November 6, 2019

8: Post-Licensure Vaccine Safety

After a vaccine is approved by health authorities, how are they ensured to be safe? If there are complications, how is it recorded? Who is held responsible if issues arise?

8: Post-Licensure Vaccine Safety


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Alright, post-licensure Vaccine Safety, what happens in terms of monitoring the safety of a vaccine once it is licensed and put onto the market. Now, the World Health Organization have a clear view on this, and that is that spontaneous reporting is the cornerstone of most post-licensure safety monitoring system because of its relative ease of implementation, and the ability to capture unexpected events. Now, what does all of this mean? Once a vaccine is approved and licensed by the FDA in America recommended by the CDC's Advisory Committee on Immunization Practices, ACIT. And it is put on to the CDC's list of recommended vaccine. What happens in terms of safety followers? This relies exclusively upon what is called passive surveillance. That means that a doctor or a patient has to spontaneously recognize a vaccine-linked adverse reaction and report that. Active surveillance on the other hand is going out on a regular basis and systematically saying to all doctors giving vaccines, "Have you seen any of the following?"

In other words, actively following up. These two are very different for reasons that I'll go into it. Post licensure surveillance of vaccine safety is in the words of the World Health Organization, critical. Why? Because the conditions and reasons for safety monitoring change following the licensure and introduction of a new vaccine. For example, vaccines that are now in use in the general population and recipients are no longer monitored in closed clinical trials with narrow inclusion and exclusion criteria. For example, those trials would only have included entirely healthy individuals. Sub-populations commonly excluded in clinical trials for example, those with underlying medical conditions or preterm infants or pregnant women are now going to receive the vaccine.

Uncommon and rare reactions that might not have been picked up in a study that was the size of the pre-licensure study may be occurring and will only be picked up with this sort of system, at least that is the thinking. And reactions with a delayed onset may also not be associated with the vaccine in these trials, the early trials where they may monitor children or adults for two, three weeks, maybe a few days. So, a reaction occurring later is not deemed to be associated with the vaccine, and will only be picked up in these post-surveillance trials. What does this actually mean in the real world? If an adverse reaction occurs and it is associated with the vaccine either by the parent or the doctor. And in the case of the doctor whether they're willing to report that, as a potential adverse reaction, and whether parents or doctors know if where and how to report those, and indeed, whether the onset is sudden and obvious or insidious and therefore neither linked by the parent or the doctor to the vaccine. And all of these will limit the effectiveness of this reporting system. Now let's go to I-CANS, letter before action and effectively to the secretary of the health and human services saying, "Let's talk about these post-licensure surveillance vaccine safety studies." In the US, the lack of pre-licensure safety data leaves the assessment of vaccine safety to the post-licensing period, when they are being administered to children in the real world.

To capture Vaccine Adverse Events in the real world, the 1986 Act that we've discussed established the Vaccine Adverse Event Reporting System, VAERS, operated by Health and Human Services. However, only a tiny fraction of adverse vaccine events reported VAERS. An HSS funded study by Harvard Medical School Track, reporting the VAERS over a three-year period at Harvard Pilgrim Health Care, involving 715,000 patients and found that fewer than 1% of vaccine adverse events are actually reported. A US House report similarly stated from former FDA commissioner David A. Kessler, which estimated that VAERS reports currently represent only a fraction of the serious adverse events and a confidential study, conducted by Connell laboratories, a manufacturer indicated that a 50 fold under reporting of adverse events is likely. So whatever else is happening this system is not working.

How does that translate into numbers? In 2016 VAERS received over 59,000 reports of adverse reactions, including 423 deaths, 1091 permanent disabilities, 4132 hospitalizations, and 10,284 emergency room visits. What of the real numbers? Closer to 42,300 deaths, 109,000 permanent disabilities, 413,000 hospitalizations, and over a million emergency room visits. This is the real world, this is the world that is not being captured by the system. And there was one answer. It was proposed and acted upon. They created an electronic reporting system, and this was pioneered in collaboration with the CDC, sponsored by them to see if they made this systematic and simple, could they capture something much closer to the true rate of adverse reactions. In this preliminary data we collected from June 2006 through October 2009, on 715,000 patients, 1.4 million doses of 45 different vaccines were given to 376,452 individuals. There were 35,570 possible reactions. That's 2.6% of the vaccinations and the study confirmed that fewer than 1% of adverse events are reported.

