The vaccine was released with very little clinical testing done on it, and absolutely none on pregnant women. Then, in a shoot first, ask questions later move, the National Institutes of Health and vaccine manufacturers began seeking pregnant volunteers for several H1N1 vaccine safety trials.
Meanwhile, women who believe that this vaccine caused them to lose their babies are forming support groups and blogs to record their experiences, with the intent of warning others not to get the vaccine.
But in reality, pregnant women should not be getting any vaccines.
Safety, as in when it comes to children, we should be especially vigilant in making sure that extensive clinical trials have proven a particular vaccine is unequivocally safe before it's given to a child – including a child in the womb of a pregnant woman.
Unfortunately – and tragically for some – the CDC, FDA and ACIP (Advisory Committee on Immunization Practices) don't think the same way.
Miscarriages, Stillbirths are Being Reported
It was bad enough that blogs around the U.S. and newspaper reports in Great Britain began reporting miscarriages, stillbirths, and other ill effects in mothers and their babies almost as soon as the H1N1 vaccination campaign started.
Since then, according to the H1N1 Vaers summary report, 9,319 adverse reactions of all sorts were reported through, January 29, 2010, including 46 deaths. Some of those reports are of miscarriages, which have been tallied by a group of women who have formed a support group for women who believe the vaccine caused them to lose their babies.
Putting the Cart Before the Horse
If you go to the government's website on clinical trials, you will see that at least one vaccine manufacturer is still recruiting pregnant volunteers for testing the safety and efficacy of the H1N1 vaccine.
First, let me say that I question the ethics of doing any kind of pharmaceutical testing on pregnant women. But the sad thing about this testing is that it didn't start until months after the CDC ordered women and their unborn babies to the head of the H1N1 vaccine line!
Talk about putting the cart before the horse!
As I've reported in previous articles, this vaccine has NEVER been tested in pregnant women – until now. That's because, when it comes to "emergencies" such as pandemics, certain things like clinical trials can be dismissed in order to speed up the delivery of what officials define as life-saving drugs.
In other words, making H1N1 an emergency gave officials the right to shoot first, and ask questions later, when it came to safety trials for this vaccine.
Government Guidelines Have Double Standards for Pregnant Women
One place that women go when they're looking for information on how to have a healthy pregnancy and baby is the CDC's own website. There, under "Birth Defects: Having a Healthy Pregnancy," they list the ABC's of pregnancy tips for making sure nothing bad happens to your baby while you're pregnant.
I find it interesting, if not ironic, that the "A" of the ABC's is:
Avoid exposure to toxic substances and chemicals – such as cleaning solvents, lead and mercury, some insecticides, and paint. Pregnant women should avoid exposure to paint fumes.
A hyperlink under "toxic substances" takes you to the March of Dimes website, which expounds on all kinds of substances that can harm or disrupt embryonic development.
The "C" is cigarette smoking, which can cause major health problems for both mother and child, from birth defects, to premature delivery, to Sudden Infant Death Syndrome (SIDS), and more.
The "L" of the ABC's is for legal drugs such as alcohol – which has no known safety level – and caffeine, which can be found in many over-the-counter drugs, off-the-shelf foods and in beverages besides coffee and tea.
"O" is a warning to avoid certain over-the-counter drugs that contain ingredients to be avoided during pregnancy.
So – if you're pregnant, the CDC advises you to avoid smoking, alcohol, caffeinated food, drugs, paint fumes, pesticides, and other environmental toxins that you might breathe, ingest or even absorb through your skin.
But what do they tell you about vaccines – many of which contain the very substances they tell you to avoid, such as formaldehyde, pesticides, and mercury?
'V' is for Vaccines
Vaccines are a "very important concern" during pregnancy, the CDC says under the "V" of the ABC's of pregnancy. A non-working hyperlink directs you to what is suppsed to be the CDC's website on getting vaccines during pregnancy.
