Outstanding Package Insert Quotes 1

I’m sure I have said it a million times, “read the package insert, read the package insert, read the package insert!”

Here are a few excerpts from the DTap, Gardasil and Varivax package inserts. All indented material is quoted directly from the insert which you can find a link to at the bottom of the page. Enjoy! I know I did.

If using a combination vaccine, such

 as Pediarix, then your baby will likely

 get three shots and RotaTeq, an oral

 vaccine, at her/his two- and four-month-old

 well child checkup.

 Photo © Vincent Iannelli, MD

DTap -  Pediarix (GSK)

(The pediatric DTap is administered to children at 2 months, 4 months, 6 months, 15 months, 4-6 years old. The Tdap vaccine is then administered at 11 years old and for pregnant mothers- check out this new 2012 recommendation here. The Td vaccine is given every 10 years.)

"The role of the different components produced by B. pertussis in either the pathogenesis of, or the immunity to, pertussis is not well understood. There is no established serological correlation of protection for pertussis."

14 Clinical Studies

The efficacy of the pertussis component, which does not have a well established correlate of protection, was determined in clinical trials of INFANRIX.

This could explain why there is a large population of vaccinated individuals acquiring pertussis. (this post gives several examples ‘So an Unvaccinated Child Got Your Kid Sick?) . The vaccine does not even attempt to lay claim in endowing “immunity” to pertussis. What a crock.

HPV - GARDASIL (Merck)



Now that's what I call a shot!



The number one warning and precaution listed in package insert (Quoted directly)

5.1 Syncope

Because vaccines may develop syncope, sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended. Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following vaccination with GARDASIL. When syncope is associated with tonic-clonic movements, the activity is usually transient and typically responds to restoring cerebral perfusion by maintaining a supine or Trendelenburg position.

Syncope is a fancy term for fainting – but don’t forget “other seizure-like activity”. The CDC made Merck add this to their package insert after being on the market for several years.[1]

          

Recipients of Gardasil should be closely observed for 15 minutes after vaccination. 

This minor change took Merck three whole years to put into place.

Merck has stated that these seizures are not epileptic in nature, however, even they have to admit that a faint followed by tonic-clonic movement and seizure like activity, which ever way they dress it up, is really saying in the broad sense, a child could have a seizure after having a Gardasil vaccination.[2]

The Epilepsy Foundation describes a seizure, in the same way as Merck is now describing on their new labeling as “seizure-like”.[3]

Vaccines have been linked to seizures as far back as 1950.[4][5][6][7]

6.1 Clinical Trials Experience

12.1 Mechanism of Action

…safety was evaluated using vaccination report cards (VRC)-aided surveillance for 14 days after each injection

That’s what I call a long term safety study.  

8.1 Pregnancy

There were 45 cases of congenital anomaly in pregnancies that occurred in women who received GARDASIL and 34 cases of congenital anomaly in pregnancies that occurred in women who received AAHS control or saline placebo.

For pregnancies with estimated onset within 30 days of vaccination, 5 cases of congenital anomaly were observed in the group that received GARDASIL compared to 1 case of congenital anomaly in the group that received AAHS control or saline placebo.

(congenital anomalies included pyloric stenosis, congenital megacolon, congential hydronephrosis, hip dyplasis, and club foot)

8.3 Nursing Mothers

In a post-hoc analysis of clinical studies, a higher number of breast-feeding infants whose mothers received GARDASIL has acute respiratory illnesses within 30 days post vaccination of the mother as compared to infants whose mothers received AAHS control.

Friggin’ crazy.

11 Description

Each 0.5mL dose of the vaccine contains approximately 225 mcg of aluminum (AAHS), 9.56 mg of sodium chloride, 0.78 mg of L-histidine, 50 mcg of polysorbate 80, 35 mcg of sodium borate.

Interested to learn more about aluminum adjuvants? Check this out.

12.1 Mechanism of Action

HPV only infects human beings, Animal studies with analogous animal papillomaviruses suggest that the efficacy of L1 VLP vaccines may involve the development of humoral immune responses. Human beings develop a humoral immune response to the vaccine, although the exact mechanism of protection is unknown.

Hello! Might as well state, “We’re not sure what the hell is going on.”

14 Clinical Studies

CIN 2/3 and AIS are the immediate and necessary precursors of squamous cell carcinoma and adenocarcinoma of the cervix, respectively.  Their detection and removal has been shown to prevent cancer; thus, they serve as surrogate markers for prevention of cervical cancer. …CIN 2/3 and AIS were the efficacy endpoints to assess prevention of cervical cancer.

Gardasil does not prevent cancer, instead it was shown to decrease CIN 2/3 and AIS. Most cases of CIN regress and are eliminated by the immune system without intervention. Most (90%) regress within 2 years.[8][9]

Interestingly enough, the majority of women who develop CIN are 25 to 35 years old.[8][9]

Progression of CIN typically takes 15 (in some cases 40) years.[9]

Risk factors that have been shown to increase a woman's likelihood of developing CIN, including poor diet, poor personal hygiene, multiple sexual partners, lack of condom use, and cigarette smoking.[10][11]

14.8 Immunogenicity

The duration of immunity following a complete schedule of immunization with GARDASIL has not been established.

