CDC ACIP Meeting, February 22, 2023 — Meryl Nass, M.D.

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Good morning! CDC’s vaccine advisory committee (ACIP) is back for a marathon 3 day meeting to discuss many different vaccines. All day Friday is reserved for COVID vaccines.

As usual, CDC does not allow us to see the speakers, running a photo of a CDC building. If there is a vote, we will briefly see tiny boxes with their faces.

The pro forma listing of each doctor with a claim they have no conflicts of interest is repeated at each meeting.

This group is essentially a rubber stamp for predesignated decisions made by CDC. My own states’s CDC head has just moved to CDC to take the #2 slot there (Nirav Shah) a doctor lawyer combo.

Dr. Beigel of NIAID is observing as usual. The observers can ask questions (occasionally) but cannot vote.

Some of the observers are lobbyists, like Phyllis Arthur.

Monkeypox had its name changed because it stigmatized pharma companies and bankers ($Moneypox) so it is now Mpox.

Interesting that there was a long period without any reported cases between 1970 and 2003–though maybe there were cases in Africa during that time that were not reported.

Pleased he is acknowledging what I have noted–there was no human to human spread in 2003 and 2021 cases–so NONE in the US before last year.

Therefore something significant changed to allow Mpox to spread between people last year.

However CDC was testing Jynneos in the Congo DRC since 2016 and if there was human to human spread then we need to know.

If there was human to human spread in Nigeria after 2017 we need to know how the virus changed.

CDC continues to urge use of Jynneos for “high risk groups” even though the epidemic has died out.

They are redefining outbreaks to be as few as one person.

Brett Petersen ran the Congo trial of Jynneos–let’s see if he appears and tells us about that study of Jynneos.

There were over 30,000 US cases last year. Cases peaked in August and there are 2 cases per day in the US now

Cases occurred in cis and transgendered and all races. Duh.

Of those for whom HIV status was known, 53% were HIV positive. There is no asymptomatic spread

CDC focuses on sexual practices for some reason. Yet CDC omits the most important data, from its African study of Jynneos.

Note that in pre-licensure studies, there was a lot of myocarditis associated with this vaccine. Note also that while there were a small number of deaths in people with monkeypox, CDC admits that they were severely immune compromised. Probably all had end-stage AIDS.

Huge emphasis on transgender and gender-diverse cases for some obscure reason

1.2 million doses were administered for this 2 dose vaccine.

No surprise, blacks were much less likely to go for the moneypox vax than whites

The poor black PhD presenter is stumbling over the fact that blacks took less, as if it is her fault there was a lack of equity here — blacks knew that there was no reason to take a dangerous vaccine for a mild illness. CDC did offer vaccine to pregnant patients but none took CDC up on the offer. Smart ladies!

There were no pediatric deaths.

Efficacy inferred was never demonstrated in clinical trials. Now Ms. Chard lies and indicates the Congo clinical trial does not exist.

The USG lied and said it did not have enough vaccine for those wanting it, so it had to dilute the vaccine 1:5 and inject it intradermally instead of subcutaneously.

The USG owns a stockpile of about 30 million doses of two kinds of moneypox/smallpox vaccines made by Bavarian Nordic in Denmark. For reasons never explained, the US did not bring these doses we owned back to the US. The reason might have to do with the fact that, since it is licensed, it would have liability attached. By diluting it an EUA was issued with no liability to the manufacturer or government.

This chart indicates little if any benefit from the vaccine, at least no statistically significant benefit

Israel vaccinated 2,000 gay men and there were 5 cases in the vaccinated, 16 in the unvaccinated. But was exposure the same in both groups?

Not much got explained about this Israeli study.

Big US study claims 36% VE in 1 dose patients and 66% in 2 dose vaxxed. The question I’d want answered, but was not asked, was WHY did so many people refuse the second dose?

