US Food and Drug Administration – FDA
The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.
More specifically, within the FDA is the Center for Biologics Evaluation and Research (CBER) whose mission it is to use sound science and regulatory expertise to protect and enhance the public health through the regulation of biological and related products including among other things, vaccines.
Vaccines are given to about 4 million American infants annually and are not put through the same level of safety testing as new pharmaceuticals. One can argue that vaccines, which are given to healthy patients, should be tested more rigorously than drugs because they are not given to treat an existing disease or condition.
Inadequate testing ensures that the true risk/benefit assessments for the safety and cost of vaccines are impossible to calculate accurately, and, therefore, the FDA is failing to protect the public from preventable vaccine injuries.
Paul Offit Unwittingly Exposes Scientific Fraud of FDA’s Vaccine Licensure
By Jeremy R. Hammond, Contributing Writer, Children’s Health Defense
By telling parents not to do antibody blood tests to avoid needlessly vaccinating their child, Paul Offit unwittingly exposes scientific fraud by the FDA.
Many parents today are naturally concerned about the number of vaccine doses their children are exposed to by following the schedule recommended by the Centers for Disease Control and Prevention (CDC). To many parents, it makes sense to avoid vaccinating their children unnecessarily, and to this end a blood test can be done to determine an antibody titer, or the level of antibodies in the blood. If a child already has a protective antibody titer, indicating immunity to a given infectious disease, then there would be no reason for the child to undergo the risks associated with vaccinating against that disease.
To persuade parents that this is wrong thinking, the Children’s Hospital of Philadelphia (CHOP) has published a video in which Dr. Paul Offit argues that such blood tests are of little practical use, and that the best thing for parents to do is just to get their children all of the vaccinations strictly according to the CDC’s schedule.
Offit’s argument, however, is fallacious.
Moreover, the nature of his argument reveals how advocates of existing public vaccine policy rely on deception in order to persuade the public to comply with the wishes of the bureaucrats and technocrats who determine that policy.
In fact, properly understood in its context, Offit’s argument undercuts the case for public vaccine policy inasmuch as it highlights how, in order to get vaccine products to the market, the Food and Drug Administration (FDA) colludes with the pharmaceutical industry in what is arguably scientific fraud.
In the video, Paul Offit introduces himself as coming from the so-called “Vaccine Education Center” at the CHOP. Then he acknowledges parents’ concern about unnecessary vaccinations:
One thing that parents worry about, or wonder about is, do I really need a vaccine if I’ve already had one or two doses? Do I really need to finish out the schedule, for example? Or maybe I’ve already been exposed to a virus or bacteria, so I don’t really need to even get vaccines at all.
So instead, how about if I just have my blood tested to see whether or not I have a protective immune response already against that particular virus or bacteria.
But, Offit argues, this is “not as easily done as you would think” because antibody titers are not necessarily indicative of immunity.
He names the hepatitis B virus and the Haemohilus influenzae type B bacterium as examples of pathogens for which a certain quantity of antibodies in the blood is equivalent to immunity.
This is not the case, however, for other pathogens, including the measles virus; rotavirus; and the pertussis bacterium, which causes whooping cough.
With measles, having a certain antibody titer does correlate with immunity, but a lack of antibodies isn’t necessarily indicative of a lack of immunity. In Offit’s words (bold emphasis added):
However, there was an outbreak of measles in the late 1980s, early 1990s that swept through the United States that caused more than 50,000 hospitalizations and caused about 120, children mostly, to die from measles.
When people looked back at that outbreak, you found that there were many people who had been vaccinated, but who didn’t have antibodies against measles who were still protected. The reason they were still protected is they had something called memory cells. Memory immunological cells, like B- and T-cells, which then when they were exposed to the virus became activated, differentiated, made antibodies, which then protected them. So even though they didn’t have circulating antibodies in their bloodstream, they still have these memory cells in their immune system that could then respond when they were exposed. So, if you looked at those people and saw they didn’t have antibodies, you would have falsely concluded they weren’t protected when they were.
In short, just because someone doesn’t have a protective level of antibodies doesn’t necessarily mean that they aren’t immune. One can still be immune to a disease due to what is known as cell-mediated immunity, which is a different branch of the immune system from humoral, or antibody, immunity.
