In 2023, the FDA has approved two new RSV vaccines, the first ones ever. Both are approved for folks over 60 years old, and one is approved for pregnant women at 24-36 weeks of gestation. So, should all those folks get them? Well, my trust in experts is not with the FDA for vaccines, it is with the ACIP, the American College of Immunization Practices. These are among the best medical scientists in the field. For these new vaccines, there is some safety concern. The main concern is a signal that they may trigger atrial fibrillation in around 6/34284 in the clinical trial of one of them, 6/24966 in the other, and perhaps 1/30000 cases of Guillain-Barre syndrome. These potential harms are a caution. These are NOT mRNA vaccines, like the Covid shots. They are instead made of the fusion glycoprotein. This makes them conventional, but novel. The risk of adverse effects is inherently higher than with mRNA vaccines.
So what does the ACIP recommend? They have not as of this writing ruled on pregnant women. Pregnancy is THE number one risk factor for death from influenza, so the hazard from RSV may also be much higher, and the trade-off with adverse effects also higher. Wait for that one. For those adults over 60, the recommendation can be summarized thus: only for those clearly at high risk for complications and severity of lower respiratory infections. In English: bad hearts, bad lungs, frail, nursing home residents, diabetic, bad kidneys, bad liver, bad immune system (NOT autoimmune, that’s different).
So, will I be getting this one. No. I’m 71 and healthy. I’m not at very high risk of lower respiratory infections, or at least not high enough to take a small risk of Guilain-Barre or atrial fibrillation, which itself triples the risk of stroke, or more. Not for me, yet. Harms cannot be well quantified during initial trials, ever. Only surveillance after wide use. The safest vaccine we have? Think…..It’s the Covid shot! More widely used than any other vaccine, ever. Despite it’s small problems, we know more about it’s adverse reactions than any other vaccine. That’s what 13.5 BILLION doses can tell us.
Oops! I forgot: I personally succumbed to the newness and price (zero) and got the vaccine before I read The Medical Letter and the ACIP recommendations. Today I would choose to put it off, but I got away without adv. effects, this time.