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RSV vaccine receives FDA approval for first time

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This is fantastic news!

I can’t tell you how many of my patients have been sick with respiratory syncytial virus, also known as RSV. And older adults are especially at high risk of developing a severe infection, so I’m very excited about this new single-shot vaccine.

Arexvy is made by the pharmaceutical company GlaxoSmithKline, and it's been FDA-approved for adults aged 60 and older. The agency approved the shot based on a phase three clinical trial that involved nearly 25,000 older adults.

In the trial, the vaccine was 83% effective at preventing lower respiratory tract disease. That was defined as two or more symptoms like coughing, wheezing, shortness of breath, low blood oxygen or lung crackles - meaning short, explosive sounds. In addition, the vaccine was found to be 94% at preventing severe disease in older folks with underlying health conditions like COPD, heart failure or heart disease. Severe disease is when an infected person needs supplemental oxygen or a ventilator to help with breathing.

As for when it’ll be available, we first need the CDC and its advisory committee to meet to review data. And if they recommend it, then the shot will mostly likely be ready this fall. Just before RSV season typically kicks in.

Side effects included pain at the injection site – which is pretty common with any shot – as well as fatigue, muscle pain, headache, and joint stiffness or pain. These symptoms cleared up within a day or two for most participants.

The FDA also noted a few participants experienced atrial fibrillation within 30 days of vaccination. That’s when the heart beats very rapidly or irregularly. And it can lead to blood clots in the heart. In the vaccine group, 10 participants reported atrial fibrillation and in the placebo group, 4 participants reported this side effect. Remember, the placebo group does not get the actual shot. Regardless, this is something scientists will keep a close eye on.

As for how long the protection lasts, it’s unclear at this moment. But so far, it looks like it’s lasting roughly a year. The participants in the trial will be monitored for three years, so we’ll get more info down the road.

Overall, I’m pleased there’s finally a vaccine. Because in the US, roughly 159,000 adults aged 65 and older end up in the hospital because of this virus. And between 10,000 to 13,000 die every year. So it’s important that we protect our seniors.