Conversely, Offit continues (bold emphasis added):
Sometimes you can have antibodies in your bloodstream and not be protected.
So, for example rotavirus or pertussis bacteria affect really just the mucosal surfaces. So, rotaviruses just infect the lining of the small intestine. Pertussis or whooping cough infects sort of the lining of the trachea or windpipe and the lungs. That virus and that bacteria don’t really spread into the bloodstream and cause a systemic infection. They’re so-called mucosal infections. So when you look at immunity in the bloodstream, that doesn’t necessarily predict whether or not there’s going to be adequate immunity at that mucosal surface.
In short, just because someone has a high antibody titer doesn’t mean that they are immune. Cell-mediated immunity and mucosal immunity—or both—may also—or instead—be required to provide adequate protection against disease.
Offit summarizes by saying that “titers are difficult” and “not a perfect predictor” of immunity, concluding that “the best way of knowing that you’re protected is to get the vaccines that are recommended at the time they are recommended.”
Thus, Offit dismisses the idea of trying to avoid vaccination with a blood test as practically useless while characterizing vaccination as the best guarantee of immunity.
But this argument is neither logically valid nor honest.
Legitimate Concerns about Vaccine Safety
Today, children vaccinated according to the CDC’s schedule will have received fifty doses of fourteen vaccines by the age of six. By the age of eighteen, children may may have received upwards of seventy-two doses of nineteen vaccines.
As acknowledged by the Institute of Medicine in a 2013 report, no studies have been done to test the entire vaccination schedule to determine the long-term effects of the cumulative number of vaccines and their ingredients, which include the known neurotoxins aluminum and mercury.
(Aluminum is used in some vaccines as an adjuvant, or a substance intended to provoke a stronger immune response, i.e., an increased level of antibodies. Mercury is used as a preservative. Specifically, the preservative thimerosal is about half ethylmercury by weight. It was included in numerous childhood vaccines until the turn of the century, when it was removed from most after it became publicly known that the CDC’s schedule was exposing children to cumulative levels of mercury that exceeded the government’s own safety guidelines. Multi-dose vials of the inactivated influenza vaccine, which is recommended for pregnant women and infants as young as six months, still contain thimerosal.)
Naturally, the large number of vaccine doses and the lack of safety studies, coupled with alarming rates of chronic disease and developmental disorders among children, is a cause of concern for many parents. The idea that they should try to avoid unnecessary vaccinations is certainly a reasonable one.
Yet in his response to these parents, not even the slightest effort is made by Offit to address the question of safety. That it’s safe to vaccinate children according to the CDC’s schedule, by his reasoning, is merely assumed.
That, of course, is the fallacy of begging the question. But Offit’s fallacies don’t end there.
To strengthen his characterization of vaccines as the best guarantee of immunity, Offit highlights cases in which vaccinated individuals did not have a protective antibody titer and yet were still immune to measles.
Naturally, he doesn’t mention that the outbreak he speaks of was to a much greater extent characterized by large numbers of children who were vaccinated and yet who still got measles.
Bringing up the phenomenon known as “vaccine failure” just wouldn’t do, given his purpose of persuading parents to vaccinate their children strictly according to the CDC’s schedule.
In fact, during the mid to late 1980s, about 40 percent of measles cases were occurring in vaccinated schoolchildren, according to a study published in the journal of the American Medical Association, JAMA, in 1990.
Most of these cases were attributed to what is known as “primary vaccine failure”, which refers to the failure of the vaccine to confer immunity. Another possible explanation was “secondary vaccine failure”, which refers to the waning effect of vaccine-conferred immunity.
For outbreaks occurring in the year 1989, according to a paper published in Clinical Microbiology Reviews in 1995, “Approximately 80% of the affected school-age children were appropriately vaccinated.” As prior studies had shown, “epidemics of measles can be sustained in school-age populations despite their having very high vaccination rates.”
Among the explanations for this were both primary and secondary vaccine failure.
Until that time, a single dose of measles vaccine was recommended for children by the CDC, to be administered between the ages of twelve and fifteen months. It was precisely because measles outbreaks were occurring in highly vaccinated populations, however, that the CDC’s Advisory Committee on Immunization Practices (ACIP) began considering adding a second dose to the schedule, to be administered between the ages of four and six years.
