The world’s first RSV vaccine approved by the FDA

Medicine

By Brooke Kato

May 3, 2023 | 7:35 p.m.

The Food and Drug Administration on Wednesday approved Arexvy, the world’s first vaccine against RSV, or respiratory syncytial virus – a scientific breakthrough that has been in progress for 60 years.

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

“Our goal now is to ensure that eligible older adults in the United States can access the vaccine as soon as possible and to advance regulatory review in other countries,” said Tony Wood, chief scientific officer of GSK, in a statement.

RSV, which usually causes mild cold-like symptoms, can lead to serious illness in the elderly and young children.

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

The CDC also estimates that up to 80,000 children under age 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 percent and reduced the risk of developing severe RSV-associated LRTD by 94 percent, according to the FDA.

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

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

GSK promises the vaccine will be available to older people before the RSV season, which is expected to begin in the fall.

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

The FDA noted that it is asking GSK to continue monitoring vaccine recipients 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 of the brain and spinal cord.

In one study, two participants developed ADEM after receiving Arexvy and the flu vaccine, with one of the patients dying, 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, would become the first RSV vaccine to gain FDA approval.

Agency approval is expected to arrive in August, which would allow the vaccine to be given to pregnant women at the end of their second or third trimester – the first RSV vaccine for expectant mothers.

“If approved, RSVpreF would help protect infants from their first breath from the devastating effects of this infectious disease, which, while well known, has been particularly evident throughout this RSV season,” Annaliesa said. Anderson, scientific director of vaccine research at Pfizer and Development, said in a February statement.

The vaccine is said to be 82% effective in preventing serious illness in infants during their first 90 days of life and 70% effective in curbing hospitalizations due to RSV in infants up to 6 months of age.

Doctors reported a record number of RSV patients over the past season, with NYC emergency departments caring for more children than beds available.