If you do your own search through Google, you'll come up with the right site, here, where you'll find which vaccines the CDC recommends for pregnant women, and which ones they don't. For example, the measles shot is a no-no. So is the live flu virus.
But the regular flu shot is recommended, even though studies have shown that flu vaccinations don't make a bit of difference in whether a pregnant woman is going to get sick with the flu or not (read further down for more on that).
The point is, the CDC goes to great lengths in spelling out the ABC's of protecting an unborn baby from all kinds of toxic substances – except those in vaccines.
CDC: Say No to Toxic Substances – Unless They Come in a Vaccine
The reason the CDC doesn't recommend live flu virus vaccine for pregnant women, the site says, is because of the "theoretical" risk of transmission of the virus to the fetus.
The word "theoretical" is repeated a couple of times on their site. The risk is theoretical, the CDC says, because:
"No evidence exists of risk from vaccinating pregnant women with inactivated virus or bacterial vaccines or toxoids."
In other words, the CDC is saying that it knows for certain that breathing paint fumes, drinking coffee or alcohol, or being exposed to such things as pesticides and mercury can definitely pose a possible hazard to your unborn baby – but when it comes to vaccines, they want you to believe that no risk exists.
Nothing could be further from the truth!
What the CDC isn't bothering to tell you is that one reason no evidence of risk exists is because several vaccines, including the ones for the flu, have never actually had any clinical trials done on pregnant women. Until now.
Before Novartis and the other manufacturers started their flu vaccine clinical trials for pregnant women this fall, all they had was the public health experiments called post-marketing surveillances.
And that is no comfort to Connie Sylvester, an Ohio mother who lost her baby just one week after she got the H1N1 shot.
'I Wish I Had Known'
Connie was 16.5 weeks pregnant when she went to a flu clinic on October 22, last year. She'd just had her regular prenatal checkup on October 16, and everything was fine, she said.
"I had ultrasounds and heard my baby's heartbeat many times," she said. "I have two other children, with no problems in my pregnancies. This was a normal one, too. And then I got my flu shot."
Her H1N1 shot was a multi-dose vial, which was not thimerosal- (mercury) free. Connie was given a Vaccine Information Sheet, which is mandated by the federal government with all vaccines, but she was not told that no safety studies had ever been done on pregnant women.
"That was a Thursday," Connie said. "By Saturday I was feeling really bad. Sunday I was bent over with cramping. Monday I called my doctor, and she gave me a pain prescription. Tuesday, the pain was still so bad, I went in the office for the doctor to check me. Then Wednesday my water broke, and I delivered a dead baby on Thursday, October 29."
Connie's obstetrician refused to even consider that the shot could be connected with her miscarriage. The doctor also refused to make a report to VAERS.
"So I had to do it myself," Connie said.
Autopsy Showed a Normal Baby
Determined to find out why she lost her baby, Connie demanded an autopsy on the child – and learned that there was absolutely nothing wrong with her baby, nothing that would have triggered death and spontaneous abortion.
As a result, Connie believes that the vaccine did something to her body that caused her to lose her baby. In the weeks since, Connie has done two radio talk shows in an effort to call attention to the possibility of miscarriage after the H1N1 shot.
She also formed an advocacy group, the National Coalition of Organized Women, and has posted her phone number – (614) 893-8775 – on media websites in an effort to encourage other women who have suffered an adverse reaction to vaccines to call her.
"My doctor to this day will not admit a connection to that shot. She told me to not even consider trying to connect that shot with losing my baby, that the two were not related," Connie said.
"But I know that's what did this. I think it was the mercury in the shot. Pregnant women should not be getting any vaccines. I asked my doctor if this shot was safe. Now my baby is dead.
If I had known what I know now, I would never have gotten this vaccine. I wish I had known."
What Do We Know About Vaccines and Pregnancy?