They claimed in their report that the barriers to reporting, included the lack of clinician awareness. The doctors didn't know this system existed. There was uncertainty about when and what to report as well as the burdens of reporting. Reporting is not part of the clinician's usual workflow. It takes time and it's duplicative. Now, what that really means, I think, is that since physicians are not paid for recording these, it does not become part of their routine work. The report continued unfortunately there was never an opportunity to perform system performance assessment because the necessary CDC contacts were no longer available. And the CDC consultants responsible for receiving data were no longer responsive to our multiple requests to proceed with testing and evaluation. In other words, there was a simple system which worked, which captured a great deal more, if not the majority of true adverse events and the CDC did not want it to happen.

They cut off communication and it went away. Now let me give you a real world example of how the surveillance works and throws up a severe problem. This is in relation to the influence of vaccine. Firstly neither the seasonal influence of vaccine actually nor the pandemic H1N1 that you'll remember has ever been tested for safety, in pregnant women. The mercury preservative thimerosal, is in the majority, of these vaccines and represents a potential but unstudied danger, both to the pregnant woman and more specifically to the unborn child. Now in the 2009-10 flue season, the CDC recommended that pregnant women received two few vaccines, both the seasonal vaccine and the pandemic H1N1. And this has never happened before. Because the majority of the doses are both inactivated influenza vaccine formulations were preserved with thimerosal and other doses contained a reduced level of thimerosal. Using VAERS Dr Gary Goldman, a scientist who had historically collaborated with the CDC on safety assessments of the chicken pox vaccine asked the question, "Was there a synergistic toxicity associated with this two dose, this two influenza vaccine dose 2009-2010 season?" What he found is that in VAERS, there were 174 fetal death, or fetal demise reports for the 2009-2010 flu season compared with a mere 25 in the prior 2008-2009 and subsequent 2010-2011 flu seasons. This was a 4250% increase in fetal loss.

This then went before the CDC, and they took the data from VAERS and they applied this to looking at a study in what is called the vaccine safety data link. This is a database that's extremely valuable paid for by the public, but not available to the public to use for independent scientific inquiry. It is locked away. It is a CDC-secret database, but it holds the key to identifying many true adverse vaccine reactions. In this, they performed a study and showed that for fetal death following influenza vaccination a real and complex synergy was observed between serial flu vaccine exposures with an eight-fold increased risk of miscarriage supporting Goldman's original concerns. The authorities, the CDC only investigated this after safety activists pressured them into conducting an investigation. And despite finding this massive increase in fetal loss there is no blame. The advice to mothers is to carry on. In addition, the data on fetal deaths in the CDC Vaccine Safety datalink, this vaccine safety database that is concealed from the public could not be reconciled with reports to VAERS. Now doctors should by law report these cases to VAERS, but they were finding their way into the CDC's VST database, but not into the VAERS database.

There does not appear to have been reporting that may have indeed been deliberate under-reporting of these cases. Something that is typical and inherently part of the floor of the VAERS system. Passive surveillance of adverse events through spontaneous reporting doesn't work as it currently operates. It could work much better if automated as been seen by studies sponsored by the CDC, but there is an active desire or appears to be an active desire on the part of the scene just not to see this happen. Cases appeared to be deliberately under-reported, signals that are ignored and when the CDC is compelled to respond to independent scientific concerns generated from its own monitoring system. What is revealed is a major health risk associated with a completely untested vaccination policy.

So the exercise here is to review the World Health Organizations document, particularly this key point that spontaneous reporting is the cornerstone of most post-licensure safety monitoring system because of its relative ease of implementation, and the ability to capture unexpected adverse event. Cornerstone gives one sense a real sense of reassurance. Is that the real case? What part of this translates into the real world experience? Is it misleading? And please go away and read the data on influence of vaccination and pregnancy yourself.