Vutrisiran: Vaccines

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Vutrisiran: Vaccines

The following information is provided in response to your unsolicited inquiry. It is intended to provide you with a review of the available scientific literature and to assist you in forming your own conclusions in order to make healthcare decisions. This document is not for further dissemination or publication without authorization.

The full Prescribing Information for AMVUTTRA® (vutrisiran) is provided here. Alnylam Pharmaceuticals does not recommend the use of its products in any manner that is inconsistent with the approved Prescribing Information. This resource may contain information that is not in the approved Prescribing Information.

If you are seeking additional scientific information related to Alnylam medicines, you may visit the Alnylam US Medical Affairs website at RNAiScience.com.

 Summary

      In the vutrisiran phase 3 studies, patients were permitted to receive vaccines as concomitant medications2,3:

o        In HELIOS-A, 60 of 122 patients (49.2%) in the vutrisiran group received viral vaccines, the majority of which were COVID-19 vaccines and influenza vaccines.4

o        In HELIOS-B, 202 of 326 patients (62.0%) in the vutrisiran group received viral vaccines, including 118 COVID-19 vaccines and 84 influenza vaccines.5

      The safety or efficacy of vutrisiran with regard to vaccine administration was not evaluated as part of the HELIOS-A and HELIOS-B studies.6,7

      Information regarding the timing of vaccine administration in relation to vutrisiran administration is not available. The timing of vaccine administration for patients receiving vutrisiran is at the clinical discretion of the healthcare professional.

Updated 24 September 2025

References

1.  AMVUTTRA (vutrisiran) Prescribing Information. Cambridge, MA: Alnylam Pharmaceuticals, Inc.

2.  Alnylam Pharmaceuticals. Data on file. MED-ALL-TTRSC02-2300015.

3.  Protocol for: Fontana M, Berk JL, Gillmore JD, et al. Vutrisiran in patients with transthyretin amyloidosis with cardiomyopathy. N Engl J Med. 2025;392(1):33-44. doi:10.1056/NEJMoa2409134

4.  Alnylam Pharmaceuticals. Data on file. MED-ALL-TTRSC02-2200006.

5.  Alnylam Pharmaceuticals. Data on file. MED-ALL-VUTRI-2500043.

6.  Adams D, Tournev IL, Taylor MS, et al. Efficacy and safety of vutrisiran for patients with hereditary transthyretin-mediated amyloidosis with polyneuropathy: a randomized clinical trial. Amyloid. 2023;30(1):18-26. doi:10.1080/13506129.2022.2091985

7.  Fontana M, Berk JL, Gillmore JD, et al. Vutrisiran in patients with transthyretin amyloidosis with cardiomyopathy. N Engl J Med. 2025;392(1):33-44. doi:10.1056/NEJMoa2409134

 

 

 

MED-ALL-TTRSC02-2200052 3.0 Approved through Oct 2027

 

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