This message was sent to AIM, FAB, Health Systems, INE, IAP, LHD Health Officers, LHD Medical Directors, MACI, MACI 2, PH Imms Leads, MCIR Region Contacts, COVID-19 Vaccine Providers, and Imms All Staff. I apologize for any duplications

Dear Immunization Partners,

Please share the following information with providers in your jurisdiction.

Merck has initiated a voluntary recall of VAXNEUVANCE™ Lots W021510, W021512, W021637, W027250, W028846 in the US market. The Company has received reports of breakage at the syringe flange and/or hub that could be identified when the syringe was inspected before administration, while the healthcare professional was securing the needle to the syringe, during vaccine administration or during post-administration (e.g., when activating a safety needle). The breakage resulted in a small number of injuries, including laceration and needle puncture. Actions have been implemented at the syringe manufacturer to improve processes to help prevent these defects from recurring in future lots.

Merck recommends that if you have VAXNEUVANCE™ from any of the recalled lots at your facility, you immediately quarantine and discontinue use of these doses and return all these pre-filled syringes. This product was distributed between July 22, 2022 and July 06, 2023. If you have further re-distributed this product, please identify those sites, and notify them immediately of this product recall.

For questions about this recall or to report any adverse events following vaccination, please contact:

• Merck National Service Center: 800-672-6372 Select Prompt #1 then Prompt #2 (Monday to Friday 8:00 AM to 7:00 PM EST)

Merck will be notifying customers with business reply cards that will need to be filled out and returned with the recalled vaccines.

This voluntary recall is being conducted with the knowledge of the United States Food and Drug Administration.

Thank you for all you do.

Your Immunization Outreach and Education Team,

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