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What You Should Know About The FDA Approving An RSV Vaccine for Older Adults

A colorized image from an electron micrograph shows a mass of what look like overlapping blue sticks, some bent but mostly straight, on a nondescript reddish background. Little yellow specks or dots appear mostly on or over the sticks, but some on their own.
Using indirect immunofluorescence microscopy, this photomicrograph revealed the presence of the respiratory syncytial virus (RSV) in an unidentified tissue sample, RSV is the most common cause of bronchiolitis and pneumonia among infants and children under 1 year of age.
(National Institute of Allergy and Infectious Diseases
National Institutes of Health)
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The Food and Drug Administration (FDA) has approved the pharmaceutical company GlaxoSmithKline's vaccine for the respiratory syncytial virus, known as RSV, for adults 60 and older.

Although it will be several months until the vaccine is actually available to the public, this vaccine, which culminated after decades of research, is aimed at protecting the 14,000 older people who die from RSV every year, and the 170,000 who are hospitalized.

Dr. Kimberly Shriner, an infectious disease specialist at Huntington Hospital, joined LAist’s public affairs show AirTalk to discuss this development and what it could mean for the thousands who are afflicted with RSV each year.

Why now

RSV became a household name recently, especially during the “tripledemic” of winter 2022 — the colloquial term for the collision of COVID-19, RSV and flu cases that overwhelmed hospitals.

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RSV is particularly dangerous for older adults and for very young children, Shriner says, as it takes advantage of their less robust immune systems.

The technology of the RSV vaccine has been decades in the making. A recent breakthrough in identifying the process by which the virus attaches to human cells changed the trajectory of the vaccine, she says, and the outcomes have been promising.

About the vaccine and its approval

The ongoing Phase 3 trials indicate that the vaccine can decrease disease state and risk of death in over 80% of individuals above 60 years old.

Dr. Shriner says the FDA collaborates with the Centers for Disease Control (CDC) to do a deep dive into the data that pharmaceutical companies present them, weigh the benefits and adverse effects and present a calculated decision to approve it or not.

What we know from the trials

During the trials, some rare side effects were documented in a few people who received the RSV vaccine. Notably, those included Guillain-Barré syndrome, a disorder in which the body’s immune system attacks its nerves. Shriner says that with this rare side effect and others, it’s important to consider the ratio of risk to benefit.

“Many thousands of people older than 65 can die from RSV, and the risk of them getting Guillain-Barré from the vaccine is probably fairly low,” Shriner says. “And certainly for young children, it's going to be a game changer, I think, for a lot of morbidity and mortality in that population.”

When will a vaccine be ready for children?

RSV “really likes” little kids, Shriner says, and it often travels in day cares. By around age five children often have some immunity memory, either from contracting RSV or having been exposed to it.

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Pharmaceutical companies are looking towards RSV vaccines for young children and for pregnant women to protect their babies — another decision where the risk to benefit ratio will become important, Shriner says.

For now the CDC advises: "There is a medicine that can help protect some babies at high risk for severe RSV disease."

Next steps

The CDC will identify specific populations that can receive the vaccine and work towards making it publicly available, a process that Shriner says is usually relatively quick. The federal government determines whether the vaccine is free or not, but it would certainly be covered by health care providers, according to Dr. Shriner.

As the World Health Organization ends the emergency status of COVID-19, Shriner says the scientific community has learned a lot from the pandemic — lessons that can be applied to tackling other diseases.

“Even though there's been some controversy about vaccines and perhaps some hesitancy in many people, our knowledge about the use of vaccines and indications in health and what they do has grown exponentially,” she says. “And that's a very good thing for the world.”

Listen to the conversation

RSV Vax and WHO Covid 05.05.2023
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