For the 2025-26 respiratory season, we have expanded guidance and recommendations for respiratory syncytial virus (RSV) prevention, broader influenza vaccine eligibility, the elimination of thimerosal as an ingredient, and the transition to an annual vaccination cycle for COVID-19.
These developments have direct implications for clinical practice, patient care, and operational planning, and understanding these changes will be essential for staff involved in managing vaccination programs of all sizes. Our latest webinar covers the essentials and more, from high-level policy updates to what that means for you and your patients.
Topics
- Respiratory Syncytial Virus (RSV) Updates
- Influenza Updates
- COVID-19 Updates
- Respiratory Season with VaxCare
Vaccine Updates
Respiratory Syncytial Virus (RSV)
New Infant Product and Adult Recommendations
INFANT RSV
New Product
New RSV Preventive Option for Infant Administration, ENFLONSIA (clesrovimab-cfor).
- Long-Acting, Monoclonal Antibody Designed to Provide Rapid and Durable Protection for 5 Months
- Recommended for Use in Infants <8 Months of Age Born During or Entering Their First RSV Season
- Same Dose Regardless of Infant Weight
Timing: Once available, ENFLONSIA will be offered on a limited basis via a pilot program to assess payer coverage and reimbursement.
ADULT RSV
New Recommendation
ACIP Now Recommends Adults 50–74 Who Are at Increased Risk of RSV Receive a Single Dose of an RSV Vaccine
Full Recommendation Now Includes:
- All Adults Ages 75+
- Adults Ages 50–74 at Increased Risk
No CDC Preference Across the 3 FDA-Licensed RSV Vaccines:
- Arexvy
- Abrysvo (Also for Use During Pregnancy)
- mRESVIA
Available Products
| PRODUCT/AGENT | GROUP | AGE GROUP RECOMMENDATION |
|---|---|---|
| Pfizer Abrysvo RSV Vaccine* *Only vaccine approved for pregnant people. | Adult Pregnant People | 50–74 years at increased risk; ≥75 years During 32–36 Weeks Gestation |
| GSK Arexvy RSV Vaccine, Adjuvanted | Adult | 50–74 years at increased risk; ≥75 years |
| Moderna mResvia | Adult | ≥60 Years |
| Sanofi Beyfortus (nirsevimab-alip) Monoclonal Antibody | Pediatric | <8 Months, Born During or Entering Their First RSV Season 8–24 Months, for Those with Increased Risk for Severe RSV and Entering Their Second RSV Season |
| Merck Enflonsia (clesrovimab-cfor)* Monoclonal Antibody *Pending product availability and results of pilot program. | Pediatric | <8 months, born during or entering their first RSV season |
VaxCare’s platform enables partners to administer Medicare Part D vaccines to patients in your offices.
If you are interested in ordering pediatric, maternal, or adult RSV products, please contact help@vaxcare.com.
Vaccine Updates
Influenza
Recent Product Updates
Flublok Expanded Down to Age 9
FDA Expanded Label for Flublok to Include Patients 9–17 (Previously Only for 18+)
Product Can Now be Used for Patients 9+, and Continues to be Preferentially Recommended for Patients 65+ (in Addition to Fluzone High-Dose and Fluad Adjuvanted)
VaxCare System Updated to Reflect New Age Range
CDC and ACOG Recommend Flu Vaccination During Pregnancy: During the 2024 Flu Season, FDA Updated the Flublok Label to Include Data Demonstrating Flublok Safety is Consistent with a Standard-Dose Flu Vaccine and Pregnancy Related Outcomes in the General Population
Removal of Thimerosal
ACIP Modified Influenza Vaccine Recommendation to Include Only Single Dose Vials/Presentations That Do Not Contain the Preservative Thimerosal
This Change Will Not Impact Product Availability with VaxCare, as We Only Ship Single Dose Vials/Presentations
Available Products
| PRODUCT | TYPE | AGE INDICATION |
|---|---|---|
| Sanofi Fluzone Trivalent PFS | Egg Based | ≥6 months |
| Sanofi Fluzone High Dose Trivalent PFS | Egg Based | ≥65 years |
| Sanofi Flublok Trivalent PFS | Recombinant | ≥9 years |
| GSK Flulaval Trivalent PFS | Egg Based | ≥6 months |
| CSL Seqirus Flucelvax Trivalent PFS | Cell Based | ≥6 months |
| CSL Seqirus Fluad Trivalent PFS | Egg Based | ≥65 years |
| AstraZeneca FluMist Trivalent NS | Egg Based | 2 years–49 years |
Vaccine Updates
COVID-19
Timing and Product Updates
Approval and Recommendation
Ongoing SARS-CoV-2 Mutations Necessitate an Updated Vaccine for this Fall
Therefore, Similar to Influenza Vaccines, COVID-19 Vaccines Must Receive Annual FDA Approval and ACIP Recommendations
FDA approved the 2025–2026 COVID-19 Formulations on August 27, with New Indications Compared to Prior Years
