FDA approves AstraZeneca, Sanofi RSV shot for infants, toddlers

Approved by the Food and Drug Administration on Monday AstraZeneca and SanofiVaccine protects infants and young children from respiratory syncytial virus, leading cause of hospitalization in U.S. infants

Nirsevimab is the first FDA-approved vaccine that protects all infants from RSV infection, whether they are healthy or have a medical condition.

Related investment news

The FDA approval of nirsevimab, marketed under the Beyfortus brand name, comes ahead of this fall’s RSV season. An independent panel of experts from the U.S. Centers for Disease Control and Prevention will meet in August to make recommendations on how doctors should administer the vaccine.

Another vaccine, Palivizumab, is already on the market, but it is mainly given to premature babies or babies with lung and congenital heart disease that put them at high risk of severe disease. Nirsevimab is also given as a single injection. This is a major advantage over palivizumab, which is given monthly throughout the RSV season.

Nirsevimab is given before or during the infant’s first RSV season. Young children under the age of two who are still vulnerable can also receive shots during the second RSV season.

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

Children’s hospitals across the U.S. were overwhelmed by a surge in respiratory syncytial virus infections last fall, prompting calls for the Biden administration to declare a public health emergency.

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

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

Nirsevimab is a monoclonal antibody that works like a vaccine. Vaccines stimulate the immune system to produce protective antibodies, while injections like nirsevimab deliver those antibodies directly into the bloodstream.

The fact that nirelizumab is regulated as a drug has created some uncertainty about whether the federal childhood vaccine program will provide the vaccine for free to families facing financial hardship. CDC advisers are expected to discuss the issue at their August meeting.

Families may have two options to protect their babies this fall. Pfizer has developed a vaccine that can be given when the mother is pregnant to protect the baby. Independent advisers to the FDA recommended Pfizer’s vaccine in May. The agency is expected to make a final decision on whether to approve the shot in August.