November 6, 2019

7: WHO and Vaccine Safety

How does the World Health Organization (WHO) approve and endorse a new vaccine? What safety studies are performed? How is vaccine safety monitored? Is it more or less strict than other pharmaceutical drugs?

7: WHO and Vaccine Safety


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In terms of introducing a new vaccination policy for the population, clearly, there are certain standards that have to be met, certain safety studies that have to be performed. So what I want to do is now look at that in the context of how it is perceived by official sources by, for example, the World Health Organization.

And before we do that, just a brief introduction to the way in which the measles vaccine came to be used in the United States of America. It's often said that the vaccine was introduced in 1963, and to some extent that's true, but it does not tell the whole story. In 1963, a killed measles vaccine was introduced. It was relatively rapidly realized that that vaccine didn't work, and in fact, rendered people susceptible to very severe measles subsequently and it was abandoned. At the same time in 1963, John Enders' Edmonston B vaccine was introduced, that was licensed. It's impossible to know how widely used it was, because these data are, as we're told, commercially sensitive and not given to us by the drug companies, but this vaccine was abandoned and it was abandoned because the Edmonston B strain was far too reactive, it produced very high fevers and was recommended to be given with measles immunoglobulin to ameliorate the side effects.

And this became a huge burden, expensive and cumbersome, and the vaccine did not enjoy necessarily widespread use. It was not until 1965 that the Schwarz strain came in, that was then run up against the Moraten strain made by Merck, which was licensed in 1968, and that is now the strain of measles virus as part of the measles, mumps rubella vaccine that is available to American children, having an exclusive market in this country.

Now, current perception and past reality for us in terms of vaccine safety basics and understanding come from this document, which is a manual for the World Health Organization for its aspiring vaccinologists, people who are trying to get into the system to become those who will administer and teach on vaccines worldwide. An instruction manual, in effect, the test for public health workers, which is used by the World Health Organization for training purposes. So not only will this document shape the perception of those health workers, and those with whom they communicate, in other words, provide informed consent about vaccine safety; but it becomes necessary to give the answers required by the World Health Organization in order to pass the test. In other words, if you do not tell the World Health Organization what it is they want to hear, whether it is true or not, you will not pass the test.

And this also happens in schools now in biology classes. And if you do not give them the answers that they want about how wonderful vaccines are and how the association between vaccines and adverse reactions like autism are a fraud, were all made up, are just coincidence, then you will fail that test. It becomes a self-selecting process for those who will go forward and succeed in that area. World Health Organization, we've seen before, says the impact of vaccination on the health of the world's people is hard to exaggerate, that it has been responsible for these dramatic declines in deaths and illness and led to population expansion.

That is a certainty that we have already put to the test and found wanting. They pre-suppose that the Food and Drug Administration in America, the Division of Biologics conducts tests on vaccines that are identical or similar to those for pharmaceuticals, other drugs for which prescriptions are required. They say, in general, biological products that are used to treat or prevent diseases, vaccines, like traditional drug products have to be thoroughly tested and shown to be safe and effective in order to enter into state commerce in the United States. In other words, there is an equivalence between vaccines and routine pharmaceuticals in as much that their safety testing is equivalent, whose perception is that vaccines are equivalent to these drugs requiring the same degree of vigilance as prescription medications.

But unlike prescription pharmaceuticals, vaccines are not given to sick people, they are given to all children in a one size fits all fashion, they involve the administration of toxic substances into healthy individuals, they frequently are administered by a different route, dose, strain, age, that from natural infection, and frequently administered in combination with compounds of known toxicity, like thimerosal. Also, they are they are frequently given in combination with other vaccines with known risks for interference between the components.

So in this series of lectures we'll be considering single vaccines given alone, combination vaccines and combination vaccines within the broader vaccine schedule, and look at the safety basics for those. The World Health Organization goes on to say that vaccines used in national immunization programs are safe and effective; however, like other pharmaceutical products, vaccines are not completely risk-free and adverse events will occasionally result from vaccination, so they are not safe for everybody. Before a drug comes to be licensed, before a vaccine comes to be licensed, there are certain studies that it must go through, pre-licensure safety studies, and the World Health Organization says vaccines, like other pharmaceuticals, undergo extensive safety testing and review for safety, immunogenicity and efficacy, that is their ability to protect in the laboratory, in animals and in three phases of clinical trials, in human subjects, before licensure.

