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H1N1 flu vaccines in Canada are being produced with a special chemical, called an adjuvant, that boosts the effectiveness of the shot. According to the NIAID this is generally done for one of three reasons: "1) to boost the immune response in certain age groups or in people with underlying health conditions who can not mount an adequate immune response to a vaccine made without adjuvant; 2) to broaden the immune response to a vaccine to provide better protection against a virus if it mutates; and 3) to stretch the vaccine supply if it is limited."("NIAID trials of 2009 H1N1 influenza vaccines plus adjuvant") One of the reasons to use an adjuvant for H1N1 vaccine production was that the virus apparently doesn't reproduce well in eggs, the medium used for growing the vaccine culture. While the United States went ahead with a non-adjuvanted vaccine after studies showed that only one dose would provide effective protection, Canada's vaccine producer GlaxoSmithKline (GSK) opted to add its own proprietary adjuvant called AS03. This choice was made partially to speed up vaccine production after initial problems were encountered, but also in reaction to requests from the World Health Organization to use "'antigen sparing strategies' to stretch supplies." ("Frequently asked questions about the swine flu vaccine") What is AS03? AS03 is an oil-in-water suspension based on squalene, a natural substance produced in the human body. It also contains DL-α-tocopherol (vitamin D) and polysorbate-80, the same stabilizer that keeps your salad dressing and ice cream from separating. Squalene is used in cosmetic products as an emollient that is easily absorbed by the skin. In vaccinations squalene prompts the production of C4 memory cells, which in turn promotes a stronger immune response. Using a squalene-based adjuvant such as AS03 - or MF59 which has been in European flu shots since 1997 - can make it possible to produce an effective vaccine using only one-fourth the usual amount of antigen. It is also a factor in making vaccines that contain only the protein or fragments of protein, rather than a weakened or killed pathogen as was traditionally done in creating vaccines. ("Benefit and doubt in vaccine additive") Adjuvanted Vaccines Longer to Approve While some vaccines are made to protect against a single source of illness that doesn't change much over time, influenza is constantly mutating. It is for this reason that seasonal flu shots must be given each year: the trends are analyzed from year to year and a vaccine is made to protect against the three strains predicted to be the most prevalent in the upcoming flu season. Every year a different combination of strains is present in the flu shot, so every year those who want to be vaccinated need a new shot. The basic procedure used to make the vaccine remains the same however, which allows health officials to go through the approval process more quickly. Because there have never been any adjuvanted influenza vaccines used in Canada approval cannot be "fast-tracked;" therefore the new H1N1 vaccine is taking longer to approve than would a seasonal flu vaccine. The vaccines in the United States are non-adjuvanted, and probably one of the reasons these were chosen was to speed up the approval process in order to get vaccines out to the public more quickly. Judging from the difference in severity of outbreaks between Canada and the United States, this seems to have been a wise decision. Safety of Oil-in-Water Adjuvants Over 40 million people have safely received MF59-adjuvanted influenza vaccine over a period of more than a decade. AS03 has been tested on 45,000 people. It does tend to increase local reactions at the site of injection, but adjuvants in this class are not associated with any other side effects in humans. ("Vaccine Safety - Questions and Answers") The decision to order non-adjuvanted vaccine for pregnant women and young children in Canada is based on recommendations of the World Health Organization. This is due to the fact that squalene-based adjuvants have mainly been used in vaccines administered to adults over age 65, and there is no data available on safety in expectant mothers or very young children. Non-adjuvanted vaccine will therefore be reserved for this population in particular. Availability of the Non-Adjuvanted Vaccine in Canada Recent announcements indicate that the AS03 adjuvanted H1N1 vaccine manufactured by GlaxoSmithKline will shortly be approved in Canada, and that distribution of the vaccine will begin almost immediately thereafter. "Pre-positioning" of the vaccine, shipping to the provinces in advance of approval, will make this possible. The non-adjuvanted vaccine, however, has not yet been shipped or approved. All indications are that pregnant women who want the non-adjuvanted vaccine will have to wait in line a while longer, despite the fact that they were identified as being among those who were most in need of the H1N1 vaccine. Pregnant women should discuss vaccination with their health care provider, as WHO recommendations did not rule out using adjuvanted vaccine if the non-adjuvanted version was not available. Health Canada officials point out that some countries are vaccinating everyone with adjuvanted vaccine. They recommend expectant mothers go ahead and take whatever vaccine is available, as soon as possible. Pregnant women were recently identified as one of three groups at highest risk for severe illness or death from swine flu. The other groups are children under age two, and people with chronic respiratory illnesses such as asthma. In Quebec, pregnant women may also be advised to apply for preventive leave in order to protect themselves and their unborn babies. H1N1 influenza will not cross the placenta, but the respiratory symptoms in pregnant women are more severe than in the general population, and this can have negative repercussions for the pregnancy. Related Stories: H1N1 Vaccines Available in Canada Earlier Than Expected | Pregnant Women and H1N1: Quebec Offers Preventive Leave Sources: "AS03" Wikipedia "Adjuvant effect on H1N1 vaccine" Vincent Racaniello (Virology Blog) "Benefit and doubt in vaccine additive" Andrew Pollack (New York Times) "Conflicting advice offered to pregnant women on H1N1 vaccine" Maria Babbage (Canadian Press) "Frequently asked questions about the swine flu vaccine" Angela Mulholland & Dr. Neil Rau (CTV News) "H1N1 vaccine approval expected this week" Meagan Fitzpatrick (Canwest News) "H1N1 vaccines for pregnant women not yet ready" Meagan Fitzpatrick (Canwest News) "H1N1: To vaccinate or not to vaccinate?" Aaron Derfel (The Gazette) "NIAID trials of 2009 H1N1 influenza vaccines plus adjuvant" National Institute of Allergy and Infectious Diseases "Pregnant Ont. women face H1N1 vaccine delay" CBC News "Safety of squalene" World Health Organization "Squalene" Wikipedia "Vaccine Safety - Questions and Answers" City of Ottawa |
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