Page 85 - Spring2020

Claimants allege that Merck produced and sold common and severe side effects have been re- About one
“an unreasonably dangerous vaccine” and as- ported following the administration of Shingrix.
sert that the company knew—or should have Within the first four months of Shingrix being in six people
known—that the vaccine was not safe. To on the market, VAERS had received one hun- vaccinated
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make matters worse, these injured individuals dred fifty-five adverse event reports linked to the with Shingrix
may have suffered in vain; a physician at the vaccine. According to Dr. Kathleen Dooling
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University of California-Los Angeles (UCLA) of the CDC’s Division of Viral Diseases, more experienced
has pointed out that one hundred and seventy- than 70 percent of clinical trial participants side effects
five people would need to receive the Zostavax experienced pain after getting the Shingrix vac- so severe that
vaccine to prevent one case of shingles. (Note cine, and “about one in six people experienced
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that adults injured by shingles vaccines are side effects so severe that it actually prevented it actually
fortunate to be able to sue manufacturers for their normal activities.” The Shingrix package prevented
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compensation—if the vaccine had been de- insert lists adverse reactions that include allergic their normal
signed for children and recommended by the reactions (such as rash, hives and swelling of the
CDC, the spurious National Childhood Vaccine face, tongue or throat capable of causing diffi- activities.
Injury Act of 1986 would protect manufacturers culty in swallowing or breathing), chills, fever,
from any and all liability.) generally feeling unwell, headache, injection
site itching, muscle pain, redness and swelling
MORE PROBLEMS=MORE NEW VACCINES at the injection site. 47
Unfortunately for Merck, a second shingles
vaccine called Shingrix became available MANY NEGATIVES, NO PLUSES
in 2017, manufactured by GlaxoSmithKline Merck and GSK—with help from the
(GSK). The CDC currently recommends Shin- CDC—both claim that even if their herpes
grix as the preferred shingles vaccine because zoster vaccines fail to protect recipients from
of its greater reported effectiveness. Shingrix a bout with shingles, the vaccines will make
claims to be up to 90 percent effective at pre- the rashes less painful and help clear them up
venting shingles, compared to Zostavax’s of- more quickly. Is this uncertain benefit worth it?
ficial estimate of 51 percent. 40 By May 2019, the number of vaccine reactions,
GSK is aggressively marketing two doses hospitalizations, injuries and deaths reported to
of Shingrix to adults over the age of fifty. Since VAERS following vaccination with either Zos-
its 2017 approval, the vaccine has been a top tavax or Shingrix had climbed to over sixty-one
growth engine for the company, reaching sales thousand, including one hundred seventy-nine
of 1.6 billion dollars in the first nine months of deaths, over two thousand hospitalizations and
2019. The retail cost of the vaccine is around over one thousand related disabilities. 48
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two hundred eighty-two dollars for the two in- With all of these negatives, it is hard to
jections, compared to about two hundred twenty imagine why officials continue to recommend
dollars for the single-dose Zostavax vaccine. chickenpox and shingles vaccines so fervently.
As with Zostavax, a significant number of The answer seems to lie in some combination

QUESTIONABLE INGREDIENTS IN GLAXOSMITHKLINE’S SHINGLES VACCINE
Shingrix is an inactivated, genetically-engineered vaccine that does not contain a live virus like its competitor Zostavax.
The vaccine’s primary ingredients include glycoprotein E (gE)—a protein found in the varicella-zoster virus—mixed with
GSK’s proprietary adjuvant suspension called AS01. The latter consists of the saponin QS-21—a purified extract from
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the bark of a soapbark tree native to central Chile (Quillaja saponaria Molina)—and an immune-stimulating fat called
MPL (3-O-desacy1-4’-monophosphoryl lipid A). The highly potent QS-21 adjuvant is used to stimulate a strong immune
response in lieu of using a live virus, but it is experimental and little is known about its mechanisms of cellular activa-
tion. Some researchers have reported uncertainty about QS-21’s potential toxicity and “undesirable haemolytic effect”
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(rupturing of red blood cells and release of their contents into surrounding fluid) in humans. Shingrix also contains the
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problematic surfactant polysorbate 80, associated with adverse effects on female reproduction and blood-brain barrier
permeability. 44
SPRING 2020 Wise Traditions 85