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More doses of new RSV immunization for babies are on the way, White House announces

By Brenda Goodman, CNN

(CNN) — More hard-to-find doses of Beyfortus, the new immunization against respiratory syncytial virus (RSV) for infants, will be available in January, the White House says.

The announcement comes as RSV season is in full swing in the United States. On Thursday, as part of an urgent call to health care providers to increase immunizations for respiratory viruses, the CDC advised doctors to use the doses of Beyfortus that they have on hand rather than trying to hold any back for babies born later in the season.

An additional 230,000 doses of the immunization will become available in January “at the urging of the of the Administration,” according to a White House statement released after a meeting Wednesday with Sanofi and AstraZeneca, the two pharmaceutical companies that make the shot.

The move follows the release of 77,000 additional doses last month, after earlier meetings with Biden administration officials.

According to a Sanofi spokesperson, the doses announced in November had been waiting for final clearance from the US Food and Drug Administration. The company then worked with the FDA to facilitate processing.

The 230,000 doses that will be made available next month were being reserved to stock the 2024 RSV season in the Southern Hemisphere and will be replenished before that season starts in the spring.

Sanofi and AstraZeneca say they are “working to augment our manufacturing network, closely partnering with stakeholders in the immunization community to project demand, and implementing a process in February to support providers and others planning for the 2024/25 RSV season.”

In October, the companies said in a statement that “unprecedented demand” for the shots had outstripped their anticipated supply and that they were working with the US Centers for Disease Control and Prevention to ensure equitable distribution.

The CDC issued new guidelines for which babies should get the shot, prioritizing doses for the youngest and smallest infants, which left parents with older babies hunting for the immunization just as RSV season ramped up in earnest.

Beyfortus is a shot of protective antibodies that is approved for infants younger than 8 months and certain at-risk children under age 2, who are going into their first or second RSV season.

It was approved this summer, marking the first time doctors and parents had the opportunity to protect babies against RSV, the leading cause of hospitalization for infants during their first year of life.

RSV leads to roughly 80,000 hospitalizations and 300 deaths each year in children under the age of 5.

Weekly hospital admission rates for RSV have doubled over the past month among children. In the week ending November 18, there were about 23 hospitalizations for every 100,000 children under 5. But RSV is starting to near peak levels in some parts of the US, CDC Director Dr. Mandy Cohen said last week.

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