Part 3: Vaccine Safety. Don't trust the WHO to get this right. Italian scientists show why using the WHO's algorithm to identify vaccine causality is a very bad idea

Many countries, including Italy, follow WHO guidelines on assigning vaccine causality for an injury. This must change.

In mid December, I wrote 2 articles about the assessment of vaccine safety. I promised a third article on assessing vaccine safety but it has taken me awhile to get back to the topic. The 2 articles were not terribly popular. The first only garnered 9 comments. The second did somewhat better.

In it, I evaluated an important opinion article in the New England Journal of Medicine on evaluating vaccine safety. It was authored by 4 famous vaccine scientists, and it purported to be about funding studies of safety for vaccines that had been authorized (not licensed)—like some COVID vaccines and other vaccines for emergencies, like bird flu vaccines. Here is my December analysis with links to the NEJM article:

https://merylnass.substack.com/p/part-2-on-the-evaluation-of-vaccine

The NEJM article was sneakily bad for several reasons.

• First, although the authors allegedly were interested in vaccine safety, their solutions would have greatly benefited the vaccine industry and greatly harmed consumers, taking money from excise taxes on vaccines, which was intended to compensate those injured by them, and giving it to government to conduct studies or to vaccine safety scientists like themselves.

• Second, the article was probably intended to provide support for rolling out untested EUA vaccines in future, under the promise that they will be tested after authorization, and that is good enough.

• Third, the authors misrepresented the state of vaccine safety science, claiming that it was critical to know the mechanism of a vaccine injury. Yet they admitted it is almost never possible to be sure of the mechanism. So, if you need to know the mechanism in order to assign blame for an injury to a vaccine, but we almost never know it, you will almost never be able to identify vaccine injuries as being caused by vaccines

So, how DO you ascertain what the side effects are of a new vaccine? What information should you collect? An EUA (authorized) vaccine does not have a label (aka a package insert). It only has a Fact Sheet, which may or may not identify side effects, because legally if side effects are not yet known, if no clinical trial has been conducted, the vaccine can still be used. Because it is for an emergency. It is a legalized experiment. And you cannot sue anyone if injured.

Let me again emphasize that the 2005 Prep Act created a GRAY AREA between the use of drugs and vaccines that are fully licensed following extensive testing, and clinical trials, for which nothing may be known about the medical product.

Congress passed the EUA mechanism (the PREP Act) because it had been scared by the anthrax letters (remember, one of the Senate office buildings was closed for 3 months and cost a king’s ransom to remediate) and then the 2004 bird flu scare came close on its heels. So Congress created this loophole so that experimental products could be used—but only for emergencies involving very severe illness or death. OR POTENTIAL EMERGENCIES.

And you can fly a planet through that loophole. Children are still receiving COVID shots under an EUA. Today.

So, we have a vaccine candidate and I want to know what the side effects are. But does the government want to know? If the vaccine was authorized under the PREP Act, the government must pay for damages under the Countermeasures Injury Compensation Program. The government (HHS Secretary) must specify the injuries so HHS staff can decide which applicants were injured by the vaccine.

https://www.hrsa.gov/cicp/cicp-data

As of December 1, of 13,555 claims of injuries from COVID countermeasures (the vast majority vaccine claims), only 3,497 claims had been adjudicated, only 65 (1.9%) were determined in the claimant’s favor, and only 20 (0.57%) had received a payment. One reason for this is that most injuries caused by the COVID vaccine have not been acknowledged by government agencies as vaccine injuries. See how much money and aggravation they saved themselves?

Basically, only anaphylaxis and myocarditis have been accepted as actual injuries due to COVID vaccines. You could not hide these two because they happened so quickly after a shot: generally within minutes to hours for anaphylaxis and symptoms develop within 4 days for myocarditis. (Or at least for those cases that were symptomatic.) But vaccine reactions can take weeks or months before presenting themselves.

Here is what you are supposed to do, if you are serious about teasing out what side effects are caused by a vaccine. First, you collect data, without making any determination whether the adverse event might be causal. What did people complain of? When? Did they have the same reaction after another dose of the same shot?

As I noted in December, the method involves asking a lot of questions, as first identified by Austin Bradford Hill. I won’t go into the fine details, as I would bore you, but the questions below are very important, and they determine the strength of the evidence that a reaction was due to a vaccine:

Now, if you don’t want to find that a vaccine caused a certain adverse event, you bypass this process and use a different one that is less likely to identify vaccine causation.

That is what the WHO did. Create something complicated, in this case a 72 page manual; make the assignment of causality seem very difficult; and keep collecting donations from pharmaceutical companies and Bill Gates.

But it isn’t really that complicated, so in the end you can boil the questions down to about 1.5 pages:

But you focus on the wrong questions, emphasizing that maybe there was a problem with the administration of the vaccine, not the vaccine itself. Finally, you follow a simple algorithm that instructs you that in almost every case, it wasn’t the vaccine, since you have not collected all the other supporting data that Hill needed for a proper assessment:

And most countries use this method and so vaccines are safe, really safe. The literature is consistent. The doctors are convinced. Everyone makes money.

Fortunately, a group of Italian scientists said, “Wait a minute.” This is a flawed methodology, and it is especially bad when evaluating the COVID vaccines.

https://pmc.ncbi.nlm.nih.gov/articles/PMC11642405/

They took that WHO algorithm, and they tore it to shreds.

Which is what we need to do with all the vaccine science. Put it under a microscope. So much of it is irreparably flawed. Maybe with RFK, Jr. at the helm of HHS we can piece together the honest science, figure out what we really know and what we don’t know. And turn medical science and healthcare around, working for the people.