FLUARIX QUADRIVALENT, Informed Consent Information

The FDA announced earlier this month that it approved GSK’s Fluarix Quadrivalent flu vaccine. Getting this new flu vaccine, or any flu vaccine is a decision that is supposed to only be done after the patient or the patient’s guardian has been fulling informed of all of the risks involved with that vaccine. It’s called “informed consent” and it’s the law. If you are considering this vaccination for you or your children, please be aware of all of the information pertaining to this vaccine, including information that will be less readily available to you by mainstream media sources and perhaps not even by your physician.

 

The “Importance” of the Flu Vaccine

In the publicized releases, it’s noted that “seasonal influenza may cause up to 500,000 deaths per year worldwide.”

Quadrivalent by GlaxoSmithKline (a corporation out of the UK) is not currently approved or licensed in any country outside of the United States though. So, keeping things in perspective:

• Between the eight years from 2004 and 2012, 829 U.S. children under 18 died from influenza-associated causes (CNN). That’s about 104 US children a year that died from the flu and complications from the flu.
• Between the FOUR years from 2004 and 2008 alone, over 11,600 US children died of SIDS (ChildrensSafetyNetwork). That’s about 2900 US children a year that died of SIDS.

Quadrivalent Prescribing Information RE: Pregnancy and Breastfeeding

GSK says the full U.S. Prescribing Information will be available on http://www.gsk.com/products/index.htm, but I had a hard time finding it. Since it’s still new, maybe the Quadrivalent vaccine’s prescribing information is not up there yet.  So, to make life easier on you, here is a link to the info from the FDA’s site.

According to the proposed prescribing info on the FDA’s site:

“Safety and effectiveness of FLUARIX QUADRIVALENT have not been established in pregnant women or nursing mothers.”

But, if you are pregnant and living in the United States, you have a fantastic opportunity to be a part of the real-life testing! GSK invites pregnant women to give it a try and keep them posted!:

“GlaxoSmithKline maintains a surveillance registry to collect data on pregnancy outcomes and newborn health status outcomes following vaccination with FLUARIX QUADRIVALENT during pregnancy. Women who receive FLUARIX QUADRIVALENT during pregnancy should be encouraged to contact GlaxoSmithKline directly or their healthcare provider should contact GlaxoSmithKline by calling 1-888-452-9622.”

It’s like your baby being a part of history!

 

Clinical Testing of the Quadrivalent Flu Vaccine

The clinical trials involved with the licensing of this vaccine can be found online.

The National Clinical Trial (NCT) numbers involved with the licensing of this vaccine are:  NCT00714285, NCT00985790, NCT01196988 and NCT01204671. (FDA)

I’ve referenced them so that you can understand the design of the studies that have “ensured the safety” of this vaccine. You can click on their NCT numbers to find the complete clinical trial data, but I especially liked the list of things that excluded people from being a part of this safety study, so I highlighted some of them here. Keep in mind that these same things will hardly be considered prior to administering this vaccine next year at the pediatrician’s or OB’s office.

NCT00714285 – According to GSK, “The purpose of this study is to evaluate the safety and immunogenicity of GSK influenza vaccine candidate compared to a licensed trivalent influenza vaccine in adults.”

Partial List of Exclusion Criteria:

• History of hypersensitivity to a previous dose of influenza vaccine.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s). 
• Pregnant or lactating female.
• Female planning to become pregnant or planning to discontinue contraceptive precautions.
• History of chronic alcohol consumption and/or drug abuse.
• Any condition which, in the opinion of the investigator, prevents the subject from participating in the study. <— (My personal favorite.)

NCT00985790– According to GSK, “The purpose of the present study is to assess the immunogenicity and safety of vaccine GSK2321138A in children.”

Partial List of Exclusion Criteria:

• History of hypersensitivity to any vaccine.
• History of allergy or reactions likely to be exacerbated by any component of the vaccine.
• Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
• History of Guillain Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
• Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.

NCT01196988– According to GSK, “This study is designed to assess the safety and immunogenicity of GlaxoSmithKline (GSK) Biologicals’ investigational vaccine GSK2321138A in children aged 3 to 17 years, and to describe safety and immunogenicity of the GSK Biologicals’ investigational vaccine GSK2321138A in children aged 6 to 35 months.”

