Review of Global Vaccine Safety Summit for Lawmakers, Geneva, Switzerland, December 2019
A repost
The following is a repost (very lightly updated/edited) from an old entry, from back when I was still on FB. For reasons that should be obvious, I felt the topic was rather pertinent, and felt my readers might benefit from a visiting—or revisiting—of these ideas…
Before we embark on this little journey, there is one clarification I need to make. I’m not antivaxx. I’m anti BAD science, and the science of vaccination is, as I’ll attempt to demonstrate here, as bad as it gets, both in methodology and scope of application.
I’ve posted on this topic many times in the past, sometimes with a large hiatus of time whereas I’d completely avoid the topic, even while I was still on social media. And there were many reasons for this.
But this will be the beast of all posts I’ve made public on the topic. By far. So be forewarned. And be forewarned that it still won’t encompass everything, since it is such a complex topic, but it will be comprised of many points I’ve yet to address at such length.
The reason, and motivation, for this is quite simple.
Through my work at a research institute, we were all invited to watch a teleconference that was filmed live over the course of a few days, at the aforementioned summit. Of course, no one at my work would ever suspect my stance on this matter (I work from home, you see ), and none of the information being shared and dispensed, it was assumed, would end up being interpreted in any other manner than the usual blind parroting of the same old nonsense.
Right at the onset, and as per the WHO’s mantra, we were all reminded that the greatest threat to world health in our modern times is something they have come to call “vaccine hesitancy”.
And concurrent to this assertion, it can be observed that that assumption has continued pretty much unabated, over many years (decades, in fact), enforced by public “health” [sic] entity representatives, media, politicians, educators, and physicians under this one mantra: Vaccines are incredibly safe and incredibly effective.
So, we will start with Heidi Larson, anthropologist and director of a long-term study called The Vaccine Confidence Project. Her research looking into this (5 years now; “Vaccine Confidence Index”) came to be summed up with the following:
Safety concerns over vaccines are at an all-time high (this study was conducted in 148 countries across Europe and North America), and we thus need to be doing everything we can to address this. (Sounds familiar, right?) Safety concerns, her research had found, make up over 50% of the reasons people are hesitant to get, or get their children, vaccinated.
The biggest issue related by Larson during her presentation is that not only is vaccine confidence down among the population, but the trend is equally on the rise among health care providers (in other words, the very frontline of health care).
That is, the most trusted individuals within this context (and I’d argue that isn’t necessarily a good thing, mind you!), i.e. physicians and nurses, are becoming equally disenchanted by the whole issue. Larson herself concludes that remark with the following:
“If we lose that battle, we’re in trouble!”
Now, keep in mind that, on WAY too many occasions to recall, one of the most frequent arguments provided for vaccine safety when engaging other people on this topic is this notion of “trusting your physician” (what I like to call, ‘eminence-based medicine’).
Just like with nutrition, amirite…
I bring up nutrition here because, not unlike the situation with vaccines, doctors lack (or at least they should lack!) in their confidence with regards to vaccination safety, simply based on the fact that “in most medical school curriculums, even nursing curriculums, you’re lucky if you have a half-day on vaccines, never mind keeping up-to-date with all this” (Larson’s own words!).
[And, should you care to know how this minimal information is being dispensed, and by who, I’d invite you to read my other posts on this topic. I have TONS and I’d at least kindly suggest you read Joseph Dumit’s ethnomethodological work on how medical learning is being acquired and transmitted in this day and age. I’d also suggest David F. Noble’s work or, more recently, Null’s “Science for Hire”. Essentially, it has become a very VERY fine and blurry line—i.e. quasi non-existent—between education and marketing, research and agenda].
And, sure, it doesn’t help that there are myriads of antivaxxers who have never looked at this with the attention such a topic merits, more often than not spewing pseudoscience on top of more pseudoscience and “personal” uninformed opinion.
But the same is sadly true of the pro-vaccination groups, who often insist on vaccines' “proven” efficacy (more on this as we proceed), while also undermining their inherent risks, while often offering a healthy serving of ad hominems in the process!
Composing that group (pro-vaccination) are many often otherwise intelligent people who assume that anyone who dares call into question the safety and efficacy of vaccines (and, more specifically for me, the science [sic] behind vaccines) must be a scientifically illiterate fool that has never read a paper in their life, while in the other camp (antivaxxer group), there are just as many who assume all conventional docs who promote vaccines are evil and corrupt and/or incapable of looking at things objectively [although, as I did suggest above, most—especially new graduates—are in fact no longer able to tell the difference between “research” and “marketing”, their perception and recommendations, for the most part, being based on clinical trials that have largely been outsourced to pharmaceutical companies, with those companies, in turn, viewing clinical trials as investments, measuring the value of those investments by the size of the market and profits that it will create… Again, go read yourself some Dumit].
