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Paul Offit Unwittingly Exposes Scientific Fraud of FDA’s Vaccine Licensure

By Children's Health Defense | Collective Evolution

In Brief

  • The Facts:This article was written by By Jeremy R. Hammond, Contributing Writer, Children’s Health Defense.
  • Reflect On:Are vaccines as safe as they are marketed to be? Why has the mainstream and big health ridiculed and demonized those who question them instead of addressing and countering their points?

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.

… just because someone doesn’t have a protective level of antibodies doesn’t necessarily mean that they aren’t immune.

Offit’s Argument

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.

n 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.

n 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.


That it’s safe to vaccinate children according to the CDC’s schedule, by his reasoning, is merely assumed.

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.

… 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.

Vaccine Failure

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.

… 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.

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 diseaseInstead, 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.

[Read more here]

Robert O’Leary, JD BARA, has had an abiding interest in alternative health products & modalities since the early 1970’s & he has seen how they have made people go from lacking health to vibrant health. He became an attorney, singer-songwriter, martial artist & father along the way and brings that experience to his practice as a BioAcoustic Soundhealth Practitioner, under the tutelage of the award-winning founder of BioAcoustic Biology, Sharry Edwards, whose Institute of BioAcoustic Biology has now been serving clients for 30 years with a non-invasive & safe integrative modality that supports the body’s ability to self-heal using the power of the human voice. Robert brings this modality to serve clients in Greater Springfield, Massachusetts and New England (USA) & “virtually” the world. He can also be reached at romayasoundhealthandbeauty@gmail.

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