Newsguard tried a 2nd Gotcha. I replied.
Health Editor John Gregory came back again to inquire further:
On Jul 3, 2024, at 3:28 PM, John Gregory <john.gregory@newsguardtech.com> wrote:
Dr. Nass,
Thank you for the quick reply. Let me phrase my question a bit more simply and get a bit more clarification.
How is your claim that Audenz is a "deadly vaccine" supported by that FDA package insert, which you have admitted says that none of the 11 deaths among vaccine recipients were found to have been caused by Audenz? Are you saying that the FDA and the trial authors lied about deaths with a casual link to the vaccine, and if so, what evidence do you have to support that?
Thank you for your time.
I replied thusly:
When you perform a vaccine trial for the first time in humans, you rarely know which side effects might be caused by the vaccine. Human side effects cannot be predicted by animal studies, though sometimes some are. That is why you do trials, to figure out what the side effects are and how often they occur.
The trial (Study 3) described in the label (the only randomized controlled trial of Audenz) which I referenced included, from Table 2 1163 plus 1189 = 2,352 recipients of Audenz and 784 placebo recipients. During the observation period there were 11 deaths in the Audenz group and 1 in the placebo group.
If that is not a statistically significant difference (0.5% vs 0.1%), it is close, and ought to have necessitated further study before a license was issued. Which apparently was not done. Why? Perhaps you should ask the FDA and not me why a vaccine with this track record would be licensed in the absence of additional safety data.
Furthermore, note the high rate of serious, but unspecified, side effects in the children, on page 9 of the label: 2.5%. This is high compared to other trials of vaccines in children.
"Serious Adverse Events
A total of 8 (2%) children 6 months through 17 years of age in the safety population (N=326) experienced SAEs during the study. SAEs consisted of events typical for a pediatric population and were assessed as unrelated to study vaccine. No deaths were reported during the study."
The job of a regulator is to find out more when these red flags occur. The regulator instead brushed them under the rug in atypical fashion. There was smoke. FDA chose not to look and see if there was fire.
The Precautionary Principle in medicine asserts we must assume there is a problem until proven otherwise and resist the introduction of such products:
Best wishes,
Meryl Nass
Dr. Nass: I wrote him an email after the first Substack telling him I was anxiously awaiting his response to your comments about his erroneous claims. I told him that as a practicing physician I had never found you to be providing any “misinformation”. I reminded him that you had expertise int he area of Infectious Disease, and in fact, had been called to give testimony in Congress several times, was an expert in Anthrax, which had harmed our military and was once called by the Cuban government to assist in a rare tropical disease. I ended by telling him the next time he wanted to jump in the ring with an expert, he needed that second cup of coffee. 😄
So who decides that a death in the treatment group is unrelated to the treatment?