Now, to work her way around this problem, and the notion that vaccines can never be 100% safe, Larson suggests that we look at this from the perspective of what public health entities and frontline health professionals can do to regain the consumers’ trust.
The subsequent portion of Larson’s presentation highlights this, and is where it gets really interesting. Her words here:
“We’re in a unique position in human history where we’ve shifted the human population to dependency on vaccine-induced immunity, and that’s on the great assumption that populations would cooperate. And for many years, people lined up for six or ten vaccines, people were there, they saw the reason. We’re in a very fragile state now. We have developed a world that is dependent on vaccinations. So we don’t have a choice.”
Mind blown! Just wondering, do any of you remember voting anywhere or at any point in time for foregoing your natural immunity?
Those who follow my musings on this topic (and I’ve been fighting this fight for well over two decades now) might recall my alluding to two of the most absolutely unscientific principles on which all of vaccination theory is founded.
The first, that “production of antibodies” is actually synonymous with immunity. It’s not. And this has been clearly demonstrated on more than one occasion.
The second such claim, that the efficacy of vaccination on whole populations rests on this notion of “herd immunity”, the latter implying that the only reason vaccinated people are still getting infected is that 'more people need to get vaccinated and/or more of them need to get vaccinated more often' :/
Ultimately, and historically, one quickly comes to the realization that the the main reasons vaccines were adopted pertains to cost.
Dr. Ray Peat, in an interview from a while back:
People writing about the economics of immunity often refer to vaccination as the “economically viable method”; they acknowledge that sanitation and nutrition prevent disease, but they say it's cheaper to vaccinate. And the World Health Organization around 1970, I think, did an experiment in Central America in which they had a medical team with vaccinations and all of the [usual] regular medicine [providing] help to one village; another village, they didn't do anything to; the third village, they didn't provide any vaccination or medical help, but they provided clean water and a nutrition supplement to pregnant women and [to] the young children. And doing that, for several years, they came back [to assess]; and the health was best in the nutrition and clean water village; [it was] better than the controlled village. The health in the medicalized and vaccinated village was worse.
In other words, scientifically, that pretty much says that even though it might not be economically viable to clean up the environment, it definitely is better than vaccination as a way to “improve health”.
So it would appear we’ve essentially been subjecting ourselves, and our children, to an immune-suppressing large-scale program, and now all appears loss, unless we keep vaccinating more people and more people more frequently. And it’s OK, since vaccines are pretty safe anyway, right?
Well, our good anthropologist, head of The Vaccine Confidence Project, continues…
There’s a lot of safety science that’s needed. We really need to do some safety science, and we can’t just keep rehashing the same old science, hoping people will get more confident.
And she wasn’t alone.
Marion Gruber, Director of the Office of Vaccines Research and Review Center for Biologics Evaluation and Research at the FDA, added:
Vaccines require safety surveillance and monitoring that is specifically tailored to the vaccine that is under consideration using available pharmacovigilance systems. In other words, with regards to the risk management plan for each particular vaccine, we WILL NEED [meaning, of course, it’s not being done!] to take into consideration the pre-licensure safety database, potential safety signals that may have been identified during pre-licensure clinical safety trials, and other perhaps theoretical safety concerns, as well as the disease to be prevented, the target population, and the proposed indication in order to really inform risk management.
Like, yeah, shouldn’t that be the case already?
Newsflash: no, it’s not. Never has been, and likely never will be.
Now, kindly name me ONE other field of medical research and application where the same dose (in fact, many doses in this case, and administered multiple times) is administered across the board, irrespective of any potential individual differences! One, please!
Yeah, I didn’t think so…
I want to talk about adjuvants now, a topic I’ve discussed multiple times as well.
Adjuvants (vs. the actual antigens) are probably the most important aspect of this whole discussion, since it is believed they are at the root of 99%+ of all potential issues pertaining to vaccination.
Care to know what Martin Howell Friede, coordinator for the Initiative for Vaccine Research at the WHO, and adjuvant specialist, had to say? Here goes:
Adjuvants are added to vaccines primarily to make the vaccines work. […] Without adjuvants, we are not going to have the next generation of vaccines and most of the vaccines that we do have […] require adjuvants for them to work. […] When we add an adjuvant, it’s because it’s essential. We do not add adjuvants to vaccines because we want to do so [now that’s comforting; such caring and empathy], but when we add them in, it adds to the complexity [Right… As if immunity wasn’t already complex enough].
