Fact Check: New Shingles Vaccine

Last week, Vermont Public Radio aired an 8-minute radio conversation vaccine promotion with Ric Cengeri (producer of Vermont Edition) and Christine Finley (State of Vermont ).1

A quick fact check on information about the vaccine that was provided on-air reveals that Ms. Finley drastically downplayed manufacturer warnings on possible adverse effects of this new vaccine.

When asked what was “new” about this vaccine, Ms. Finley spoke of “amazing efficacy” and “comes in two shots”.

But here is what she left out:

Genetically engineered vaccine

Shingrix® is a brand new, genetically engineered (GE) vaccine from GlaxoSmithKline. The FDA licensed it just 7 months ago, on October 20, 2017. This new GE vaccine contains3 residual DNA and protein from the Chinese Hamster Ovary (CHO) cells that were used to produce a recombinant used as antigen in the vaccine. Nobody knows what the true risk of injecting this cocktail of recombinant protein, residual CHO DNA plus residual CHO protein may be.

Novel adjuvant

This GE vaccine also contains a new adjuvant called AS01B, which has never before been used in a US licensed vaccine. After this new adjuvant was used in an infant malaria vaccine study outside the US, increased incidences of meningitis and severe malaria were observed in vaccinated subjects5 .

Possible side effects

Aside from the unknowns relating to the vaccine ingredients, in Prescribing Information6 the drug giant GlaxoSmithKline discloses that more than 50% of those vaccinated with Shingrix® during premarket clinical trials reported an adverse effect.

The company lists chills, injection site pruritus, malaise, arthralgia, nausea, and dizziness as the most commonly reported side effects. They also note that gout, optic ischemic neuropathy and death were reported adverse effects in trial subjects.

The premarket FDA Briefing Document from September 13, 2017 also mentions that those vaccinated in premarket clinical studies were five times more likely to report supraventricular tachyarrhythmias compared to the control group.

When asked about side effects, Ms. Finley told listeners they might expect tenderness, swelling, redness around the injection site “probably in 10% or more of the people.” This is a major understatement.

She also told listeners they may “get some achiness, a headache, a fever…” and that “for most people it is a sore arm for a couple of days.” But the manufacturer’s Prescribing Information includes the following chart, which outlines the percentage of study subjects who reported reactions between days 0 and 6 after vaccination in premarket trials:

Labeled product warnings

It seems that Ms. Finley was not aware of the labeled product warnings.

Now that the vaccine has been licensed, Ms. Finley does not need to have people call her to report their vaccine side effects.

VAERS
In fact, there is a government database (called VAERS, the Vaccine Adverse Event Reporting System) that is used to detect safety signals and post-market consumer experiences after using vaccines.
The vaccine’s Information Statement7 comes printed with this warning: “As with any medicine, there is a very remote chance of a vaccine causing a serious injury or death.”

Sadly, there are already 1,521 Shingrix® VAERS reports filed, including five deaths.

Caveat emptor

The pharmaceutical industry spends billions each year in advertising and lobbying dollars to drive demand for its drugs and vaccines. As our spending continues to soar, prescription drugs are the third leading cause of death9 after heart disease and cancer in the United States and Europe.

Ironically, another drug giant (Merck) is currently facing lawsuits10 that allege the company failed to warn consumers that their shingles vaccine could cause side effects. If our government agency employees are to play leading roles in pharma product promotion, we should expect them to fulfill similar standards.

As this fact check demonstrates, consumers absolutely must read the fine print to ensure they are being given accurate information – even when the State is advertising “shots for free.” Let the buyer beware…

 

References:

1 VPR June 12, 2018: A New Shingles Vaccine Is Available, and The State May Pay For You To Get It. Accessed June 18, 2018 at: http://digital.vpr.net/post/new-shingles-vaccine-available-and-state-may-pay-you-get-it – stream/0

2 FDA Consumers Affairs Branch (CBER): Shingrix Product Information and Supporting Documents, access June 19, 2018 at: https://www.fda.gov/biologicsbloodvaccines/vaccines/approvedproducts/ucm581491.htm