A case control study suggested 90% VE in those not immunocompromised. So if efficacy was this good, why not show us the data from the 1000-1600 Congo vaccinees with the full dose?

NY study VE 66% for 1 dose–exactly double the earlier study, suggesting there must be wide confidence intervals. No surprise, all these studies show the vaccine works great

They do not know duration of protection. My question: where are the Congo data?

I hate it when the ACIP members fall all over themselves to compliment the briefers, even after cherrypicked talks

Finally she admits the confidence intervals are very wide. And the studies she presented give widely varying results…but across the board we see full vax better than partial. What a surprise.

Dr. Long asks about the difference between intradermal and subcutaneous–it seems the ACIP don’t know which route they will be voting on. Intradermal is preferred but subcut is being used mostly. The intradermal dose is 0.1 ml and subcut 0.5 ml

In the Epic study, 3 times as many only took one dose. This is strongly suggestive the side effects were severe.

Only 1/4 of the recipients got both doses. Funny this was not mentioned.

Now we hear about safety using VAERS, VSD and V-safe. And IND data in children.

Only 60% of recipients got both doses of the total doses given.

Half the VAERS reports were for administration problems trying to administer intradermally.

There was a lot of dizziness. 5 cases myocarditis. 2 deaths!!!

He says they were drowning and cocaine toxicity, not the vaccine causing death

We knew that earlier smallpox vaccines caused myocarditis. He claims they did not know if Jynneos would do this. I beg to differ. Having read the submission to FDA, there was much myocarditis in the clinical trials done around 2018-2019

He minimizes the existing data on myocarditis. CDC previously had posted that the other smallpox vaccine caused myocarditis in one in 175 recipients of its single dose.

So you wonder, was the “working group” given the data I have reviewed, in which case they are lying, or were they not shown other data, in which case they did not bother to do a proper search of the literature and existing data. Are the malevolent or lazy and incompetent? Which is t?

As usual, CDC wastes most of the meeting presenting data on clinically irrelevant episodes like improper administration or local reactions. Dr. Duffy gave this bogus presentation, which failed to mention the 10% and 18% elevations in troponin after vaccination in two subgroups of the trials used to license Jynneos in 2019.

A wheal is a tiny blister you will see if you inject a liquid within the skin layers, when done properly.

211 people got the vaccine im and 227 got it through an unknown route in VAERS.

Sr. Long mentions the OLD smallpox vaccine Dryvax which caused a lot of myocarditis. She asks when myocarditis occurred? She properly distinguishes myopericarditis from myocarditis.

VAERS is a bad way to look for myocarditis, since most cases are asymptomatic. You need to screen with troponins. But they failed to do this because they did not want to find the myocarditis cases.

CDC used V-safe only late after most shots had been given. Dr. Sanchez wants to know how route of administration affected myocarditis/other adverse effects?

“CDC unaware of pregnancy-vaccinated”. But earlier they admitted it was offered in pregnancy so CDC could collect data but the pregnant women have learned not to trust CDC on pregnancy vaccines after the COVID debacle.

SERMO is an “online community” of 1.3 million clinicians. It seems CDC gave them a contract to do a survey. The providers who answered said they wanted to make vaccine available. Duh.

The Sermo community thought the vaccine was safe and effective. Interesting, since there was no data available on safety and efficacy at that point for monkeypox

So the conclusion is that such surveys reveal ignorance of providers.

NIH funded a study to “build new cohorts” i.e. collect thousands of gay/bisexual males for further study. Why are they so interested in know who has what kind of sex?

Less than 40% got vaxxed, while 90% reported they were likely to be vaccinated. Conclusion: people tell the survey what the survey wants to hear, which does not reflect their vaccination uptake at all

Remember, the CDC did not even tell us how many people died, nor how many people had persistent symptoms or disability after their monkeypox infection. Because had they done so, it would have become obvious that the vaccine is utterly unnecessary as it is a brief, mild illness for most with no long-term sequelae.