And I give courses every year on how you develop vaccines, and how do you make vaccines, and the first lesson is: while you’re making a vaccine, if you can avoid using an adjuvant, please do so.
[Very few do avoid them. And, on that topic, I’d kindly invite to explore the work of Christopher Exley, professor in bioinorganic chemistry, who has gone on to show that adjuvant INVARIABLY cause a host of autoimmune issues. Same with Romain K. Gherardi, neuromuscular pathologist at the University of Paris-Est.].Lesson two, if you’re going to use an adjuvant, use one that has a history of safety [code for “use one that we’ve used before so that they won’t blame it for the dangers and harms that arise”] and lesson three, if you’re not going to do that [i.e. use a new one], think very carefully.
The obvious next question, which a kind professor (in this case, Stephen Evans, professor of pharmacoepidemiology) in the room, bless his soul, felt obliged to ask:
It seems to me that adjuvant multiply immunogenicity of the antigens that they are added to, and that is their intention. It seems to me they multiply the reactogenicity in many instances [yes, yes, they do. Care to take a good guess what percentage of children it is estimated, today, suffer from various autoimmune disorders? Or how many children suffer from adverse reactions. How about 12.8% in the 80s—when the schedule was comprised of 11 vaccines—compared to 54% today with I don’t know how many vaccines anymore. I think I’ve lost count ☹ ], and therefore it seems to me that it is not unexpected if they multiply the incidence of adverse reactions that are associated with the antigen, but may not have been detected through lack of statistical power in the original studies. Now I wonder if this thinking is correct and, if it is, whether this has implications for the way we do pharmacovigilance. Because one vaccine that has one antigen and an adjuvant, and another vaccine that has a different antigen and no adjuvant, the reason for the difference, is not immediately obvious.
Correct you are, kind sir!
No vaccine is administered in isolation. No vaccine is administered in the same body twice. And no vaccine is ever administered in the same two people with the same potential immunoreactive challenges.
Additionally, if an adjuvant can ramp up the activity of an antigen, would it not be sensible then to assume that it could also ramp up the activity of any antigen within the body that it might come into contact with?
Yes Sherlock, right again!
And that’s where autoimmune responses come into play. Again, take a good guess which subset of diseases has seen one of the sharpest inclines observed in modern times?
Well, you know what Friede’s response was?
Essentially, in a VERY long roundabout way, he points out that we have some “pretty good idea”, at this point, of local reactogenicity symptoms (and in a very haha way, points out to the pain any adult might have experienced after receiving the recent shingles vaccine…), but when he comes to addressing long term ramifications, he essentially offers what most of us in-the-know already know:
We don’t use adjuvants by themselves, and the adjuvant is used in combination with an antigen, and an adjuvant may give quite different responses depending on which antigen it is combined with. So the fact that an adjuvant is shown to be safe [sic] with one antigen might give a different response with another antigen, because of other things that act with that second antigen, including impurities. So, we need to point to the regulators [right! put the regulators in charge; let the fox guard the hen house. Makes perfect sense! But wait until later down the line, when I show you that beautiful loophole…], and it comes down to ensuring that we conduct Phase 2 and 3 studies with adequate size and with the appropriate measurement.
Now, care to take a good guess what happens to the independent scientists who do and have attempted to do those studies ☹
So, in essence, that work has NEVER been done. And they frankly don’t even know how to do it (track and study future adverse systemic issues, that is).
In clinical trials, they are actually using relatively small sample sizes and in doing so, are at risk of what one Dr. David Kaslow, V.P. for Vaccine Innovation and Access, calls the “tyranny of small numbers”. Poor them!!!!!
The latter then goes on to suggest that it’s a “real conundrum”, since it would take years to track and study all the variables [Duh!?! Yeah!?!? Like for all other drugs, you mean!?!?!? Want to know what the typical length of follow-up—officially known as the “duration of safety review after injection”—for solicited reactions is for vaccines given to our children? Forty-two days is the longest, this one for the MMR vaccine. All the others are in the order of 3 to 14 days. THREE TO FUCKING FOURTEEN DAYS!!!!!]…
So, instead, we have this situation where we are subjecting our most precious, that is, our children, to a wide-scale uncontrolled experiment! Uncontrolled in ALL sense of the word, since new antigen and adjuvant combinations are constantly being proposed and administered.
