Discover more from Meryl’s COVID Newsletter
Here is my live blog for today's ACIP meeting, and some comments first
After top CDC officials said yesterday they were not adding COVID vaccines to the childhood schedule yet, today they added them. Not really a surprise, but it was both sneaky and remarkably bold.
There were so many extraordinary goings on at this meeting, entirely apart from the braindead members and briefers who wanted to inject everyone for everything they might someday encounter somewhere.
One very peculiar thing was that the FDA ex-officio member (usually Doran Fink) did not show up at either of the two meeting days. It was a zoom meeting; surely SOMEONE at FDA could have zoomed in? Was this a snub because CDC had decided to put a vaccine on the childhood schedule before it was even licensed by FDA? Was CDC doing an end run around even the minimalist FDA regulatory processes now occurring?
And then there were the bizarre vaccines being discussed. Several before they were licensed. Why present skimpy data to the committee when the studies have not been completed yet? It would seem to be a total waste of everyone’s time. Was this another indication that CDC does not care whether FDA approves a license before it rolls out future vaccines?
Here are some of the vaccines discussed: Chikungunya. Dengue. Dengvaxia licensed in 2019 and put on the Vaccines for Children program last year.Do we need them??? The dengue vaccine, which killed dozens of kids in Philippines and caused its top health officials and Sanofi officials to be charged with crimes (cause the vax was illegally licensed and rolled out and there was a strong stench of Sanofi bribes) is about to be rolled out in Puerto Rico.
To attempt to prevent the dengue vaccines’ deadliness (yes, deadliness, not deadlines), FDA is requiring that kids have to take two tests before they can receive it. But the tests have not been licensed by the FDA that requires them! So insurance won’t pay. CDC is getting that under control, they said. CDC never explained the dengue serotypes circulating in PR and showed no data regarding how the vaccine would reduce dengue illness.
What CDC did show was a ridiculous mortality claim for dengue of 15% untreated. (There is no treatment.) I went and found the PAHO stats for dengue in the western hemisphere and deaths were less than 1 in a thousand. So it appears CDC is continuing its COVID tricks of making the illness appear much worse than it is, and making the vaccines look much better than they are.
Not only are two RSV (respiratory syncytial virus) vaccines in the pipeline, but so is an RSV monoclonal. And the mfr said they will be asking that all kids under eight months be given a dose of the monoclonal antibody!
New meningococcal and new pneumococcal vaccines are being developed and complicated schedules for the pneumococcal vaccines’ use are being devised that made everyone’s heads spin.
Let us not forget monkeypox, which was discussed without data. In fact, this may be the most data-poor advisory committee meeting I ever attended.
CDC can truly be characterized as “public health in reverse.” Here is the live blog.
Tomorrow I will write more about the vaccine schedule but after interviews and live-blogging I am exhausted.
merylnass:We are going through the roster again so everyone can claim they have no conflicts.
merylnass:Time to get a cup of coffee and get comfy for what will be a long day.
merylnass:Someone has started talking about what must be a federal grant designed to increase child vaccinations, which have fallen during the pandemic. There is of course a focus on black and hispanics. Hmmm. They are allowed to use the word hispanics again, not Latinx. 43 kids died from flu last year--the lowest I have ever heard. CDCsent staff to Orange and Rockland counties in NY to push polio vaccines. CDC worked with Israel and the UK to investigate the origin.
Let it be known that public health professionals know the UK has lifelong polio shedders from WHO reports. Meningitis C is occurring in men who have sex with men in Florida and several have died. There have been 29 measles cases in the US. All in unvaccinated people and all were associated with travel to Africa. Vax vax VAX.
merylnass:25,000 new monkeypox cases and down to about 80 new cases/day now. They don't tell us that this is about 10-20% of the peak on Aug 9.
merylnass:Now they tell us that varicella vaccine was used first, boldly in the US and it saved the US over 20 billion dollars over the last 25 years. They never said it does not work well and most kids in the US who get varicella are vaccinated. Because it is all about congratulating themselves not risk-benefit analysis.
merylnass:Next year the government (CMS) will force insurance to cover vaccines better than they have so far been covered.