Let's take a look at that. Let's take a look at the testing of measles vaccines in animals. Now, remember, the only animal model that we can use is the primate, because there is no sub-primate species that is susceptible to measles. So, World Health Organization recommendations to manufacture is they should use primates. No less than 10. It seems a very small number. The vaccine virus alone, not the rest of the vaccine, is injected not into the skin, but directly into the brain of these animals. They are observed for 17 to 21 days, and then they undergo a necropsy to look for microscopic inflammation in the brain.

Here's the problem. There are no controls, there are no animals that have their brains injected with saline as a control to see whether this is a non-specific reaction unrelated to the vaccine or not. If a death occurs within 24 hours you can replace the animal in the study, it's the animal's fault for dying, not the vaccine's fault for killing the animal, and if 20% or more animals die within 48 hours, you can scrap the entire study and repeat it. And this is bizarre, clearly utterly bizarre.

The World Health Organization go on to say that national regulatory authorities, like the CDC, like the FDA, are responsible to ensure the quality, safety and effectiveness of vaccines and other pharmaceutical products. Before their introduction into immunization programs, vaccines undergo several steps of evaluation to assess their safety and efficacy in clinical trial. After licensing, once introduced, vaccines, undergo very thorough and continuous reviews of their manufacturing process, and these national regulatory agencies continue to monitor and investigate adverse events following immunization to ensure that they are safe for the entire population.

Now, that sounds terribly reassuring. To anyone reading that, that is enormously reassuring. Does it happen in the real world? Well, the vaccine is now licensed and is being given to the entire population of children, but hang on, premature infants and pregnant women are specifically excluded from these safety trials, and yet flu vaccines and DPT vaccines are recommended for pregnant women. Premature infants are on exactly the same schedule as children who are born to term. So, this cannot be right.

The World Health Organization goes further. Students are further persuaded that not only are vaccines equivalent to pharmaceuticals, but that because the general public has a low tolerance to any adverse event following vaccination, because vaccines are given to healthy persons to prevent disease, a higher standard of safety is expected of immunizations compared with other medications that are used to treat people who are sick. This lower tolerance to risks from vaccines translates into a greater need to detect and investigate any adverse event following immunization than is generally expected for other pharmaceutical products.

In other words, this is laudable, this is wonderful, except it's not true. In the real world, the Vaccine Safety Review Committee of the Institute of Medicine that advises the government said this, "The Committee encountered many gaps and limitations in knowledge bearing directly and indirectly on the safety of vaccines and that if research capacity and accomplishment in this field are not improved, future reviews of vaccine safety will be similarly handicapped." That is not reassuring.

And so, the exercise here is the final statement of the Institute of Medicine, compatible with the WHO's didactic assurance to its students, is the primate testing adequate? Before moving into trials of children, should vaccines routinely be given to those in whom it has never been tested for safety? The World Health Organization's perception of the way in which vaccines are tested is described here: "Vaccines like other pharmaceutical products undergo extensive safety testing and review for safety, immunogenicity and efficacy in a laboratory in animals and in three phases of clinical trials in human subjects before licensure." In the last talk we discussed the animal trials that are used for measles vaccine. What about the pre-licensure clinical trials?

Well, these were published in the New England Journal of Medicine some years ago, and we have trial 1, in October 14th, 1958. Thirteen children, whose immunity to measles is unknown, at a state school for the mentally deficient. They had mongolism, microcephaly, spastic diplegia and other forms of cerebral palsy as described in the paper. It was operated by the Department of Mental Health of the Commonwealth of Massachusetts. The second study, 97 children, already half of whom were immune to measles, December 1958, susceptible children were selected from two institutions, Colorado State School for Children with Mental Retardation, and severe handicap from congenital abnormalities, and the National Jewish Hospital for Children requiring long-term in-patient therapy for chronic respiratory disease.

Trial number 3 in New Haven, Connecticut, nine children in a privately operated institution for the mentally retired. This seems to me to be somewhat extraordinary. In October 1950, a further trial by Enders' team was conducted on 1500 mentally retarded children, as they were described at the time, in New York City and on 4000 children in Nigeria.

