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Aaron Siri

@AaronSiriSG

Jul 1

My written testimony to Congress prior to testifying last week (full version with footnotes available at ):

Dear Chairman Massie,

Thank you for the invitation to testify before the House Judiciary Subcommittee ... in the hearing titled, Follow the Science?: Oversight of the Biden Covid-19 Administrative State Response.

Our firm’s vaccine practice, which spans vaccine injury, exemptions, and policy, has over forty professionals. In our lawsuits, we must prove claims regarding these products with government and high impact journal data and sources. Appeals to credentials do not suffice.

Please find below a few points regarding Covid-19 vaccines we believe provide a broader framework in which to consider the administrative state’s actions regarding these products. While these points may conflict with the cultural cognition of some, based on our experience, they reflect the best available evidence.judiciary.house.gov/sites/evo-subs…

1. Covid-19 Vaccine Trials Were Robust When Compared with Other Vaccine Trials

The pivotal trials relied upon to license Covid-19 vaccines were robust as compared to the trials relied upon to license most childhood vaccines.

The following chart compares the pivotal trials for Pfizer and Moderna’s Covid-19 vaccines with those for FDA licensed vaccines that CDC recommends be injected (three times each) between birth and six months of age:

The above data is easily confirmed by reviewing the source material on FDA’s website for each product. For example, below is a screenshot of Section 6.1 of the package insert for the Hep-B vaccine in the chart above:

The trial reports submitted to FDA to license this Hep-B vaccine (obtained via FOIA) also confirm it was licensed for infants based on a trial with 147 infants and children and 5 days of safety monitoring after injection. FDA is also over three years late in substantively responding to a petition regarding this patently invalid trial.

As another example, Prevnar 13 was licensed for babies based on a trial in which Prevnar was used as a control:

In turn, Prevnar was licensed based on a trial in which another experimental vaccine, an “Investigational meningococcal group C conjugate vaccine,” was used as a control:

A chart of each vaccine licensed by FDA on CDC’s childhood schedule, along with the control, safety review period, and link to FDA source for each, is available at . This chart reflects that none of the vaccines on CDC’s childhood schedule were licensed by FDA based on a long-term placebo-controlled trial and most were licensed based on days or weeks of safety follow up after injection. Hence, in comparison with the trials relied upon to license childhood vaccines, the trials for Covid-19 vaccines were robust.

(See Section 2 in next tweet below)icandecide.org/no-placebo

2.Covid-19 Vaccine Trials Anemic When Compared to Drug Trials

While Covid-19 vaccine trials were robust as compared to trials for vaccines on the CDC childhood schedule, they were anemic as compared to trials for most drugs.

The table below (left) lists Pfizer’s top five selling products, according to one publication. The four drugs listed were each licensed based on a long-term placebo-controlled trial – the one vaccine listed, Prevnar 13, was not. The table below (right) again lists FDA licensed vaccines CDC recommends be injected (three times each) between birth and six months.

Clinical trials are critical for assuring safety. After a vaccine is licensed, it is considered unethical to conduct a placebo-controlled trial. Yet, while drugs are typically licensed based on long-term placebo-controlled trials, this is not true of FDA licensed vaccines on CDC’s childhood schedule. (It is also noted that when another vaccine was used as a control, that “control” vaccine was also not licensed based on a long-term placebo-controlled trial. )

This provides further context for the trials relied upon to license Covid-19 vaccines. While these trials were robust when compared to other vaccines, they are anemic when compared to trials relied upon to license drug products.

(See Section 3 in next tweet below)

Read 9 tweets

Aaron Siri

@AaronSiriSG

Feb 19, 2023

Covid-19 mRNA vaccines are “vaccines.” Like it or not, mRNA vaccines are no less a vaccine than other vaccines. For everyone sending me friendly messages such as “STOP CALLING THEM A F--ING VACCINE,” I have bad news: Covid-19 vaccines are “vaccines.”
aaronsiri.substack.com/p/mrna-vaccine…

Let me suggest reading the Substack article first before commenting. The entire point of publishing this article was to address many of these comments all at once. Thanks!

CAUTION: this tweet requires reading the article attached to it.

Read 7 tweets

Aaron Siri

@AaronSiriSG

Jan 29, 2023

1/5 Pfizer's Prevnar-13 vaccine licensed based on clinical trial comparing it to Pfizer's Prevnar-7 vaccine.

And Prevnar-7 was licensed based on clinical trial comparing it to another experimental vaccine. (I can't make this stuff up, see sources below.)

2/5 Prevnar-13 trial found:

"Serious adverse events reported following vaccination in infants and toddlers occurred in 8.2% among Prevnar 13 recipients and 7.2% among Prevnar 7 recipients."

Meaning, equally safe by FDA standards. But equally unsafe by any other standard.

3/5 "Serious adverse event" means something very serious like death, life threatening, hospitalization, disability, birth defect, or medical or surgical intervention to prevent permanent harm. fda.gov/safety/reporti…

Read 5 tweets

Aaron Siri

@AaronSiriSG

Jan 24, 2023

1/5 If you think it’s an outrage Congress gave pharma financial immunity for harms from C19 vaccines, you should be absolutely incensed Congress gave financial immunity for harms from childhood vaccines. Truly, you should be.

2/5 For virtually all consumer products, you can sue for harms. That threat is what drives their safety. But, of ALL products, you can't sue for harms caused by products injected into babies and infants dozens of times?!

3/5 Eliminating the market force that assures safety by neutering product liability and class action attorneys from being able to sue for childhood vaccine injuries is insane. Think about it. It leaves no monied interest pushing back against pharma regarding vaccine safety.

Read 5 tweets

Aaron Siri

@AaronSiriSG

Jan 11, 2023

1/4 Responding to 100s of comments about mandates sent to me:

The safety valve for the human errors, mistakes, and conflicts attendant with the development, trial, licensure, and sale of any medical product is the ability to say no without penalty.

2/4 There may not currently be a medical product you are mandated to receive that you do not want, but the day may come when there is a mandated medical product you don't think appropriate for you or your loved one. Then what will you do?

3/4 Power ceded to the government is difficult to recapture. Ceding to the gov't the right to dictate what is injected into your body is a grave error. It creates a ready path to profit for a very powerful industry that already enjoys immunity to financial liability for injury.

Read 4 tweets

Aaron Siri

@AaronSiriSG

Jan 9, 2023

1/4. Pfizer's website for its C19 vaccine tells patients to advise their vaccination provider if they have any of the following medical conditions. I wonder how many vaccine providers ever bother asking about these before injecting.

Without ado, in Pfizer's own words:

2/4.

"Tell your vaccination provider about all of your medical conditions, including if you:

- have any allergies

- have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)

- have a fever

3/4.

- have a bleeding disorder or are on a blood thinner

- are immunocompromised or are on a medicine that affects your immune system

- are pregnant or plan to become pregnant

- are breastfeeding

- have received another COVID-19 vaccine

Read 4 tweets

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