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Front Page » Ethics » Bioethics » Approve First, Test for Safety Second: CDC Policy Puts Pregnant Mothers and Fetuses at Risk
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Approve First, Test for Safety Second: CDC Policy Puts Pregnant Mothers and Fetuses at Risk

In Lieu of Tdap and Ddap Safety Testing Results, CDC Collected Post-Vaccine Injury and Fatality Reports

When a woman becomes pregnant, naturally, she wants to protect her unborn child above all else. Therefore, when offered a series of vaccinations said to protect her newborn baby against disease in the first few weeks of life, she will probably accept the vaccinations without a moment’s hesitation.

But would she accept those vaccinations so readily if she knew that their effects on unborn children had not been tested, but rather, the Centers for Disease Control and Prevention (CDC) and the vaccine manufacturers had been taking a “wait and see” approach based on injury and fatality reports?

Vaccine Safety Unknown

Both the Tdap and the Dtap are vaccinations offered to pregnant women during pregnancy, supposedly to protect their newborn infant from contracting pertussis (whooping cough) in the first few weeks of life.

However, despite recommending these vaccinations to all pregnant women, the CDC readily admits in their own documentation that neither vaccine has ever been tested during pregnancy for vaccine safety and that, even today, they have no idea whether the vaccines can harm a growing fetus. How was—and is—this policy possible?

Route to Vaccine Approval

In 2008, the CDC stated the following in a report titled Prevention of Pertussis, Tetanus, and Diphtheria Among Pregnant and Postpartum Women and Their Infants—Recommendations of the Advisory Committee on Immunization Practices (ACIP):

Available evidence does not address the safety of Tdap for pregnant women, their fetuses, or pregnancy outcomes sufficiently. Available data also do not indicate whether Tdap-induced transplacental maternal antibodies provide early protection against pertussis to infants or interfere with an infant’s immune responses to routinely administered pediatric vaccines.

The safety and efficacy of using Tdap in pregnant women has not been demonstrated, and Tdap is not recommended for use in pregnant women in any country. No evidence exists of excess morbidity or any fatality among pregnant women ascribed to pertussis. No evidence exists demonstrating whether:
* Tdap in pregnant women harms the fetus or increases risk for adverse pregnancy outcomes,
* transplacental antibody induced by Tdap administered during pregnancy will protect infants against pertussis, or
* Tdap-induced transplacental maternal antibody will have a negative impact on an infant’s protective immune response to later-administered routine pediatric DTaP or to conjugate vaccines containing tetanus toxoid or diphtheria toxoid.

However, three years later, in 2011, based on no further research, the Tdap, an untested, non-recommended vaccine was recommended by the CDC as, not only safe, but necessary and offered to all pregnant women to protect their newborn babies from whooping cough.

So, not only did the CDC conduct no further testing, but the vaccine manufacturers themselves could not provide any evidence to suggest that this vaccine is either safe or effective. See Adacel information leaflet  and Boostrix information sheet.

CDC Rationale for Approving Untested Vaccines During Pregnancy

The CDC began their updated recommendation paper by explaining that the majority of children who are hospitalized and who die from whooping cough are below the age of two months and are therefore, too young to be vaccinated. It is for this reason that they felt it was necessary to put another strategy in place.

To reassure the public, they explained that although they were fully aware that the vaccines had not been tested for safety in pregnancy, they had used the pregnancy registries put in place by the vaccine manufacturers and small studies to collect safety data after the vaccines were given to pregnant women.

Again, using the advice given to them by the AICP, the CDC stated:

… ACIP made recommendations for use of Tdap in unvaccinated pregnant women and updated recommendations on cocooning and special situations.

They also stated, “In pre-licensure evaluations, the safety of administering a booster dose of Tdap to pregnant women was not studied,” but then attempted to reassure them by stating:

Because information on use of Tdap in pregnant women was lacking, both manufacturers of Tdap established pregnancy registries to collect information and pregnancy outcomes from pregnant women vaccinated with Tdap. Data on the safety of administering Tdap to pregnant women are now available. ACIP reviewed published and unpublished data from VAERS, Sanofi Pasteur (Adacel) and GlaxoSmithKline (Boostrix) pregnancy registries, and small studies. ACIP concluded that available data from these studies did not suggest any elevated frequency or unusual patterns of adverse events in pregnant women who received Tdap and that the few serious adverse events reported were unlikely to have been caused by the vaccine. (own emphasis)

It is clearly apparent that the CDC decided to recommend a potentially unsafe and ineffective vaccination for use in pregnancy, even though they could not provide any convincing data to reassure mothers that it couldn’t harm their growing fetuses.

Sadly, this policy has not changed, and five years later, we have to wonder whether pregnant women are being warned by their physicians of the risks and unknown safety of this vaccine—and what other vaccines are being recommended without adequate testing?

Note: This article was reprinted with the author’s permission. Claire Dwoskin is founder and president of the Children’s Medical Safety Research Institute (CMSRI)—a medical and scientific collaborative established to provide research funding for independent studies on causal factors underlying the chronic disease and disability epidemic.

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