3 Ingredients found at CDC Vaccine Excipient & Media Summary – accessed 6/18/2018 at: https://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/b/excipient-table-2.pdf

4 FDA/CBER Vaccines and Related Biologicals Advisory Committee, Issues associated with residual cell-substrate DNA in viral vaccines accessed June 20 2018 at: http://slideplayer.com/slide/8723367/

5 Vaccines and Related Biological Products Advisory Committee Meeting September 13, 2017 FDA Briefing Document SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) Applicant: GlaxoSmithKline Biologicals – accessed 6/14/2018 at https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/UCM575190.pdf

6 GlaxoSmithKline Biologicals, Shingrix Vaccine Prescribing Information, accessed 6/14/2018 at https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM581605.pdf

7Recombinant Shingles Vaccine Information Statement, dated 2/12/2018: https://www.cdc.gov/vaccines/hcp/vis/vis-statements/shingles-recombinant.pdf

8 Medalerts VAERS reports, accessed June 18, 2018 at: http://medalerts.org/vaersdb/findfield.php?TABLE=ON&GROUP1=VNA&GRAPH=ON&GROUP6=VACM&EVENTS=ON&PERPAGE=10000&VAX%5B%5D=VARZOS&VAXNAME=shingrix&VAX_YEAR_LOW=2017

9 Peter C. Gøtzsche,MD: Our prescription drugs kill us in large numbers . http://pamw.pl/sites/default/files/inv_14_Gotzsche%20online.pdf

10 Zostavax Shingles Lawsuits https://www.drugwatch.com/vaccines/zostavax/lawsuits/

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Chicken Pox Vaccine Info.

Updated April 1, 2015. Related Posts

Chicken pox (Varicella) vaccine consists of a genetically engineered virus made from human & guinea pig cells and contains residual proteins. Ingredients include: sucrose, phosphate, glutamate, gelatin, monosodium L-glutamate, sodium phosphate dibasic, potassium phosphate monobasic, potassium chloride, sodium phosphate monobasic, potassium chloride, EDTA, residual components of MRC-5 cells including DNA and protein, neomycin, fetal bovine serum, human diploid cell cultures (WI-38), embryonic guinea pig cell cultures, human embryonic lung cultures. (Source: CDC).

Chicken Pox Vaccine was added to Vermont school “requirements” in 2008. That requirement doubled the Vermont vaccine exemption rate.

exemption-jump

Recommended Reading:

The stage was set  to claim that unvaccinated children are a risk was set a long time ago  (Read Article-2008) and now parents are facing off with health authorities over state mandates for school children.

One major consideration is that “Merck’s VARIVAX vaccine has a high failure rate and mass vaccination of American children has driven the disease into atypical older age groups where it can be far more dangerous.”(from: Chicken Pox: The Disease vs. The Vaccine. See also New England Journal of Medicine, 2007:  Loss of Vaccine-Induced Immunity to Varicella over Time) Also, as reported in the Journal of Infectious Disease in 2013, Vaccine-strain herpes zoster (HZ) can occur after varicella vaccination – and herpes is 10 times more frequent in vaccinated children 0-2 years old as compared to not vaccinated peers.

French Doctor: Chicken Pox is A Good Thing When Caught at a Young Age. Article, May 3, 2013 

Chicken Pox is one of the least defensible vaccines on the schedule. The documented rate of vaccine provoked seizures dramatically outpaces the natural infection risk.

Chicken pox is not, and never has been, a public health threat. It has been described as a “convenience vaccine”.
We are already seeing shingles in young persons and will see more in adults because the immunity from the vaccine is not equivalent to the much more effective healthy immunity gained from the natural wild varicella virus infection.

It is a common assertion by vaccine proponents that administering multiple vaccines at a visit, or using combination shots, are no more reactive than single doses. Linked below are CDC charts and slides detailing that this assertion is completely false. The MMR is more reactive than single vaccines, adding a Chicken Pox shot to an MMR visit jumps the normal MMR 1/3500 seizure rate to 1/2500, and using the MMRV Pro Quad 4 in 1 doubles the seizure rate again to 1/1250. How can a parent be considered unscientific if they can dramatically cut their child’s seizure risk by dose timing or product selection when the infection is Chicken Pox?

