November 8, 2019

10: Efficacy and Safety

Manufacturers of vaccines attempt to provide an immunity that parallels the immunity that follows natural infection, but what happens when the vaccine doesn’t provide this immunity? Are the drug manufacturers culpable in a fraud that used a flawed testing methodology?

10: Efficacy and Safety

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Transcript

I'd like to talk now about vaccine efficacy and problems associated with vaccine efficacy. Now, what is meant by that? This is the effectiveness of a vaccine at inducing immunity that protects against the target disease, such as measles or mumps. And it is a measure of the proportion or the percentage of individuals given the vaccine who are subsequently protected, so the protection amongst those vaccinated. It's a measure not only of the number who produce antibodies, but the duration of the protective antibody response, and something that's not usually considered is the nature or the characteristic of that protection. I will come to that in a later lecture. How is efficacy perceived by the World Health Organization? Key point, vaccines stimulate the immune system to develop long-lasting immunity against antigens, proteins to which the immune system reacts from specific pathogens, such as measles. Well, do they? We'll look at that. The second key point is that, immunization triggers an immune system response by which the vaccinee develops long-term protection, immunity, that would normally follow recovery from many naturally occurring infections. Another question, natural infections and vaccines produce very similar results, immunity, do they? Let's look at that.

The World Health Organization again, says that vaccine manufacturers strive to develop vaccines that are effective in preventing or reducing severity of the disease, they provide durable long-term protection against the disease. They achieve immunity with a minimal number of doses and they cause no or mild adverse events. WHO would have us believe that that is what the manufacturer strives for. Well, do they? You see, the problem if these assurances are not true, is that a vaccine that does not work, is not efficacious, is dangerous. Why? Because with vaccination, if in contrast, having the vaccine, rather than experiencing the natural infection, leads to imperfect immunity, then this will in turn lead to susceptibility to the disease again, at ages when the natural disease may be more dangerous.

We've seen that with the measles virus. We've seen examples of this for measles. I want to show you an example now for mumps, a real-world example with mumps. Merck, we have a problem. Mumps is a trivial disease in childhood; indeed, it was deemed that a vaccine was never necessary. In the UK there was no need for a mumps vaccine at all, it was a mild childhood disease that had so little adverse consequences in the long term in terms of morbidity or mortality that it was not deemed necessary. And the same with the United States of America.

Mumps, however, is not a trivial disease after puberty. In post-pubertal males, it can produce testicular inflammation and sterility. What happened was, in the face of universal mumps vaccination, there were repeated large and severe outbreaks of mumps in highly vaccinated populations, that is school-age populations and college populations, where they had received two to three to four doses of the mumps vaccine, yet they were still developing mumps. On the product insert from Merck, which has the exclusive license for mumps vaccine in the United States, it claims 95% to 96% efficacy or protection. That was clearly not the case, it was very much lower.

And the FDA went to Merck, apparently, and said to them, either you prove that what you say on your product insert is correct, or you lose your license. Now, if you lose your license for mumps, and you have a monopoly on MMR in the United States, then you lose your license for MMR, and that is a big market. How did this play out? Merck thought they had found a solution. And the story of that solution will play out in Federal Court in Pennsylvania later this year, where scientists from the Merck laboratory acting as whistle-blowers against the company have reported what appears to be clear evidence of scientific fraud.

The allegations were that the fraud had occurred on multiple levels. First of all, Merck were charged with testing the efficacy of their antibody against the wild-type or natural mumps virus. Now, this is obvious, this is the virus that you want children to be protected against in the community by your vaccine. But it didn't work and so, they substituted in the test the weakened vaccine virus instead of the natural virus. The problem? It still didn't work. Once they tested the efficacy against the vaccine virus, it didn't produce what they needed. They then decided to rig the test, to rig the test with something completely non-specific, adding something to the blood sample in the tube to produce a positive result artificially.

And this was rabbit's blood, they added rabbit's blood, it had nothing whatsoever to do with protection against mumps in children or indeed rabbits. It was just a laboratory artifact. It still didn't work. Why? Because the way in which you test the efficacy of a vaccine... Let's say you take 100 babies who have never experienced mumps in any form, you take a blood sample, you then give them the mumps vaccine and six weeks later you take a second blood sample.

