Why Is the Swine Flu Vaccine Creating Controversy?

Why is the swine flu vaccine creating controversy?

Flu season is approaching, and fear is riding along. Many people are aware that the H1N1 virus could re-emerge with a vengeance once the time for seasonal flu is upon us. Thankfully, a vaccine is currently being tested for potential release before “traditional” flu and the H1N1 virus or “swine flu” have a chance to hit us with a double whammy.

However, there are still other people who are afraid of the vaccine itself. In fact, fears surrounding the swine flu vaccine are growing by the day. First we heard from groups concerned that there may not be enough of the vaccine to go around (some estimates put the total number of ready vaccines at the start of flue season somewhere around 60 million doses, a far cry from what is needed) — now, people are pointing to the 1976 swine flu epidemic, also treated with a vaccine. The problem then? After receving vaccinations, hundreds of people came down with Guillain-Barre syndrome allegedly related to that vaccine.

I say allegedly because nothing has ever been proven. Sure, the illnesses lent bad publicity to the creators of that vaccine, and the program was halted only after an estimated 40 million Americans received the vaccine, but no scientific proof exists to link the 70s era swine flu vaccine and Guillain-Barré syndrome.

Regardless of any medical “proof”, many people are remembering what happened over 30 years ago and voicing their concerns about what might happen with the current round of planned vaccinations. Also, there’s a new buzz word in the game of vaccine fear — “adjuvant”. What is “adjuvant”, and why are people angry about its addition to the proposed swine flu vaccine?

An adjuvant is “something that allows the immune system to respond with higher levels of effectiveness,” according to the pharmaceutical company Aventis Pasteur. Basically, an adjuvant is an additive that could eventually lower the amount of vaccine needed per person, opening up the door for more individual doses to be available.

Consumers are most likely concerned about adjuvants because they haven’t heard of them before. However, adjuvants (which are mostly made of different forms of aluminum) are already in use in the United States, and if you’ve had a vaccine in the past twenty years, you’ve already been in contact with them. Adjuvants are currently used in vaccinations for everything from hepatitis A and B, to diphtheria-tetanus-pertussis vaccines.

According to researchers working on the new swine flu vaccine, the adjuvant in the current incarnation of H1N1 vaccine would be a water-oil mixture.

The first run of drug trials on the new swine flu vaccine will use a form without adjuvants — the reason why is unclear — but later trials of the vaccine will use an adjuvanted form, but only if deemed necessary. This is also a point of contention for many people, who worry that testing a vaccine that isn’t identical to the vaccine that will be released is dangerous and pointless. The reason why unadjuvanted forms are being tested is simple. To the medical community, it is unneccessary to test a vaccine ingredient that has already been in use in this country for decades.

Consumers, having never really heard of adjuvants, are assuming this is a new addition to vaccines.

The hope for adjuvant use is simple — in the future, vaccines with adjuvants will require much smaller doses while giving patients an even better immune response. Less of a drug to get a better result means higher profits for vaccine manufacturers and better results for patients, not to mention more individual vaccine doses available for clinical use. The ability of the medical community to stretch this year’s supply of swine flu vaccine is a major issue. Fears about a shortage of swine flu vaccine could be put to rest if the doses could be split in two — that would bring the reported number of available doses at flu season’s outset to 120 million. The short answer on adjuvants — they will give a patient a better immune response while increasing the likelihood that all patients who need the vaccine will get it.

An example of how an adjuvant works — a bird flu vaccine is being tested in Asia. This vaccine is made up of 90 micrograms of an antigen (the ingredient that gives a patient an immune response) that could be reduced to as little as 3 micrograms in the presence of an adjuvant. This is allowing the manufacturer to split what was once a single dose into 24 usable doses of vaccine.

The flu vaccine that most of us get every year requires about 15 micrograms of antigen. Imagine a vaccine containing an adjuvant that could bring that number down to about 1 or 3 micrograms. With a smaller dose, there is less chance for complications and more vaccine to go around.

Still, it is difficult to look past the fact that vaccines have a history of safety concerns in this country, some legit concerns mixed up with the standard American paranoid response. For instance, when news broke that no flu vaccine ever used in the United States has contained an adjuvant up to this point, people immediately questioned the need for adjuvants this time around.

The simple answer is this — adjuvants weren’t used in flu vaccines because adjuvants weren’t necessary. Flu vaccines in America work well — doctors see a great immune response from the products already on the market. The addition of an adjuvant to a vaccine that didn’t need it would have been a wasteful and costly decision, and that cost would have passed down to you and me, the consumers.

If adjuvants are going to be used in this year’s swine flu vaccine, they will probably be used mostly for adults and the elderly — groups where the additives have been tested. In other words, children’s vaccines would not come with adjuvant, mostly because adjuvants haven’t been tested in children.