19 Comments

Thanks for this! Your reputation for prudent caution makes this endorsement even more meaningful for primary care docs like me who are reading and filtering, then educating and recommending.

I am troubled slightly by the GBS potential and I’m sure you’ll be watching this closely too. Helen Branswell wrote a good piece recently about these RSV vaccines:

“The background rate of GBS — the rate at which it occurs in the general population — is about 1 case per 100,000 people per year. Three cases in less than half that number — the people vaccinated in the adult RSV trials — gave pause to the members of ACIP’s adult RSV work group…”

https://www.statnews.com/2023/05/26/rsv-vaccines-will-older-adults-care/

I have at least 3 patients who experienced GBS within a suspicious time frame after flu shots, which seems like more than I should see based on the probability. Nonetheless I know experts and advisory committees do the tough and thankless job of weighing risks and benefits, so once again, thanks! I get a flu shot every year of course.

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May 16, 2023·edited May 16, 2023

I'm a layperson but know enough to know this is great news and a vaccine I will get not too many years from now. I do have a question for anyone who knows and would be so kind as to answer. With the COVID vaccine, much of the medical establishment repeatedly said that "vaccines are not expected to prevent infection. Rather they are meant to prevent serious illness." And that was indeed news to me. I knew that they were not 100 percent effective, but I never knew that vaccines in general were not developed and intended to prevent infection with whatever virus they were developed to prevent. And what jumps out at me with this RSV Vax is that it too prevents infection. My question is, do most vaccines actually prevent infection despite what the public was told after discovering that the COVID vaccines did not prevent infection? Pertinent quotation here: "Participants were studied for one year. Those who received the vaccine reduced their risk of RSV acute respiratory infection by 72 percent, of RSV pneumonia by 83 percent, and of severe RSV disease requiring supplemental oxygen or hospitalization by 94 percent." I don't know that Dr. Offit said this and don't mean this to be anything but a sincere question. My feeling is that the medical establishment sort of bent the truth on how vaccines work in order to avoid further public anger in general which was already prevalent with the COVID vax. Thanks.

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Thoughts from a skeptic:

1) If there 3 million cases a year against 77 million people > 60, why were the numbers of RSV cases in the placebo group (40 out of 12,499) so low by ratio? Granted the study period was only 6.7 months, but even that is a nearly a 6-fold decrease in cases in observed study population against the estimate. I would think the estimate would be undercounted as we don't PCR surveil the population for RSV like you would in a trial.

Is this concerning at all? It would suggest either our estimates are wildly off, and we are attacking a problem nearly a magnitude smaller than it is, or, that the GSK trial failed to accurately capture RSV burden and was underpowered.

Now the study does attempt to answer this, making the debatable claim that "Public Health measures to limit Covid-19 transmission reduced the spread of RSV and altered the RSV season" - but if that is the case, wouldn't the prudent approach be to study your vaccine in a regular RSV season before declaring victory? Flu disappeared in 2020 as well (even in countries that didn't mask or distance), would we trust a new Flu vaccine only tested in 2020?

2) I've got 16 years before I would have to consider this shot, but it's a tough sell to take a shot that reduces risk of catching a cold from 40/12,500 down to 7/12,500, when 879/12,500 experienced pain or fatigue.

3) Let's say 10,000 elderly people with diabetes, chronic heart, lung, or kidney disease die each year due to pneumonia following an RSV infection. Do we expect 8,250 of those elderly people not to die that year if vaccinated? Or, would we just whack-a-mole it so another of the hundreds (?) of respiratory viruses takes the place of RSV, and some other virus of opportunity infects the elderly person, causes pneumonia, and the outcome is no different?

I know this is speculative questioning but it seems to me the true measure of efficacy would be if the study also measured overall mortality with a focus on all-cause ILI triggered deaths.

I'm just thinking about when my grandfather passed in 2018, he was very frail already, sitting in a nursing home with late stage Alzheimer's, declining rapidly since his wife passed the year before. Eventually some cold got him, then hospitalized, pneumonia, living will says no vent, they make him comfortable and that's it. 87, lived an amazing life, but didn't know much about the last 4-5 years.

All the way back then we weren't PCR testing to trace every cold source, so who knows what pushed the domino. RSV? Flu? a regular Coronavirus? Any of the other hundreds of ILI?

Even if it was RSV, I just can't imagine had he been vaccinated with RSV that his outcome within a month or two would have been any different, and it seems to me this type of death is what mainly comprises the 10,000 RSV yearly fatalities.

Hope it works though, even if ROI is sketchy (3.5 billion a year to vaccinate yearly everyone 60+)

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What was the all cause mortality in the two groups? Link to FDA GDK data?

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important summary of the long-awaited RSV vaccine

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This is great news.

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Ops. J

Hoy the wrong button... COVID War” and if so what did you think of it?

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Thanks,Dr.Offit. As an 80yo with young grandkids I’ll definitely be getting this vaccine. I was wondering read Lessons from if you’ve had a chance to

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