CDC ACIP Meeting, August 3, 2023 – Meryl Nass, M.D.

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Hi everyone. Today the ACIP will be discussing a monoclonal antibody against the RSV virus

“Safety and efficacy were supported by 3 clinical trials”–note they don’t say proved

Nirsevimab “reduced the risk” by about 70% in one trial. MARSVLRTI is what it protected against!

Nirsevimab “reduced the risk” by about 70% in one trial. MARSVLRTI is what it protected against!

Efficacy in high risk patients was ‘extrapolated’ in high risk kids from the healthy kids. Not reassuring.

FDA asked for “a number of post marketing commitments” including a look for enhanced RSV disease

FDA says a pharmacovigilance strategy is necessary–in other words, FDA is frightened of the safety of this drug and is CYAing by doing this.

He omitted all info on safety from the 3 trials.

BYW, the ACIP is looking for more members as people resign at the end of their term.

Here is what the slide said from FDA : Monoclonal antibodies for prevention of infectious diseases – With development of long-acting monoclonal antibodies (mAbs), there is an opportunity to provide protection beyond what can be provided by traditional vaccines • Especially valuable when – Full protection is needed without delay – A traditional vaccine is not available • For some indications, a long-acting mAb might provide “long enough” protection – For a respiratory disease season – For a critical part of a pregnancy – For prevention of travel-related infection

Note the FDA said the drug “might provide long enough protection”

Why is FDA approving drugs that MIGHT work?

Usually RSV is seasonal though it was not during the early pandemic

Dr. Farley from the FDA was the first speaker. Not sure why he spoke before they went through the roll call which is happening now

It looks like close to 100 people were involved with the work groups and consultants on this drug.

Sarah Long presents.

She tells us they did a heck of a comprehensive job. On June 8 the FDA antimicrobial advisory committee voted 21-0 in favor of use in 01 year olds and 19-2 for at-risk kids up to age 2.

On July 17 the FDA licensed Nirsevimab for both indications

The proposed votes are whether infants under 8 mos should get it and infants up to 19 months at high risk should get it.

Jefferson Jones is extremely soft, barely audible

Is that deliberate? Why hasn’ anyone commented on this?

It is better but he goes in and out

EtR–my least favorite thing, as it can be jiggered to make all products appear to be needed. As I have said before, this is an attempt to pretend subjective data are objective and quantitative

They want it to appear that seasonality no longer exists, to justify using the drug during all months–or at least that is my guess.

Benefits and Harms: There were no RSV deaths in the 2b and phase 3 trials.

I think I just heard that placebo was more dangerous in terms of SAEs than nirsevimab, which is of course impossible.

There were more deaths in the nirsevimab arm!!! than in the control but FDA judged them to be not related to the drug.

The Harmonie study data only go to Feb and follow up only median 2.5 months.

The claim is that AEs similar in control and nirsevimab arm, data unpublished.

The work group felt the desirable effects were moderate to large and outweighed the undesirable. But what about that imbalance in deaths–we have not been told the numbers, sneakily.

The Domain in which parents are asked how they would judge the intervention, you can always get the answer you want by the way you frame your questions.

Doctors think it is a good idea. How much do they know about the product?

Now he is silent. A better mike works.

Feasibility–you know they will want to give it on the day of birth or at a one month check

$500 per kid list price and to CDC $395

BTW I checked the prices of the two adult RSV shots recently approved and each is near $300

And now we hear how cost effective it is–which reflects the trial results that are always better than in the real world. The group calculated it would cost $102 K/yr for lives saved. But there were more deaths in the nirsevimab group so I suspect this is a wild guess.

Now for the kids aged 8-19 months. They would get another dose (200 mg) and this is only for chronically ill kids.

Limited info on these older babies. But let’s give it anyway, said the work group

He has gone silent again

At 150 days, all the kids had the desired antibody level. BUT did it work???? “May be effective” Low certainty”

Very low certainty evidence. I can’t believe they admit their data is worthless. Will that stop them recommending it?

No additional data

$890 for the second year dose–estimated. In order to make the drug look valuable, they increased their estimate of deaths from RSV. You can’t make this stuff up.

1.5 million dollars per year gained for normal kids in year 2, but much cheaper to keep the chronically ill alive according to these estimates.

I would LOVE to see how the real world QALYs compare to the estimates for these ACIP meetings. Of course the work group wanted native kids and sick kids to receive this possibly deadly product in their second year as well.

There are problems implementing the recommendation–sounds interesting.

Now they are redefining vaccines!!!Save this for a clip. Some states have different definitions, it is claimed

monoclonal antibodies, btw, and not vaccines and that is why the FDA did not have its vaccine advisory committee look at it, but instead had its antibody/antibiotic committee look at it.

This seems to be #4 of vaccine definitions issued by CDC over the past ten years or so–changing the meaning of words is a characteristic of the Great Reset

She is happy it “looks” like other vaccines–i.e., it will fool parents. Storage and handling is similar to other routine vaccines.

Will practitioners be able to give it since it is a drug and not a vaccine? In most states medical assistants can but not all, it appears not to be a huge issue related to scope of practice.

It could be given as soon as a baby is born. Hep B vaccine is bundled into newborn care, but it costs under $16 per dose and this costs $400-$500 so hospitals won’t eat that fee.