“Most people do not know that chicken pox vax gives little protection, kills & maims many, and treatment may kill children who’d have lived through the disease. So more children probably die now from vaccines & chicken pox than died of chicken pox before modern medicine. Worse, the vaccine may be triggering a new epidemic of shingles.” – Heidi Stevenson

135 deaths following this vaccine (VZV) have been reported in the adverse drug reports since it was recommended in the US in 1995.

Another 9 deaths have been reported post the MMRV vaccine.

Reviewing how other countries handle Chicken Pox can illustrate the contrasts between the US Vaccine Authority and more rational medical organizations.
See this link to see how few countries use this vaccine, and remember that very few countries require vaccination for school attendance.

The Netherlands performed a study to determine if they should follow the US for Chicken Pox. Netherlands does not. The UK recommends Chicken Pox only after exposure and for HCW who never had the natural infection.
This link also has CDC Vaccine Safety Datalink charts detailing the seizure rates.

Calculate these febrile seizure rates against the 8 million US children receiving their first or second of 2 doses every year, you get 3200 to 6400 events (depending on whether it is a MMR + V or MMRV) requiring emergency room treatments. Averaging this out, are 5,000 or so Vaccine provoked febrile seizures requiring hospitalization to prevent the 11 or 12,000 natural infection hospitalizations referenced above an acceptable ratio? At a cost of $75 times 8 million, $600,000,000?

Certainly, in rare cases chicken pox can be dangerous for children. And it is moderately dangerous for adults. Although not, very often, fatal. However, the vaccine has already demonstrated that it doesn’t provide long-term immunity. Millions of adults now are vulnerable to chicken pox. Worldwide, only a very small group of countries have decided to use this vaccine, so there is no hope at all that the illness will be eradicated. What a mess!

by Sandy Reider MD, Deborah Kahn, Jennifer Stella and Karl K.

Stroke after chicken pox vaccination; see http://www.ncbi.nlm.nih.gov/pubmed/15580216?dopt=Abstract

Note: To “debunk this myth” a retrospective study was done through the Vaccine Safety Datalink (which is NOT the VAERS system but an industry-set-up system), removing many patients form the cohort, and then declaring the vaccine perfectly safe. See: http://www.ncbi.nlm.nih.gov/pubmed/19171574

Severe Varicella Caused by Varicella-Vaccine Strain in a Child With Significant T-Cell Dysfunction; see http://pediatrics.aappublications.org/content/120/5/e1345.long

“This case report illustrates the fact that, although VZV vaccine has been proven to be safe in immunocompetent patients, it is potentially dangerous in patients with altered immunity, especially those with severely suppressed cell-mediated immunity, in whom it can produce long-lasting severe generalized eruption or organ dissemination. Although it may not be cost-effective to perform routine immunodeficiency screening in all apparently healthy children who present for vaccination with LAVV, particular attention should be paid to clues such as abnormal anthropomorphic data to detect patients who might be at increased risk of immunodeficiency and, therefore, at increased risk of adverse effects from vaccination with LAVV. This case also highlights the fact that if immunodeficiency is suspected, assessment of function in addition to phenotype should be conducted before excluding it.”

Vaccine Shedding – consult package insert 18/614

http://www.pdr.net/full-prescribing-information/varivax?druglabelid=397#i4i_section_id_5471b8f9-b7a1-4c7e-8891-cfa66855a128

coinfection – recombination question is open? http://www.unboundmedicine.com/medline/citation/18996045/A_case_of_varicella_caused_by_co_infection_with_two_different_genotypes_of_varicella_zoster_virus_

Timeline: 1995: CP (Varicella) Vaccine launch
2006: One dose of varicella vaccine does not prevent school outbreaks: is it time for a second dose?

Fatal wild-type varicella-zoster virus encephalitis without a rash in a vaccinated child. Varicella-zoster virus encephalitis should be considered in the differential diagnosis for children presenting with acute neurologic symptoms, even vaccine recipients. http://www.ncbi.nlm.nih.gov/pubmed/22982982