Important Update from Sanofi on Beyfortus Supply

Dear Provider,

There has been unprecedented demand for Beyfortus™ (nirsevimab-alip) 50 mg and 100 mg Injection since it began shipping to providers in late September. For the first time in history, health care providers are currently helping to protect infants against respiratory syncytial virus (RSV) disease.

Despite an aggressive supply plan built to outperform past pediatric immunization launches, demand for both the 50 mg and 100 mg dose presentations have been higher than anticipated. In just 1.5 months of shipping, the demand has consumed the available supply for this season. We, along with our alliance partner in charge of manufacturing, AstraZeneca, are working to deliver all the doses in the supply plan while we continue to explore solutions to address the exceptional demand now and for next season.

We have previously communicated that new orders for the 100 mg dose were no longer being accepted. As of today, due to demand, we need to allocate supply of the 50 mg dose to support equitable access of the private market. Beginning 11/2, Sanofi direct ordering platforms will state that 50 mg presentation is temporarily unavailable for new orders. On 11/16 our ordering system will reopen on a limited supply based on allocations.

Given the need for allocations of the 50 mg dose, wholesalers and distributors will exhaust their current supply of 50 mg doses and will not receive additional shipments. Customers typically ordering through the wholesaler or distributor channel are asked to purchase through Sanofi directly if offered an allocation. We understand the importance of all channels of distribution and look forward to including wholesalers and distributors in the future RSV seasons. Field representatives and customer service will continue to update providers on the status of their orders, any remaining shipments, and potential allocation.

In addition, Sanofi is in close collaboration with the Centers for Disease Control and Prevention (CDC) who are working to ensure equitable distribution of available doses through the Vaccines for Children Program. The CDC has published a CDC Health Alert Network (HAN) Health Advisory that provides options for clinicians to protect infants from RSV in the context of limited Beyfortus supply (https://emergency.cdc.gov/han/2023/han00499.asp).

Sanofi and Astra Zeneca understand and apologize for the challenge that these supply constraints present for providers and parents. While we are working through the current situation, we are also actively planning for the 2024/2025 RSV Season manufacturing campaign. To ensure a robust supply, we will continue to work with immunization stakeholders and will initiate an early reservation process with providers in Q1 2024. Thank you for your continued partnership to help protect infants and children from RSV disease.

INDICATION
Beyfortus is indicated for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in:

  • Neonates and infants born during or entering their first RSV season.
  • Children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.

Sincerely,

Deborah Glasser
Head of North America Commercial Operations, Vaccines

MAT-US-2310392-v1.0-11/2023


Important Safety Information of Beyfortus™ (nirsevimab-alip) 50 mg and 100 mg Injection

Contraindication:

BEYFORTUS is contraindicated in infants and children with a history of serious hypersensitivity reactions, including anaphylaxis, to nirsevimab-alip or to any of the excipients.

Warnings and Precautions Hypersensitivity Including Anaphylaxis:

  • Hypersensitivity Including Anaphylaxis: Serious hypersensitivity reactions, including anaphylaxis, have been observed with other human IgG1 monoclonal antibodies. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, initiate appropriate medications and/or supportive therapy.
  • Use in Individuals with Clinically Significant Bleeding Disorders: As with other IM injections, Beyfortus should be given with caution to infants and children with thrombocytopenia, any coagulation disorder or to individuals on anticoagulation therapy.

Most common adverse reactions with Beyfortus were rash (0.9%) and injection site reactions (0.3%).

Please see full Prescribing Information accompanying this letter.

© 2023 Sanofi Pasteur Inc. All rights reserved.

MAT-US-2310392-v1.0-11/2023

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