The Centers for Disease Control and Prevention notified doctors across the country Monday of a limited supply of a newly-approved antibody drug that is given to infants in order to prevent RSV.
RSV (respiratory syncytialvirus) cases are on the rise now that cold and flu seasons has begun.
“RSV Season is Here,” said Dr. Buddy Creech, pediatric infectious disease specialist at Vanderbilt University Medical Center Nashville, Tennessee, said, “RSV season is here.” “We have seen a significant increase in RSV cases, and in some areas it is the respiratory virus that causes the most disease in children.
He said that this is why there was a lot scrambling to identify the babies who were at greatest risk, and to give them priority, because resources are limited.
In July, the Food and Drug Administration (FDA) approved Beyfortus as an antibody drug. This is not a vaccination, but works similarly: instead of stimulating the immune system into developing its own antibodies against RSV, the injection delivers antibodies directly into the blood.
Beyfortus is available to infants and newborns who are at risk of severe illness due to RSV. Children aged 2 and older, with a high-risk for the virus, can also receive Beyfortus in their second RSV.
According to a CDC alert the supply of the highest dose, 100 milligrams is very limited. The agency advised doctors to give the doses first to infants who are at high risk of severe RSV. This includes infants under 6 months old and infants with other conditions. The CDC advised doctors to save 50 mg doses of the drug for infants weighing less than 11 lbs.
The drugmaker Sanofi announced in a press release on Oct. 13 that, “despite an aggressive plan to supply this product and outperform other pediatric vaccine launches before, demand has exceeded expectations, particularly for the 100mg doses used by babies born just prior to RSV season.”
The FDA has confirmed that it does not list the drug as being unavailable in its database.
Synagis, an antibody drug, is another option for infants to avoid RSV infection. The drug is only approved for infants at high risk, and can only be administered during RSV season.
The FDA approved Abrysvo, a RSV vaccine for pregnant women during their third trimester in August. The vaccine will provide protection for their babies during their first six-months of life.
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