From results of a news poll released October 22, ABC News/Washington Post reported that 62% of Americans are considering not taking the H1N1 vaccine. The main reasons include:
- Safety concerns
- Worry about side effects
- Doubts whether the vaccine has been sufficiently tested.
This article may be controversial, so all statements have been carefully sourced to government health websites.
Has the H1N1 Vaccine been Properly Tested?
Although government health agencies are officially touting the vaccine as safe and effective, the fine print on those agencies' own websites may tell another story.
Material here is from Health Canada (Health Canada, "Product Information Leaflet Arepanrix™ H1N1 AS03-Adjuvanted H1N1 Pandemic Influenza Vaccine", Version 1, October 21, 2009 ) unless otherwise cited; italics for emphasis are by the author.
- Approval of the vaccine included "clinical data in humans from a small safety and immunogenicity study to indicate that the H1N1 flu vaccine is safe" (Public Health Agency of Canada, H1N1 Flu Virus FAQ, Oct 20 2009 update).
- "In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products."
- "There is currently limited clinical experience with Arepanrix™ H1N1, and limited clinical experience with an investigational formulation of another AS03-adjuvanted vaccine containing the same or a slightly higher amount of antigen derived from A/California/7/2009 (H1N1) ) in healthy adults aged 18-60 years and no clinical experience yet in the elderly, in children or in adolescents."
- The safety and immunogenicity (effectiveness) of the vaccine are based on testing of other similar vaccines for the H5N1 influenza virus. For example, on "limited immunogenicity data from 2 studies obtained three weeks after administration of a single dose of an investigational formulation of another AS03-adjuvanted H1N1 vaccine containing either 5.25 µg or 3.75 µg HA derived from A/California/7/2009 (H1N1) (Pandemrix™) to healthy adults aged 18-60 years."
Yes, the safety and effectiveness of the H1N1 flu shots are estimated, based on limited studies involving a totally different vaccine with a totally different adjuvant (see below) called AS03.
H1N1 Vaccine – "No Clinical Data"
A repeated refrain in this Health Canada document is that there is simply no clinical data:
- "The need for a second dose is currently unknown."
- For the elderly (> 60 yrs): "No clinical data are available for Arepanrix™ H1N1 in this age group."
- For children and adolescents: "No clinical data are available for any influenza vaccines with AS03 in this age group."
- For pregnant women: "No data have been generated in pregnant women with Arepanrix™ H1N1 nor with the prototype AS03 adjuvanted H5N1 vaccine. Data from vaccinations with seasonal trivalent influenza vaccines in pregnant women do not indicate that adverse fetal and maternal outcomes were attributable to the vaccine."
- For lactating women: "No data have been generated in breastfeeding women."
Data will be collected in "rolling trials;" in other words, as people are vaccinated, the results will be collected and used to guide further vaccination procedures.
The argument seems to be that since previous vaccines were okay, probably this one will be too. Given these quotes, though, it's easy to conclude that the health authorities just don't know for sure what the effect of this vaccine will be.
Adjuvants in the H1N1 Vaccine for Swine Flu
The Center for Disease Control and Prevention (CDC) states that, "A vaccine adjuvant is a substance that is added to the vaccine to increase the body's immune response to the vaccine.... Seasonal influenza vaccines used in the United States do not contain adjuvants."
The adjuvants in the swine flu vaccine include DL-α-tocopherol, Squalene, and Polysorbate. (Health Canada). Squalene in previous vaccines has been implicated in long-term health problems (although the World Health Organization argues convincingly against this; see "Squalene-based adjuvants in vaccines" on the WHO site).
Based on quotes from Health Canada and the CDC, the implication is clear that the vaccine has had limited testing at best. Those 62% of Americans (and 50% of Canadians, according to various media reports) concerned about the safety of the H1N1 Vaccine may in fact have some reasonable basis for their concerns.
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