Following this, Kaslow recognizes that we need to invest in better biomarkers, better mechanistic understanding [yeah, ‘cause mechanistic understanding is really what it should all be reduced to, of course], so as to better understand adverse events as they arise.
The lovely Marion Gruber then takes the stand again, and suggests that one of the “new struggles” [it should have never been a new struggle. It should have always been THE struggle!!!)], is the length of the follow-up that should take place pre-licensure and even post-marketing. If that’s even possible, because, as she herself specifies, one has to acknowledge that the longer you follow-up, the more you see adverse events that have nothing to do with the adjuvant vaccine combination [or does it?] but maybe, again, “coincidental” [here’s that word again!]. But the problem is how do we deal with that data and, ultimately, pre-licensure clinical trials may not be powered enough…
Great! So let’s just put everyone on this half-ass built plane they didn’t want to be on and, as it takes flight—or not—we can just wing it along the way :/
You know what Gruber addresses next?
One of my main arguments for the absolute inanity of mass immunization: it’s not and has never been individual-specific. It’s the same dose (doseS, actually) for everyone, irrespective of anything.
Gruber points out that:
“the subject population that you administer an adjuvant to, a particular adjuvant added to a vaccine antigen, sometimes does really nothing when administered to a certain population, but when administering the same formulation to another subset, the effects are different”. Huge revelation here!!! This, she then goes on to say, “further complicates safety and effectiveness evaluation of adjuvants, combined with vaccine antigens.”
I don’t know about you, but it certainly feels like we somehow put a bunch of third graders in charge of world health!!!!
As if you needed it at this point, but how about further proof that the research and medical establishments have NO clue what adjuvants really do?
Here’s Dr. Kaslow again (that so-called adjuvant specialist)…
Here he addresses a brand new group that they want really badly to include in their “clients”, but with quite a few obstacles and challenges in the way.
A new target population for us in vaccines is maternal immunization, and these are women who are pregnant who will have all kinds of adverse events associated with their pregnancy. Part of the problem is that we don’t have a strong enough pharmacoepidemiologic baseline and the target populations that we’re studying to be able to say ‘is this is an expected adverse event due to pregnancy or is this related to the vaccine’. So I do think that an investment in that kind of epidemiological baseline is going to be critically important if we don’t want to derail some of our maternal immunization vaccines as they go into low resource settings.
So we know, and they know, and they’ve acknowledged, that adjuvants react differently in different subsets of the population. And we know, and they know, and they acknowledge that “we should invest in epidemiological baseline research” when it comes to maternal immunization.
And yet, the number one group I see being targeted with the flu and Tdap vaccines is which one? Yeah, you guessed it. Pregnant women!!!! #fluseason is ALL about ensuring that pregnant women (and their fetus), get their flu shots ☹ And yet both the CDC and the WHO, public health entities in charge of ensuring the health of its populations, admits to having no idea what vaccines and their adjuvants might do systemically and in the long term, both to the mother and fetuses… Hmmmm.
You want to know what’s worse (as if it could get any worse, you say).
In line with this admission, one of the top officials for the CDC (Dr. Wellington Sun, who’s basically in charge of dealing with all lawsuits against vaccine adverse reactions), back at one of those ACIP meetings (2017, this time), did insist on clarifying that vaccination in pregnant women was and should still be considered “off label”!!!!
Say what?!?!?!?
Outside of the aforementioned Stephen Evans, there was one other bright spot in these whole multiday presentations, and it was provided by Dr. Bassey Okoposen, program manager at the National Emergency Routine Immunization Coordination Centre in Nigeria.
And here’s the obvious question he asked:
Outside of vaccines… are there any other drugs like that, where at six weeks, ten weeks, fourteen weeks, a child is given different antigens, from different companies, and these vaccines have different adjuvants, different preservatives, and so on… We go again to nine months, currently the child at nine months will receive maybe eight vaccines. That same child will receive yellow fever. That same child will receive measles vaccine. Something crosses my mind… Is there a possibility of these adjuvants, preservatives, cross-reacting among themselves? Has there ever been a study on the possibilities of cross-reactions, that you can share the experience with us? Because this is one thing that is also crossing my mind, going back home. This is an area that will need to work with the regulatory agency. Let’s even see what is happening. Is there any possibility. So we’ll need guidance from the panel members, whether there has ever been any study on these cross-reactions, on multiple antigens, from different companies, given to each other at the same time [irrespective of the subset of population/individual!!!!] What counsel do you have for us? Thank you.
