Blood sample for respiratory syncytial virus (RSV) test.
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The Food and Drug Administration on Monday approved AstraZeneca AND Sanofia vaccine that protects infants and young children from respiratory syncytial virus, which is the leading explanation for child hospitalization within the U.S.
Nirsevimab is the primary injection approved by the FDA to guard all infants from RSV, whether or not they are healthy or have a disease.
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The FDA’s approval of nirsevimab comes months before the RSV season this fall. A panel of independent experts from the Centers for Disease Control and Prevention will meet in August to make recommendations on how healthcare professionals should administer injections.
One other injection called palivizumab is already in the marketplace, however it is especially given to infants born prematurely or with congenital lung and heart conditions that put them at high risk of severe illness. Nirsevimab, sold under the brand name Beyfortus, is given as a single injection. That is a serious advantage over palivizumab, which is run monthly throughout the RSV season.
Nirsevimab is given before or in the course of the infant’s first RSV season. Young children as much as two years of age who remain sensitive may receive an injection during a second explanation for RSV.
In response to a study published within the medical journal JAMA Open Network last 12 months, RSV is a serious public health threat that kills nearly 100 infants a 12 months. In response to one other study published within the Journal of Infectious Diseases, the virus is the leading explanation for hospitalization in children under the age of 1 12 months.
The surge in RSV infections last fall overwhelmed kid’s hospitals across america and led to calls from the Biden administration to declare a public health emergency in response.
In response to an FDA review, nirsevimab was as much as 75% effective in stopping lower respiratory tract infections in infants requiring medical attention and 78% effective in stopping hospitalization.
The FDA found no safety concerns in its review of nirsevimab, although other monoclonal antibodies have been related to allergic reactions corresponding to skin rashes.
That is an evolving story. Check for updates.