As the CDC itself explains in its Morbidity and Mortality Weekly Report (MMWR) of June 14, 2013, “measles outbreaks among school-aged children who had received 1 dose of measles vaccine prompted ACIP in 1989 to recommend that all children receive 2 doses of measles-containing vaccine, preferably as MMR vaccine.”
Moreover, the CDC openly acknowledges that for most children who’ve received the first dose of measles vaccine, the second dose is unnecessary.
In the CDC’s own words (with my bold emphasis), “The second dose of measles-containing vaccine primarily was intended to induce immunity in the small percentage of persons who did not seroconvert after vaccination with the first dose of vaccine (primary vaccine failure).”
Offit’s argument is that since a negative antibody titer after the first dose is not necessarily indicative of a lack of immunity, therefore parents should just go ahead and get their child the second dose, too. But that argument doesn’t make any sense. It’s a non sequitur fallacy. The conclusion simply does not follow from the premise.
Rather, the conclusion that follows, in the case of the measles vaccine, is that parents who think that the second dose might provide no additional benefit and would hence pose an unnecessary risk for their child are probably correct in their assessment.
The FDA’s Unscientific Surrogate Marker of Immunity
The second part of the argument presented by Paul Offit on behalf of the Children’s Hospital of Philadelphia is that, in the case of other pathogens such as rotavirus and pertussis, a high concentration of antibodies in the blood is not a good indicator of immunity.
It does not follow, however, that there’s no point in getting a blood test to determine antibody titer.
To illustrate, if a child has not yet received any doses of pertussis vaccine and yet has a high antibody titer, it would indicate that the child has already been exposed to and successfully mounted an immune response against the bacterial infection, hence rendering vaccination an unnecessary risk.
Nevertheless, Offit is correct to conclude that, for vaccinated children, there is little use in parents getting a blood test to determine antibody titer. But that’s just because of the differences between natural and vaccine-conferred immunity.
The example of pertussis is salient. Natural immunity to pertussis confers both cell-mediated (Th1) and mucosal immunity (Th17), whereas vaccination skews the immune system toward an antibody response (Th2). And as observed in a paper published in February 2019 in the Journal of the Pediatric Infectious Diseases Society, “The Th17/Th1 response prevents infection and disease and also provides longer-lasting protection than does the Th1/Th2 response.”
In other words, the immunity conferred by natural infection is superior to that conferred by the vaccine.
In light of that acknowledged fact, now consider the fact that, for the purposes of licensure by the Food and Drug Administration (FDA), vaccine manufacturers are not required to demonstrate that their product is actually protective against the target disease. Instead, the FDA uses antibody titers as a surrogate measure of immunity, which is unscientific precisely for the reason given by Paul Offit and the CHOP: antibody titers are not necessarily evidence of immunity.
As an example, take Infarix, the brand name for the diphtheria, tetanus, and acellular pertussis vaccine (DTaP) produced by GlaxoSmithKline Biologics (GSK). The pertussis component was approved by the FDA on the basis of blood tests to measure the antibody response to the pertussis antigens included in the vaccine.
The FDA did so even though, as GSK itself admits right on the package insert for Infarix, “The role of the different components produced by B. pertussis in either the pathogenesis of, or the immunity to, pertussis is not well understood. There is no well established serological correlate of protection for pertussis.” (Emphasis added.)
In other words, they don’t really understand how immunity to pertussis works or hence how the vaccine works (although continued science is illuminating those questions, as reflected in the recent study elucidating differences between naturally acquired and vaccine-conferred immunity). What they do know is that in most children, the vaccine stimulates the production of antibodies against the included pertussis antigens, but that doesn’t necessarily mean that the vaccine confers immunity to those children.
In short, what Offit and the CHOP fail to inform their viewers when trying to convince parents that there’s no practical use for getting antibody blood tests is that antibody production is precisely the endpoint the FDA considers for vaccine licensure as a surrogate for demonstrated immunity.
Other inconvenient facts that Offit and the CHOP choose not to disclose to their viewers are that (1) the antibody protection conferred by vaccination lasts only two to four years, (2) vaccination does not prevent people from becoming carriers and spreading pertussis to others, and (3) mass vaccination has caused a genetic shift so that the dominant strains in circulation today lack a key antigen component of the vaccine called pertactin (PRN).
