Important: NEW COVID-19 mRNA Vaccine Information Statement (VIS) and Updated RSV VIS

This message was sent to AIM, Health Systems, INE, IAP, LHD Health Officers, LHD Medical Directors, MACI, MACI 2, PH Imms Leads, COVID-19 Vaccine Providers, and Imms All Staff. Apologies for any duplication.

Hello Immunization Partners, 

Please share the following information with providers in your jurisdiction. 

The Centers for Disease Control and Prevention (CDC) released a new COVID-19 mRNA vaccine information statement (VIS) and an updated respiratory syncytial virus (RSV) VIS for recipients and caregivers.

The new COVID-19 mRNA VIS should be used when vaccinating people aged 12 years and older who will receive one of the licensed mRNA vaccines (Comirnaty by Pfizer-BioNTech or Spikevax by Moderna).

 

Healthcare providers should continue to provide the product-specific Emergency Use Authorization (EUA) Fact Sheet when administering COVID-19 vaccine under conditions of EUA. EUA Fact Sheets should be used when vaccinating children aged 6 months through 11 years (Pfizer or Moderna) and before giving Novavax COVID-19 vaccine (2023-2024 Formula) to any eligible recipient.

 

The respiratory syncytial virus (RSV) VIS, originally issued earlier in 2023 for vaccination of adults aged 60 and older, has been updated with information regarding the September 2023 ACIP recommendation for RSV vaccination of pregnant people between 32 and 36 weeks gestation. A separate immunization information statement (IIS) should be used for the RSV preventive antibody (nirsevimab) recommended for infants. 

Providers should begin using the updated Michigan version of these VISs/IISs immediately.

VIS/EUA/IIS Reminders:

• In Michigan, it is important that vaccine recipients, their parents, or their legal representatives be given the Michigan versions of VISs/EUAs/IISs because they include information about the Michigan Care Improvement Registry (MCIR). By state law in Michigan, parents must be informed about MCIR. Those obtained from other sources (e.g., from the CDC or IAC websites) do not contain information about MCIR.
• Translations - There is always a lag time before translations are published. Once Immunize.org posts translations, MDHHS will add the MCIR language onto the translations and post them on the MDHHS website as soon as possible.

Resources:
The MDHHS VIS page Vaccine Information Statements (VIS) (michigan.gov)
Immunization Material Order Form Immunization Material Order Form (michigan.gov)
Important VIS Facts Important Vaccine Information Statement (VIS) Facts (michigan.gov)

Please email checcimms@michigan.gov with any questions.

Thank you for all you do! 

Your Immunization Outreach and Education Team, 

Alyssa, Andrea, Dianne, Heidi, Lisa, and Sarah