The govt took the vaccine to LGBT events because it wanted to help the LGBT community so much and be sure they had true equity. This led to 25,000 extra vaccination doses given.

A study of moneypox vax in the homeless population has a picture of a house on the intro slide.

74% of the homeless at-risk identified, said they would take the vaccine. I would guess this population is even more likely to tell the surveyor what they think it wants to hear. Worthless data. Why even do it? Or did they then offer vaccine and almost no one too it, so they just dropped those data?

“We know that providers didn’t get the vaccine” said Ms. Bhatta–a survey was only open for 48 hours–not sure, sounds like they are trying to minimize the fact that providers did not want the vaccine.

Why were blacks the earliest to get it, then at the end they were least to get it?

Dr. Sanchez wants CDC to educate high risk groups to want the vaccine.

They adapted the messaging and made it sound “sex positive” says the briefer, who is proud of the work his group did.

Dr. Long says all the work groups struggle with equity. (decoded: how to we convince all minority groups to accept more vaccinations). She says that equity decreased–because blacks took the vaccine less overall. Maybe the blacks just had more experience with CDC and could make more informed choices?

These white people sound so clueless wrt equity.

Grace Lee says a lot of nothing. Now we need to find positive deviance (or deviants?), finding the successes and imitating them. Poor choice of words.

Equity now becomes give public health more money to go to the minority communities. No one seems happy that so many black people will avoid the vaccine-induced harms. Note that the 2 black ACIP members keep quiet when equity is being discussed by their clueless colleagues.

Why did they give post-exposure prophylaxis with Mpox vax within 14 days? Because we know you don’t make a strong immune response till then. about 14 days

51% of recipients were white and 12% black. There is a large “multiple” category, not sure what that meant.

“Key role that community based organizations had to the success of vaccine implementation.” In other words, bribing local groups was an effective use fo funds, and managed to create massive conflicts of interest for such groups. Is this part of the strategy for separating people, as vaccinees find out later that each person vaccinated got more money to the local group they trusted.

Note how the government always makes sure there is a “shortage” when it rolls out a vaccine, which leads to increased early uptake.

Only 62% of recipients got both doses. This is a remarkably low number.

Actually, I think I am wrong and even less got 2 doses. I think if 734,000 of the doses went to the doubly vaccinated, and 452 went to the singly vaccinated, then maybe 30.9% got both doses.

Where is the information about why people did not come back for the second dose? This is the most critical information for determining the value of the monkeypox vaccine!!!

Why did CDC never tell us how many got both doses? They were hiding this data within the presentation, never made it explicit how many only took one dose–especially as everyone would have been given a date or a way to come back and get a second dose when they got the first dose.

Why not use single dose vials? Vaccines are so expensive, and the only reason for multidose vials is to save a tiny amount of money, adda few pennies to the cost and make them all single dose, which is safer and won’t require wasting doses, which providers seem to worry about.

Dr. Rao says the outbreak is not over!!! 2 cases/day demands more vaccinations!!!

Now we consider evidence to recommendations. Just remember, you can only consider the evidence we provided, not all known evidence.

Public health will define an outbreak, which can be only one case–they are emphasizing this. They really want this vaccine given out.

Decades with no reported cases in some countries–so curious. No high risk exposures or human to human transmission despite close monitoring. Only in 2020-1 was there reported human to human transmission

Typically symptoms resolve without treatment. Myocarditis can occur as a result of the disease. So why deny it occurs with the vaccine?

Myocarditis has occurred in immunocompetent. She fails to tell us the incidence. The bad cases however occur in the immunocompromised. In this case, one might have a generalized infection, though in nearly every other case it is highly localized.

She says deaths occurred despite use of therapeutics (Tposs) which “is not virucidal”–they what is it doing? Why are we using it?

She presents US data claiming 35.8% VE for one dose and 66% for 2 doses from a case-control study, which may not be the best. NY case-control study 68% one dose and 89% 2 doses VE. with very wide confidence intervals, n?

