As a pro-safety drug- and vaccine advocate, I believe it?s imperative to be able to unequivocally prove that a drug or vaccine will cause no harm, AND be able to show that it offers measurable benefit, before releasing it to market. This is especially important when we?re dealing with pregnant women and young children.

Neither is true for the flu vaccine during pregnancy, and even less so for the H1N1 vaccine when given to pregnant women.

Flu vaccine manufacturers clearly indicate that safety and effectiveness of their flu vaccines have not been established for pregnant women and nursing mothers. Ditto for their H1N1 vaccines.

Heartbreaking Stories of Losses After H1N1 Vaccination

The source links above contain personal stories of heartbreak ? women who lost their babies just hours or days after getting the H1N1 vaccine this year. Naturally, the standard comeback is that miscarriages are commonplace, and surely have nothing to do with the vaccine. However, to simply dismiss these events as ?coincidences? is a serious mistake.

Perhaps some of the 20 women on one of the blogs would have miscarried anyway, but when a number of women have healthy, uneventful pregnancies up until they?re injected with a vaccine, and then suddenly miscarry, it most certainly warrants investigation!

Be Part of the Solution ? REPORT All Side Effects to VAERS!

I'm willing to bet that most of these incidents have not been properly reported to the authorities, and this is something everyone needs to be better informed about.

Please know that any time you take a pharmaceutical drug, or are injected with a vaccine of any kind, you need to report any and all side effects to your doctor and insist that he or she report it to the Vaccine Adverse Event Reporting System (VAERS). Ask to get a copy of the report to make sure it was done.

Also know that YOU can report it yourself! You don?t have to go via your doctor.

The VAERS web site allows you to fill out an adverse event report on your own.

Unfortunately, since reporting side effects to VAERS is voluntary, only one to 10 percent of all side effects are ever reported!

Yet VAERS can serve a vital function, alerting authorities to significant problems with various drugs and vaccines. We NEED this information, because without it, authorities and drug makers can simply continue to say that a drug or vaccine has been used safely for a number of years, without ever having done any real studies and follow up.

The truth is, we know extremely little about the true safety and effectiveness of most drugs and vaccines on the market.

None of the H1N1 Flu Vaccines Have Ever Been Tested on Pregnant Women

If you are willing to be a guinea pig, then so be it. But I urge you not to be. It?s simply not your responsibility to subject yourself to this type of cruel field testing. Know this: the vaccine manufacturers and the doctors administering the shots are legally protected, should something go wrong. You cannot sue them for damages.

If you read the package inserts, you?ll find that NONE of them have ever been tested for safety and effectiveness in pregnant women and nursing mothers, and none of them are recommended for pregnant women ?unless clearly needed.?

(And this is something I?ll get to in a moment?)

You also need to understand that no reproduction studies have been done to determine how these flu vaccines (whether for seasonal- or the H1N1 vaccine) affect future fertility, and whether or how they affect a developing fetus.

So truly, YOU are little more than a test subject; a statistic that may or may not be counted, depending on whether your side effects are properly reported and investigated, should something go awry.

In the US, four H1N1 vaccines have achieved FDA approval, and you can read their package inserts by clicking on the hyperlinks below:

• MedImmune (intranasal spray)
• Novartis
• Sanofi-Pasteur
• CSL Biotherapies, Inc.

For more information about these vaccines, and a quick review of each vaccine?s list of ingredients, please see my previous article A Review of Four Approved Swine Flu Vaccines? Ingredients.

How Effective is the H1N1 Vaccine, Really?

If you read through the package inserts (hyperlinked above) for the injectable, inactivated flu vaccines, you will find the following paragraph:

"Specific levels of HI antibody titers post-vaccination with inactivated influenza virus vaccine have not been correlated with protection from influenza virus. In some human studies, antibody titers of 1:40 or greater have been associated with protection from influenza illness in up to 50% of subjects."

What that paragraph explains, is that, to the best of our knowledge, the vaccine only works in half, or less, of those individuals who attain the specified level of seroconversion after vaccination.

The FDA defines seroconversion as achieving an antibody titer of 1:40.

This means that if a vaccine was 100 percent effective at achieving this level of seroconversion, it would protect up to 50 percent of the recipients of the vaccine.

But none of the vaccines are 100 percent effective at achieving seroconversion.