Now, there are a number of major, major ethical concerns with using children who cannot say no and who are, one presumes, considered expendable. This was described in a book by Hornblum and Newman, Against Their Will, and they described this as "the utilitarian calculus of convenient self-interest and the chance of a grand scientific payoff." An extraordinary situation. There's a pragmatic issue as well, and that is if you are testing a vaccine for safety where you know that the measles virus is capable of causing brain inflammation and damage, you're already taking a group of children who have physiological, neurological, anatomical brain abnormalities and hoping to extrapolate from that group to normal children. Again, on both an ethical level and a practical level, this would seem a bizarre choice. And it is most certainly not how safety tests are conducted for prescription pharmaceuticals, especially in children.

So we have ICAN to thank for the next series of slides, the Informed Consent Action Network, under Del Bigtree, my producer on the film Vaxxed, and he writes in a letter before action to the head of Health and Human Services, the secretary of HHS, about the deficiencies in pre-licensure safety studies, and a review of pediatric vaccines. All drugs licensed by the FDA undergo long-term double-blind, pre-licensure clinical trials in which the rate of adverse reactions in the group receiving the drug under review is compared to the rate of adverse reaction in a group receiving an inert placebo, a placebo-controlled trial, and the placebo is a sugar pill or a saline injection, but not with vaccines.

Now, I'll just give you an example for the drug Enbrel, the pre-licensure safety trials followed subject for up to 18 months and controls received to a saline injection. Lipitor's pre-licensure safety trials lasted for a median of 4.8 years and controls received a sugar pill. And Botox pre-licensure trials lasted a median of 51 weeks and controls received a saline injection. This is the way in which trials should be conducted and even with these long-term follow-up studies, drugs are still recalled.

What about vaccines? In contrast, unlike other pharmaceutical products, vaccines are not required to undergo long-term double-blind inert placebo control trials to assess their safety, even though the World Health Organisation would have us believe that there is an even greater need to assess and monitor safety for vaccines given to healthy individuals than drugs given to patients who are sick. In fact, ICAN informs us, not a single one of the clinical trials for vaccines given to babies and toddlers had a control group receiving an inert placebo. Further, most pediatric vaccines currently on the market have been approved based upon studies with inadequate follow-up periods of only a few days or weeks.

For example, of the two hepatitis B vaccines licensed by the FDA for injection into one day-old babies Merck's was licensed after trials that solicited adverse reactions for only five days. If your child died on day 6, it was nothing to do with the vaccine. GlaxoSmithKline's hepatitis B vaccine was licensed after trials that solicited adverse reactions for only four days after vaccination. The Haemophilus influenzae b vaccines sold by these same companies were licensed based on trials which listed adverse reactions for three and four days respectively after vaccination and the only standalone polio vaccine was licensed after a mere 48-hour follow-up period.

And what about beyond the pre-licensing stage? This is a study which was presented to me as being the gold standard. This is a true and meaningful assessment of the true rate of adverse reactions to MMR. It was conducted by Dr. Peltola in Finland. Now, MMR was introduced in Finland in 1982, and it went over to a two-dose schedule of 14 months and six years, and this study was conducted some years later, between 1985 and 1986. It was an interesting study design. They took 581 twin pairs, these were fraternal twins or identical twins, between 14 months and six years of age.

They gave one twin the vaccine and they gave one twin the placebo, a saline injection. They followed them for three weeks with a parental diary card of adverse reactions and then the child who had not been vaccinated got the vaccine and the child who had been vaccinated got the placebo. It was randomized, so the parents did not realize nor did the doctors realize what they were getting. Elegant, the gold standard study or irrelevant? Irrelevant. Why? Because the great majority of children in this study had already suffered measles or had been vaccinated and the rest had no documentation to confirm whether they have been exposed to measles disease or not. There was no antibody testing of the groups to determine who was and who was not immune.

In other words, if you are already immune to measles, you have neutralizing antibodies, then vaccination is of little consequence, and your reaction cannot be considered the same as someone who had never seen measles before. So what do we take away from this study? We don't know.


So telling the truth about pre-licensure safety studies of measles vaccine meant that we would have failed the World Health Organization's test, we would not have graduated and we would not be let loose on the public and available to give informed consent. So with this knowledge as an exercise, please, take the World Health Organization's course and see if you would pass after these lectures.