A: The product from GlaxoSmithKline, Canada's sole provider of H1N1 vaccine, called Arepanrix, uses an adjuvant called AS03, which consists of squalene (shark liver oil), DL-alpha-tocopherol (vitamin E) and polysorbate 80 (an emulsifier also used in ice cream). There are claims about the dangers of squalene but very little evidence to back them up. For example, it is claimed that the adjuvant used in the anthrax vaccine was to blame for Gulf War syndrome, but there was not adjuvant in that vaccine.
Q: This is a new, experimental vaccine. Has it been properly tested?
A: The H1N1 vaccine is similar to past flu vaccines, which have a good safety record. New versions of the flu vaccine do not require new human trials each year. The controversial aspect of Arepanrix is the adjuvant. While adjuvants have been used in vaccines for some time, AS03 has undergone limited safety testing. Health Canada insists that there have been no shortcuts taken in the approval process for the vaccine.
Q: What do you mean by limited safety testing?
A: Approximately 45,000 people have received a flu vaccine containing AS03 but that was a vaccine designed to protect against H5N1 (avian influenza) not H1N1. A similar adjuvant, MF59, has been used in about 40 million vaccinations in Europe.
Q: Is H1N1 vaccine safe?
A: Like every drug, the H1N1 vaccine has benefits and risks. The benefit is that it can prevent infection with swine flu - though the protection is not 100 per cent. The risks for most people are minimal, some redness and maybe a slight fever but in rare cases, there can be serious complications like Guillain-Barré syndrome. But those risks are not unique to this vaccine. And bear in mind that vaccines are among the safest drugs on the market.
Q: Isn't there mercury in the vaccine?
A: Flu vaccine is packaged in vials that contain multiple doses; to avoid contamination, a mercury-based preservative called thimerosal is added. One dose of vaccine contains about 5 micrograms of mercury; a tuna sandwich contains about 25 micrograms of mercury. There are persistent claims that mercury in vaccines causes autism but this has been debunked.
Q: Should pregnant women get the H1N1 vaccine?
A: Pregnant women, whose immune systems are suppressed, are at high risk of complications from the flu. Therefore, it is recommended that they be the first in line to get the H1N1 vaccine. The H1N1 vaccine that is recommended for pregnant women does not contain adjuvants.
Q: If adjuvants are safe, then why the exception for pregnant women?
A: The short answer is that there is no safety data related to pregnant women, so officials are erring on the side of caution. The World Health Organization says pregnant women should get non-adjuvanted vaccine where possible, but that an adjuvanted vaccine could be used if necessary.
Q: Is it true there is no non-adjuvanted vaccine available? In that case what should a pregnant woman do?
A: The federal government has purchased some non-adjuvanted vaccine from Australia and it is waiting for a Canadian-made version to come out of production in a few weeks. But none is yet available. As the risks are greater for women who are further along in their pregnancy, those in the third trimester should get the adjuvanted vaccine, and as soon as possible. Women in their first and second trimester can choose to wait or get the vaccine that is available now. The risk of adjuvants is theoretical. The risk of the flu is real.