ICWA Weekly News 11-21-23
Avoid the rush - give before Giving Tuesday; Paul Marik on the radio show; finally, concerns emerge about combining COVID-19 and flu shots; and additional concerns emerge about hidden VAERS data.
By Gerald Braude
In this issue:
Giving Tuesday – a request from the hard-working volunteers with Informed Choice Washington
Radio show links from Health Hour with Paul Marik, M.D., and Liberty Hour with Prof. Murray Sabrin
Emerging information emphasizes concerns with combining COVID-19 and flu shots
Has VAERS captured all cases of Pulmonary Hypertension after the COVID-19 Shots? The British Medical Journal finds problems with the U.S. injury reporting system.
A quick message to our valuable readers and ICWA members:
We know your time is dear and your inboxes are deep, so for Giving Tuesday--one of our most important annual fundraising periods--we will be sending only two sincere donation requests as part of this issue and the next Weekly News mailing.
Informed Choice Washington receives appreciation and high regard for our efforts and communications. We actively monitor and report on Washington State public health agency and legislative proceedings, proposing good policy and calling out the bad. We strive to send timely alerts and to encourage action. We aim to provide you with deeper insight into these activities that support or threaten your right to informed consent.
ICWA is primarily volunteer-operated, and we need financial donations to carry out our efforts. We get the word out using our email platform, via our website, and on our weekly radio show on 1150 KKNW. These tools cost money. Our work is possible only with your belief in our mission and your generous financial backing.
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Please accept our sincerest gratitude as we continue this fight together. At this time of Thanksgiving, we are thankful for YOU!
And now for the news . . .
November 19 Episode of An Informed Life Radio - Links
Reversing Diabetes
Guest: Dr. Paul Marik, M.D. has been one of the leading voices for the medical freedom movement from the time COVID-19 hit the mainstream press. He is often associated with the topic of repurposed drugs and other alternative treatment options. Much less widely known, however, is this doctor’s personal health journey. On ‘Informed Life Radio’ this week, Dr. Marik talks about how lifestyle changes have contributed to reversing disease without prescribed medications in his own fight against diabetes.
Website: FLCCC | Front Line COVID-19 Critical Care Alliance (covid19criticalcare.com)
Substack articles: The FLCCC Alliance Community | Substack
Recent Book: Cancer Care: The Role of Repurposed Drugs and Metabolic Interventions in Treating Cancer by Marik, Paul
Incentivizing Wellcare
Liberty Hour Replay on X Liberty Hour Replay on Facebook
Guest: Professor Murray Sabrin discusses the "misaligned incentives” that now drive a system of “Sickcare” and proposed solutions for re-aligning incentives to “Wellcare."
Emerging Studies Raise Concerns about Co-administering COVID-19 and Flu Shots
Last month, ICWA Weekly News ran a series of stories on the Washington Department of Health’s (DOH) inability to substantiate its claims that it is safe and effective to co-administer the COVID-19, flu, and RSV shots.
One of the reasons the stories needed to be written was this Question from the DOH newsletter, repeated here due of its growing absurdity:
The DOH asked “Can the updated 2023-2024 COVID-19 vaccines be co-administered with other vaccines?” and started their self-written answer with “Yes. Clinical data has shown…”
Well, we’re listening! The DOH has continually failed to provide any “clinical data” with their references even though they’ve had many opportunities to clear the record.
In their next newsletter, the DOH still promoted combining shots with the following headline:
PROMOTING UPTAKE OF COVID-19, INFLUENZA, AND RSV VACCINES FOR FALL 2023 – WA DOH Newsletter
They imply this mixture as a time for celebration while reminding us it’s the first time they’ve been available, which should bring caution:
Fall 2023 marks the first time that vaccines for three respiratory illnesses - COVID-19, seasonal influenza, and respiratory syncytial virus (RSV) - will be available simultaneously. If taken, these vaccines can mitigate increases in cases, hospitalizations, and deaths that could strain the healthcare system, negatively impact the economy, and add to stress for individuals and families over the coming months.
This point in the newsletter would have been the right time for the DOH to provide the efficacy and safety data for this mixture. Instead, through the National Academies’ Societal Experts Action Network (SEAN), the DOH promoted co-administration even more:
We are happy to share the most recent rapid expert consultation from the National Academies' Societal Experts Action Network (SEAN). The rapid expert consultation, Promoting Uptake of COVID-19, Influenza, and RSV Vaccines for Fall 2023, addresses communication strategies and practical strategies for overcoming accessibility challenges to promote uptake of the COVID-19, flu, and RSV vaccines this fall.
