New drug approved by FDA to protect infants from RSV

New drug approved by FDA to protect infants from RSV

New Drug Approved to Protect Children Against Respiratory Syncytial Virus

Parents around the United States have a new reason to celebrate as the U.S. Food and Drug Administration (FDA) recently approved Beyfortus (nirsevimab-alip), a long-acting drug designed to protect newborns and infants against respiratory syncytial virus (RSV) during their vulnerable first RSV season. RSV is a common germ that can cause serious respiratory infections, leading to hospitalization in up to 3% of children under the age of 1 each year in the U.S. This groundbreaking approval aims to reduce the impact of RSV disease on children, families, and the healthcare system.

RSV is a highly contagious virus that causes respiratory infections in individuals of all age groups. It is estimated that about two-thirds of infants become infected with RSV during their first year of life. While most infants and young children experience mild symptoms similar to a common cold, some cases can progress to severe pneumonia and bronchiolitis, which is the swelling of the small airway passages in the lungs.

RSV is a significant cause of hospitalization in infants, particularly those younger than 1 year old, surpassing even the annual rate of hospitalization for influenza by a factor of 16. Surprisingly, about 75% of infants hospitalized for RSV are born healthy and at term. Premature infants or newborns with chronic lung disease of prematurity or significant congenital heart disease are the most vulnerable and at highest risk for severe RSV disease.

Until now, there has been a pressing need for effective preventive measures against RSV. The approval of Beyfortus represents a pivotal moment, offering hope for significantly reducing severe respiratory disease caused by RSV in a broad population of infants in the U.S. This milestone has been made possible by AstraZeneca, the company that developed the drug.

Beyfortus is a monoclonal antibody, which is a laboratory-made protein that mimics the immune system’s natural antibodies that target and fight against RSV. It works by providing passive immunity to infants, protecting them from severe RSV disease during their susceptible period. Administered as a single injection before or during RSV season, Beyfortus offers protection throughout the season.

The FDA based its approval of Beyfortus on three clinical trials, all supporting its safety and efficacy in reducing the risk of severe RSV cases that require medical treatment. In one trial, 1,453 preemies born during their first RSV season or entering it were studied. Results showed that only 2.6% of infants treated with Beyfortus required medical treatment for RSV, compared to 9.5% of infants in the placebo group, indicating a remarkable 70% risk reduction.

The second trial focused on 1,490 term and late preterm infants and demonstrated a similar 75% risk reduction for those receiving Beyfortus compared to the placebo group. The third trial specifically targeted children up to 24 months of age who remained vulnerable to severe RSV as a result of chronic lung disease of prematurity or congenital heart disease. Once again, the data supported the effectiveness of the drug in protecting this population.

With the approval of Beyfortus, parents can now have peace of mind knowing that there is a treatment option available to protect their children against RSV. This achievement is not only a game-changer in preventing RSV but also sets the stage for a paradigm shift in the approach to respiratory disease prevention in infants.

It is important to note that RSV is largely transmitted from person to person through close contact with an infected individual. Additionally, RSV circulation is seasonal in most parts of the United States, typically beginning in the fall and peaking during the winter. Therefore, it is crucial for parents and caregivers to remain vigilant during these seasons and take all necessary precautions in order to minimize the risk of RSV infection.

In conclusion, the approval of Beyfortus is a significant breakthrough in the fight against respiratory syncytial virus. This drug offers a new level of protection for newborns, infants, and children up to 2 years old during their most vulnerable periods. By significantly reducing the risk of severe RSV disease, Beyfortus not only benefits individual children and families but also helps to alleviate the burden on the healthcare system. It is an exciting advancement that brings hope for a healthier future for our children.


Which illness is known as a viral upper respiratory tract infection? See Answer

More information The U.S. Centers for Disease Control and Prevention has more about RSV.

Sources: U.S. Food and Drug Administration, news release, July 17, 2023; AstraZeneca, news release, July 17, 2023