Scientists already know that physiological changes in a woman's body during pregnancy can alter her metabolism and the way her body absorbs drugs. One of the most succinct evaluations that I have found on those changes come straight from the CDC.
In a six-part series, "Treatment of Pregnant Women for Infections and Bioterrorism Emergencies: Special Physiologic Features of Pregnancy," the CDC explains that drugs in a pregnant woman's body are affected by four major factors:
Those four factors are influenced by increased progesterone, the woman's digestive system, her blood flow – which is increased because of a 30-50 percent increase in cardiac output – and even plasma volume, which can increase the volume of a drug in her system.
The enzyme activity in her liver changes too, meaning a drug she ingests may not be metabolized in the same way it would, were she not pregnant. (Most drugs are metabolized in your liver.) Changes in kidney function can also affect how a drug is eliminated from her system.
Another factor is the woman's stage of pregnancy – with hormones fluctuating week to week and month to month, from inception to birth. Her blood flow, heart rate and liver and kidney function change also, meaning she may not metabolize a drug in the first few weeks of pregnancy the same way she would near the end of her pregnancy.
What I found most interesting about this lengthy series is that the CDC acknowledges its own ignorance on how a pregnant woman's immune system works:
"How these immune alterations affect maternal response to vaccination during pregnancy is unknown," the CDC says. "…limited data on several vaccines (e.g., hepatitis B, influenza, group B Streptococcus) suggest that the immune response of pregnant women to these vaccines is similar to that of nonpregnant women."
Suggest? I thought we were talking science here, not suggestions based on limited data.
The truth is, it is not science to assume that one vaccine's trial results would be like another's. If the CDC isn't aware of that, at least the manufacturers are. For example, Sanofi Pasteur says so in the package insert for its H1N1 vaccine:
"Because clinical trials are conducted under widely varying conditions, adverse event rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trial of another vaccine, and may not reflect the rates observed in practice."
The reason the CDC has nothing but suggestions to go on is because vaccine researchers admit that few studies have examined vaccination during pregnancy, mainly because of the ethics of possibly harming an unborn human in the name of research.
Because most researchers are not willing to take that chance, they rely on animal studies to see what kinds of neurological and physiological adverse events are possible with vaccines during pregnancy.
But, since animal studies aren't always done either, sometimes they don't even have that to go on, as was the case with the H1N1 vaccines, according to their package inserts.
So What Do We Know About Flu Vaccines and Pregnancy?
Right now, the only information we have about flu vaccines and pregnancy is the post-marketing surveillance reports through VAERS which, as I already said, show that some women have been reporting miscarriages after a flu vaccine, whether it's seasonal or H1N1.
The tragic thing about this is that, like Connie Sylvester, many of these women have physicians who refuse to even consider the possibility of the vaccine causing harm to them or their babies.
What really is distressing to me, though, is that so many physicians, as well as the mainstream media, steadfastly ignore compelling research that shows that flu vaccines have no effect on whether pregnant women get sick with the flu or influenza-like illnesses – meaning it's not necessary to even give pregnant women flu vaccines in the first place!
This study from the Vaccine Safety Datalink Workgroup – made up of researchers from Kaiser Permanente and the CDC's National Immunization Program – shows that there is no reason to vaccinate pregnant women.
This study also found that:
- Women who received influenza vaccine during pregnancy had the same risk for influenza-like illness doctor visits as unvaccinated women
- When asthma visits were excluded, there was no difference in the risk of outpatient visits for vaccinated and unvaccinated women
- Infants born to women who received influenza vaccination had the same risks for influenza or pneumonia admissions as infants born to unvaccinated women
- Getting a flu vaccine also was not a significant determinant of risk of an influenza-like illness
- Hospitalizations for respiratory illness were uncommon both in vaccinated and non-vaccinated women
- Hospital admissions for influenza or pneumonia for women in the study were quite rare and no women died of respiratory illness during pregnancy
Or, consider this study published in the Journal of American Physicians and Surgeons, which points out that the ACIP's recommendation of influenza vaccination during
pregnancy is not supported by citations in the ACIP's own policy paper or in
current medical literature!