This reference was another opportunity where they could have provided safety and efficacy data when co-administering these shots.
Following the thread further, the SEAN page discusses promotion and administration strategies:
ABOUT THIS RAPID EXPERT CONSULTATION State, tribal, local, and territorial authorities can be instrumental in promoting these vaccines. This rapid expert consultation describes vaccination strategies for fall 2023 that are based on current research in science communication, decision making, sociology, anthropology, and social psychology.
They have sections that address:
Key communication strategies
Using data to highlight susceptibility to infection
Using trusted messengers
No Data.
The DOH could have again provided co-administration data during their October 24th COVID-19 and RSV Vaccine Updates Webinar. Slide 10 promoted co-administration and came with references to other sites.
This slide is concerning: by itself, it mentions no limits for how many shots can be co-administered, and will possibly be interpreted by providers that it’s okay for COVID-19/RSV/Flu shots during the same visit for other childhood shots - another untested scenario.
For a moment, there was hope that the link to the CDC’s General Best Practice Guidelines for Immunization would finally have some data or study references. Looking at the Guideline section for simultaneous shots and searching for text like COVID-19 and RSV yielded no information on co-administration of the specific shots being touted by our DOH.
Then we looked at the Health Alert Network (HAN) for any guidance or data. The guidance is:
Healthcare providers can co-administer the vaccines for which a patient is eligible in the same visit, including RSV, COVID-19, and influenza vaccines…
To recap: so much finger pointing and no study citations. Clicking on other references and links on the HAN site failed to turn up any co-administration data.
So, during the Oct. 24th lunchtime Vaccine Update by the DOH, ICWA vice-president Bob Runnells took the opportunity to ask the presenters for co-administration data in the Zoom Q&A window. They responded with the same link to the CDC site on General Guidelines. He then pointed out that the site had no data or studies on combined shots. There was no further answer, even during the live Q&A session at the end of the webinar when numerous other questions in the Q&A chat were answered.
The November 1 issue of ICWA Weekly News covered Dr. Francis Bell’s recommendations on this matter during that same October 24 webinar. He said the following about mixing the RSV shots designed for those sixty and over with COVID-19 shots:
Co-administration with other vaccines that might be due, in particular flu and COVID, is considered acceptable. This should be discussed with your patient. Some patients will want them one at a time, and that’s totally fine. But if we are worried that the patient may not come back, then this is the time to seize the opportunity, for it’s okay to give all three together.
Bell spoke highly of the Morbidity and Mortality Weekly Reports (MMWR) as his source and referred the webinar’s participants to the following link:
But this one MMWR article only states that “evidence is mixed” and “Data are lacking on the safety” for mixing shots in older adults:
Administering RSV vaccine with one or more other vaccines at the same visit might increase local or systemic reactogenicity. Data are only available for coadministration of RSV and influenza vaccines, and evidence is mixed regarding increased reactogenicity. Data are lacking on the safety of coadministration with other vaccines that might be recommended for persons in this age group, such as COVID-19 vaccines; pneumococcal vaccines; adult tetanus, diphtheria, and pertussis vaccines; and the recombinant zoster vaccine (the recombinant zoster vaccine and GSK’s RSV vaccine contains the same adjuvant).
This month, data on the safety of co-administering the COVID-19 shots with flu and RSV shots has emerged, but it works against the DOH’s promotion.
In the November 2 issue of the Vaccine Reaction published an article about a study that found an increased risk of stroke in the elderly after mixing the COVID-19 and high-dose Adjuvanted influenza shots.
The study’s secondary analysis found that of those Medicare eligible patients who received both COVID shots and an influenza vaccine, there was a 20 percent increase in the risk of ischemic stroke with the bivalent WT/OMI BA.4/BA.5 shot, and a 35 percent increased risk of transient ischemic stroke after the bivalent Spikevax shot.
Even though the bivalent shots are no longer available in the United States, the above article and study leads one to continue to question the safety of mixing flu and RSV shots with the current COVID-19 2023-24 booster XBB1.5, which according to Dr. Ryan Cole, during his Veteran’s Day presentation at the Florida COVID-19 Summit at the 4:14 mark in the Epoch TV video, is an expired shot because the variant is now extinct.
