Respiratory syncytial virus (RSV) blood sample
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The Food and Drug Administration on Monday approved AstraZeneca And sanofiThe shot protects babies and toddlers against respiratory syncytial virusIt is the leading cause of neonatal hospitalization in the United States
Nirsevimab is the first FDA-approved injection to protect all Infant against RSV regardless of whether they are healthy or have disease.
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FDA approval of nirsevimab, sold under the brand name Beyfortus, will come ahead of RSV season this fall. The Centers for Disease Control and Prevention’s independent panel of experts will meet in August to make recommendations on how doctors should administer vaccinations.
Another injection called palivizumab is already on the market, but it is mainly given to babies born prematurely or with congenital heart and lung disease that puts them at high risk for serious illness. Nirsevimab is also given as an injection. This is a major advantage over palivizumab, which is given monthly during the RSV season.
Nirsevimab is given before or during an infant’s first RSV season. Toddlers up to two years of age who are still vulnerable can also be vaccinated during their second RSV season.
According to a study published in the medical journal JAMA Open Network last year, RSV is a major threat to public health, killing nearly 100 babies each year. According to a study published in the Journal of Infectious Diseases, the virus is the leading cause of hospitalization for children under the age of one.
A surge in RSV infections last fall overwhelmed children’s hospitals across the US and led to calls for the Biden administration to declare a public health emergency to reply.
According to an FDA review, Nirsevimab is up to 75% effective in preventing medically necessary lower respiratory tract infections in infants and 78% effective in preventing hospitalization.
The FDA has not identified any safety concerns when considering nirsevitab, although other monoclonal antibodies have been associated with allergic reactions such as skin rashes.
Nirsevimab is a monoclonal antibody that functions similarly to a vaccine. Vaccines stimulate the immune system to produce protective antibodies, while shots like nirsevimab deliver those antibodies directly into the bloodstream.
The fact that nirsevimab is regulated as a drug has created some uncertainty about whether the federal Vaccines for Children program will provide free vaccines to financially disadvantaged families. . CDC advisors are expected to discuss the issue at their August meeting.
Families may have two options for protecting their newborns this fall. Pfizer has developed a Vaccine protect the newborn by vaccinating the mother while she is pregnant. FDA independent advisors recommended Pfizer’s vaccine in May. The agency is expected to make a final decision on whether to approve the footage in August.