According to the National Cancer Institute’s website, Gardasil might only protect against HPV for four years. “The duration of immunity is not yet known. Research is being conducted to find out how long protection will last. Studies thus far have shown that Gardasil can provide protection against HPV 16 for 4 years.”

The vaccine is administered at the age of 9 years old. Again, the majority of women who develop CIN are 25 to 35 years old.

Varivax Merck & Co., Inc.

No placebo-controlled trial was carried out the VARIVAX using the current vaccine

That’s reassuring.

no placebo-controlled trial was carried out in adolescents and adults

More reassuring information.

A boost in antibody levels has been observed in vaccines following exposure to natural varicella which could account for the apparent long-term persistence of antibody levels after vaccination in these studies. The duration of protection from varicella obtained using VARIVAX in the absence of wild-type boosting is unknown.

Please read that excerpt again – hello!

Elevated antibody levels are not from the vaccine, but instead from the exposure of wild, natural chicken pox!?!

And who knows how long protection will last in the absence of wild-type varicella.

Does anyone else read this stuff? I don’t get it.

Post-marketing experience suggests that transmission of vaccine virus may occur between healthy vaccinees who develop a varicella-like rash and healthy susceptible contacts. Transmission of vaccine virus from vaccinees who do not develop a varicella-like rash has also been reported.

Ok, so you could get chicken pox from someone that has received the vaccine whether or not they have a rash or not. Ugh.

Vaccine recipients should attempt to avoid, whenever possible, close association with susceptible high-risk individuals for up to six weeks.

(immunocompromised individuals, pregnant women, newborns)

Six weeks!

Varicella (vaccine strain)

What a joke. Aren’t parents administering the vaccine to avoid varicella. Not only did they get chicken pox, but they caught it from the vaccine!

Reye’s Syndrome

Clinical Pharmacology; One-Dose Regimen in Children

Physicians advised varicella vaccine recipients not to use salicylates for six weeks after vaccination.

Salicylates occur naturally and artificially. Aspirin, of course, is a salicylate – but also strawberries are extremely high in salicylates. Other foods extremely high in salicylates are: raisins, oranges, honey, and all varieties of tea.[12]

Indications and Usage

The duration of protection of VARIVAX is unknown.

Again – does any manufacturer have a clue?  

In highly vaccinated populations, immunity for some individuals may wane due to lack of exposure to NATURAL varicella.[emphasis added]

The hell with herd immunity – if you reach high levels of vaccinated levels then you might not be protected. So, in part, this is saying we need unvaccinated people around to keep kids who have been vaccinated protected! What a friggin’ joke!

Links to package inserts:

DTap -  Pediarix (GSK)

HPV - GARDASIL (Merck)

Varivax Merck & Co., Inc.

References

[1]FDA-Vaccines, Blood & Biologics. Information Pertaining to Labeling Revision for Gardasil

[2]England, Christina. Merck admits the vaccine Gardasil, can cause faints and seizures. American Chronicle. Jun 14 2009 The  

[3] The Epilepsy Foundation.Website. Glossary Page

[4]Baraff LJ et al (1988). Infants and children with convulsions and hypotonic-hyporesponsive episodes following diphtheria-tetanus-pertussis immunization: follow-up evaluation. Pediatrics 81(6):789-94 1988. Department of Pediatrics, University of California, Los Angeles, School of Medicine.

[5]Cizewska S, Huber Z, Sluzewski W, "[Prophylactic inoculations and seizure activity in the EEG]," Neurol Neurochir Pol 1981 Sep-Dec;15(5-6):553-557. [Article in Polish]

[6]Coplan J, "Seizures following immunizations," J Pediatr 1983 Sep;103(3):496

[7]Jacobson V et al (1988). Relationship of pertussis immunization to the onset of epilepsy, febrile convulsions and central nervous system infections: a retrospective epidemiologic study. Tokai J Exp Clin Med 13 Suppl:137-42 1988. Department of Neurology, UCLA School of Medicine.

[8]Kumar, Vinay; Abbas, Abul K.; Fausto, Nelson; & Mitchell, Richard N. (2007). Robbins Basic Pathology (8th ed.). Saunders Elsevier. pp. 718–721.

[9]Bosch FX, Burchell AN, Schiffman M, Giuliano AR, de Sanjose S, Bruni L, Tortolero-Luna G, Kjaer SK, Muñoz N (August 2008). "Epidemiology and natural history of human papillomavirus infections and type-specific implications in cervical neoplasia". Vaccine 26 (Supplement 10): K1–16.. 18847553.

[10]Murthy NS, Mathew A. (February 2000). "Risk factors for pre-cancerous lesions of the cervix". European Journal of Cancer Prevention 9 (1): 5–14. 

[11]Hogewoning CJ, Bleeker MC, van den Brule AJ, Voorhorst FJ, Snijders PJ, Berkhof J, Westenend PJ, Meijer CJ. (2003-12-10). "Condom use promotes regression of cervical intraepithelial neoplasia and clearance of human papillomavirus: a randomized clinical trial.". Int J Cancer 107 (5): 811–6.

[12]Adams, Maria MS,MPH, RD. Low-Salicylate Diet. Aug 11 2011  

The following adverse reactions have been reported since the vaccine has been marketed:

Clinical Pharmacology; Two-Dose Regimen in Adolescents and Adults