Furthermore, the November 16 episode of “Facts Matter” on Epoch TV with Roman Balmakov discussed the campaign across the United States called “Two Vaccines, One Visit,” encouraging people to get the COVID-19 booster and the flu shot at the same time.
Balmakov cited a growing body of research showing the risk of stroke after taking these shots are administered together. From Medicare data, he said:
For people who received the Pfizer jab with an influenza shot, an elevated risk of non-hemorrhagic stroke was detected. For people who received a Moderna with an influenza shot an elevated risk of transient ischemic attack was detected.
Our study did find an elevated risk of stroke when the COVID-19 bivalent vaccines were administered with a concomitant high-dose/adjuvanted influenza vaccine. However, the observed effects were not consistent.
While not definite, the results are concerning. And foreshadowing. A week-and-a-half after his analysis, Kaiser Permanente issued a their own report concluding with:
An increased risk (of stroke) for people under sixty-five was found for people who received the Pfizer-BioNTech COVID-19 vaccine and a flu shot on the same day.
Digging into the results section of the paper, Balmakov notes:
With 4,933 cases, we found no increased risk within 21-day risk interval across vaccines and by subgroups. However, an elevated risk emerged within 42-day risk interval among individuals under the age of sixty-five years old who received co-administration of Pfizer-BioNTech COVID-19 bivalent vaccine and influenza vaccine on the same day.
Balmakov was also able to cite reports from Australian researchers in September:
More adults reported adverse events after receiving Pfizer’s vaccine and a seasonal inactivated influenza vaccine together than after receiving either vaccine alone.
From his deeper research, he said “It should be mentioned that this association between stroke and vaccination is not a new discovery.” Balmakov referenced a British Medical Journal/Yale preprint from October 10th, 2023 titled Evaluation of Stroke Risk Following COVID-19 mRNA Bivalent Vaccines Among U.S. Adults Aged ≥65 Years which looked at FDA and CDC data from late 2022.
Following the updated and use of the updated (bivalent) COVID-19 vaccines, CDC’s Vaccine Safety Datalink, a near real-time surveillance system, met the statistical criteria to prompt additional investigation into whether there was a safety concern for ischemic stroke in people ages 65 and older who received the (Pfizer bivalent vaccine). A rapid-response investigation of the signal in the Vaccine Safety Datalink system raised a question of whether people 65 and older who have received the Pfizer-BioNTech COVID-19 vaccine were more likely to have an ischemic stroke in the 21 days following vaccination compared with days 22 to 44 following vaccination.
Balmakov also pointed to an October 26, 2023 article (two days after the DOH’s vaccine webinar) by CNN in which Dr. William Schaffner, an infectious disease expert at Vanderbilt University, said people who are worried could consider getting each shot at different times rather than together. “That’s a reasonable thing to do,” he said.
In this article, Dr. Peter Marks, head of FDA’s Center for Biologics Evaluation and Research, said he was planning to get his COVID-19 vaccine first, followed by his influenza vaccine about two weeks later.
“If you want to minimize the chance of interactions and minimize confusing the side effects from one with another, you wait about two weeks between the vaccines,” Marks said on an FDA stakeholder call in September.
What about vaccine effectiveness? A closer look at the conclusions of a September 2023 paper titled Immunogenicity and Reactogenicity of Coadministration of COVID-19 and Influenza Vaccines reveals the following:
Although this may not be generalizable to other COVID-19 vaccines, and further studies on vaccine efficacy could likely shed more light on the repercussions of this practice, we believe that our results suggest that the co-administration of this COVID-19 vaccine along with SIV is a feasible and harmless tactic to increase vaccine uptake.
As for the need for further investigations, Balmakov just hopes that they take place sooner rather than later. It is an understatement to say that perhaps the DOH should refrain from making unsubstantiated claims about the safety and efficacy of co-administering these shots.
Also note that co-administration data involving RSV shots is rarer than the COVID-19 + Flu shot combos discussed above.
Has VAERS captured all cases of Pulmonary Hypertension after the COVID-19 Shots? The British Medical Journal finds problems with the U.S. injury reporting system.
The November 14 issue of The Defender featured an article about the British Medical Journal’s investigation into the Vaccine Adverse Event Reporting System, or VAERS. It found multiple deficiencies in the reporting system, and notably a revelation that the government runs two VAERS systems — one for the public, and a private back-end system that contains all of the corrections and updates, including deaths that occurred after an initial injury.
