Respiratory Season Webinar Series

Nirsevimab Supply and Prioritization Updates: November 8, 2023

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Moderator:

Anne Edwards, MD, FAAP
AAP Chief Medical Officer

Guest Speakers/Panelists:

CDC
Kevin Chatham-Stephens, MD, MPH, FAAP
Acting Preparedness and Response Lead – Immunization Services Division (ISD)

Meredith McMorrow, MD, MPH, FAAP 
Chief, Surveillance and Prevention Branch
Coronavirus and Other Respiratory Viruses Division

Sarah Meyer, MD, MPH
Chief Medical Officer, Immunization Services Division (ISD)

Manisha Patel, MD, MS, MBA
Chief Medical Officer, National Center for Immunization and Respiratory Diseases

Charlene Wong, MD, MSHP
Senior Advisor for Health Strategy, Immediate Office of the Director

Sanofi
Ayanna Santos, PharmD
Associate Vice President, Head of RSV Franchise - US

Timestamps:

• 3:30  Dr. Chatham-Stephens’ presentation “Nirsevimab Supply and Prioritization Updates”
• 13:45 Please provide updates regarding the 100mg doses of nirsevimab based on the October 23, 2023 HAN detailing interim CDC recommendations during this shortage
• 16:05  What is the status of supply for the 50mg doses of nirsevimab?
• 16:51  Based on the limited supply of 50mg nirsevimab doses, will there be additional CDC recommendations for prioritization?
• 18:13  Can two 50mg doses be administered in place of one 100mg dose?
• 19:12  If distribution is uneven in a specific state or jurisdiction, is there anything that can be done to ameliorate the circumstance?
• 20:39 What is the prioritization for tribal clinics considering this high-risk group?
• 23:05 Are Sanofi or AstraZeneca planning to manufacture additional nirsevimab supply for this season?
• 24:00  Why is it taking so long for clinics to receive nirsevimab supply?
• 26:30  How can we help families find nirsevimab during these distribution challenges?
• 27:53  How is the CDC working with birthing hospitals to provide access to our youngest patients?
• 33:05  Should babies who have contracted RSV receive a dose of nirsevimab following this diagnosis?
• 33:05  Regarding prioritization, should nirsevimab supply be administered now or should some stock be saved for later in the season?
• 34:25 Is borrowing between VFC and commercial stock still allowed for this season?
• 36:23  What is the guidance for the scenario where VFC stock is borrowed and then commercial stock is not received?  
• 38:04  Has there been issues with private insurers covering nirsevimab?
• 42:30  How do pediatricians learn specifics about their nirsevimab allocation?
• 44:25 Is CDC planning to conduct research to anticipate uptake of the maternal RSV vaccine to inform the demand for next season?
• 47:23 Can you provide more information on barriers for hospitals regarding coverage, payments, and nirsevimab access?
• 48:39  How available is the maternal RSV vaccine?
• 53:03  What is Sanofi doing to understand root causes and planning for next season, 2024-2025?
• 54:48 What are key points for participants for this 2023-2024 season?

RSV product information and practice implementation resources mentioned in this webinar can be found on the RSV patient care page.

Nirsevimab Implementation Strategies for Outpatient Settings: October 17, 2023

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Moderator:

Jesse Hackell, MD, FAAP
Chairperson, AAP Committee on Practice and Ambulatory Medicine

Experts:

Suzanne Berman, MD, FAAP
Immediate Past Chairperson, AAP Section on Administration and Practice Management (SOAPM)

Christoph Diasio, MD, FAAP
Member, AAP Payer Advocacy Advisory Committee

Maria Morrill, MHA, BSN, RN, CPN
Clinical Operations Manager,  Odessa Brown Children’s Clinic, Seattle, WA

Timestamps:

• 14:37  What is the update regarding availability of 100 mg doses for nirsevimab? Can we give 2 doses of 50 mg when we need to administer a dose of 100 mg? Would the cost be the same?
• 19:10  What arrangements are you making for recalling children who are no longer in the immediate post birth period?
• 21:10  How do we check for insurance coverage in a patient? How can I know whether I will be paid by insurance companies (real time claim estimators)?
• 27:55  What is the guidance when mother receives maternal RSV during pregnancy?
• 29:40  If you live in an area where RSV season runs later, what is the optimal time to start administering?
• 30:19  What CPT codes should I use?
• 40:25  What is the guidance with palivizumab, particularly for high-risk infants?  Several examples cited.
• 43:00  What are newborn nurseries in birth hospitals doing? How are we communicating with birth hospitals to learn about the mother’s history of receiving the maternal RSV vaccine?
• 48:10  What are recommendations for the following scenarios: 
  For a parent who wants to pay cash for nirsevimab, can we bill them for the dose while waiting to see if they have insurance coverage? How should we communicate with parents of a child who doesn’t meet the criteria for nirsevimab but really wants it?
• 56:16 What have you noticed for parental demand for nirsevimab?

