45 Comments

Shouldn't the CDC be more circumspect before recommending this drug to millions of healthy infants on the basis of a few short-term studies of a couple thousand children? Do we know its effect on total mortality? Could there be a substantial major adverse event rate that small studies would miss? Could the drug affect the infants' immune system in other ways making children more susceptible to other infections? Will the manufacturer be required to do large, unbiased, post-market surveillance studies to assess RW effectiveness and safety? Also, you call the product a "drug" while the CDC Director called it an "immunization". I agree that it is a drug - a prophylactic monoclonal antibody therapy. CDC playing games with words will not promote public confidence.

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1. Words matter in science. It is a passive immunization and a drug.

2. Maybe should learn some statistics if you want to understand why the sample sizes were choosen.

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No. Why exactly should it be more "circumspect" now?

As for healthy infants. what part of "Every year in the United States, RSV causes 1.5 million out-patient visits, 500,000 emergency department visits, 80,000 hospitalizations, and 100-300 deaths. About 80 percent of hospitalizations occur in children less than 6 months of age who were otherwise healthy" didn't you understand?

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What do you call this scenario?

In the third trimester pregnant women are vaccinated against pertussis. This creates antibodies which cross the placenta into the baby.

Mum breast feeds her new baby, in the breast milk there are antibodies against pertussis.

Is it immunisation? There is an argument that yes it is because it is providing the baby with a ready made immune response. To refer to a vaccination as immunisation is a misnomer as it doesn’t make you immune to the infection.

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The reason they use the term immunization rather than drug is simply

1) legal immunity against side effects

2) no need for safety testing.

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It’s passive immunization rather than active. It’s a monoclonal antibody.

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Which is not immunization.

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Thanks again for reminding us again that the anti-vacc fraud is predicated on folks being too clueless to read.....

https://www.britannica.com/science/passive-immunization

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Aren't we lucky?

I have posted the law and the claim there is a legal immunity is a lie predicated on folks being too stupid to read.

I have posted the regulations and they are required to do safety testing.

Thank you for the continuing public service in proving the stupidity of the anti-vacc fraud.

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Do we have any sense how the mAbs will affect babies' adaptive immune response to RSV?

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What was the placebo? Why would there be so many severe events? Is the application/trial data on the fda website?

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1. the placebo was normal saline.

2. pre-term babies have more adverse events.

3. you can find (with some clicking) data etc here: https://www.fda.gov/news-events/press-announcements/fda-approves-new-drug-prevent-rsv-babies-and-toddlers

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Aug 9, 2023·edited Aug 9, 2023

Can you provide a link where they describe the placebo as normal saline? I've been looking for that information but was unable to find it. When I read through the description, it describes the placebo as "A single IM dose of placebo matched to MEDI8897 on Day 1 of the study."

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It is in the supplement from the NEJM publication:

"Participants in the placebo group will receive a corresponding volume of normal saline"

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Can’t wait to read the submitted application and placebo control? trial data. Hopefully this injection will be safer than the mRNA that has injured so many young like the sixteen yr old son of a pharma exec who now has a pace maker… he had a sudden heart stoppage during choir at his high school. Never heard of anything like that before the gene mRNA. He was not the only high schooler to fall over singing… a boy in Illinois died during a state competition. Hopefully monoclonals are not as dangerous.

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no info on side effects yet. https://pubmed.ncbi.nlm.nih.gov/35235726/

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Thanks for the link. How odd. I thought pharma had to complete their trials before rolling out novel therapies.

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6.8 percent of recipients had a severe adverse event? And 7.3 had an adverse event in the placebo group? Lol. Remember when babies were healthy? What was the placebo? A failed RSV “shot”? Why would anyone take this?

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Instead of listening to some random person's postings, how about looking at the facts?

The trials were completed and per-term babies have more adverse events.....

BTW: do you know what adverse events are?

https://www.fda.gov/news-events/press-announcements/fda-approves-new-drug-prevent-rsv-babies-and-toddlers

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Guess that means, no you won't read the words and see the facts.

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I missed that. More adverse events than Effective cases? Did I misread that too?

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the introduction of a new vaccine to be given to expectant mothers and also a new mAb for preventive treatment of RSV infection will save thousands of babies from hospitalization and possible death from this leading infectious disease killer of infants.

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Depending on the outcome (hospitalization/severe disease) this drug is1% effective ARR. number needed to treat is about 200. Death benefit was zero in the one study we have.

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I think you mean the one study that you know about....deaths were much lower in the vaccinated group in trial 03.

https://www.fda.gov/news-events/press-announcements/fda-approves-new-drug-prevent-rsv-babies-and-toddlers

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Thank you for the link. I went there and didn't see deaths/fatality. I followed the link to trial 3 on preterm births and also no numbers (the word death was there at least) Am I having a paywall issue?

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Please see the results tab.