In France, 10% of vaccinees got mpox. in another study 4% got mpox. POST-exposure

This was considered large benefit. But how many unvaxxed exposed got Mpox?

Note how the studies overestimate benefit and underestimate risk

Over 70% of the homeless surveyed said they wanted the vaccine. But how many actually got it?

Dr. Gao says it is “unclear” why the at-risk did not get vaccinated. But from data presented it seems CDC never asked. Or if they asked, they hid the results.

Sermo survey made it appear doctors were all in

Vaccine equity pilot program allowed minority clinics to get more than their share of
vaccine–how innovative. 25K doses were used in this program (2% of total vaccines used)

The vaccine was free, since it was an EUA, which is of course not mentioned. Nor is the issue of liability for vaccine injuries.

How can there be a balancing of risks and benefits when you don’t make any attempt to learn about the side effects that stopped so many people coming back for a second dose? This balancing is such a joke, “the fix was in”

Giving vaccine is feasible. Why is this mentioned? You gave the vaccine to 1.2 million people, so of course giving it was feasible.

They love the community based organizations and engagement of trusted messengers. In other words, vaccinations work well when bribes are provided to mask the true agenda of previously trustworthy organizations

The CDC sure knows how to set things up so no organizations will be trusted in future

The work group agrees the vaccine should be offered in outbreaks. Regardless of timing of exposure. CDC defined this outbreak as continuing–so I guess you can give the vaccine forever.

The CDC briefers adroitly avoid the potholes and now the ACIP members show what boosters they are. Lehrer says he thinks there is one death in 1,000. My guess is that CDC did not state this because they did not die from Mpox. Now the briefer admits that in countries without vaccine the epidemic has also passed.

Dr. Rao says people who want the vaccine should not be stigmatized. Yet CDC studies demand to know their race, sexual preference, gender, and other very invasive questions. So we don’t stigmatize them but we put their private information into our federal databases.

These idiots wrap themselves into pretzels to make themselves appear inclusive and equitable. Dr. Brooks (who is black) is concerned that public health can designate an outbreak based on everything or nothing, and this could be politicized.

Dr. Rao blathers to not answer his implied question of “Isn’t it a dumb idea to not have specific outbreak criteria?”

I imagine the lack of criteria was deliberately chosen to make it easier for CDC to spread out its scary messages by saying something like “There are 20 outbreaks of monkeypox” when there may only be 20 cases.

Paley: “we have had multiple outbreaks her in the US over the last 20 years”… Yes, there were exactly 2 in 20 years.

CSTE person gets back to the definition of an outbreak. Appreciates the flexibility to implement more aggressive vaccination measures with the loose definition of an outbreak.

Grace Lee the chair applauds that 90% of recipients have race and ethnicity “captured”

It would be great if all our clinical trials had race and ethnicity she says–so much for not stigmatizing people–instead we add to the federal data collection of personal information.

Now we have a long break till 12:30. Yay.

Jose Romero, currently in Nancy Messonier’s old job, head of the center for immunizations and respiratory diseases, is here for a pep talk on additional vaccines. We had “cocirculation” of covid, flu and RSV. Now there is a decrease in all three and in hospitalizations due to them. RSV can be misdiagnosed as the other diseases, though it can be a severe disease in older, frail elderly with comorbidity. Each year they ESTIMATE 6-10,000 deaths in older adults due to RSV.

Now they have a dashboard for flu, RSV and COVID. And a syndromic dashboard for flu-like illnesses coming to the ER. Trends can be compared–please go look at our shiny new dashboards. They explain why we must remain vigilant, remain aware, and push covid vaccines. We will discuss pedi, maternal and elderly RSV vaccines that “may” become available soon. Many people continue to suffer from long covid infection, while safe and effective vaccines remain available. 670,000,000 doses have been used. But only 15% of Americans got a bivalent booster. (NYT using CDC data said 16% last I heard, but of course these are likely ESTIMATES of the actual number of vaccinated people.