merylnass:Again, the FDA has not deigned to show up for this meeting.
merylnass:VICP had over 2,000 claims last year and today over 900 claims have been made. There is a backlog of about 1500 claims. 7,412 claims went to CICP for COVID vaccines. 2 claims for monkeypox vaccine injuries so far.
merylnass:The tribal health service referred to "Indian Country." Are we starting to use normal English again as the midterms loom?
merylnass:They are trying to get Jynneos into tribal communities. He didn't get the message that monkeypox has almost died out.
merylnass:They will roll out a new vaccine strategy--at every visit the poor patients will have every vaccine for which they are eligible pushed on them. Thank you Dr. Clark.
merylnass:Dr. John Beigel for Fauci's NIAID's Vaccine Research Center. They have a roadmap to end the Hep B epidemic that does not exist according to data on CDC's website. They want a universal influenza vaccine, and have been working on it for decades... Studying H5 influenza vaccine with novel adjuvants to improve antibody responses and cause more side effects. NIAID collaborated with GAVI, CEPI and Liberia to test a Lassa virus vaccine--these are Bill Gates organizations.
merylnass:Monkeypox dosing is being studied and they think this will add data. Nipah virus vaccine study being done with Moderna and NIAID. Fauci's collaborators will apparently not be stiffed when he leaves, nor will the bioiterrorism portfolio leave NIAID.
merylnass:David Kim has an NBACC report coming out to improve vaccine confidence. David is reading his statement. Wants to increase Tdap in pregnancy. New "Boo to the flu" program. I feel sorry for David Kim. He is a smart, savvy guy and this is just silly. They have videos about equity and monkeypox!
merylnass:Now they are going to sort out the pneumococcal vaccine mess from yesterday. I am not going to blog this silliness. I will tell you the results of the vote. Now the audio is echoing.
merylnass:Grace Lee is the evil twin of Arnold Monto at VRBPAC--shepherding the members to vote when they don't want to.
merylnass:Vote 1 passed as CDC had newly written it. For normal healthy elders the next vote is about giving a third type of pneumococcal vaccine to those who already got 2, and asking for "shared decisionmaking". This means they have no data but they still want to give out the vaccine, and yet it will (by modelling) cost betwee 150K-500K per year life saved. Keipp Talbot wanted to get rid of the "shared decisionmaking" and recommend the vaccine for all.
merylnass:They repeat "no conflicts" many times a day, as if to cement what is clearly false (since some do research and are paid by CDC)
merylnass:Naturally a Black member was chosen to discuss the immunization schedule.
merylnass:Sybil Cinneas will discuss the proposed edits to the schedule
merylnass:Dr. Wodi will now discuss the changes, and she has a strong accent. The first edit is to add COVID-19 vaccines!
merylnass:Here is what Dr. Jose Romero said was not happening yesterday. This schedule is to be published in February which I think means that they have decided to postpone the school requirements till Sept 2023
merylnass:They are adding COVID-19 vaccines to the NVIP, I think, but not clear. She is being deliberately vague about what is being done
merylnass:She is going through a form that CDC is publishing, but has been a bit vague about whether this is the recommended childhood schedule and when it would come into force
merylnass:Dengue is on this form, for example, and the dengvaxia vaccine is NOT on the childhood schedule.
merylnass:CDC made sure to make this form illegible. You can rely on them to produce the FOG of war with CDC's very own fog machine
merylnass:I think she may be going over the changes placed on CDC's webpage on October 17 at the following site:
merylnass:Note the date of 2023 at the top right of this form
merylnass:Lyn Bhata, RN has the guts to ask about adding an EUA to the childhood schedule and the DOJ's Office of General Counsel said CDC could do this, according to Dr. Wodi.
merylnass:No more questions????!!!!! Have these braindead experts not realized they are going to be left holding the bag on this?
merylnass:Matthew Daley now points out that this really could be turned into a mandate at the state level.
merylnass:He tries to remove Doctor responsibility by pretending pediatricians are vaccinating to prevent disease and not to enable kids to attend school.
