Intended for healthcare professionals

News

Questions over human papillomavirus vaccine in the US and Australia

BMJ 2007; 334 doi: https://doi.org/10.1136/bmj.39237.424537.4E (Published 07 June 2007) Cite this as: BMJ 2007;334:1182

Adverse reaction to vaccine no surprise

The adverse reactions to Gardasil vaccine should be no surprise.
Doesn't anyone read the vaccine maker's insert regarding the vaccine's
content and potential for adverse reactions?

The Food & Drug Administration allowed Merck to use a potentially
reactive aluminum containing placebo as a control for most trial
participants, rather than a non-reactive saline solution placebo.[1] A
reactive placebo can artificially increase the appearance of safety of an
experimental drug or vaccine in a clinical trial. Gardasil contains 225
mcg of aluminum and, although aluminum adjuvants have been used in
vaccines for decades, they were never tested for safety in clinical
trials. Merck and the FDA did not disclose how much aluminum was in the
placebo.[2]

Animal and human studies have shown that aluminum can cause nerve
cell death [3] and that vaccine aluminum adjuvants can allow aluminum to
enter the brain, [4 5] as well as cause inflammation at the injection site
leading to chronic joint and muscle pain and fatigue. [6 7] Nearly 90
percent of Gardasil recipients and 85 percent of aluminum placebo
recipients followed-up for safety reported one or more adverse events
within 15 days of vaccination, particularly at the injection site.[8] Pain
and swelling at injection site occurred in approximately 83 percent of
Gardasil and 73 percent of aluminum placebo recipients. About 60 percent
of those who got Gardasil or the aluminum placebo had systemic adverse
events including headache, fever, nausea, dizziness, vomiting, diarrhea,
myalgia. [9 10] Gardasil recipients had more serious adverse events such
as headache, gastroenteritis, appendicitis, pelvic inflammatory disease,
asthma, bronchospasm and arthritis.

Where are the long term double blind studies to establish above all -
safety - and efficacy? There aren't any.

The approval and subsequent withdrawal of two rota virus vaccines in
the past 8 years underscores the inadequacy of safety studies on the part
of the manufacturers and calls in to question the competence and the
potential for conflicts of interest of those participating in the
regulatory process.

1. Merck & Co., Inc. 2006. Gardasil [Quadrivalent Human
Papillomavirus Types 6,11,16,18) Recombinant Vaccine] product insert.
Table 6.

2. Food and Drug Administration. May 18, 2006. FDA Background
Document for Vaccines and Related Biological Products Advisory Committee:
Gardasil HPV Quadrivalent Vaccine.

3. Kawahara M et al. 2001. Effects of aluminum on the neurotoxicty of
primary cultured neurons and on the aggregation of betamyloid protein.
Brain Res. Bull. 55, 211-217.

4. Redhead K. et al. 1992. Aluminum-adjuvanted vaccines transiently
increase aluminum levels in murine brain tissue. Pharmacol. Toxico. 70,
278-280.

5. Sahin G. et al. 1994. Determination of aluminum levels in the
kidney, liver and brain of mice treated with aluminum hydroxide. Biol.
Trace. Elem. Res. 1194 Apr-May;41 (1-2):129-35.

6. Gherardi M et al. 2001. Macrophagaic myofastitis lesions assess
long-term persistence of vaccine-derived aluminum hydroxide in muscle.
Brain, Vol 124, No. 9, 1821-1831.

7. Shingde M eta la. 2005. Macrophagic myofastitis associated with
vaccine derived aluminum. MJA, 183 (03):145-146.

8. Merck & Co. May 18, 2006. Merck briefing document for Vaccines
and Related Biological Products Advisory Committee: Gardasil. Table 24.

9. Merck & Co., Inc. 2006. Gardasil product insert: Serious
Adverse Experiences.

10. Food and Drug Administration. May 18, 2006. FDA Background
Document for Vaccines and Related Biological Products Advisory Committee.:
Gardasil. Table 32.

Competing interests:
None declared

Competing interests: No competing interests

07 August 2007
Croft Woodruff
Nutrition research and consultant
Omira Health Centers Inc., #104 - 233 West 2nd, North Vancouver BC V7O1B4