Imperative to get everyone back on schedule, reduce barriers, safe and effective, and lucky Americans may soon have access to RSV vaccines too.

Grace emphasizes his key points, which CDC no doubt wrote for her, as it wrote his little speech.

Uninsured kids are 8x as likely to not be vaccinated, yet the VFC program was created under Clinton to get poor kids vaccinated. We have a major problem. It seems that poor and rural families seem to want our vaccines less. Could it be they have not drunk the koolaid? Could it be that all the woke equity and inclusivity talk turned them off as they know how to read between the lines?

Maybe poor people know that a free vaccine might not be a quality vaccine? Now these folks are crying crocodile tears over the fact that adults may not have vaccines covered and the copay alone may prevent them getting vaccinated. What will it take to get them vaccinated.

Dr. Goldman demands to know what they are doing about misinformation regarding safe and effective vaccines. Romero says it is not the role of CDC to actively insert itself into jurisdictions. Goldman represents some outside organization.

CDC definitely inserts itself into jurisdictions, but does so by bribing state health departments or organizations to push its desired policies, while be sure those policies are not seen as directly being imposed by CDC.

I guess that means CDC passively inserts itself into jurisdictions. Or secretly. Now to flu

Keipp Talbot is here to talk about her favorite virus, presumably that means she has made a lot of money on it.

This winter we had a very surprising early flu season and it is over now.

The area under the brown curve represents the number of total cases, which is no greater than earlier seasons. Nearly all cases are flu A, not flu B. Hospitalizations are way way down. compared to pre-COVID’s 3 recent seasons.

There are also fewer pedi deaths from flu than during an average pre-COVID year.

They did not mention adult flu deaths surprisingly, probably indicating a very mild season with few deaths. CDC always contextualizes things in a biased way, such as comparing pedi deaths to the 2 covid lockdown years and not the normal years, except for one year.

There is no flu season that peaked in October except possibly the swine flu 2009–Grohskopf (bighead in English) deliberately misleads regarding the surprising early flu season this year.

Vaccination status can be based on self-report, which means they have chosen to enter unreliable data into their analysis–even though CDC has data on everyone who got a flu shot.

NVSN got data from 7 sites from Sept through late January 2023. WHY rely on self-report when they can confirm who is vaccinated?

Vaccine efficacy is based on small numbers of people in the first analysis presented. A second method is called IVY with many more sites and presumably more subjects. It appears the number of immunocompromised in the unvaxxed group is higher, so probably they were a frailer group, which would increase apparent vaccine efficacy which is around 36% in elderly and 45% in younger.

VISION network is the 3 system which looks at the same thing basically. There are 3 big systems in 4 states. This one uses a variety of adjustments for odd things like study site, which may introduce bias.

30% VE in immunocompromised, and 39-46% in others. Next slide shows lower efficacy against hospitalization, whereas the first study showed better against hospitalization.

Last year, VE was only 25% for emergency visits or hospitalizations in the vaxxed.

I would have liked to look at the differences between the three sites, and learned why CDC felt the need to perform an adjustment to the data based on the site it came from.

Dr. Paley notes that over 65s are recommended the high dose vaccine–how many actually go it? 66% got high dose and 26% got the novel adjuvanted MF59 vaccine. Why were they not compared to each other to see how the standard shot compares to the adjuvanted compares to the high dose flu vaccines in terms of safety and efficacy?

I believe the vaccinator gets a higher reimbursement for using adjuvanted or high dose vaccine–anyone know those prices?

