NewsGuard fact-checked me today, providing the opportunity to clarify questions about the Audenz vaccine and the extremely high mortality rate in its small trial.
The big guns, the Health Editor, approached me this afternoon. Happy to learn the presentation is getting attention.
Below is the email I received and below that is my detailed reply.
On Jul 3, 2024, at 1:26 PM, John Gregory <john.gregory@newsguardtech.com> wrote:
Dr. Nass,
My name is John Gregory, health editor at NewsGuard. We're a news organization that reports on and tracks online misinformation.
I'm emailing in regards to your April 20, 2024, CHD video in which you cited the FDA package insert for the H5N1 vaccine Audenz, and said, "One in 200 people who got this vaccine in a clinical trial died," and later added, "This is a dangerous vaccine for a nothing disease.”
Video of your remarks has begun circulating widely on social media platforms in the past two weeks, used as evidence for claims like "Dr. Meryl Nass: One of the approved Bird Flu quackccines, Audenz… had a death rate of 1 in 200 during clinical trials.”
I noticed the screenshot included in your original video highlighted the sentence, "“Fatal SAEs [Serious Adverse Events] included 11 (0.5%) Audenz recipients and 1 (0.1%) placebo recipients," even though the very next sentence said, "“No SAEs were assessed as being related to Audenz,” meaning that none of the reported serious adverse events – including deaths – that occurred among trial participants were caused by the vaccine.
You also did not mention that the FDA's own statistical review of Audenz stated that, "No deaths occurred that were considered related to the vaccine,” and concluded, “No major statistical or safety issues have been identified” with the vaccine, or that the published results of the Audenz trial said:None of the serious AEs or AEs of special interest reported by subjects who received aH5N1c were considered vaccine related. Two subjects in the placebo group reported a related AE of special interest (immune thrombocytopenic purpura and polymyalgia rheumatic); these events were also considered serious AEs. During the study, 12 (0.4%) subjects had serious AEs with a fatal outcome, none of which were attributed to the study treatment, and most (n = 11) occurred after Day 43 during the follow-up period in subjects ≥65 years with underlying severe comorbidities and multiple concomitant medications.
Is there any reason why you did not mention any of this countervailing information?
My deadline is 5pm eastern today, July 3. Thank you.--
Best regards,
John Gregoryjohn.gregory@newsguardtech.com
Office: (312) 489-8676
More about NewsGuard criteria here.
Dear Mr. Gregory,
Since I provided a screenshot of the package insert of the Audenz licensed vaccine and repeated what it said, this can hardly be characterized as misinformation, which you claim to be investigating. Since I included the next sentence in the presentation, it cannot even be construed as incomplete.
Had you been working on issues of vaccines for over 25 years as I have, you would have been aware that the sponsor (mfr) and FDA, who together craft the vaccine labels aka package inserts, ALWAYS assert that most or all of the deaths and serious adverse events occurring during a clinical trial were adjudged to be not due to the vaccine. Had they judged otherwise, a license would probably not have been issued. A license was issued for Audenz.
Later, when a vaccine is given to millions of people, not just a few hundred as in this case, one learns which side effects are IN FACT attributable to the vaccine.
For example, at least a hundred million Americans had received an mRNA COVID vaccine before it was determined to cause myocarditis, in late May of 2021 by FDA.
That is the reason why the raw data, which I presented, are important. So that people have the information to judge for themselves what risks they may face when choosing vaccination. In fact, clinical trials often exclude sick subjects, and drugs and vaccines almost invariably appear more safe and effective in clinical trial data than they do later, in the real world—a fact known to all medical researchers.
Why did I not mention material from an article? Because I was referring to the Audenz label, which is the legal document that FDA attests is true, unlike published articles which are generally written by the vaccine sponsor and have a lesser degree of reliability. In fact, the numbers in the article versus those in the label are not exactly the same.
Furthermore, if the US government was comfortable with the H5N1 Audenz vaccine, why did DHHS’ BARDA just place an order with Moderna for H5N8 mRNA vaccines, even though the avian flu circulating in the US is H5N1? Even though it makes much more sense to match the neuraminidase portion of the vaccine to the circulating strain… which is done every year when seasonal influenza vaccines are produced?
Finally, I invite you to take a look at the WHO data on deaths in humans worldwide from the H5N1 bird flu, which confirms it is a nothing disease in humans, having mutated to a different form than it once had. The federal health agencies have monitored 9,000 farm workers and all they found were 4 mild cases of disease, no hospitalizations and no deaths in the US over the past several years.
I appreciate you giving me the opportunity to clarify the information so that your readers will be fully informed.
Meryl Nass
Bird flu is everywhere, so culling 97 million chickens, ducks and turkeys solves nothing—particularly since you can’t get the disease from eating the chicken, the eggs, drinking the milk or eating the meat. There are no cases of foodborne, H5N1 bird flu illness in the US. Or anywhere else.
So why are we doing all this? To create a fake serious disease where none existed —before we started aggressively seeking one?
The virus can be found using (presumably) accurate tests, but so what? Other diseases kill chickens or cause cows to be ill for awhile. Some of them very rarely spread to humans. We didn’t go mad about those diseases. Why this one? What if every cow and every chicken got it? A few would die and the rest would recover and most would probably gain immunity. What would be wrong with that?
I love your response to him.
keep 'em hopping, Dr. Nass! Thanks so much for all your labors!