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NEWS: Janice Hopkins Tanne Questions over human papillomavirus vaccine in the US and Australia BMJ 2007; 334: 1182-1183 [Full text]

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Safety is important for any vaccine

Pendru Raghunath   (9 June 2007)

Adverse reaction to vaccine no surprise

Croft Woodruff   (7 August 2007)

Safety is important for any vaccine 9 June 2007
Pendru Raghunath, Senior Research Fellow Unesco-Mircen for Marine Biotechnology, College of Fisheries, Mangaloe-575002. Send response to journal: Re: Safety is important for any vaccine	I congratulate Mr. Janice Hopkins Tanne for providing valuable information on human papillomavirus vaccine in the US and Australia. However, i was surprised know about side effects of vaccine even after the FDA approval. Protective efficacy of this vaccine against different types of human papillomavirus was very low and the protection may be because of sub-clinical infection with human papillomavirus or antigenically related viruses. I feel safety is more important for any vaccine than efficacy. Competing interests: None declared
Adverse reaction to vaccine no surprise 7 August 2007
Croft Woodruff, Nutrition research and consultant Omira Health Centers Inc., #104 - 233 West 2nd, North Vancouver BC V7O1B4 Send response to journal: Re: 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