As the CDC itself concluded in 2013 based on data from pertussis outbreaks in Washington and Vermont, “vaccinated patients had significantly higher odds than unvaccinated patients of being infected with PRN-deficient strains.” Hence, pertactin-deficient strains “may have a selective advantage in infecting DTaP-vaccinated persons.”
Far from providing parents with a convincing argument for why they should strictly comply with the CDC’s childhood vaccine schedule, what Paul Offit and the CHOP have provided us with in this video is a strong argument for why the very process by which vaccines obtain licensure by the FDA is scientifically invalid.
Indeed, the conclusion seems inescapable that the FDA’s use of antibody titers as a surrogate measure of immunity for the purposes of vaccine licensure amounts to scientific fraud.
Offit and the CHOP’s Undisclosed Conflicts of Interest
That Paul Offit and the Children’s Hospital of Philadelphia would produce a piece of propaganda intended to manufacture parents’ consent for public vaccine policy should come as a surprise to no one.
After all, Paul Offit is a vaccine industry insider who has worked for both the pharmaceutical industry and the government. In fact, he once sat on the CDC’s advisory committee, and during his time on the ACIP, he advocated the rotavirus vaccine for routine use in children. At the same time, he was working on the development of a rotavirus vaccine under a grant from the pharmaceutical giant Merck.
The Children’s Hospital of Philadelphia co-owned the patent for that rotavirus vaccine with Offit. The patent was later sold to Merck under a deal in which Offit profited handsomely. He has publicly acknowledged making “several million dollars; a lot of money” from the deal.
In addition to profiting from the development of Merck’s RotaTeq vaccine and directing the so-called “Vaccine Education Center” at the CHOP, he also holds the hospital’s Maurice R. Hilleman Chair in Vaccinology, which was created in honor of the former senior vice president of Merck, which provided a $1.5 million endowment to the CHOP and the University of Pennsylvania to “accelerate the pace of vaccine research”.
Naturally, Offit didn’t disclose his or CHOP’s lucrative partnership with the pharmaceutical industry when introducing himself as coming from the “Vaccine Education Center” of a children’s hospital and presenting his argument that parents should strictly comply with the CDC’s recommendations by getting their children all of the vaccine doses on the schedule.
Paul Offit and the Children’s Hospital of Philadelphia argue that there’s no practical use to parents getting blood tests for their child to determine antibody titers and that vaccination is the best guarantee of immunity. But neither of those premises are true.
For one, in this propaganda video, Offit begs the question by presuming that its safe for children to be vaccinated strictly according to the CDC’s schedule despite no long-term clinical studies ever having been done to determine the schedule’s safety.
For another, he characterizes the measles vaccine as conferring a long-lasting immunity even after antibody levels have waned while completely ignoring the known phenomenon of vaccine failure.
He tries to dissuade parents from doing a blood test to avoid vaccinating unnecessarily, but the reality is that parents who believe the second dose of measles vaccine may be unnecessary for their child are likely correct, given the CDC’s acknowledgment that the second dose is specifically intended to try to stimulate a protective antibody titer among those who didn’t seroconvert after the first dose.
The argument presented is that the lack of correlation between antibodies and immunity for some pathogens, including rotavirus and pertussis, means parents should forego blood testing and just get their children all the vaccine doses on the CDC’s schedule. But the more valid conclusion to be drawn from this lack of correlation is that, in order to get vaccines to market, the FDA colludes with the pharmaceutical industry in what is arguably scientific fraud.
Paul Offit and the Children’s Hospital of Philadelphia in this video aren’t presenting parents with the knowledge they need to know in order to make an informed choice about whether to vaccinate their children. Instead, they are issuing deceitful propaganda intended to manufacture consent for public vaccine policy, which isn’t too surprising given Offit and the hospital’s own partnership with the pharmaceutical industry.
This article was originally published at JeremyRHammond.com and has been republished here with permission.
Jeremy R. Hammond is an independent political analyst, publisher and editor of Foreign Policy Journal, author, and contributing writer for Children’s Health Defense. To stay updated with his independent journalism on vaccines, subscribe to his newsletter.
