The Food and Drug Administration (FDA) on Wednesday approved Arexvy, the world’s first vaccine against respiratory syncytial virus (RSV), a scientific breakthrough that has been 60 years in the making.
Manufactured by pharmaceutical giant GSK, the single-dose injection aims to prevent lower respiratory tract disease (LRTD) caused by RSV in people aged 60 and over.
“Our focus now is to ensure that eligible older adults in the US can access the vaccine as quickly as possible and advance regulatory review in other countries,” Tony Wood, GSK’s chief scientific officer, said in a statement.
RSV, which usually causes mild cold-like symptoms, can cause severe illness in older adults and young children.
Each year, the highly contagious virus is responsible for more than 60,000 hospitalizations and more than 6,000 deaths in American adults age 65 and older, as well as 100 to 300 deaths in children under age 5, according to the Centers for Disease Control and Prevention. Disease Prevention.
The FDA said it analyzed data from an ongoing clinical study involving 12,500 participants who received Arexvy and 12,500 participants who received a placebo.
The vaccine reduced the risk of developing RSV-associated LRTD by 83% and reduced the risk of developing RSV-associated severe LRTD by 94%, according to the FDA.
The most frequently reported side effects are pain at the injection site, fatigue, muscle pain, headache, and joint stiffness/pain.
“With this vaccine, Americans 60 and older, and particularly those with underlying health conditions such as COPD, asthma or congestive heart failure, will have a vaccine to help protect them against potentially serious outcomes from RSV,” said Dr. John Kennedy, the president of the American Medical Group Association, said in a statement.
GSK promises that the vaccine will be available for seniors before the 2023-24 RSV season, which is expected to start in the fall.
The CDC’s Advisory Committee on Immunization Practices is set to make recommendations on the appropriate use of the vaccine in June.
The FDA said it is telling GSK to continue to monitor Guillain-Barré syndrome, a rare neurological disorder that can cause paralysis; and for acute disseminated encephalomyelitis (ADEM), a rare bout of inflammation in the brain and spinal cord.
In one study, two participants developed ADEM after receiving Arexvy and the influenza vaccine, and one of the patients died, according to the FDA. In another study, a 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 that Pfizer’s vaccine, RSVpreF, could become the first RSV vaccine to gain FDA approval.
Agency approval is expected to come in August, which would allow pregnant women to be given the shot in their late second or third trimester, the first RSV vaccine for moms-to-be.
“If approved, RSVpreF would help protect babies at their first breath from the devastating effects of this infectious disease, which while well known, has been particularly evident this RSV season,” Annaliesa Anderson, scientific director of research and Pfizer vaccine development. she said in a February statement.
The vaccine is said to be 82% effective in preventing serious illness in infants within the first 90 days of life and 70% effective in curbing RSV hospitalizations in infants up to 6 months of age.
The CDC estimates that up to 80,000 children under the age of 5 are hospitalized each year due to RSV.
Last season, doctors reported record numbers of RSV-infected patients, and New York City emergency departments treated more children than beds were available.