merylnass:Dr. Nirav Shah of Maine claims that today's vote is separate from yesterday's vote for the VFC--well duh, I explained that. Today's vote he claims does not create a requirement but of course it does, depending on the state.
merylnass:These people are angrily trying to shift responsibility and it is amusing to watch, as if the Nuremberg 2 trial will pay attention to what Dr. Nirav Shah, who rarely gets emotional, just tried to do to absolve himselvf of responsibility for school mandates due to his vote.
merylnass:Let me be clear. After the Director fo CDC's National Center for Immunization and Respiratory Diseases (Jose Romero) said yesterday that they were not putting COVID 19 vaccines on the childhood schedule yet, today the CDC is asking its single advisory committee to do just that.
merylnass:Putting an experimental vaccine on the childhood schedule is also a new thing and I'd love to see that OGC opinion telling CDC this could legally be done.
merylnass:I warned you that CDC is a very sneaky organization that collects an enormous amount of data relevant to public health, and then shares a tiny fraction of what it collects, and massaging it in the CDC sausagemaking machine. Only those who can easily lie make it at the CDC. You are now seeing an example of the deliberately created confusion and confabulation at which CDC excels. No one is entirely clear about what is going on.
merylnass:I wonder if that is why Dengue vaccine was added--because clearly no states will demand dengvaxia shots, since the age groups for which it is approved are limited, and recipients have to be tested before they get it.
merylnass:But it is on the childhood schedule now. Why? What sense is there in putting dengue on the childhood schedule when there is very little dengue in the US?
merylnass:Was the dengue vaccine part of a smokescreen being created to make it seem that putting COVID-19 vaccines on the childhood schedule doesn't really mean much--when clearly it does???
merylnass:Why did CDC make its new childhood and adult schedule slides illegible, too small--when all the other slides shown earlier were easy to read?
merylnass:Look at the polio slide now--it only takes up about 1/8th teh area of the slide
merylnass:Everything presented is carefully vetted by large committees. With malice aforethought.
merylnass:CDC provides dozens of new changes, buries the COVID vax in among them, and then expects the ACIP members to vote on all these dozens of changes simultaneously. Grace Lee will be prepped to shut down discussion, that is, if there is any.
merylnass:CDC, having given these members only a few seconds to consider each of these changes, will blame all the additions nd edits on the ACIP Committee.
merylnass:I describe this process as CDC hiding behind the skirts of the ACIP.
merylnass:Questions? Grace has 2 questions. But she can't find them. Slide 133 -- she asks a question wrt the PCV13 vaccine. She also asks if COVID vaccines should be in the contraindications and precautions section. Wodi said the workgrooup decided to hold off for now.
merylnass:That is the sneaky way to pretend there are no contraindications and precautions.
merylnass:Grace would appreciate it if there was some type of link re covid vax contraindications to cya. CDC flunky says we will do that as we are able to. I am not surprised that there are no questions or comments. Dr Paling makes a motion to accept all these edits and Dr. Sanchez seconds it. I have called these members supine. But now I have to say they are robotic. Grace wants a 5 minute break but CDC has new language and is presenting it for the vote to approve.
merylnass:Wanna bet they are unanimous in approving COVID-19 vaccines for the childhood schedule?
merylnass:5 min break now. RSV vaccine is next
merylnass:They are concerned about the increasing complexity and volume of vaccines but want to emphasize the significance of RSV in older adults
merylnass:GSK's Australian lead is talking and at least his accent is pleasant.
merylnass:We are seeing a strange phenomenon--the presentation of clinical trials that have not been completed. I guess now they get the approval before the evidence has been generated. This means we cannot trust any vaccines any more
merylnass:71% efficacy for all RSV cases--not so good--with lower bound of CI of under. The sicker you are the better it works, he claims on slide 14. Who believes that? 60%
merylnass:Lower bound of efficacy was under 60%
merylnass:Subset of participants show robust antibody response. No surprise there, but he has produced no evidence that his measured immune response has anything to do with immunity.
merylnass:AEs: 33.6% developed fatigue after the shot, double the placebo group. 1 GBS case and 1 fatal serious adverse event! in 12,000 vaccinees or perhaps in the safety subset of less vaccinees. My sound just shut off 3x.