Food Additives Causing Harm, Reforms Urgently Needed, AAP Says
Today, more than 10 000 chemicals are allowed to be added to food and food contact materials in the United States, either directly or indirectly, under the 1958 Food Additives Amendment to the 1938 Federal Food, Drug, and Cosmetic Act (FFDCA) (public law number 85-929). Many of these were grandfathered in for use by the federal government before the 1958 amendment, and an estimated 1000 chemicals are used under a “generally recognized as safe” (GRAS) designation process without US Food and Drug Administration (FDA) approval.1 Yet, suggested in accumulating evidence from nonhuman laboratory and human epidemiological studies is that chemicals used in food and food contact materials may contribute to disease and disability.
Reproductive Toxicity and Vaccines
This memo and subsequent guidance spelled out the critical need to conduct preclinical studies in animal models to assess reproductive and developmental toxicity “prior to licensure of vaccines intended for maternal immunization and/or women of childbearing age”. However, the documents admitted that “lack of adverse effects on embryo/fetal development in an animal study does not necessarily imply absence of risk for humans.” Moreover, given the FDA’s emphasis that all of the recommendations included in its guidance are non-binding, the extent to which vaccine manufacturers choose to abide by them is largely unknown.
Overview: FDA is Still “Asleep at the Switch”
By Lyn Redwood, RN, MSN, Executive Director
On March 30th of this year, Robert F. Kennedy, Jr., and the Children’s Health Defense team met with the Director of the FDA’s Center for Biologics Evaluation and Research (CBER) Dr. Peter Marks, M.D., Ph.D. and his colleagues to discuss the agency’s ongoing refusal to ban thimerosal, a mercury-based preservative, from vaccines in the United States. CBER is the division of the FDA responsible for approving and monitoring the safety of all biological products, including vaccines, allergenic products, blood and blood products, and cellular, tissue, and gene therapies.
At the meeting, we presented a large amount of research showing the toxicity of thimerosal in humans, animals and cellular models, including at levels similar to those resulting from vaccine exposures. We expressed our alarm regarding the total lack of adequate safety testing of thimerosal prior to licensure, especially given its current use in vaccines approved for infants and pregnant women and its worldwide use in millions of vaccines given to children, particularly in developing countries. Dr. Marks promised to look over the studies and seriously consider our concerns.
Here is the correspondence that followed:
April 24, 2017: Lyn Redwood Letter to Peter Marks, FDA [PDF]
July 11, 2017: Peter Marks Letter to Lyn Redwood [PDF]
One FDA Hand Doesn’t Know What the Other FDA Hand is Doing
One FDA Hand Doesn’t Know What the Other FDA Hand is Doing
It seems ludicrous for one arm of the FDA, the Center for Drug Evaluation and Research (CDER), which regulates over-the-counter products to find that thimerosal and other mercury products are not generally recognized as safe and effective (GRASE) while CBER allows their widespread use in over 120 vaccines and other prescription products. In 1998, FDA issued final rules banning thimerosal and mercury product use in over-the-counter products. Our goal at Children’s Health Defense is to extend that ban to all use of mercury in medical products both in the United States and worldwide.
Vaccine Technology Outpacing Ability To Predict Adverse Events, FDAer Says
Advances in vaccine technology may be outpacing researchers’ ability to predict potential vaccine-related adverse events, Center for Biologics Evaluation & Research Viral Products Division Director Peter Patriarca, MD, said at a recent forum on immunization issues.
FOIA: Peter Patriarca – Asleep at the Switch Email
Peter Patriarca, an FDA employee, admitted back in 1999, in a confidential e-mail obtained through FOIA, that, “… the greatest point of vulnerability on this issue is that the systematic review of thimerosal in vaccines by the FDA could have been done years ago and on an ongoing basis as the childhood immunization schedule became more complex. The calculations done by FDA are not complex. I’m not sure if there will be an easy way out of the potential perception that the FDA, CDC and immunization policy bodies may have been “asleep at the switch” re: thimerosal until now”.
CDC & FDA Committee Members Have Financial Conflict of Interest with Vaccine Pharmaceuticals
A House Government Reform Committee staff report published this week criticized the FDA and the CDC for routinely allowing scientists with conflicts of interest to serve on two influential advisory committees that make recommendations on vaccine policy.