RSV prevention shot for babies gets OK from CDC

The Centers for Disease Control and Prevention (CDC) has recommended that all infants under eight months old receive nirsevimab, a monoclonal antibody that fights off a respiratory virus called RSV.

The big picture: Nationwide, babies will be eligible for the nirsevimab shot to combat RSV, a virus that leads to lung disease in infants and young children.
* This recommendation follows the FDA approval of the prevention shot last month, which in trials has shown to lower the need for infants’ RSV medical care by 70% to 75%.
* Children up to 19 months old who are at heightened risk of serious RSV disease – such as those with chronic lung disease, and American Indian and Alaska Native children – are recommended to get the shot for their second RSV season.

Hurdles to overcome: There are obstacles, including cost and state restrictions, that need to be addressed before the shot becomes available in hospitals and doctors’ offices.
* The drugmakers AstraZeneca and Sanofi estimate the shot to cost $495 per dose on the commercial market.
* Some states have restrictions on who can administer injectable drugs, which could pose regulatory and logistical challenges.
* Broader record keeping and delivery coordination are needed to ensure each baby gets their single dose.

Expanding protection: There are plans to include nirsevimab within the CDC’s Vaccines for Children program to improve accessibility.
* The program covers costs for kids who are uninsured, making it an important step in making the drug, which is technically a therapeutic not a vaccine, more accessible.

Expectations and competition: The drug, currently marketed under the trade name Beyfortus, is anticipated to launch this fall.
* It will broaden the preventive treatment options available for babies, which prior to this only included a monoclonal antibody shot called palivizumab, requiring monthly administration for high medical risk babies.
* The FDA is also expected to make a decision on an RSV vaccine for newborns given to pregnant mothers by late August.

View original article on NPR

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