merylnass:It can be coadministered with flu shots. It has a "faorable safety profile"
merylnass:They hope to get FDA approval.
merylnass:Why is it coming before ACIP before it has been approved by FDA?
merylnass:The GBS was probably due to the vaccine and occurred during the risk windoow. GSK says there was no neurology consult nor special studies so GSK says they are not sure it was GBS. If GSK was doing the study, why didn't GSK make sure this patient was seen by a specialist and fully evaluated? This is a crime committed by GSK in order to challenge the diagnosis. What is the adjuvant? The same as in a shingles vaccine? ASO1e adjuvant, which is a GSK proprietary product that revs up immunity and is not used in any other vaccines.
merylnass: LET ME CLARIFY FOR THE AUDIENCE. THE ACIP WILL VOTE LATER TODAY TO ACCEPT THE NEW CHILDHOOD, ADOLESCENT AND ADULT VACCINE SCHEDULES. THEY COMPLETED THEIR DISCUSSION, WHICH TOOK ABOUT 1 MINUTE, AND ARE CLEARLY IN AGREEMENT. BUT THE VOTE HAS BEEN PUT OFF UNTIL LATER TODAY
merylnass:They all want to talk about the RSV vaccine;no one wanted to talk about putting mRNA vaccines on the childhood schedule.
merylnass:The schedule says the vote on the childhood schedule will occur at 1:20 pm today.
merylnass:AHHH. The same mutations to keep the protein in a certain conformation for the RSV vaccine were developed at NIH. That means that NIAID will get royalties on this vaccine, as they are getting royalties for the same type of mutation used in the COVID-19 mRNA vaccines.
merylnass:This is important to note.
merylnass:Now for Pfizer's RSV vaccine. Slides are not visible.
merylnass:Yet another presentation on a vaccine still in development. Up to 40,000 participants of whom half will get the vaccine.
merylnass:They used a safety subset. Why vaccinate so many people when only 7,000 (35%) complete an AE diary?
merylnass:Also only a subset are checked for immunogenicity. Apologies, I am having trouble focusing.
merylnass:Wow--FDA is only requiring a lower bound for the confidence interval of 20%. This tells you FDA does not care whether the vaccine works. They just want to give it.
merylnass:What this means is that FDA will accept this vaccine for a license if it has a 5% chance from Pfizer's data that it works with efficacy less than 20%. How is that for a regulatory agency?
merylnass:Can we trust Pfizer that its vaccines are what they claim to be after the COVID shots and the lack of interest in whether the vaccine works by the FDA?
merylnass:What is Miller Fisher syndrome? Pfizer did not have this patient worked up despite them living in Japan where there is access to tertiary care
merylnass:No sfety signal according to Pfizer's Gurtman. REALLY?
merylnass:It doesn't work that well. Lower bound CI is 28%.
merylnass:I don't understand why the CI is so low with 20,000 subjects. It does not make sense.
merylnass:It seems there was very little RSV in this trial and in one trial the confidence interval went negative.
merylnass:If there was so little RSV, why vaccinate?
merylnass:The GBS case also had a heart attack we now hear! GSK denies this was vaccine-related
merylnass:Miller Fisher syndrome is a rare, acquired nerve disease that is considered to be a variant of Guillain-Barré syndrome. It is characterized by abnormal muscle coordination, paralysis of the eye muscles, and absence of the tendon reflexes. Like Guillain-Barré syndrome, symptoms may be preceded by a viral illness.
merylnass:Therefore, in about 17,000 recipients, they had 2 GBS cases. I do not have a duration, but there is only supposed to be about 1 GBS case per 100,000 people per year--if this trial lasted 7 months like GSK's, then you are looking at a much higher rate of GBS than expected.
merylnass:More thn 10 times the expected rate
merylnass:Now Gurtman hands this off. One GBS case started 8 days after vax with resp syndrome and a few weeks later had ascending paralysis with ocular symptoms who was NOT WORKED UP. This is criminal malpractice. When you have a GBS case you must hospitalize and evaluate to see if they need immediate case such as IVIG, steroids, plasmapheresis. To avoid a workup in a person with a potentially life-threatening disease cannot be explained or excused.
