World’s first RSV vaccine approved by FDA

The Food and Drug Administration on Wednesday approved Arexvy, the world’s first vaccine for RSV, or respiratory syncytial virus — a scientific breakthrough 60 years in the making.

Manufactured by pharmaceutical giant GSK, the single-dose shot aims to prevent lower respiratory tract disease, caused by RSV, in people 60 years and older.

“Our focus now is to ensure eligible older adults in the US can access the vaccine as quickly as possible and to progress regulatory review in other countries,” Tony Wood, the chief scientific officer at GSK, said in a statement.

RSV, which typically brings mild, cold-like symptoms, can result in severe illness in older adults and young children.

Each year, the highly contagious virus is named as the cause of more than 60,000 hospitalizations and 6,000-plus deaths of US adults 65 and older, as well as 100 to 300 deaths of children younger than 5, according to the Centers for Disease Control and Prevention.

The CDC also estimates that up to 80,000 children younger than 5 are hospitalized each year due to RSV.

The FDA said it analyzed data from an ongoing clinical study with 12,500 participants receiving Arexvy and the same number receiving a placebo. 

The vaccine reduced the risk of developing RSV-associated LRTD by 83% and lowered the risk of developing severe RSV-associated LRTD by 94%, according to the FDA.

The most commonly reported side effects of the vaccine are injection-site pain, fatigue, muscle pain, headache and joint stiffness.

“With this vaccine, Americans over the age of 60, and particularly those with underlying health conditions like COPD, asthma or congestive heart failure, will have a vaccine to help protect against potentially serious outcomes from RSV,” Dr. John Kennedy, the president of the American Medical Group Association, said a statement.

GSK promises the vaccine will be available for seniors ahead of the RSV season, which is expected to start in the fall.

The CDC’s Advisory Committee on Immunization Practices is set to make recommendations in June on the appropriate use of the shot.

The FDA noted it is telling GSK to continue to monitor vaccine receivers for Guillain-Barré syndrome, a rare neurological disorder that can lead to paralysis, and for acute disseminated encephalomyelitis, or ADEM, a rare attack of inflammation in the brain and spinal cord.

In one study, two participants developed ADEM after receiving Arexvy and the influenza vaccine, with one of the patients dying, according to the FDA. In another study, one participant developed Guillain-Barré syndrome nine days after receiving Arexvy.

Other RSV vaccines are expected soon.

US clinical trials for an RSV vaccine date back to the mid-1960s.

Researchers had predicted Pfizer’s vaccine, RSVpreF, would become the first RSV vaccine to be granted FDA approval.

The agency’s approval is expected to arrive in August, which would allow the shot to be administered to pregnant women in their late second or third trimesters — the first RSV vaccine for moms-to-be.

“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 February statement.

The vaccine is said to be 82% effective in preventing severe illness in infants within their first 90 days of life and 70% effective in curbing hospitalizations from RSV in infants up to 6 months old.

This past season, physicians reported record numbers of RSV-infected patients, with NYC emergency departments caring for more children than available beds.