Yesterday, VRBPAC— FDA’s external scientific committee—met to discuss the latest clinical trial data for RSV vaccines. This is a big deal because it could be the first RSV vaccine to market— something we’ve been waiting on for decades. (Literally since the 1960s, with the first RSV vaccine candidates ending in terrible
Very grateful to Dr. Jetelina, once again, for the report on this. Have to say, as one in the target group, this is the first time where I find I am hesitant to get a vax, at least until more is known. I thought there were really good cautionary comments coming out of some members of the committee.
>The level of incidence of adverse events gives me pause, for one, and I’m not too keen on the potential duration of side effects—a 20%+ chance of four days of fatigue or myalgia post-vax is not high on my hit parade (though here I may not understand the charts).
>I was also struck by this: “Some advisory committee members felt that because RSV is not currently a public health emergency in this age group, it would be best to conduct trials for additional data before granting licensure.”
>Information on durability also seems suboptimal, per Dr. Jetelina’s comment in that section, “However, what this means for protection against severe disease in humans is not currently known. This is particularly a concern with RSV because we know that infection-induced immunity is incomplete.”
So far, I find myself in the camp of the dissenting votes. Of course there are several more months before the vaccines will be offered, so perhaps we will know enough more by which to make a judgment.
Will be interested in the thoughts of others on these issues.
Concur with Susan. Anyone who has read this newsletter for a significant time knows I am a Covid maximalist, fearing (by temperament) the virus and what it can do. Note the use of the present tense. That same fearfulness makes me loath to take a vaccination that has even a 1 in 15,000 chance of getting GBS. I don't think the outcomes of getting RSV for lack of vaccination, are worse than the total catastrophe GBS would be.
How does misinformation show with a vaccine that currently wouldn’t be required? Do we see similar misinformation campaigns for the flu vaccines? Or was COVID uniquely targeted because of the mandates that government put in? I am curious what is the trigger for the misinformation attacks. Science itself or science plus government intervention?
Are there resource bottlenecks that make co-administration necessary, or is it simply a matter of convenience for the person getting the vaccine? My inclination is always to space out my vaccines.
Excellent write-up Edward, subscribed to your substack.
Katelyn/Edward - What about the Moderna mRNA RSV vaccine? Why wasn't that under review at this meeting? Too early? Granted it's their own press release, so you take with a grain of salt, but phase 3 trials were promising.
Thanks for the highly informative post. Are you aware that there's yet another RSV vaccine in trials? I'm a 65+ aged male enrolled in a yearlong study led by Bavarian Nordic A/S. I believe part of the trial is in Europe, so perhaps that's where they hope to market it.
So with these two possible "side-effects," both of which seem fairly significant, how soon after the vaccine is administered do they manifest themselves? Minutes, hours, or days? And once they appear, what are the remedies? Thank you, Katelyn.
Thank you for unpacking this and for all the work you are doing! I have a question and I think the answer is "we don't know?" However, I am going to ask it anyway . . . Are we getting closer to where this awful virus will actually be more like "other" respiratory viruses?
No, but it's conceivable that many risks turn out to be more deterministically heterogeneous as advances are made in, for instance, genetics and AI. Interesting world we're headed for.
I'd love to see our heroine write something about the public health implications of AI.
Hmmm. It would be helpful to have some sense of the mortality rate of RSV in various age groups, as well as the consequences of the neurological conditions that appeared more often in the vaccinated group. In the absence of these pieces of information, it's difficult for a lay person to make a decision about the RSV vaccine.
Very grateful to Dr. Jetelina, once again, for the report on this. Have to say, as one in the target group, this is the first time where I find I am hesitant to get a vax, at least until more is known. I thought there were really good cautionary comments coming out of some members of the committee.
>The level of incidence of adverse events gives me pause, for one, and I’m not too keen on the potential duration of side effects—a 20%+ chance of four days of fatigue or myalgia post-vax is not high on my hit parade (though here I may not understand the charts).
>I was also struck by this: “Some advisory committee members felt that because RSV is not currently a public health emergency in this age group, it would be best to conduct trials for additional data before granting licensure.”
>Information on durability also seems suboptimal, per Dr. Jetelina’s comment in that section, “However, what this means for protection against severe disease in humans is not currently known. This is particularly a concern with RSV because we know that infection-induced immunity is incomplete.”
So far, I find myself in the camp of the dissenting votes. Of course there are several more months before the vaccines will be offered, so perhaps we will know enough more by which to make a judgment.
Will be interested in the thoughts of others on these issues.
Concur with Susan. Anyone who has read this newsletter for a significant time knows I am a Covid maximalist, fearing (by temperament) the virus and what it can do. Note the use of the present tense. That same fearfulness makes me loath to take a vaccination that has even a 1 in 15,000 chance of getting GBS. I don't think the outcomes of getting RSV for lack of vaccination, are worse than the total catastrophe GBS would be.
How does misinformation show with a vaccine that currently wouldn’t be required? Do we see similar misinformation campaigns for the flu vaccines? Or was COVID uniquely targeted because of the mandates that government put in? I am curious what is the trigger for the misinformation attacks. Science itself or science plus government intervention?
Are there resource bottlenecks that make co-administration necessary, or is it simply a matter of convenience for the person getting the vaccine? My inclination is always to space out my vaccines.
Question: is there data on the risks of having RSV so we can compare that with the risks of the vaccine?
Excellent write-up Edward, subscribed to your substack.
Katelyn/Edward - What about the Moderna mRNA RSV vaccine? Why wasn't that under review at this meeting? Too early? Granted it's their own press release, so you take with a grain of salt, but phase 3 trials were promising.
https://investors.modernatx.com/news/news-details/2023/Moderna-Announces-mRNA-1345-an-Investigational-Respiratory-Syncytial-Virus-RSV-Vaccine-Has-Met-Primary-Efficacy-Endpoints-in-Phase-3-Trial-in-Older-Adults/default.aspx
Thanks!
Thanks for the highly informative post. Are you aware that there's yet another RSV vaccine in trials? I'm a 65+ aged male enrolled in a yearlong study led by Bavarian Nordic A/S. I believe part of the trial is in Europe, so perhaps that's where they hope to market it.
So with these two possible "side-effects," both of which seem fairly significant, how soon after the vaccine is administered do they manifest themselves? Minutes, hours, or days? And once they appear, what are the remedies? Thank you, Katelyn.
Thank you for unpacking this and for all the work you are doing! I have a question and I think the answer is "we don't know?" However, I am going to ask it anyway . . . Are we getting closer to where this awful virus will actually be more like "other" respiratory viruses?
Pediatrician here. Where are the infant studies??
No, but it's conceivable that many risks turn out to be more deterministically heterogeneous as advances are made in, for instance, genetics and AI. Interesting world we're headed for.
I'd love to see our heroine write something about the public health implications of AI.
Hmmm. It would be helpful to have some sense of the mortality rate of RSV in various age groups, as well as the consequences of the neurological conditions that appeared more often in the vaccinated group. In the absence of these pieces of information, it's difficult for a lay person to make a decision about the RSV vaccine.
Thanks, always.
Be sure your daughters are getting adequate Mommy not just the MDR.