merylnass:care not case
merylnass:Now for the CDC workgroup. Policy questions being considered for VACCINES WHOSE TRIALS ARE NOT COMPLETED, ARE UNLICENWEED, AND FOR WHICH ONLY MINIMAL DATA HAVE BEEN PROVIDED. WTF?
merylnass:Why woould we believe CDC's data when it has proved to be grossly inaccurate for COVID-19?
merylnass:After showing a first slide indicating RSV is a serious illness leading to many hospitalizations, he admits both trials found remarkably few cases of RSV
merylnass:Is the RSV test accurate?
merylnass:Isn't it usually a PCR? And the trials were underpowered to assess hospitalizations and deaths. There were no deaths and less than 5 hospitalizations per trial. What does <5 mean? Why does CDC avoid providing a number?
merylnass:Now we have the estimates again, to demonstrate this is a severe disease, except the trials showed the opposite.
merylnass:He confirms that each trial lasted less than a year. So you can put your patients at risk of GBS to prevent possibly no hospitalizations or deaths. Great
merylnass:3 GBS cases in the 2 trials of about 26,000 vaccinees that lasted less than a year. All occurred soon after vaccination.
merylnass:Doctors will need to educcate patients to get them to take this as practically no one appreciates the dire risk form this illness.
merylnass:RSV in infants and babes--97% have already had RSV by age 2. CDC says 2-3% of all infants are hospitalized with RSV. That sounds like a big number. Wondering if it is true. CDC quotes old studies and not its own data, which itself is interesting.
merylnass:Based on CDC's claim that 58,000 kids under 5 are hospitalized yearly for RSV, that number of 2-3% is only accurate if all of them are in the 0-6 month age group and no older kids are hospitalized for RSV.
merylnass:Based on this cdc website https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=&cad=rja&uact=8&ved=2ahUKEwikq5Hxlu_6AhX8EGIAHdqYBcUQFnoECA0QAw&url=https%3A%2F%2Fwww.cdc.gov%2Frsv%2Fresearch%2Fus-surveillance.html&usg=AOvVaw1sewVc6B_bgVXXOryjWrYb
merylnass:Nirsevemab is a monoclonal antibody product of Sanofi for RSV in little kids
merylnass:Sanofi applied for a license after only half its study was done, but then completed the study and so they seem to have two data sets. Which makes no sense because they should be providing the totality of the data
merylnass:3,000 subjects through 5 month followup. They used preemies and gave 50 mg per baby. But the 11 lb plus babes needed a higher dose. 2000 subjects and 1000 placebo subjects. Efficacy 76%, but how is efficacy defined?
merylnass:They report no serious adverse events and no deaths. So in the 1000 kids who got placebo and the 500 who got the drug but it did not work, there were NO DEATHS, which provides some assessment of how serious the RSV illness is.
merylnass:It worked about 80% for RSV a and b, which is good.
merylnass:The placebo group had the same incidence of RSV as the tretment group a year later. This indicates the drug did not impair later immunity. However, I am concerned that 4% of the kids who had RSV initially got it again the next winter.
merylnass:And it looks like Sanofi may want to use this monoclonal antibody preventively in the immunocompromised
merylnass:No efficacy in second year, despite his claim there looks like longer efficacy than shown in 5 months
merylnass:Grace asks what the serious adverse events were, and Dr. Leach does not seem to know; she is going through slides to find an answer. She is the Safety person. Hmmm.
merylnass:Grace asks for an answer, and Dr. Leach does not "have them to hand" but will share them secretly after the meeting. Why not during the meeting, later, to the public?
merylnass:DURING the meeting, the way this is normally done when the mfrs cannot anser a question?
merylnass:OMG, they are considering recommending monoclonal antibodies for all infants under 8 months and for all increased risk babies up to 24 months. This is TERRIBLE
merylnass:So these bastards are going to vote on giving this product, for which the mfr will not tell us the serious adverse events, in all US infants up to 8 months? Can you see what a travesty this is and how these people are criminals if they vote for it?
