While Swine Flu Vaccine Has Been Declared "Safe", Novel Adjuvants Will Be Used Before Any Meaningful Testing has been Conducted

Dr. Meryl Nass is an expert on vaccines.

Over the years, I have found Dr. Nass to be reasonable, balanced and well grounded in science in her discussions about the anthrax attacks and the criminal investigations into Dr. Hatfield and Dr. Ivins. So I wanted to see what she thought about the safety of the swine flu vaccine.

On July 3rd, Dr. Nass discussed the use of the adjuvant called "squalene" in swine flu vaccines (an adjuvant is a chemical which increases the body's reaction to a vaccine, and thus stretches the number of doses which a given quantity of vaccine can produce):

The US government has contracted with at least 5 pharmaceutical manufacturers to develop and produce H1N1 vaccines, using a variety of platforms and manufacturing methods...

A novel feature of the two H1N1 vaccines being developed by companies Novartis and Glaxo-Smith Kline is the addition of squalene-containing adjuvants to boost immunogenicity and dramatically reduce the amount of viral antigen needed. This translates to much faster production of desired vaccine quantities.

Each company has its own proprietary adjuvant, acquired in each case at high cost and intended for the high-stakes business of rapidly producing vaccines for novel pandemics or biological warfare threats.

Novartis' adjuvant is named MF59, and Glaxo's is ASO3. We know they work beautifully to strengthen vaccine efficacy. But how safe are they?

That is a very difficult question to answer. Novartis claims MF-59 has been used safely by over 40 million people. However, FDA has not seen fit to approve even a single US vaccine that contains these novel adjuvants.

On August 11th, ABC News wrote an article entitled "Swine Flu Vaccine: What The Heck Is an Adjuvant, Anyway?" Commenting on the ABC article, Dr. Nass wrote:

One error in the article is this statement: "No link has ever been proven between vaccine and Guillain Barre" Syndrome (GBS). Actually, about ten separate studies of the 1976 swine flu vaccine confirmed that the rate of GBS increased 6 to 10 fold in the 6-8 weeks after vaccination. The link has been absolutely confirmed in all the medical literature. I discussed it as an expert witness in a legal case and the opposing attorney didn't challenge the link...

Fauci continued, "There's not a lot of data on adjuvants in young kids--even from the Europeans." [Not to mention lack of data in pregnant women, the potential to cause cancers, etc.--Nass]

Here's a key point: novel adjuvants stretch the supply, so from the perspective of getting enough vaccine for the country or the world in a hurry, they would be indispensable. But from the point of view of the individual, the risk-benefit calculation is problematic.

The June 19, 2009 Science magazine discussed use of novel, antigen-sparing adjuvants for the swine flu pandemic. It quoted Norman Baylor, director of FDA's Office of Vaccine Research and Review, who pointed out that antigen-sparing strategies benefit populations, not individuals. "You have to think about those trade-offs," Baylor said.

If Baylor doesn't understand the issue of novel adjuvant safety, then nobody does.

On August 15th, Dr. Nass noted that British doctors are weary of the vaccine, as it contains squalene:

The Daily Mail reported on letters sent to 600 neurologists in the UK by its Health Protection Agency, asking them to be observant for, and immediately report, cases of Guillain-Barre Syndrome [GBS].

The letter is a tacit acknowledgment of the risk of using an untested vaccine with novel ingredients. But it also indicates that the UK's health services are cognizant of the risks and are taking them seriously, setting up improved surveillance so that if the vaccine does cause Guillain-Barre, vaccinations can be stopped promptly. Bravo.

However, the risk does not begin and end with Guillain Barre Syndrome, as Dr. Tom Jefferson, head of the Cochrane Collaboration vaccine group pointed out in the article. Cochrane performs meta-analyses of the entire world literature on medical therapies. Unfortunately, Cochrane has not found any literature on the squalene-containing adjuvants set to be used in some (most?) swine flu vaccines:

‘New vaccines never behave in the way you expect them to. It may be that there is a link to GBS, which is certainly not something I would wish on anybody.

‘But it could end up being anything because one of the additives in one of the vaccines is a substance called squalene, and none of the studies we’ve extracted have any research on it at all.’