Now, ACIP Must Make a Recommendation for the 2025–2026 COVID-19 formulation
Given the Delay in FDA Approval and Recommendation, COVID-19 vaccines are Shipping Later than Usual
Product Updates
Moderna’s Spikevax Received FDA Approval Down to 6 Months of Age for Patients with at Least One Underlying Condition that Puts Them at High Risk for Severe Outcomes from COVID-19; the Product was Previously Indicated for 12+; Spikevax has Different Dosing for Patients 6m–12y and 12+
Moderna’s New COVID-19 Vaccine, Mnexspike, also Received FDA Approval for the Following Age Groups:
- ≥65 Years
- 6 Months–64 Years with at Least One High Risk Condition
Available Products
| PRODUCT | DOSING | STORAGE & EXPIRATION | AGE GROUP |
|---|---|---|---|
| Pfizer Comirnaty PFS “Never Frozen” | 0.3 mL | 8 Months at Fridge Temperature | 12–64Y WITH RISK CONDITION; 65+ |
| Pfizer Pfizer-BioNTech Covid-19 Vaccine SDV “Blue Cap” | 0.3 mL | 10 Weeks at Fridge Temperature | 5–12Y WITH RISK CONDITION |
| Moderna Spikevax PFS | 0.5 mL | 12 Months, Frozen 60 Days, Once Thawed in Fridge | 12–64Y WITH RISK CONDITION; 65+ |
| Moderna Spikevax PFS | 0.25 mL | 12 Months, Frozen 60 Days, Once Thawed in Fridge | 6M–4Y, 5–12Y WITH RISK CONDITION |
| Moderna mNEXSPIKE | 0.2 mL | 12 Months, Frozen 60 Days, Once Thawed in Fridge | 12–64Y WITH RISK CONDITION; 65+ |
Pfizer’s previously authorized COVID-19 product for patients aged 6 months–4 years is no longer available. Any Partner who forecasted that product will instead receive Moderna’s Spikevax for the 6 month–4 year age cohort. Please look out for relevant communication if your practice is affected by this change.
Attestation of At-Risk Condition
To comply with new FDA indications, VaxCare is implementing a risk factor attestation for COVID-19 vaccine administration.
Providers will be required to confirm the patient has at least one condition that puts the patient at risk for severe outcomes from COVID-19 when administering a COVID-19 vaccine to patients aged 6 months through 64 years.
This attestation will ensure VaxCare and Partners comply with the new FDA label for COVID-19 vaccines.
Additionally, providers are encouraged to document the patient’s condition that puts them at risk for severe outcomes from COVID-19 in the medical chart.
At-Risk Conditions
The CDC considers patients with the following conditions, along with others, as having a health condition that puts them at risk for severe COVID-19:
- Cancer
- Cerebrovascular disease
- Chronic kidney disease
- Chronic liver disease
- Chronic lung disease
- Cystic fibrosis
- Dementia or other neurological conditions
- Diabetes (type 1 or 2)
- Disabilities
- Heart conditions
- Hemoglobin blood disorders
- HIV infection
- Immunocompromised or weakened immune system
- Mental health conditions
- Overweight and obesity
- Physical inactivity
- Smoking – current or former
- Solid organ or blood stem cell transplant
- Substance use disorders
- Tuberculosis
VaxCare Updates
Respiratory Season with VaxCare
VaxCare’s Adherence Programs
Respiratory / Flu Outreach
TARGETED PRODUCTS
Flu
TARGETED PATIENT AGE
6+ Months
Enrollment Closes Sep. 30
Infant
RSV
TARGETED PRODUCTS
Infant RSV Immunizations
TARGETED PATIENT AGE
0-8 Months
Enrollment Closes Nov. 28
Series Completion
TARGETED PRODUCTS
HPV, Zoster, MenACWY, MenB, MenABCWY
TARGETED PATIENT AGE
Product Dependent
Open for Enrollment
What to Expect from Adherence Programs
Targeted Programs
- Pediatric Patient Outreach (Sent to Guardian)
- Adult Patient Outreach
VaxCare will send your patients reminder text messages on behalf of your practice.
What’s the impact?
19%
Average Improvement Seen Through VaxCare’s Adherence Programs.
Sample Blast Message
Simplifying the VFC Workflow
VaxCare Adapts to Each Jurisdiction’s Program Policies
- State-specific policies for Medicaid/CHIP VFC eligibility.
- Clinic-specific policies, including underinsured, American Indian/Alaskan Native, and secondary Medicaid children.
- VFC administration in 27 states, with additional states opening in the coming months.
- VaxCare can also support tracking for other public stocks, including Section 317 doses and state-specific stocks.
One Workflow
To track, manage, and bill all inventories.
Point of Care Eligibility
For patient coverage and stock selection.
Convenient Reporting
To streamline ordering and auditing.
VFC Billing Expansion
Currently Open States: 29
VaxCare is working on securing payer contracts to open VFC billing in all states.
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