First RSV vaccine could be approved, roll out by August

A vaccine to protect against severe cases of Respiratory Syncytial Virus could roll out as early as August.

Pfizer has developed RSVpreF, a vaccine to prevent severe cases of RSV, and the Food and Drug Administration is reportedly expediting its review approval process.

The FDA is expected to make their decision in August — just before respiratory virus season comes out in full force.

The vaccine is a single dose administered to pregnant women in the late second or third trimester of their pregnancy.

If approved, it would be the first vaccine given to expectant mothers to protect against the disease in infants from birth through their first six months.

Currently, there is no vaccine that exists for RSV, and infants younger than 6 months old are too young to receive most vaccines recommended by the Centers for Disease Control and Prevention.

“If approved, RSVpreF would help protect infants at their first breath from the devastating effects of this infectious disease, which though well-known, has been particularly evident throughout this RSV season,” Annaliesa Anderson, Pfizer’s chief scientific officer of vaccine research and development, said in a press release.

“We look forward to progressing the review of Pfizer’s RSV maternal vaccine candidate with the FDA and other regulatory authorities, given its significant potential to positively contribute to global health in the prevention of RSV in infants.”

The vaccine was nearly 82% effective at preventing severe disease in infants in the first 90 days of life, while the shot was 70% effective at preventing hospitalization and assisted breathing in infants through 6 months old.

RSV is currently the leading cause of hospitalizations for infants, according to a 2022 study published in the Journal of Infectious Diseases.

Each year in the US, RSV leads to 58,000 to 80,000 hospitalizations among children younger than 5 years old, according to the CDC.

Almost all children catch RSV by the time they are 2 years old, and while most cases are mild and cold-like, infants have a higher risk of a severe case.

Anyone can catch RSV, but infants are most prone to it. People infected are usually contagious for three to eight days. Babies and people with weakened immune systems, such as older adults and other vulnerable populations, can spread RSV for up to four weeks.

RSV can cause bronchiolitis, inflammation of the small airways in the lung, and pneumonia, an infection of the lungs, according to the CDC.

Infected people typically show symptoms within four to six weeks, and symptoms usually include runny nose, decreased appetite, coughing, sneezing, fever and wheezing.

RSV is at its worst since 2012, according to Dr. Juanita Mora of the American Lung Association.

“Usually 100% of kids will have had [RSV] by age 2. But over the last two years, these kids who are now 2- to 4-year-olds have never seen RSV,” Mora told The Post in December. “So you have a whole new crop of little ones — plus bigger ones as well, too — that have never seen RSV.”

The US has recently seen a surge in RSV and flu cases. The combination of RSV, flu and COVID-19 circulating has been called a “tripledemic.”