That is the bigger problem: the potential variety of adverse reactions to the vaccine is very large, and it will be very difficult to sort out quickly (before tens or hundreds of millions have been vaccinated) which might be vaccine-related.

On August 23rd, Dr. Nass wrote:

The Washington Post's Rob Stein updates us ...:

Another wild card will be whether the vaccine will be delivered with an "adjuvant" to boost its effectiveness or stretch limited supplies into more doses. Adjuvants have been used in Europe, but the Food and Drug Administration has not authorized their use in the United States.

Officials stress that they are proceeding cautiously. A final decision to move forward will not be made until they get the results of clinical trials -- testing to determine safety and dosing -- and assess the virus's threat. But officials are confident the vaccine will pass muster and expect a campaign will be launched as soon as manufacturers deliver the first vials.

Authorities are adamant that vaccination will be voluntary, and they say there is no reason to think the vaccine will be any less safe than the usual flu vaccine. An adjuvant will be used only if necessary and proven safe, they say...

[So tests of swine vaccines using novel adjuvants won't start until mid to late September, but vaccine is expected to be available for use in mid-October. If I understand this correctly, the adjuvants will have been tested for less than 4 weeks when they start being used. Yet autoimmune side effects take months to appear, in general. GBS took 4-8 weeks. Why aren't they already in US clinical trials?!--Nass]

And on August 24th, Nass pointed out:

A US News article of Aug 21 claimed,

"Early results for this first trial among adults have found the vaccine to be safe with no serious side effects," said Tony Fauci.

Yet the reportage is misleading. Since none of the US trials have so far used novel adjuvants, they fail to provide any information about the safety of MF59 or ASO3-adjuvanted vaccines.

Dr. Nass - an expert on Gulf War Syndrome - has also pointed out that the official, Congressionally-chartered Research Advisory Committee on Gulf War Veterans' Illnesses found evidence of a link between squalene and Gulf War Syndrome which warranted further study.

I asked Nass if the rumors that the swine flu vaccine contains much higher amounts of squalene than the Gulf War vaccine is true. She responded by email:

No one knows how much, if any, squalene was in which vaccines used in the Gulf War vaccine, as the government has denied using it and there was no vaccine tested independently.

However, compared to the parts per billion squalene measured in 5 lots of anthrax vaccine by FDA around 2000, use of current squalene-containing adjuvants is likely to provide many orders of magnitude more squalene per vaccine dose than found by FDA.

No one knows what this means: i.e., how much it takes to cause adverse effects and what kind, in which populations.

Update: Someone in the medical field sent me the following comment by email:

For what it's worth, my understanding from a drug/vaccine rep from
one of the vaccine companies is that there will be a live weakened
intranasal vaccine for H1N1 available (similar to Flumist). It
shouldn't have or need an adjuvant (adjuvants are used in injectable
vaccines to cause the body to notice and react to the antigen you are
trying to produce immunity to - Aluminum is the most commonly used
adjuvent).

So, for anyone who wishes to be vaccinated for H1N1 but not via a
shot (which will no doubt contain some sort of adjuvant) there will
be an alternative (it would probably only be recommended for the
populations who qualify for Flumist, but that hasn't been clarified
for us - Flumist the intranasal live weakened vaccine for the regular
flu is approved for patients over 2 who don't have a condition such
as asthma that's contraindicated with it).

Currently the H1N1 doesn't seem any worse than the regular flu, but
there have been some deaths (the regular flu causes deaths every year
too). The H1N1 like the regular flu is more dangerous and more likely
to cause serious illness and death in certain groups such as pregnant
women, so it might be more important for some groups to be immunized
than others.

If H1N1 transformed into a nastier bug and became drug resistant the
flu vaccine could become very important for everyone who doesn't have
immunity though.

At this point it looks like distribution of vaccine will be through
the government (probably at schools, libraries and other public
venues that are felt to be easy places to vaccinate large numbers of
people who want/need vaccine) rather than private offices. My
understanding is that high risk populations such as pregnant women
and children and health care workers will be prioritized.

Anyway, I hope this info is helpful.