CDC rushes extra doses of Sanofi, AZ's Beyfortus to ease supply shortfall

In response to a supply squeeze for Sanofi and AstraZeneca’s respiratory syncytial virus (RSV) antibody Beyfortus, the U.S. Centers for Disease Control and Prevention (CDC) is fast-tracking tens of thousands of extra doses into circulation.

More than 77,000 additional doses will be distributed “immediately” to physicians and hospitals through the CDC’s Vaccines for Children program and commercial routes, the agency said in a Thursday statement.  

Alongside the FDA, the CDC plans to maintain “close contact” with manufacturers to secure availability of extra supply through the end of this year and early 2024, the CDC added.

The supply strain began last month despite Sanofi's "aggressive" plan that was designed to "outperform past pediatric vaccine launches,” the company said at the time. The company said it was working with AstraZeneca to “explore a number of actions” to extend the manufacturing network. AZ handles manufacturing under the duo’s Beyfortus partnership.

Sanofi previously noted that new orders for Beyfortus’ 100mg dose were no longer being accepted as demand exceeded supply. A few weeks ago, the company said it was “carefully managing” private-market distribution of the 50-mg doses to fulfill existing orders.

As the first option for infant RSV protection, demand was expected to be high even before the drug's July approval. Sanofi’s global RSV franchise head Kimberly Tutwiler said in a June conference call that many physicians have been “waiting for decades” for an RSV prevention option.

Now, as the season ramps up, there's another RSV prevention option for babies. Pfizer’s Abrysvo scored FDA approval shortly after Beyfortus and is recommended for people who are between 32 and 36 weeks pregnant to protect their infants against RSV-associated lower respiratory tract disease through the first six months of life.