An alarming fact in this same study also reveals that the solitary safety study the ACIP cites for vaccinating pregnant women
"… has very little to do with the safety of influenza vaccination. The reported outcomes were strictly related to malignancies, mostly after polio vaccination during pregnancy."
In the interest of brevity, I will not copy all of the startling revelations that the authors of this study, Drs. David Ayoub and F. Edward Yazbak, include in their report. But I will urge you to read it for yourself here, and to pay special attention to the scientific evidence cited on thimerosal in vaccines, including their conclusion that:
"Coupling the incontrovertible evidence of the experimental reproductive toxicity of thimerosal and its metabolites to the limited scope of available human safety studies, it is astonishing that the ACIP's recommendation to administer the influenza vaccine during pregnancy has not been previously challenged.
The omission of these known risks of a major influenza vaccine component from the package inserts would imply that the drug is clearly mislabeled. …
Considering the potential risks of maternal and fetal mercury exposure, the administration of thimerosal during pregnancy is both unjustified and unwise."
So What Do We Know About Other Vaccines and Pregnancy?
The same argument that Ayoub and Yazbak make against using the flu vaccine for pregnant women can be used for other vaccines.
The truth is, all vaccines contain a variety of toxic substances, from antibiotics to adjuvants (such as aluminum), disinfectants, sterilants, pesticide components, and detergents.
For me, that alone is enough to say that before pregnant women get any vaccine, they should make sure they learn as much as possible about the vaccine first.
Becoming an informed health care consumer will empower you to ask your doctor questions and help you to take control of your health choices. If your doctor does not support your informed health choices, consider consulting another doctor who will work as a partner with you in making important health care decisions for yourself or your child.
One way to obtain detailed information about a vaccine, its components and any warnings, precautions, and possible adverse events is to read the manufacturer's product package insert included with the vaccine.
However, many physicians simply don't have time to read all the package inserts. So, they rely mostly on health officials' recommendations when it comes to vaccinating pregnant women. And in my opinion, the recommendations they are getting from these health officials are not coming from sound, science-based evidence.
For more proof that the CDC, FDA and ACIP are playing guessing-games on this topic, just go back to this section of the six-part series the CDC wrote on pregnant women and vaccines. It says:
"Whether use of a medication or vaccine is harmful to the embryo or fetus depends on multiple factors, including the nature of the agent …
Potential adverse effects of an exposure on the embryo or fetus include spontaneous pregnancy loss, structural malformations, intrauterine growth restriction, preterm delivery, hearing loss, and neurobehavioral abnormalities, among others. …
Timing of exposure during gestation is particularly critical."
Talk about ignoring your own evidence! This article goes on to explain what kinds of adverse reactions can occur during each trimester of a pregnancy – and the evidence of harm is damning.
If you are pregnant or are thinking of becoming pregnant, and are considering getting vaccinated for anything, this report should be at the top of your reading list!
The Evidence is Clear
The evidence is clear that pregnant women should be living the healthiest lifestyle possible, and not ingesting or drinking any substances that could possibly harm their babies. The bottom line is, when it comes to protecting the unborn, there should not be a double standard.
As for vaccines during pregnancy, better to exercise the precautionary priniciple and be safe than sorry, as the sad blogs of women who have lost their babies can attest to.
It's also important to realize that should you suffer a miscarriage, stillbirth, or deliver a baby with birth defects or other problems after you've received a vaccination of any kind, you can report it to VAERS yourself, even if your health care professional won't.
If you're pregnant or planning your pregnancy, please continue to do your homework on vaccines. Part of making an informed decision includes reading through the package insert of any vaccine you're considering getting.
You can find the package inserts for many of the most common vaccines on this page, including those for the H1N1 flu.