Dr Sanchez wants to know if the pedi deaths were vaccinated? CDC briefer babbles…roughly stable…in the past only about 22% were fully vaccinated…not sure…she will clarify that. This is a fact they don’t want us to learn

The human immune system has not figured out how to fight flu and rsv, so “we are asking a lot of the vaccine” for it to work. Duh. Fauci says we cannot develop a good flu, rsv or covid vaccine using current platforms. his article was published in Cell host and Microbe dated January 11, or 11 days after he finished working at NIH Fauci and 2 colleagues still at NIH admitted the truth.

First study paid for and conducted by CSL Sequirus, a flu company. Only 43 viruses were sequenced. 545 subjects total. Claim is 54% efficacy and 60% efficacy for the two types of flu A–efficacy is always higher when the mfr does the trial.

Now they seem to be discussing flucelvax, which is grown in Maden-Darby canine dog kidney cells, but they are cagey and call it a cell-based vaccine.

The numbers are tiny, but they claim 71% efficacy with a huge confidence interval.

That was in children. There is dog kidney proteins and DNA in this vaccine.

They say some got recombinant vaccine–which one is that? They don’t use the generic or the brand names to keep us guessing about what they are actually referring to.

He is wrong about number needed to vaccinate–because these numbers suggest one case in 500-1200 days, and since it seems that there was only about a 50 day period during which flu was rampant, only 5-10% of people would have been exposed, and then 2/3 of them would have been protected if you believe these numbers, which I don’t, since as Grace Lee also said, we have not seen such efficacy from flu shots in the last 20 years

Lisa presents non-US data for past 3 years of flu, when there was very little flu, and these claim the shots ranged from 36-73% efficacy. Hard to believe.

For some reason, CDC does not like to show head to head comparisons of the dozen or so different flu vaccines available. Ms McNally, a consumer rep, said the public would like that information. So would I.

It is 2 pm and public comments will be made. Jack Baker is first speaker and he has done this before, as an employee of NFID–national foundation for infectious diseases. More vaccinations for flu, rsv desired, and communities of color are at higher risk. Thanks CDC.

Angie Bluford got 2 Moderna vaccines and is severely ill as a result, no longer able to work, though she was a kickboxer before the vaccines. She was still making spike 2 years post vaccination. She notes that CDC lied that a stroke signal was only found in one database. Why is CDC silent about vaccine injuries? Stop the pedi vaccines. Please help us.

Sara raganstan is not prepared but is injured also after 3 Pfizer shots. She has vaccine-induced pericarditis and loss of quality of life. There have been no answers. She spent $25K of her own money to try and recover as regular drugs did not help. Very lonely journey and so little support from federal agencies.

Christina Labette. 2 Pfizer doses then stroke like illness, cardiac and neuro symptoms, needs help with basic needs. Over$35K in medical bills and has over 30 new diagnoses. Mostly bedridden. You know we are real. What would you do if I was your family?

Monkeypox vote. Grace Lee did not provide any courtesy to the 3 vaccine injured, just brushed them aside so the ACIP could vote to rubberstamp the current policy, which is recommending the 2 Jynneos doses for those at risk of Mpox during an Mpox outbreak.

Short break to reconvene at 2:30 to discuss pneumococcal vaccines. Just to emphasize the important points: we were not briefed on the severity of the disease, not briefed on if/how it actually caused deaths, not briefed on a normal risk-benefit analysis, which would include all information on vaccine side effects and not the whitewash presented, and would make clear the amount of benefit the vaccine provided. Especially, a huge percentage of vaccinees did not go back for their second shot (most of the vaccinees, and the reason for this was not revealed, the number was not given directly (I had to do some calculating to get an estimate) and therefore the entire charade of data presented simply produced a fog under which the CDC and ACIP members jointly conspired to approve current use of a vaccine for which almost nothing important was revealed.

Did you hear anyone mention that fact that the death rate last spring from monkeypox was estimated to be 1-10%, and it was on that basis that so many young men agreed to be vaccinated? Did anyone explain that the benefit was far less than originally claimed?

