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/

Like being armed with the facts?

 SIGN UP NOW