The United States on Wednesday approved the first RSV vaccine, shots to protect older adults against a respiratory virus that is most notorious for attacking babies but also endangers grandparents.
The Food and Drug Administration's decision makes GSK's shot, called Arexvy, the first of several potential RSV vaccines in the pipeline for licensing anywhere.
The move sets the stage for adults 60 and older to get vaccinated this fall, but first, the Centers for Disease Control and Prevention must decide whether all older people really need protection against RSV or only those considered high. risk of respiratory syncytial virus. CDC advisers will discuss that issue in June.
After decades of failure in the search for an RSV vaccine, doctors are eager to finally have something to offer, especially after a virus rise that hit hospitals last fall.
"This is a great first step ... in protecting older people from severe RSV disease," said Dr. William Schaffner, chief medical officer for the National Foundation for Infectious Diseases, who was not involved in its development. Next, "we're going to work our way down the age scale" for what is expected to be a series of new protections.
The FDA is considering a similar vaccine from competitor Pfizer for older adults. Pfizer is also seeking approval to vaccinate pregnant women so that their babies are born with some of the mother's protection.
There is no vaccine for children yet, but high-risk babies often receive monthly doses of a protective drug during the RSV season, and infants European regulators recently approved the first single-dose option . The FDA is also considering approving the unique drug from Sanofi and AstraZeneca.
“This is a very exciting time with multiple potential RSV solutions emerging after years of nothing,” said Dr. Phil Dormitzer, head of vaccine research and development at GSK, formerly known as GlaxoSmithKline.
RSV is a cold-like nuisance for most people, but it can be life-threatening for the very young, the elderly, and people with certain high-risk health problems. It can prevent babies from breathing by inflaming their tiny airways or go deep into the lungs of older people and cause pneumonia.
In the US, about 58,000 children younger than 5 years are hospitalized for RSV each year, and several hundred die. Among older adults, up to 177,000 are hospitalized with RSV and up to 14,000 die annually.
Why has it taken so long to find a vaccine? The field suffered a major setback in the 1960s when an experimental vaccine worsened infections in children. Scientists eventually figured out a better way to develop these vaccines, though modern candidates were still first tested with adults.
GSK's new vaccine for older adults trains the immune system to recognize a protein on the surface of RSV and contains an ingredient called an adjuvant to further speed up that immune reaction.
In an international study of approximately 25,000 people aged 60 years and older, one dose of the vaccine was almost 83% effective in preventing RSV infections of the lungs and reduced the risk of serious infections by 94%.
To see how long the protection lasts, GSK is following study participants for three years, comparing some who get just one shot during that time and others who get an annual booster.
Vaccine reactions were typical of vaccines, such as muscle pain and fatigue.
There were hints of a rare but serious risk: one case of Guillain-Barré syndrome, which can cause usually temporary paralysis, and two cases of a type of inflammation of the brain and spinal cord. The FDA said it was requiring the company to continue studying whether there really is a link to the vaccine.
If the CDC finally recommends vaccination for some or even all seniors, it will add another shot for the fall along with your annual flu shot, and perhaps another booster against COVID-19.
“We will have to educate the public that this virus that not everyone has heard of is actually a major threat to their health during the winter,” said Schaffner, an infectious disease expert at Vanderbilt University. ___
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