Challenges entering it into electronic payment systems.

Pediatricians will have to front a major cost and will they be fully reimbursed? What if they can’t sell it all?

There need to be new codes, partners have to work on this and create systems to make this work and we hope it happens quickly.

Because it is coded as a therapeutic it could create problems. Seasons in different states are different. Redoing the old monoclonal recommendations is needed. AEs are reported to medwatch but if given with vaccines the AE reports go to VAERS. This is going to be totally confusing for doctors and medical offices.

What will the demand be? Vaccine hesitancy is anticipated. Docs will need to do lots of counselling. She is hesitant about everything–it seems CDC thinks this is a tar babuy. And her last sentence was something like “make sure we are protected.” I don’t think she meant the babies. I think she meant the CDC and the medical providers need to be protected, but I am not sure.

Sanofi provides the prices already given, but indicates this is based on the VFC buying enough. Will private insurance cover it?

Talbot says we should lie and call it a vaccine to make it easier to educate families.

By making some AE reports go to VAERS and some to the drug AE database, it will be more difficult to sort out the risk of the product.

2 people note that the drug is very expensive for healthy kids, and in high risk kids, we have no data to really assess the cost per life saved (and it may be lives killed)

Dr. Lehrer in private practice notes it can take 22 months after an ACIP approval before private insurance will begin to cover a vaccine or monoclonal.

It sounds like birthing hospitals are not going to be able to, in practice, give the drug the day of birth and get it paid and registered correctly since most of their babies seem to be private pay.

Dr. Daley asks about data from Dr. Jones who waffles.

Indian Health Service is evaluating the logistics of this drug.

Paling says if the mom got the vaccine in pregnancy, you don’t need the monoclonal in the baby.

What about antibody levels in the immunocompromised? Sanofi says we don’t have the data yet. So why are they considering using it in this population?

How quickly can the electronic medical records capture and send the data properly is another issue per Dr. Peacock in the drawing room. Her weapon is a syringe. Sorry, I saw the play “Clue” recently.

Providers should target the drug “in the first week of life” before the RSV season but can be given at any time.

Could be used for 6 mos Oct-March. For infants born before RSV season it should be given within the first week of life.

Timing may vary in tropical areas or Alaska. Giving it with age-appropriate vaccines is recommended. They say there was no increased safety risk, without providing any data.

The only contraindication seems to be anaphylaxis to a component in the past.

“many work group members prefer a lower cost per dose”–whodoesn’t?

The work group recommends a second dose for native children and sick kids as well as all kids below 8 mos entering their RSV season.

Lehrer asks if it will interfere with live vaccines since other immunoglobulins do

Limited data re coadministration, so we decided to wing it

Dr. Lehrer asks if babies born in April will get the drug? Reasonable approach he is told. When should he start it up again? Oct through March is most cost-effective, so it looks like it will be given for 6 months a year.

Dr Shimabukuro says CDC works closely with FDA to monitor safety and so he will work closely with CDER (which evaluates FAERS) . The problem, of course, is that each agency provided unreliable information re COVID products and so the public needs access to the raw data to monitor them itself

The VSD will be used to assess nirsevimab safety. Dr. Chen wants it ready for this fall.

I’m always surprised by how much the administration issues interest the committee, compared to how little the safety issues interest them.

Now someone wants a script provided for doctors to explain what nirsevimab is. CDC is already on it.

McNally wants reassurance the baby will be safe if it got eh drug along with a fetal vaccination of the mom. The answer is a waffle.

No data to support safety. Ms. McNally may be awaking from a long sleep. She wants to know what information will be given to parents. She is interested in injury claims–mechanism to adjudicate them. HRSA says what is done for vaccines. They think the 1986 Act does not contain a vaccine definition so they will try and move nirsevimab into the VICP. Fascinating.

Grace Lee talks about the financial costs to doctors and if they are not guaranteed to get their money back they may not use this product.

CDC refuses to discuss the maternal vaccine until licensed–which is not the usual, since they discuss products all the time pre-licensure

I wish someone counted the minutes they spend on administration and payments compared to minutes spent discussing safety.

Why has not a single member asked about the imbalance in deaths?!!!

Dr Sanchez says the work group struggled over the year 2 recommendation. Cause of lack of data. Why didn’t they demand more data instead of guessing?

So boring

Now there will be the public comments

All 3 commenters chosen by lottery they say represent organizations that were intimately briefed on insurance and financial issues prior to commenting. All they want is money so it can be used.

For young babies there were 10 yes votes and Dr. kotton got lost. For 8-19 months there was also a unanimous vote yes.

The big issue is whether it will be given in the hospital on the day of birth, or whether parent will be instructed to see the doc to get it within a week of birth. It seems CDC is very frightened that neither the doctors nor the hospitals will want to front the high cost. Ait is that which could slow down the rollout–not any questions about safety, deaths in trials, or whether it makes sense to give it when the mom was vaccinated during pregnancy.

I cannot bear listening to the members justifying their votes so I am signing off now. We know the monoclonal antibody will be put into the Vaccines for Children Program, which means the USG (taxpayer) will pay for half the US children, the poorer half for whom equity is such a big issue, and these will be the ones to get it first.