Placebo: n=484, deaths=3

Vaccinated: n=969, deaths=2

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Very helpful. Thanks. You may be on to something. Given the small sample size there is no statistical power to these numbers. But...it definitely is a good indicator that in Premature births this treatment could reduce deaths.

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You are welcome.

I am glad you cared enough to read.

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I've been waiting for this for a LONG time. Good news, even if it's expensive. And I expect pushback from insurers even though it's been added to the list.

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I was hoping Dr Offit would write about this, too. Sounds like a great option for parents to protect their babies against RSV during those most vulnerable months when the immune system is immature, and so many hospitalizations, and some awful deaths.

I don’t think experts worry about the baby’s immune system being deprived a full look at RSV. There will be plenty more chances, but with a more fully functional immune system after that critical first year of life/maturation. I think it’s fair to say these monoclonal antibodies are analogous to the many maternal antibodies transferred to the fetus before birth.

I would absolutely do this for my child if they were of the recommended age, and will translate this to patients. Thanks!

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Aug 7, 2023·edited Aug 7, 2023

a layperson's question on terminology: is a long-acting monoclonal antibody still a vaccine? I thought vaccine's stimulated an immune system's response, both short-term and long-term, ideally, but if I understand mAbs correctly the antibody is introduced directly.

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They are calling it passive vaccination. I had to look it up.

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Oh that's right, I've also heard that term used for monoclonal antibodies for covid, though from what I understand those aren't considered to be long-lasting. Thanks

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I don't think this would meet the definition of a vaccine according to the CDC (https://www.cdc.gov/vaccines/vac-gen/imz-basics.htm#:~:text=Vaccine%3A%20A%20preparation%20that%20is,or%20sprayed%20into%20the%20nose.) definition but I could be missing some way that it might be slid into that definition.

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I guess the question isn't so much whether it's a vaccine, as whether it counts as preventive one way or another for the purpose of ACA plans. If we didn't have such a do-nothing gridlocked Congress maybe we'd amend the statute, but in the meantime, whatever works.

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This is even more necessary than the COVID vaccines for children. I have been seeing RSV cause illness and morbidity, though luckily not mortality, since i was in medical school in 1992. This is finally progress on the RSV front. The adult colleagues who ask questions about whether an RSV “vaccine”/treatment is needed (due to the unwarranted questioning of the CDC that everyone does now since COVID) don’t know about Synagis and only started hearing about RSV when it started killing their older patients. And I won’t even start about how masking a few short years ago dropped RSV illness precipitously in my practice. RSV came back with a vengeance once the masks came off.

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Thanks for the comments.

Isn't it amazing how when large sections of society take basic steps to reduce the risk of Covid that the risks from lots of other respiratory virus also dropped.....

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% should be absolute, not relative. Those quoted numbers are false, just like those for covid vaccines were. Fake science, fake data and, of course, NO long term study. Just a mountain of cash.

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I take great comfort from the fact that anyone that everyone that understands 5th grade math/science is laughing at the idiocy of your posting!

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SD has no credentials listed. Enough said. 🙄🤷🏻‍♂️

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You are if anything excessive kind.

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https://classic.clinicaltrials.gov/ct2/show/NCT02878330

Follow that link, scroll down to study protocol. Download the pdf. On page 37 of the pdf. Table 4.5.1-1 Identification of Investigational Products: Commercially available 0.9% (w/v) saline (sterile for human use)

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Thank you Dr. Offit. I'm wondering, if a child truly hasn't had RSV, like my 2 1/2 year old granddaughter, can she get the vaccine? We were so cautious about covid with her, that she literally has never been sick! Unless she had an asymptomatic case of something. Thanks!

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Is this medication more efficacious than the Synagis we currently give to at-risk babies? Or just cheaper?

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Dr. Offit, could you comment on the data presented on number needed to treat and cost presented at the ACIP meeting (about slide 26 in the EtR presentation). I think the numbers seem off. 5% of babies in placebo group (for "term" babies) has MA-LRTI, so even if drug were perfect, NNT would be 20, right? They reported 17. If preemies are added in, it still doesn't come out to 17, and those are 2 very different groups so shouldn't really be merged. Accepting 17 as the number, with $445 as treatment cost, cost per event avoided should be much higher than on the slide. I think for healthy term babies, NNT should be 27 (1/5.0-1.2) to avoid MA-LRTI. For commercially insured patients at cost of $495/dose, cost to avoid an outpatient bronchiolitis visit is $13365 (not accounting for the 17% min above cost we should be paid for vaccines in private practice to account for our costs in providing the service). I realize VFC cost is less, but comes with admin costs too, they are just harder to pin down. Cost to avoid a hospital stay would be much more, and actually isn't even known for the closer to term group, since effect was not statistically significant. I can really see the value of this product for preterm infants not eligible for synagis, but worry about the cost/benefit for healthy term infants being unfavorable, with a universal recommendation wasting resources better used for children in other ways. If I'm missing something in my calculations please let me know-I would be relieved to find that out. Thank you very much.

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