CSL's vaccine insert, for example, (see pages 11-12), states that their H1N1 vaccine provides seroconversion for:

• 48.7 percent of people aged 18-65
• 34 percent for seniors, 65 and older

That means that, at best, their vaccine works in one out of every four people! (49 percent of 50 percent).

Which, of course, means that the vaccine does NOT work in three out of every four people?

Is a 25 percent chance of reaping any sort of benefit worth the risk, especially if you?re pregnant?

Many health officials and doctors say this benefit is worth the risk, and urge pregnant women to get vaccinated with one or both flu vaccines this year. They claim the potential dangers inherent in getting sick with the flu while pregnant is a far more significant than any potential danger from the vaccine.

But is that really true?

How Dangerous is the Flu While Pregnant, and is Flu Vaccination Warranted?

A paper published in the summer 2006 issue of the Journal of American Physicians and Surgeons, titled Influenza Vaccination During Pregnancy: A Critical Assessment of the Recommendations of the Advisory Committee on Immunization Practices (ACIP), concludes that the flu vaccine recommendation for pregnant women should be withdrawn as:

a) flu is rarely a complication for pregnant women, and

b) no safety studies have been done

The authors? state:

?Influenza vaccination during all trimesters of pregnancy is now universally recommended in the United States. We critically reviewed the influenza vaccination policy of the CDC?s Advisory Committee on Immunization Practice and the citations that were used to support their recommendations.

The ACIP?s citations and the current literature indicate that influenza infection is rarely a threat to a normal pregnancy.

There is no convincing evidence of the effectiveness of influenza vaccination during this critical period.

? The ACIP policy recommendation of routinely administering influenza vaccine during pregnancy is ill-advised and unsupported by current scientific literature, and it should be withdrawn??

Interestingly, it explains that the ACIP?s recommendations are based on just TWO scientific papers that support the claim that the flu is more serious during pregnancy than at other times, and points out the multiple flaws with each of these two studies.

Here?s an excerpt explaining the lack of true evidence presented by the first study:

?A British study compared maternal and neonatal outcomes in women infected with the influenza virus during the second and third trimesters of pregnancy with those of pregnant, uninfected controls. Only 11% of the 1,659 pregnant subjects had serological evidence of the illness; none had detectable influenza A-specific IgM.

There was also no evidence for transplacental transmission of the influenza virus, or autoantibody production in influenza-complicated pregnancies. Influenza infection had no significant impact on labor outcomes, health of the newborn, or maternal well-being.

The authors claimed that overall ?complications? in pregnant women with influenza infection occurred more frequently than in controls; however, no individual complication achieved statistical significance.

Many of the listed complications appeared to be subjective complaints such as chest pain and ?taking medication,? rather than specific diagnoses, and some could have been related to comorbid conditions that the authors failed to address.

While there was only one recorded case of pneumonia during pregnancy, an uncommon but serious complication of influenza, all other ?complications? lacked biological plausibility.

When such nonspecific complications were excluded, there were no significant differences between the two groups??

Another interesting fact brought to light in this paper is that, ironically, some of the ?evidence? used to create the recommendation for flu vaccination for pregnant women shows that it may cause more harm than good!

?Munoz et al. also failed to demonstrate effectiveness of influenza vaccination in pregnancy during five influenza seasons (1998-2003). Rates of upper respiratory tract infection did not significantly differ between vaccinated and unvaccinated women.

Paradoxically, the authors found four times as many influenza-like illness-related hospitalizations in vaccinated women (2.8% vs 0.7%), an observation similar to that of Neuzil et al (2.2% vs 0.7%) [the second study used to support the ACIP recommendation].

These observations not only challenge vaccine effectiveness, but also raise concern that vaccination actually carries added risk of influenza-like illness.? [Emphasis mine.]

Lastly, the paper questions the rationale for using a polio vaccine study ? which was rejected by the Institute of Medicine on the basis of flawed study design ? in support of their decision that flu vaccinations are safe for pregnant women.

The authors called the decision ?peculiar.?

Indeed?

Final Thoughts

Hopefully, this information will help you weigh the risks and benefits to make a more educated decision for yourself and your family. No one can, nor should, make this decision for you.

I urge you to continue educating yourself about vaccines before yet another generation is lost to medical arrogance and greed.