merylnass:They are going to delay a decision until February or June 2023 pendign licensure of the product.
merylnass:Are the natives getting restless? One points out that ACIP was not to consider evusheld, a monoclonal antibldy for COVID, so why are they considering this monoclonal now? What types of products does ACIP review? And someone else wants to know if now they will be putting monoclonals on the vaccines for Children Program? These issues are "to be discussed later" and now we are off to lunch until 1:15, when the vote to put the covid vaccines on the childhood schedule will take place. Don't be late.
merylnass:Oh, another comment period.
merylnass:Jack Baker who works for the govt's NFID another vaccine agency is a speaker. Providng an opinion while collecting his salary, how nice.
merylnass:He pats CDC on the backfor its COVID and RSV vaccine work. Og concern, lots of older adults are not planning to get vaccinated. Surprise! They don't prevent deaths in the elderly anyway, so why get vaccinated? The entire vaccine edifice is being undermined by itw own bureaucrats, who could have predicted it?
merylnass:The second speaker talks about adverse events, and points out that Greg Poland developed tinnitus after a covid vaccine, and Poland is the person who singlehandedly brough universal flu shots to the US.
merylnass:Karma appears to be real.
merylnass:There is no question that tinnitus is a vaccine adverse event; why wouldn't it be when the spike protein and the lipid nanoparticle easily cross the blood brain barrier?
merylnass:3d speaker notes the complexity of the PCV recommendations confuse doctors and patients. This is an unsolvable problem for the CDC. They cannot simplify and still work within their other guidelines. As long as they keep adding vaccines, things will get more and more complicated and people will be less and less inclined to show up and get their jabs.
merylnass:4th speaker is the med director a company with a competign monoclonal for RSV and he wants CDC to stop ignoring his product.
merylnass:5th speaker is from Voices for Vaccines which is an astroturf fake advocacy organization funded by industry. I think he is bemoaning the lack of childhood vaccinations, using the examples of Detroit and Flint, which happen to be primarily black. He claims that a girl who was not recommended for flu shots died 19 years ago. Well, buddy, let me tell you that now, everyone from age 6 months and up is recommended to get a yearly flu shot, so what is his point?
merylnass:6th speaker is great! She points out how the cDC and advisors ignore everything in the public comments. When will they become accountable? Why do they ignore adverse events like myocarditis? This is not a vaccine. It does not meet the definition of vaccine--until FDA changed the definition of vaccine in 2021. It is time to pivot away from these deadly and dangerous injections, more dangerous than all the others behind. We question your motives. We demand you obey the Hippocratic Oath. VAERS and V-Safe show this vaccines should be pulled off the market immediately. Nuremberg Trials for crimes against humanity!
merylnass:And now THE VOTE
merylnass:HERE IS THE QUESTION FOR A VOTE: APPROVE THE RECOMMENDED CHILD AND ADOLESCENT IMMUNIZATION SCHEDULE 2023 AND ADULT SCHEDULE 2023.
merylnass:No questions. Here we go. And as I predicted, the vote is unanimous 15-0
merylnass:MENINGOCOCCAL VACCINES AND DISEASE ARE DISCUSSED. Note that the incidence was dropping steadily prior to vaccine introduction.
merylnass:Note that efficacy and duration of effect of these vaccines are unclear. Note that meningitis cases occur in 1 in a million Americans, or 1 per year in my state of Maine.
merylnass:Yet these recommendations would have 8 million kids per year vaccinated with the Men A vaccines and some to get Men B as well.
merylnass:GBS was listed as a side effect, but its frequency is also unknown. Once these vaccines are licensed and put on the childhood schedule, further data collection can only harm the manufacturer, which is why we know so little about them.
merylnass:Most meningitis occurs in babies who are too young to get vaccinated! That is why this is a joke.
merylnass:Sandra Fryhofer wants to make it easier to use the meningitis vaccines off-label
merylnass:Now we are discussing the label differences in colors, but 14 of these same 'advisors' had no questions about mandating covid vaccines for 75 million American kids to go to school and collegequest
merylnass:The work group is working on putting the Men B and ACWY vaccines together in a pentavalent form. They plan to vote on this in 12 months assuming the formulas have been licensed. So why discuss it now? There is no sensible understanding of what CDC chooses to put in front of this committee.
