The Centers for Disease Control and Prevention said it was releasing 77,000 additional doses of a respiratory syncytial virus (RSV) drug from Sanofi and AstraZeneca to help improve its availability.
The additional doses of Beyfortus will be distributed immediately to physicians and hospitals through the Vaccines for Children Program, which covers the cost of the shots for uninsured and underinsured kids, as well as commercial channels, the CDC said.
CDC said officials identified a batch of the immunization that was awaiting final clearance from the Food and Drug Administration (FDA), and were able to expedite that clearance.
Shortages of the drug have been plaguing the country since it was approved in August. Pediatricians and hospitals have been struggling to stock the immunization due to what Sanofi said was “unprecedented” demand for the drug to prevent RSV in infants.
Sanofi stopped taking new orders for the 100 milligrams (mg) doses in October because it said supply had exceeded the high demand. The 100 mg dose is recommended for babies 11 pounds and heavier until they’re 8 months old.
In recent days, it also paused ordering 50 mg doses for babies who weigh less than 11 pounds, though it reopened on Thursday.
According to a company spokesman, only customers with an assigned allocation will have the ability to place a new order. The company has said it will continue shipping existing orders of both the 50mg and 100mg doses into December.
CDC and FDA said they will continue to be in close contact with manufacturers to ensure the availability of additional doses through the end of this year and for early 2024 to meet the demand.
RSV cases in the U.S. began a sharp upward trend in the middle of October. There are more than 6,800 cases detected in the country, according to the CDC.
Last year saw scores of young children infected by RSV much earlier than in past years, overwhelming children’s hospitals and emergency rooms across the country.
Prior to this year, there’s never been a drug that can prevent RSV in all infants. But it wasn’t approved by federal regulators until late summer, and public health experts and pediatricians have questioned the wisdom of such a condensed timeline in making sure there were enough doses on the market before the start of RSV season.
