FDA approves AstraZeneca and Sanofi’s RSV vaccine for infants and younger youngsters

Blood sample for Respiratory Syncytial Virus (RSV) test

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The Food and Drug Administration granted approval Monday AstraZeneca And Sanofiis a vaccine that protects infants and young children from respiratory syncytial virus, which is the leading cause of hospitalizations in babies in the United States

Nirsevimab is the first FDA-approved vaccine that protects all infants from RSV, whether they are healthy or have an illness.

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The FDA approval of nirsevimab, sold under the brand name Beyfortus, comes ahead of the fall RSV season. The Centers for Disease Control and Prevention’s independent panel of experts will meet in August to make recommendations on how vaccines should be administered by physicians.

Another shot called palivizumab is already on the market, but it’s mainly given to premature babies or infants with lung and congenital heart disease who are at high risk for serious illness. Nirsevimab is also given as a single injection. This is a major advantage over palivizumab, which is administered monthly throughout the RSV season.

Nirsevimab is given to an infant either before or during the first RSV season. Infants up to two years of age who remain at risk can also receive the vaccine in their second RSV season.

According to a study published last year in the medical journal JAMA Open Network, RSV is a major public health threat, killing nearly 100 infants each year. According to a study published in the Journal of Infectious Diseases, the virus is the leading cause of hospitalization in children under the age of one.

A surge in RSV infections last fall overwhelmed children’s hospitals across the US, prompting calls for the Biden administration to declare a public health emergency in response.

According to an FDA review, nirsevimab was up to 75% effective at preventing lower respiratory tract infections requiring medical attention in infants and 78% effective at preventing hospitalizations.

The FDA found no safety concerns in its review of nirsevimab, although other monoclonal antibodies have been linked to allergic reactions such as skin rashes.

Nirsevimab is a monoclonal antibody that has a similar function to a vaccine. Vaccines stimulate the immune system to produce protective antibodies, while vaccines like nirsevimab release those antibodies directly into the bloodstream.

The fact that nirsevimab is regulated as a drug has led to some uncertainty about whether the federal Vaccines for Children program will make the vaccine available free of charge to families with financial difficulties. CDC advisors are expected to discuss this topic at their August meeting.

Families may have two choices to keep their children safe this fall. Pfizer has developed a vaccine that protects infants by giving the vaccine to the mother during pregnancy. The FDA’s independent advisors recommended Pfizer’s vaccine in May. The agency is expected to make a final decision on approving the recording in August.

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