merylnass:Chen asks why we need to give this to 12 year olds?
merylnass:CDC briefer answers a different question; maybe that Q was from Sanchez.
merylnass:Now we at a study of flu shots in pregnancy. FluBlok (the fall armyworm shot) and Flulaval were compared to each other but there is no placebo. They tried to enroll them early in pregnancy--this is the clue that the people doing the study are criminals.
merylnass:188 in each group. 7% of the women had a serious adverse event but all were designated as unrelated to the shots. 6-9% of infants had serious adverse events, also deemed unrelated but many serious congenital anomalies, for which they do not provide clearcut info on the numbers.
merylnass:The recombinant is the fall army worm/Flublok vaccine. FluLaval is the "standdard" flu shot.
merylnass:Geeta Swamy does not even know if the fetal death was a congenital anomaly case or not. I guess she left the data analysis to the CDC.
merylnass:Geeta Swamy Associate Vice President for Research and Vice Dean for Scientific Integrity Email: firstname.lastname@example.org
merylnass:Dr. Swamy works with leaders across campus to provide a consistent University vision for scientific integrity standards and expectations and will drive efforts to ensure the advancement of scientific integrity across Duke University and the School of Medicine. A highly accomplished clinician-scientist, Dr. Swamy specializes in perinatal infection and maternal immunization. She is the principal investigator on numerous grants from the NIH, CDC, and other funding sources and has published more than 100 articles.
merylnass:The above is from her Duke bio/ Office of Scientific Integrity
merylnass:I just learned that the European Medicines Agency approved the Pfizer and Moderna vaccines for babes down to 6 months old. Were they given an October 20 deadline? It is curious that they approved this the same day the ACIP approved (essentially) mandating still unlicensed vaccines for kids starting at age 6 months.
merylnass:This allows any state that chooses to mandates the vaccines for daycare, school, college, and any other educational activity they choose.
merylnass:In the US, several states have removed all vaccine exemptions except for medical exemptions, and there are efforts to remove doctors from the decision on medical vaccine exemptions, as you know.
merylnass:The states that offer no religious or philosophic exemptions include Maine, New York, Connecticut, West Virginia, Mississippi and California.
merylnass:What we have seen so far is that legislatures that are majority Democrat have been aggressive at imposing vaccine mandates, while Republican states have been less aggressive, and most Republican states' Attorneys General have filed lawsuits against various adult COVID short mandates.
merylnass:It seems that belief in the safety and efficacy of vaccines has becomes a religious litmus test in the US. The religion is Science, while everyone who adopts Science as a religion does not actually understand what science is, by definition and practice.
merylnass:Science is about making hypotheses, testing them, examing data dispassionately and drawing unbiased conclusions. It has nothing to do with tribalism.
merylnass:Takeda vaccine for Dengue is being presented but the study will be presented next February. WTF.
merylnass:I have no clue how the Dengvaxia vaccine got put into the Vaccines for Children program, when the vacccine killed (I think) about a hundred kids in Philippines several years ago, causeing both Sanofi execs and Ministry of Health staff to be charged criminally for a bogus approval.
merylnass:I believe the 15% untreated mortality is incorrect. I see that the briefer is misleading the listeners by reporting Dengue hemorrhagic fever and shock syndrome as a complication of infection rather than explaining it is an autoimmune result that almost always requires a prior infection.
merylnass:"By 2080 6 billion people will be at risk of dengue"--she has a crystal ball, it seems. Climate change, of course, if the guilty party.
merylnass:This is Dr. Adams giving this talk. Puerto Rico has had many outbreaks over more than the last 30 years.
merylnass:Here is the real info from the WHO/PAHO. they say there were a total of over 2 million dengue cases in the Americas since 2010 and the mortality rate was 0.045%, significantly less than the BD 15% of untreated cases according to this charlatan.