RSV product information and practice implementation resources mentioned in this webinar can be found on the RSV patient care page.

Prevention of RSV in Children – Clinical Updates: October 10, 2023

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Moderator:

Sean O’Leary, MD, MPH, FAAP
Chair, AAP Committee on Infectious Diseases 
Professor of Pediatrics at the University of Colorado School of Medicine and Children’s Hospital Colorado

Experts:

Jefferson Jones, MD, MPH 
Medical epidemiologist in the United States Public Health Service and the Centers for Disease Control and Prevention, working in the Coronavirus and Other Respiratory Viruses Division
Co-lead of the Advisory Committee on Immunization Practices Maternal and Pediatric RSV Work Group

Mary T. Caserta, MD, FAAP
Member, AAP Committee on Infectious Diseases
Professor of Pediatrics in Infectious Diseases at the University of Rochester Medical Center (URMC)

Jill Moses, MD, MPH 
Deputy Director for Program Implementation in the Immunization Services Division (ISD) in the National Center for Immunizations and Respiratory Diseases at the Centers for Disease Control and Prevention

Timestamps:

• 00:52 Introduction & Webinar Overview
• 02:22 Dr. Jone’s presentation: Clinical considerations and timing for use of maternal RSVpreF vaccine and nirsevimab
• 30:00 Dr. Caserta’s presentation: AAP recommendations for nirsevimab & palivizumab considerations

Q&A

•  37:34 What will the cost difference be to a family for maternal RSV vaccine vs. infant nirsevimab?
• 39:30 When will nirsevimab be available, and what’s the VFC requirement for private stock?
• 41:30 There will be a situation where mother is vaccinated in January/February, baby is born in March – not given nirsevimab – and enters the second season younger than 8 months. What is the guidance?
• 43:00 How should we think about palivizumab/SYNAGIS at this point; is there any role for it?
•  44:00 Any recommendation(s) regarding length of time between RSV natural infection and when to give nirsevimab who meet criteria?
• 46:00 Is the maternal RSV also on VFC?
• 46:33 Can you clarify the provider agreement policy on inventory and borrowing rules for nirsevimab for VFC?
• 49:00 Can you talk a little bit about how pediatricians may interpret underinsured eligibility for VFC vaccine?
• 51:25 Do you think nirsevimab will eventually be a standard recommendation during birth hospitalization like Hepatitis B vaccination?  
• 53:00 Should infants born to women living with HIV, who receive RSV vaccine during pregnancy receive nirsevimab or only those born to women with poorly controlled HIV? Do women with well-controlled HIV have reduced transplacental antibody transfer? 
• 54:46 Is nirsevimab a vaccine?

RSV product information and practice implementation resources mentioned in this webinar can be found on the RSV patient care page.

COVID-19/RSV/Influenza Town Hall with CDC Special Guests: October 4, 2023

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Special Guests:

Mandy K. Cohen, MD, MPH
Director, Centers for Disease Control and Prevention (CDC) 
Administrator, Agency for Toxic Substances and Disease Registry

Sandy Chung, MD, FAAP
President, American Academy of Pediatrics

Experts:

Georgina Peacock, MD, MPH, FAAP
Director, Immunization Services Division, National Center for Immunization and Respiratory Diseases, CDC

Charlene Wong, MD, MSHP
Senior Advisor, Immediate Office of the Director, CDC

Timestamps:

• 00:56  Introduction & Overview
• 05:18 Dr. Cohen’s Presentation: State of Play – Preparing Your Practice and Your Patients for the Fall and Winter Virus Season

Q&A

• 24:40  Are there updates on ACIP’s recommendations for nirsevimab?
• 27:33  Do you have strategies for payment with public and private payers?
• 29:34  Given that nirsevimab is recommended within seven days of birth, insurance coverage may not be able to be verified within this timeframe. Are you able to use VFC immunization for an infant with unknown insurance status or for an infant that is underinsured?
• 31:42 Can you describe what’s happening in birthing hospitals since this seems to be the ideal time for administration?
•  34:00 Where can we direct local hospitals who have questions about enrollment to become a specialty provider?
• 35:00 Regarding the maternal RSV vaccine, what are key points pediatricians should discuss during prenatal visits? How is CDC engaging with the OB/GYN community?  
• 37:25 Is nirsevimab a vaccine? What is the best way to talk about this product?
• 41:55 Should pediatricians continue using palivizumab?
• 44:16  Updates on new CPT codes for nirsevimab administration 
• 46:43 What are vaccine messaging strategies for COVID-19 vaccines for children under 4 years of age? 
• 49:40 I work at the Indian Health Service, are there scenarios where maternal RSV for the mom and nirsevimab for the infant would both be indicated?