is required if you wish to receive your initial shipments as scheduled. Be aware of product-specific storage requirements and potential regulatory changes, particularly regarding the 6m–4y formulation. Stay tuned for further updates from Pfizer regarding the 2025–26 season.

More Comirnaty Resources:

Reserve Your Clinic’s COVID-19 Vaccines Now

COVID-19 vaccines from Moderna and Pfizer are now available for reservation for the 2025-2026 season. Additionally, Sanofi will offer Novavax’s COVID-19 vaccine, Nuvaxovid, for sale starting sometime in September or October. Please see below for additional information on each of these manufacturers’ COVID-19 vaccine programs.

Moderna

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Moderna offers three different COVID-19 vaccines tailored to different age groups of patients. Moderna’s available COVID-19 vaccines are:

• Moderna’s COVID-19 vaccine pediatric dose (patient 6 months to 11 years old)
• Spikevax (patients 12 years and older)
• mNexSpike (patients 65 years and older, as well as patients 12 years and older with a high-risk condition)

PCA members must sign a participation agreement and declaration form. Please contact Amy at abullock@primarycarealliance.com to confirm you are registered for the Moderna program.

Pfizer

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Pfizer offers three different COVID-19 vaccines tailored to different age groups of patients. Pfizer’s available COVID-19 vaccines are:

• BioNTech Pfizer mRNA pediatric dose (patients 6 months to 4 years old)
  • Must be reconstituted
• BioNTech Pfizer mRNA pediatric dose (patients 5 to 11 years old)
• Comirnaty (patients 12 years and older)

Pfizer is offering a 2% discount on reservations placed by July 31, 2025.

PCA members must specifically sign up for discounts on COVID-19 vaccines through the Pfizer portal. Please contact Amy at abullock@primarycarealliance.com to confirm you are registered for these discounts.

Sanofi

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While reservations are not available for Sanofi yet, this year Sanofi will offer Novavax’s COVID-19 vaccine, Nuvaxovid, and will be for sale starting sometime in September or October on a first come first serve basis.

• Nuvaxovid (patients 12 years and older)
  • Adjuvanted vaccine, not mRNA

Those wishing to purchase Nuvaxovid when it is on sale this fall can purchase on Sanofi’s website www.VaccineShop.com.

Conclusion

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As always, we recommend that each clinic review its COVID-19 vaccine usage for this year before reserving doses for the upcoming season. If you have any questions, please don’t hesitate to contact us by emailing Amy at abullock@primarycarealliance.com.