At last, we can prevent one of the most common causes of pediatric hospitalizations in the United States.
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.
Do we have any sense how the mAbs will affect babies' adaptive immune response to RSV?
What was the placebo? Why would there be so many severe events? Is the application/trial data on the fda website?
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.
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.
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.
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.
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.
% 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.
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)
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!
Is this medication more efficacious than the Synagis we currently give to at-risk babies? Or just cheaper?
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.