U.S. Government Wants Additional RSV Passive Immunization Supply

The U.S. Administration recently confirmed officials met with suppliers to discuss the manufacturing, distribution, and accessibility of Respiratory Syncytia Virus (RSV) immunizations through the private market.

On November 27, 2023, senior administration officials underscored the importance of manufacturers such as Sanofi and AstraZeneca working to meet demand with a sense of urgency.

During the meeting, manufacturers and senior administration officials agreed on proactive planning to meet 2024's projected demand for RSV passive immunizations. 
 
These manufacturers committed to producing tens of thousands of additional RSV immunizations for infants and confirmed that all of the recently allocated 77,000 doses of Beyfortus™ (Nirsevimab-alip) had been released.

Beyfortus is the first U.S. FDA-approved extended half-life monoclonal antibody that prevents RSV in young children. It is designed to protect infants experiencing their first or second RSV season and those with congenital heart disease or chronic lung disease. 

In a media release on November 28, 2023, the Administration confirmed it continues prioritizing access to safe and effective vaccines for all Americans who want to protect themselves and their loved ones from preventable illness.

Previously, U.S. Senators sent a letter to Sanofi and AstraZeneca with questions about various aspects of Beyfortus's launch. The Senators requested a response to their questions by November 30, 2023.

These senators wrote, "We recognize the first season of implementation carries complexity and challenges, from forecasting demand months in advance to efficient supply chains and distribution, as well as public awareness and education. However, inadequate supply and onerous out-of-pocket costs for providers have caused the rollout of nirsevimab to be more chaotic than anticipated."

In October 2023, Sanofi and AZ revealed the Beyfortus shortage, saying that demand in the U.S. had outstripped existing supplies.

Beyfortus is the second monoclonal antibody developed to prevent RSV in young children. Arexis AB's multi-dose palivizumab (Synagis) was approved for initial use in the U.S. by the FDA in 1998.

Additional RSV vaccine and immunization candidates are being developed.

From a payment perspective, the U.S. CDC's Vaccines for Children program provides vaccines to half of America's children, focusing on our most vulnerable communities, including infants.

Globally, the World Health Organization's Influenza Update N° 459 revealed that in countries with RSV surveillance, RSV activity increased in parts of Europe and North America, remained elevated in Central America and the Caribbean, and was generally low or decreasing elsewhere.

In the U.S., RSV outbreaks continue to expand nationally.