As it happens every winter, the marketing push for receiving a flu shot continues. CVS is offering a 20% shopping pass when you get your flu shot. They are also marketing a high-dose vaccine, which is of course more profitable for the manufacturer and the pharmacy, but there are plenty of reasons to be wary of it — especially for seniors.
Fluzone® High-Dose is an injectable vaccine, specifically approved for people ages 65 and older. Manufactured by Sanofi Pasteur, this shot contains three flu strains and four times more antigen (substance that causes an immune response) than regular flu shots, claims CVS Pharmacy (Rite Aid also offers it and admits that “more studies are being done” to see whether it actually offers an improvement at all).
The pharmacy does admit that the vaccine is not recommended for anyone who has experienced an adverse reaction (especially Guillain-Barré syndrome) to vaccines in the past.
But between their marketing campaigns and promoting a 20% shopping coupon, they omitted a vital piece of information: 105 seniors died after taking part in two Fluzone high-dose vaccine trials, and 91 died after getting the regular Fluzone vaccine.
Deaths after the Fluzone Clinical Trials
Rite Aid and other pharmacies also offer the shot, but many people have questioned whether seniors are being told the truth about their risks.
Two clinical trials were conducted before Fluzone received approval. Both studies were led and sponsored by Sanofi Pasteur, the vaccine manufacturer itself (clear potential for conflict of interest).
In the first study 2,573 adults ages 65 and older received the Fluzone high-dose and 1,260 received regular Fluzone shots. Out of those a surprising number of seniors, 156 high-dose and 93 regular-dose recipients, had a severe adverse event (SAE) within 6 months post-vaccination.
In addition, 16 high-dose and 7 regular-dose recipients died between 29 and 180 days post-vaccination. But as the package insert received by unsuspecting patients puts it, “no deaths were reported within 28 days post-vaccination.”
Pharmaceutical companies have been known to present and phrase study results in ways that downplay the risks, and many have wondered if this is indeed the case with Fluzone, including the website Health Impact News in a 2013 article that went viral on social media. Usually studies report the results in round numbers, such as what adverse reactions happened during the first 30, 60 and 90 days. In this case the study chose to state in the package that no one died during the first 28 days. But a total of 23 (high-dose and regular dose) participants died starting on day 29. Why did they choose the 29th day to begin counting?
Second Study: More Adverse Reactions, Deaths
In the second study 15,992 adults ages 65 and older received the Fluzone high-dose and 15,991 received the regular Fluzone. Results show that 1,323 high-dose and 1,442 regular Fluzone recipients had a SAE within 6 to 8 months post-vaccination (204 high-dose and 200 regular-dose experienced a SAE within 30 days). In addition, 83 high-dose and 84 regular-dose died within 6 to 8 months, and 6 high-dose recipients died within 30 days post-vaccination.
According to the Fluzone vaccine information sheet none of these deaths were linked to the vaccine. They state that “these data do not provide evidence for a causal relationship between deaths and vaccination with Fluzone High-Dose.”
The first study claims the deaths cannot be linked to the clinical study because “the majority of these participants had a medical history of cardiac, hepatic, neoplastic, renal, and/or respiratory diseases.” The second study claims the same due to the majority of participants having “one or more chronic comorbid illnesses.”
The question arises – without further investigating, how did they arrive at the conclusion that none of the deaths were connected to the vaccination? Why wasn’t the data between seniors with existing conditions and without existing conditions ever compared or added to the package insert? And can we trust the word of the pharmaceutical company who sponsored its own study?
At any rate, 105 deaths and the sheer amount of adverse effects recorded between the two studies are serious red flags for anyone considering a flu shot. Serious adverse events include life-threatening issues like Guillain-Barré Syndrome, which has symptoms similar to polio including paralysis.
Perhaps, that is one of the reasons why when receiving the vaccine, the patient needs to sign a consent form first.
The Consent Form: Risk Awareness and Inability to Sue the Company
When receiving a vaccination (this one from Rite Aid), the patient has to read and sign a form which includes the following:
“I have read, or have had read to me the Vaccination Information Sheet (VIS) regarding the vaccine(s). I have had the opportunity to ask questions that were answered to my satisfaction and understand the benefits and risks of the vaccine(s). I consent to, or give consent for, the administration of the vaccine(s). I fully release and discharge Rite Aid Corporation, its affiliates, officers, directors, and employees from any liability for illness, injury, loss, or damage which may result there from,” states the Rite Aid consent form.
There are two important parts to this consent: you are signing that you understand the risks and that you cannot sue the company if adverse reactions occur.
To fully understand the risks, you would have to read the full information sheet about Fluzone or Fluzone High-Dose, which includes the data on clinical trials and deaths post-vaccination, as well as almost 30 adverse reactions (from mild to potentially life-threatening) reported post-approval of the vaccine. However, this sheet is printed for the health provider only, and they are not likely to show it to the patient (could they be hiding something)?
What does the patient receive? – An official patient information sheet that only lists pain, aches, tiredness and headache for side effects of Fluzone high-dose and tells you to ask your health provider about the rest. This is where as a patient, you have to be vigilant and ask very specific questions and do your own research.
The second part of your consent is understanding that you cannot sue the pharmacy that gave you the shot, but also it is important to know that you cannot sue the manufacturer of the vaccine as well.
Unlike suing the company that manufactured a drug that caused an adverse reaction (which is becoming a huge problem as anyone who watches late night TV has noticed), vaccine manufacturers cannot be sued. Instead, the adverse reactions can be reported to The Vaccine Adverse Event Reporting System (VAERS), and the person can apply for compensation through the National Vaccine Injury Compensation Program (VICP), which has paid out over $3 billion to vaccine injury victims since it was started in 1986 (two-thirds of applicants are denied, so the real number of victims could be far higher).
While some people were successful at proving that the vaccine caused an injury (as in the case of Bailey Banks whose MMR vaccine caused ADEM, an intense swelling in the brain), the vaccine manufacturers can never be held liable. It’s an unfortunate reality that has allowed the industry to thrive even as these “significant adverse events” (like deaths) continue to mount. Be sure to keep these points in mind before you or your loved one goes in for their next shot.
Disclaimer: This article is for informational purposes only. Consult a doctor before making any major changes to your health, diet, or medicine-related routine.
Further reading: Why the High-Dose Vaccine for Seniors is Dangerous and Ineffective