Partial List of Exclusion Criteria:

• Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration.
• Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
• History of seizures or progressive neurological disease.
• History of Guillain-Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
• History of hypersensitivity to a previous dose of influenza vaccine, history of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
• Acute disease and/or fever at the time of enrollment.
• Ongoing aspirin therapy.
• Pregnant or lactating female.
• Female planning to become pregnant or planning to discontinue contraceptive precautions.
• Any other condition which, in the opinion of the investigator, prevents the subject from participating in the study
• Child in Care.

NCT01204671– According to GSK, the purpose of this study was “to assess the safety and immunogenicity of a GSK Biologicals’ investigational vaccine GSK2321138A in adults 18 years old and older. This study is also designed to assess the lot-to-lot consistency of vaccine GSK2321138A.”

Partial List of Exclusion Criteria:

• Planned administration / administration of a vaccine not foreseen by the study protocol within 30 days before vaccination and up to Day 21.
• Any contra-indication to intramuscular administration of the influenza vaccines.
• History of hypersensitivity/anaphylaxis to a previous dose of influenza vaccine, history of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
• Any administration of a long-acting immune-modifying drug within 3 months before study start, or planned administration during the study period.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• Acute disease and/or fever at the time of enrollment.
• History of Guillain-Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
• History of chronic alcohol consumption and/or drug abuse.
• Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.
• Pregnant or lactating female.

Important Safety Information for Fluarix Quadrivalent

The following is a list of what GSK considers important safety information regarding the Fluarix Quadrivalent. It is unlikely you will be permitted to read this information at your doctor’s office, so look it over now. You can always print out a copy for your purse and take it to your physician’s appointment to assist open communication with the doctors and nurses there. The following information is in GSK’s own words, the links are mine:

• Do not administer Fluarix Quadrivalent to anyone with known severe allergic reactions (anaphylaxis) to any component of the vaccine, including egg protein, or a life-threatening reaction to previous administration of any influenza vaccine.
• If Guillain-Barré syndrome has occurred within 6 weeks of receipt of prior influenza vaccine, the decision to give Fluarix Quadrivalent should be based on careful consideration of the potential benefits and risks.
• The tip caps of the prefilled syringes may contain natural rubber latex which may cause allergic reactions in latex sensitive individuals.
• Syncope (fainting) can occur in association with administration of injectable vaccines.
• In clinical trials with Fluarix Quadrivalent, the most common adverse reactions in adults were pain at the injection site, muscle aches, headaches and fatigue.  In children 3 years to less than 18 years of age, the most common adverse reactions were pain at the injection site, redness and swelling.  In children 3 years to less than 6 years of age, the most common adverse reactions were drowsiness, irritability, and loss of appetite.  In children 6 to less than 18 years of age, the most common systemic adverse reactions were fatigue, muscle aches, headache, arthralgia and gastrointestinal symptoms.  (See Adverse Reactions section of the Prescribing Information for Fluarix Quadrivalent for other potential adverse reactions and events).
• Vaccination with Fluarix Quadrivalent may not result in protection in all vaccine recipients.

 

If after doing your own research, you have decided against getting this flu vaccine, talk to your doctor about vitamin D3 and its involvement in helping you body resist the seasonal flu.

 

Disclaimer: This article is not intended to be used as medical advice. This is not a substitute for professional medical advice or care. It is intended to be used as a tool for open discussion with your medical professional.

Further Reading:

• VIROLOGY JOURNAL: On the epidemiology of influenza
• THE “AUTISM AND FLU CORRELATION” STUDY AND ITS INEVITABLE USE IN MARKETING THE FLU SHOT.  
• VITAMIN D3 AND PREGNANCY  
• THE FLU VACCINE IS SUPER-DUPER EFFECTIVE… I GUESS.

Other Vitamin D3 Articles:

• Depression: Patient friendly summary
• Vitamin D deficiency is associated with anxiety and depression in fibromyalgia.
• The Need for Vitamin D
• Vitamin D3 enhances mood in healthy subjects during winter.
• Calcium and Vitamin D Intake and Risk of Incident Premenstrual Syndrome
• Vitamin D for Cancer Prevention
• Half the world Vitamin D deficient.