THANK YOU!!!! Yes, thank you!!!!
And, to answer the good doctor’s question myself, no, these studies have not been done. Never. Not even close.
They keep using that word, “immunity”, throughout the panels, failing to recognize, to begin with, that “antibody count”, which is often the sole biomarker being used to determine an immunization approach’s efficacy, does not correlate whatsoever with immunity. Nada.
I know, because the head CDC official, back in a 2018 ACIP meeting, was asked that very question, and her answer was as follows:
“We have no data to make a recommendation one way or the other.”
However, another official (Amanda Cohn) did offer the following very “consoling” observation:
While no study has been conducted on these vaccines being administered simultaneously, our general approach to immunizations is that they can be given at the same time, in different, um, limbs.
OhMyEffingGawd. Everything is fine then.
Makes me feel reassured and all warm and fuzzy inside now, knowing this.
At the WHO summit, Dr. Okoposen did go on to get his answer too, from Dr. Robert Chen, scientific director at Brighton Collaboration.
This is a very important question, because in general, the clinical trials with any particular new product frequently, is just done by itself, and then ultimately, frequently, the regulators will ask if that vaccine could be added to the routine immunization program [that sounds pretty foolproof, right? Have the regulators—that our public health entities put in place to protect its citizens—ask the manufacturers if THEY think it’s safe to add their product to the rest of the regimen!!!!!!!]. But your question is almost kind of the next step [you’d think that would be the first step before recommending—in certain cases, now FORCING!!!!—people to subject themselves to their schedules, but who am I to question their motives…], because in reality, frequently there are multiple vaccines from different manufacturers that maybe you’d receive at different age schedules, etc. And if you take a look at the immunization schedule over the last let’s say 15-20 years in high-income countries as well as in low-resource countries, the schedule has gotten more and more complex [goodie!!!] and so if you take a look at the exposure, what we call the “vaccine exposure” in the typical adverse event report to a spontaneous reporting system in any country, you’ll see that increase in heterogeneity of those different vaccine exposures, especially if you take the manufacturer into account. Now the only way to tease that out is if you have a large population database like the vaccine safety datalink, as well as some of the other national databases that are coming into being [notice the future tense being used here again. Not past, not even present, but future, as in, it’s not been done. Because, you know, it’s “complex”!], where the actual vaccine exposure is tracked down to that level of specificity of who is the manufacturer, what is the lot number, etc., ant there’s initiative [future!] to try and make the vaccine label information barcoded so that it includes that level of information so that in the future, when we do these type of studies, we’re able to tease that out. And each time you subdivide, then the sample is becoming more and more challenging, and that’s why I said earlier today, that we’re really only in the beginning of the era of large data sets where, hopefully [“hope” heh?], we could start to harmonize the databases for multiple studies and there’s actually an initiative on the way to try to get more national vaccine safety databases linked together so that we could start to link together and answer these type of questions that you just raised.
Thank you Dr. Chen. Essentially, you just shared with us a whole lot of words to get to the real point: These things haven’t been done, these things are complex, and these things, we hope, will be implemented, so that we can, hopefully, answer these types of questions… Shucks…
So, the schedule has gone from 11 (in the mid-80s) to a now much more complex 50+ vaccines. None are ever administered alone, and none are ever studied in combination. The manufacturers are exempt for any legal pursuit. And the regulators, aka the public health entities put in place to protect us (CDC, Health Canada, European Medicines Agency (EMA), FDA, etc.) have basically set up a system where they get to kindly “ask” the manufacturers (that loophole I alluded to above) if adding a new vaccine to their already complex immunization schedule, is safe!
Do you get the picture now?
All these conversations, need I remind you, occurred within the context of the WHO Summit on vaccine safety, not some random weekend get-together at the club...
But to contrast with all this info I just shared with you, let’s hear what Dr. Soumya Swaminathan, Chief Scientist at the WHO, actually tells you, the laypeople, back in November 2019, essentially a mere few days before the summit in December…
And then, if you didn’t do so during your first viewing of that video, contrast her message with the second part of that video, where attending an actual summit and where her tone isn’t quite as reassuring and paternalistic (there’s more, when viewing the entire conferences, but this short excerpt certainly gives us the gist of it).
OK... I’m stopping here, for now. I can assure you I’ll be revisiting this, adding to it, making corrections, but I want to post this now, so here it is. No concluding remarks for now.
Let the onslaught begin.