What you want to see is no antibodies in the first sample, protective antibodies in the second sample, that is sero conversion. And the problem with the rabbit's blood is because it was entirely non-specific, it produced positive results in both the pre-serum and the post-serum. Both were positive, so there could be no sero conversion, it had failed. So, despite fraud on multiple levels, they had failed and at that stage, they called their scientists in and asked them simply to change the offending data. The scientists who filed the case in Federal Court refused, they said, "This is fraud, we will not do this," and subsequently filed the case against Merck.

So, while we await the outcome of that court case perhaps later this year, let's look at what the World Health Organization say about manufacturers. Once again, manufacturers strive to develop vaccines that are effective in preventing or reducing the severity of the disease. That clearly was not the case with Merck and mumps, to provide durable long-term protection against the disease. No, they didn't, they had a vaccine that was producing grossly sub-optimal protection rendering people susceptible to this disease, again, later in life, that they would achieve immunity with a minimal number of doses. What an open-ended point that is, because they couldn't achieve immunity.

It kept waning and therefore they kept having to boost. So the only answer to this was to keep giving dose after dose after dose of the mumps vaccine, even though it didn't work. Now, this extraordinary ironic situation that the mumps vaccine was a huge market success precisely because it didn't work and caused no or mild adverse events. And this is extremely important to understand, because as I said at the beginning, a vaccine that doesn't work, it doesn't produce lasting immunity will render you susceptible to the disease when it is much more serious, as is the case with mumps. And so, a vaccine that doesn't work is a dangerous vaccine.

So, do they? A word of caution, it has been suggested that the best metric in measles for measuring vaccine effectiveness is morbidity, that is reported number of cases and not mortality. I just want to reflect upon this graph, because this sort of thing is often shown. We have the epidemic pattern of measles virus troughing and peaking before the introduction of the vaccine, which is labeled here as 1963. Beyond that, we see this precipitous fall in the number of cases to a baseline level.

Firstly, this kind of graph does not show the overall picture in terms of measles cases that I've shown you before. The other thing to bear in mind is that even though measles vaccine was licensed in 1963, it wasn't as straightforward as that. First of all, a killed vaccine, a killed measles vaccine was licensed first, that was found to be dangerous, it rendered people incompletely immune, and led to them developing a severe atypical form of measles when they were subsequently exposed and it was withdrawn. The other vaccine that was licensed in 1963 was the Edmonston B vaccine, and you will remember that that was so reactogenic, produced such high temperatures, that it had to be given, it was recommended to be given with immune globulin, measles immune globulin. Now, that became very cumbersome, very expensive and eventually that vaccine was removed from the market. It's impossible to know how many numbers of vaccines were distributed, because these are called commercially sensitive data, but it was not until 1965 that the Schwarz vaccine was introduced and later in '68, the Moraten vaccine. And clearly, this is well after the decline in the number of cases of measles.

This graph is perhaps more accurate in terms of representing what happened and I think what you get the sense of here is, there was a downward trend in the number of reported cases in advance of the vaccine being introduced. Now, as I say, this doesn't mean that there weren't cases of exposure and infection in individuals, it just that because the disease was becoming milder, fewer and fewer of those cases were being reported to the authorities as measles, because they were so mild. This is seen again in this graph; in green you see the data from Mexico, you see a clear downward trend in the number of cases of measles being reported prior to the introduction of the vaccination.

So, this pattern is repeated around the world, once again reflecting the fact that measles I believe was becoming a milder and milder disease over time. So the exercise here is to consider the extent to which the World Health Organization's assurances reflect real-world experience. Please follow the Merck whistleblower case in Federal Court in Pennsylvania and consider where we stand. If for example, other live viral vaccines in addition to mumps, say measles and chickenpox, are measured in Merck's laboratories in the same apparently flawed way, where do we stand in terms of our belief in levels of immunity and effectiveness of immunity with those vaccines in that case?