at the highest risk for severe RSV disease, according to the FDA.
In most parts of the United States, RSV circulation is seasonal, typically starting during the fall and peaking in the winter. It is transmitted from person to person through close contact with someone who is infected.
How does the drug work?
Beyfortus is a monoclonal antibody — a laboratory-made protein that mimics immune system antibodies that target and fight RSV.
A single injection of Beyfortus administered before or during RSV season can provide protection during the season, according to the FDA.
The FDA cited three clinical trials that supported the safety and efficacy of Beyfortus in reducing the risk of RSV cases serious enough to require medical treatment.
One trial included 1,453 preemies born during or entering their first RSV season. About 2.6 percent of infants treated with Beyfortus needed medical treatment for RSV, versus 9.5 percent who received a placebo — a risk reduction of about 70 percent.
The second trial included 1,490 term and late preterm infants, and showed a similar 75 percent risk reduction for Beyfortus compared to placebo.
The third trial focused on children up to 24 months of age who remained vulnerable to severe RSV disease through their second RSV season because they had either chronic lung disease of prematurity or congenital heart disease. Again, the data supported the drug’s use in children.
The FDA granted its approval to AstraZeneca, the company that developed the drug.
“Beyfortus represents an opportunity for a paradigm-shift in preventing serious respiratory disease due to RSV across a broad infant population in the U.S.,” Iskra Reic, executive vice president for vaccines and immune therapies at AstraZeneca, said in a company news release.
The FDA in May approved the first RSV vaccine for use in adults 60 and older. It is expected to roll out later this year, with the approach of the annual RSV season.
Preventing RSV
There are some steps you should take to help prevent its spread. According to the American Lung Association, the most effective means of protection are some of the simplest, such as:
- Avoiding close contact with infected people
- Avoiding sharing cups, bottles or toys that may have been contaminated with the virus since the virus can live on surfaces for several hours
- Thoroughly washing hands with soap and water after coming into contact with an infected person