Remember, we have 4 pneumococcal vaccines in the US and it is very confusing as to what to actually give people. Babies get 3 doses by 15 months of the 13 or 15 valent version. The fifteen valent is newer. Read “Turtles all the way down” to see how all these recommendations are basically based on sand.

Now there is a 20 valent in addition to a 23 valent. What should be recommended for whom?

I just realized that CDC created this concept: Evidence to Recommendations or ETR in order to jettison risk-benefit analysis.

I wonder if you have to have a personality disorder to last at CDC? Invasive pneumococcal disease is sepsis (septicemia) or pneumonia or meningitis due to streptococcus pneumoniae serotypes.

When these vaccines were first introduced (PCV7, not used now) it did not slow down ear infections or strep throats. But it did reduce serious infections. Then serious disease dropped and stayed very very low.

The 19F serotype has only increased, while most serotypes declined. Is 19F included in the current vaccines? Or is this the reason to bring new vaccines to market?

19F IS included in all 4 current vaccines–suggesting that the immunity related to it may be a case of vaccine-associated enhanced disease. VAED

Otitis media ESTIMATES: 24% OF EARACHES IN KIDS DUE TO STREP PNEUMONIAE. Only 11% drop due to the vaccine–which does not make a whole lot of sense when the invasive illness is down considerably–but this is what the data have shown over many years.

Pneumonia reduced 17-35% after the vaccines especially in kids under age 2.

The fact that there was no benefit in 2-4 year olds but good effects in younger and older groups tells us the numbers of cases are small and data unreliable.

Interestingly, only 20% of acute respiratory infections leading to visits are associated with antibiotic prescriptions. She attributed this to using a vaccine with more serotypes in it, which began in 2010

But at the same time, doctors have been urged to prescribe fewer antibiotics for viral illnesses, so a reduction is not only due to vaccination

Estimates estimates estimates. The only time you stick a needle in the middle ear is when the child is very very sick. So not random in any way.

Wide range of estimates means meaningless data. She just said it, “Scarcity of data”.

Many limitations. Tell us how likely your analyses are to be accurate please.

In other words, we have no idea how much benefit the higher valent, more expensive and new pneumococcal vaccines will yield. But they provide an excuse to revaccinate kids, and they are extremely expensive (over $200/dose) so we should definitely use the newer vaccines and recommend that already vaccinated kids be revaccinated with the newer, broader coverage vaccines, even though we have no idea how much incremental benefit they might provide.

Laura King, the briefer, is unable to say how much benefit there will be. Someone else “doesn’t have the numbers.” Then why are we even discussing this.?

Now Pfizer presents the 20 valent vaccine data. Wendy Watson is the presenter, no letters after her name–is she a marketer?

She is an MD and will ‘take us through” the program and key results. Built on a legacy. Pfizer wants to expand PCV13 to become PCV20. No efficacy trial was performed for PCV13 (see the Turtles explanation) and the PCV vaccine will also be allowed to skip efficacy studies. What a load of BS. Is CDC scrambling these slides so I can’t read the fine print?

Immunogenicity is simply measuring antibody levels after giving the vaccine. As with COVID boosters, they mean absolutely nothing in terms of preventing disease, unless you have done a study to show they are relevant–as they often are not.

Always the claim that real world evidence shows the vaccine works–but then we get more antibody levels not real world data.

As I have said before, the reason they show you antibody levels is two fold. First, this is a much cheaper study to do. Second, the antibody levels always go up after antigen is injected.

70% of babies were irritable, 60% drowsy– and now we quickly move to the next slide and ignore discussing any possible serious reactions that did not resolve

Or even any other side effects that did not occur immediately post-shot. FDA appears to be allowing vaccine manufacturers to pretend there are no side effects besides immediate ones.

Serious adverse events in the PCV-20 group, but Pfizer does not consider any of them to be due to the vaccine. Well then, what were they do to? This was about 1% more serious AEs compared to the PCV-13 vaccine. PCV-20 is under review at FDA with licensure expected in April.

