First RSV vaccine approved in U.S. after decades of attempts

The US approved the first vaccine for respiratory syncytial virus (RSV) on Wednesday, a shot to protect parents from the respiratory virus that is most notorious for attacking babies but also endangers grandparents.

The Food and Drug Administration’s decision made GSK’s shot, called Arexvy, the first of several potential vaccines in the pipeline for RSV to be licensed everywhere.

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 seniors really need RSV protection or just those considered at high risk from respiratory syncytial virus. CDC advisers will debate the question in June.

After decades of unsuccessful efforts to develop an RSV vaccine, doctors are eager to have what’s on offer — especially after a surge in the virus that hit hospitals last fall.

“This is a good first step … to protect the elderly from serious RSV disease,” said Dr. William Schaffner, medical director of the National Foundation for Infectious Diseases, who was not involved in its development. Next, “we’ll walk down the age ladder” for what we hope will be a new string of protections.

The FDA is considering a vaccine similar to competitor Pfizer’s for the elderly. Pfizer is also seeking approval to vaccinate pregnant women, so that babies born with some of the mother’s protection.

There is no vaccine for children yet, but high-risk babies often get a monthly dose of a protective drug during the RSV season — and European regulators recently approved a single-dose option. The FDA is also considering whether to approve Sanofi and AstraZeneca’s one-shot drugs.

“It’s an exciting time with so many potential RSV solutions coming out after years of nothing,” said Dr. Phil Dormitzer, head of vaccine research and development for GSK, formerly known as GlaxoSmithKline.

Up to 14,000 older Americans die from RSV each year

RSV is a common cold-like nuisance for most people, but it can be life-threatening for the young, the elderly and people with high-risk health problems. It can block a baby’s breathing by burning the small airways, or it can get into the parents’ lungs causing pneumonia.

In the US, about 58,000 children younger than five are hospitalized with RSV each year and several hundred die. Among the elderly, 177,000 are hospitalized with RSV and up to 14,000 die each year.

Why is it taking so long to make a vaccine? The field suffered a major setback in the 1960s when experimental shots increased infections in children. Scientists have finally found a better way to develop the vaccine – although modern candidates are still being tested first on adults.

GSK’s new vaccine for older adults trains the immune system to recognize proteins on the surface of RSV, and contains ingredients called adjuvants to further rev up the immune response.

In an international study of 25,000 people 60 and older, a single dose of the vaccine was nearly 83 percent effective in preventing RSV lung infection, and reduced the risk of severe infection by 94 percent.

To see how long protection lasts, GSK tracked study participants for three years, comparing some who got just one vaccination during that time and others who were given annual boosters.

Reactions taken are typical of vaccination, such as muscle pain and fatigue.

There are some rare but serious risks – one case of Guillain-Barre syndrome, which can cause temporary paralysis, and two cases of inflammation of the brain and spinal cord. The FDA said it will require the company to continue to study if it is indeed related to the vaccine.

If the CDC eventually recommends vaccination for some or even all seniors, it will add another shot for the fall along with the annual flu vaccine — and possibly another COVID-19 booster.

“We need to educate the population that this virus that not everyone has heard of is actually an important threat to health in the winter,” said Schaffner, an infectious disease expert at Vanderbilt University.

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