merylnass:Here is the link for the data https://ais.paho.org/ha_viz/Arbo/Arbo_Bulletin_2022.asp?env=pri
merylnass:In USVI, seroprevalence for dengue was over 40% starting at age 9
merylnass:Now comes the scary stuff. The mosquito vectors are in more than half the US, so expect it to keep increasing in prevalence. In 13 years, 8,000 cases were reported cumulatively.
merylnass:There were nearly 8,000 cases reported in travellers over the past 13 years. Highest case rate is in 10-19 year olds. There is very sporadic transmission in FL, TX and HI.
merylnass:Now Dr. Paz-Bailey will present on the Dengvaxia vaccine. She also repeats the climate change warnign. She shows the same slide as before
merylnass:Dengue vaccine fiasco leads to criminal charges for researcher in the Philippines Rose Capeding could face years in prison for her role in clinical trials of Dengvaxia https://www.science.org/content/article/dengue-vaccine-fiasco-leads-criminal-charges-researcher-philippines
merylnass:Philippines to charge officials of Sanofi, government over dengue vaccine https://www.reuters.com/article/us-sanofi-fr-philippines/philippines-to-charge-officials-of-sanofi-government-over-dengue-vaccine-idUSKCN1QI41L
merylnass:The vaccine was -144% against severe dengue--Negative efficacy in Philippines
merylnass:"most children will need to have testing before they can be vaccinated to avoid this deadly complication. NO existing test is accurate, so FDA said use 2 tests in kids and both must be positive in order to more safely give this vaccine.
merylnass:280,000 eligible children in Puerto Rico. CDC says most parents will give it. But how many will really go thru the testing rigmarole, since this is not one of the firs (as she claims), but is THE FIRST vaccine to require a test before it can be given. Who will do it? It requires 3 doses over a year and 4 doctor visits, one lab visit.
merylnass:You can get it at 4 clinics on the island
merylnass:Soon it is planned that in January all medical providers in PR may offer the dengue vaccine.
merylnass:The tests needed are not FDA-approved! Yet they are required by the FDA-approved label for the vaccine. Insurance did not cover it but this has somehow been resolved.
merylnass:A new vaccine from Takeda is being reviewed. 7 days ago it was approved by EMA in EU.
merylnass:Marketing authorization in Europe is expected in the next month
merylnass:Both are live viral vaccines, and the recommendation is it can be used in some HIV patients but unclear about other immunocompromised people.
merylnass:Unknown if they need to test for the Takeda vaccine. First do no harm seems to be an unknown saying to this group.
merylnass:Dr. Sanchez will present on monkeypox. He says it spreads through fomites. I wonder how big that risk is?
merylnass:ACIP voted in June for Jynneos as an alternative to ACAM2000.
merylnass:Using shared clinical decisionmaking which is a metaphor for the professionals refuse to take responsibility for this shot.
merylnass:We are at under 20% of the new cases that were being reported at peak on Aug 9. See graph at https://merylnass.substack.com/p/bye-bye-moneypox-we-barely-knew-you
merylnass:906,000 doses administered in the US in 54 jurisdictions reporting data.
merylnass:Does it work? As I pointed out, CDC conducted a study in the Congo of at least 1000 healthcare workers given the Jynneos vaccine beginning in 2016 or 2017, and they have completed the study. But CDC has pretended it never occurred. The principle investigator, Brett Petersen of CDC, briefed the ACIP on the vaccine and never told them he had done a study on it in the Congo.
merylnass:Sanchez said they will be studying efficacy. Isn't that grand? You give the vaccine to a million Americans while hiding the data you have and claiming you don't know whether it works. He neve mentioned that it caused myocarditis and worsening of HIV.
merylnass:Yet the research to get the vaccine licensed in 209 clearly show that it does.
merylnass:And so the discussion is around intradermal vs subcutaneous or intramuscular. Where is the data on these different routes of administration?
merylnass:Now they are talking about vaccinating people after they have had monkeypox. Because they need to check duration of immunity. Mybe they will need vaccine, even though the epidemic is dying out.
merylnass:OMG, Grace Lee is asking about "our youngest kids" and monkeypox vaccine. There will be an MMWR coming out describing infection in kids.
merylnass:And that is the end! Bye.