Sorry, there were about 4.5% serious adverse events. What country was this study conducted in? US babies should not have this high adverse event rate.

She says no babies died but why did so many get serious infections? Did the vaccine make them more susceptible to serious infections–as the COVID shots have done a few months after a vaccination?

There were 13 babies with temps above 104 after the shot, one with temp 105.4. There were 9 febrile seizures all together in kids with lower temps than 104 degrees.

Grace Lee identified a problem–that one of the serotypes causing a considerable amount of current pneumococcal disease seems to have reduced antibody levels in the PCV20 shot compared to earlier shot. Dr. Watson show a slide and claims it has red lines etc. that are invisible and I have no idea what she is talking about.

Q: Can one vaccine cause a reduction in response to a serotype? We haven’t seen a problem. Did Pfizer look?

We did not study immunocompromised kids specifically. We have studies from older vaccines that safety is comparable. So does that mean you don’t need to study the newer vaccine? We have some preemie data, will that be enough?

Is black data enough? Please don’t ask me about this, we chose not to look. The members are perplexed, but that will not affect their later votes.

Should be change our rec for kids under 2 years to a PCV20 vaccine instead of the PCV 13 or 15 currently recommended?

Should it be recommended for kids with underlying conditions in whom it was never studied?

There are no studies whatsoever of PCV20 against serious pneumococcal disease. “Serious adverse event data were reviewed.”

Old studies show the PCV 13 is highly effective against serious IPD caused by vaccine serotypes. PPSV23 data are very limited. In the old days, around 15 years ago, the UK considered junking the PPSV23 vaccine cause it could not be shown to be beneficial.

PCV20 yielded lower antibody levels than PCV13 for most serotypes they shared. Hmmm. Certainty of evidence is moderate, and no correlates of protection exist. Unclear how much protection and unclear info on adverse reactions. however, the work group of course still liked the vaccine. There is no option to say, let’s go back to the drawing board and bring us better quality data.

Wow, they admit that the quality of evidence is low. Very low in compromised kids. But still no one said don’t use the vaccine.

Let me make clear that this PCV20 is NOT licensed. ACIP never used to consider vaccine before licensure, but now all that is out the window.

Why not just admit this is a question of the blind leading the blind, and send Pfizer back to the drawing board? are these (too early) discussion happening because the 2016 21st Century Cures Act requires ACIP to consider adding vaccines to the childhood schedule almost immediately after licensure?

Thank you Dr. Long for using the term “diminishing returns” I would call this “unknown returns with possible loss of benefit and unknown risk”

The ETR framework–Grace Lee–doesn’t vaccinating kids with more serotypes help elders? Whenever she says something controversial, she laughs. It annoys me, but if you listen for the laugh, you can see that she is saying something that may be worth noticing, and she may be trying to put one over her committee.

The Merck guy is given 3 minutes to challenge the Pfizer vaccine as his is its main competitor.

The CDC work group has been asked to add medical conditions to the list for which more pneumococcal vaccines are advised, in addition to considering what vaccines kids should receive. “Does the committee agree with the policy questions?” What does that mean? The right question is whether they agree with the work group answers. Again the members bitch that insurance companies will not cover vaccines until a year after they get licensed. Clearly they work for pharma, not for insurance companies.

Grace Lee does not even understand the options posed. Dr. Kobayashi is embarrassed, but admits probably after the 20 valent is approved, the 13 valent will be pulled off the market in the US. The PCV20 will be more expensive, and Pfizer will push to revaccinate, most likely, as they did after rolling out the PCV13.

The PCV13 retain price is $226 and the PCV15 is $217 per dose. 4 doses before age 15 months. Big moneymaker. Merck does not want their PCV15 elbowed out by Pfizer’s PCV20. And just like that, the meeting was adjourned! See you tomorrow at 8 am.
Retail price, not retain. Sorry. Let’s clear our heads.