CDC Runs Two VAERS Systems — The Public Can Access Only One of Them (childrenshealthdefense.org)
The Defender article cited the case of Dr. Robert Sullivan, who collapsed on his treadmill three weeks after his second COVID-19 vaccine in early 2021. He fell into a “nightmare” ordeal that he said exposed glaring deficiencies in the nation’s vaccine safety monitoring system.
Diagnosed with sudden onset pulmonary hypertension, the healthy and fit forty-nine-year-old anesthesiologist from Maryland attempted to file a report through VAERS.
But like others interviewed in the investigation by the BMJ Is the US’s Vaccine Adverse Event Reporting System broken?, Sullivan hit barrier after barrier when trying to submit and update his report.
Almost three years later, still grappling with debilitating symptoms, Sullivan’s experience highlighted the systemic problems with the VAERS, which is run jointly by the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA).
Nevertheless, somehow and in some manner, 445 cases of pulmonary hypertension across the United States and its territories have made into VAERS.
Five of those cases have occurred here in Washington, two of them resulting in death.
The latest entry into VAERS was one of those deaths.
VAERS ID: 2632422
A 56-year-old male died on the same day, August 9, 2021, as his onset, which was forty-four days after taking a second Moderna shot. The submission listed two known adverse events from vaccine administration.
Accidental improper storage of vaccine leading to temperature excursion prior to vaccine administration.
Second dose was administered too early (22 days, instead of 30 days after 1st dose). Dose 1 - 8/9/21 Moderna lot 040B21A Dose 2 - 8/31/21 Moderna lot 040B21A
On September 7, 2021, the patient was seen by a PCP. There were no documented concerns regarding the COVID-19 shot or concerns for COVID during that visit. Then on September 22, 2023, the patient was found by his family deceased in his bed. Death certificate noted the following causes of death: - Non-ischemic Cardiomyopathy - Paroxysmal A. Fib - Pulmonary Hypertension.
The other death was of a ninety-year-old female.
VAERS ID: 1808783
She received the Pfizer COVID-19 shots on September 23, 2021 and October 14, 2021. On October 19, 2021, she was admitted to her facility’s medical surgery unit for acute on chronic hypoxemic respiratory failure secondary to pulmonary hypertension. The rest of the submitted write-up reads as follows: HF with preserved EF, and COVID-19 pneumonia. On 10/21/21, patient was transferred to CCU for about 18 hours, then transferred back out to the med/surg unit. As of today (10/22/21), patient is still admitted in the med/surg unit.
Above the submitted write-up, the report had the following:
Died? Yes
Date died: 2021-10-23
Days after onset: 4
Another case had the onset begin on the same day as taking the COVID-19 jab.
VAERS ID: 126223
This forty-five-year-old female’s onset occurred on the same day as when she took the first Pfizer shot on April 17, 2021.
Submitted write-up: Dr. consult EMS called to assess via 911. Dr. visit in person Urgent Care Trouble breathing, dizziness, heart pain, numbness and tingling in extremities, blurred vision, muscle spasms, poor muscle tone, rapid heart rate, drop in blood pressure, elevated heart pressure, trouble talking, brain fog, intestinal upset, cold sweats, tremor, poor coordination, restlessness, fatigue Onset at time of vaccine administration Labeled NOT anaphylaxis.
Below are the other two reports entered into VAERS:
VAERS ID: 1536395
38-year-old male
Submitted write-up: Hypertensive emergency; Newly diagnosed uncontrolled hypertension; Elevated troponin; pulmonary hypertension.
VAERS ID: 2070104
63-year-old male, 46 days after third COVID-19 shot
Submitted write-up: Patient received Moderna COVID vaccine on 4/19/21 (lot # 043B21A), 5/17/21 (lot # 041C21A), and Pfizer COVID vaccine on 12/10/21 (lot # FF2589). On 1/25/22, patient admitted to our inpatient facility (med/surg unit) with acute hypoxic respiratory failure, COVID19 pneumonia, severe pulmonary hypertension, chronic right heart failure, uncontrolled HTN, and methamphetamine abuse (urine toxicity test positive). As of today (1/27/22), patient is still admitted in the med/surg unit.
We wish you a very Happy Thanksgiving. We are thankful for YOU! And we leave you with two quotes from Dr. Ryan Cole’s Veteran’s Day presentation during the Florida COVID-19 Summit:
“There is no justification for taking away individuals’ freedom in the guise of public safety.”
Thomas Jefferson
“A free democracy requires that we love our freedom more than we fear a virus.”
Robert F. Kennedy Jr.