What is the Tdap Vaccine?

illustration by aimee sicuro

Chances are you already got the whole spiel on why you should get the Tdap vaccine during pregnancy from your OB or CDC. You may have been told it is perfectly safe, and that thousands of pregnant women get this vaccine every year and it’s no big deal. You’re ‘protecting your baby’ after all.

But you may have not been given ‘informed consent’, that is, that just like with every medication, there are risks with vaccination, especially prenatal vaccination. We aren’t all genetically identical, so just because some people experience no adverse effects from vaccination, does not mean that no one will. There are some things you should know, that your doctor may have not told you.

The Tdap vaccine is a vaccine against tetanus, diphtheria and pertussis, also known as whooping cough. According to their package inserts, for both Adacel and Boostrix — safety and effectiveness have not been established in pregnant women.

The Tdap is formulated with reduced quantities of antigens compared to DTaP. The DTaP is less effective at preventing pertussis than the DTP or DTwP, which is why we have seen a resurgence in cases. The Tdap is less effective than the DTaP which is less effective than the DTwP.

For example, the acellular component of the vaccine does not prevent colonization and infection with Bordetella pertussis and allows for transmission to contacts. This is how vaccinated people unknowingly spread pertussis.

High Amounts of Aluminum Adjuvants

Each 0.5-mL dose of Adacel® (Sanofi Pasteur) contains 5 Lf tetanus toxoid, 2 Lf diphtheria toxoid, and acellular pertussis antigens (2.5 µg detoxified PT, 5 µg FHA, 3 µg pertactin, 5 µg FIM). Other ingredients per 0.5-mL dose include 1.5 mg aluminum phosphate (0.33 mg aluminum) as the adjuvant, ≤5 µg residual formaldehyde, <50 ng residual glutaraldehyde, and 3.3 mg (0.6% v/v) 2-phenoxyethanol (not as a preservative).

That translates to 1500 mcg of aluminum phosphate.

Each 0.5-mL dose of Boostrix® (GlaxoSmithKline) is formulated to contain 5 Lf of tetanus toxoid, 2.5 Lf of diphtheria toxoid, 8 µg of inactivated PT, 8 µg of FHA, and 2.5 µg of pertactin (69 kiloDalton outer membrane protein). Each 0.5-mL dose contains aluminum hydroxide as adjuvant (not more than 0.39 mg aluminum by assay), 4.5 mg of sodium chloride, ≤100 µg of residual formaldehyde, and ≤100 µg of polysorbate 80 (Tween 80).

This vaccine doesn’t even list the amount of aluminum hydroxide, but it’s more than 1500 mcg.

By comparison, Engerix B, which is the Hep B birth shot given to newborns contains .25 mg of aluminum hydroxide, which converts to 250 mcg of aluminum hydroxide.

Material Safety Data Sheets

Aluminum Hydroxide

Aluminum Phosphate

Sodium Chloride

Polysorbate 80

2-phenoxyethanol

Formaldehyde

Never Tested In Pregnant Women

In 2012, the CDC recommended all pregnant women should receive a Tdap vaccine during every pregnancy, despite never being tested on pregnant women.

“Safety and effectiveness have not been established in pregnant women”

The manufacturers of both Tdap vaccines have ZERO information whether the Tdap vaccine is safe for pregnant and/or lactating women. Women who receive an unapproved vaccine during pregnancy may be enrolled into ‘postmarketing surveillance’ via the Vaccine Safety Datalink. However it’s important to realize that most adverse reactions are not recognized or acknowledged by doctors, and therefore not reported. Even though there is no data either way, doctors often call adverse reactions to vaccines–whether it’s a miscarriage,  viral infections, or pregnancy complications–merely ‘coincidental.’

The Vaccine Adverse Event Reporting System (VAERS) is a passive surveillance system which allows vaccine recipients to file their own reports. Because most people don’t know about this, it is estimated to represent only about 1%-10% of actual adverse events.

How Effective Is Post-Marketing Vaccine Surveillance?

We did not know until 2017 that pregnant women who received an H1N1 Flu vaccine and a regular Flu vaccine during pregnancy in the 2009 and 2010 season were 7 times more likely to miscarry than women who did not get either vaccine. Women who received one Flu vaccine were twice as likely to miscarry than women who received no vaccine at all.

For SEVEN YEARS no one knew this.

I would not rely on post-marketing surveillance.

Not Approved for Pediatric Use

What we take and what we consume we share with our unborn baby. These vaccines are not approved for children, regardless of whether they are in utero or they are in our arms:

Adacel vaccine is not approved for individuals less than 10 years of age. Safety and effectiveness of Adacel vaccine in persons less than 10 years of age have not been established.

BOOSTRIX is not indicated for use in children younger than 10 years of age. Safety and effectiveness of BOOSTRIX in this age group have not been established.

Altered Immunocompetance

Pregnancy has often been characterized as a state of immune suppression, and while this may not be completely accurate, pregnancy represents ‘a unique immune condition that is modulated.’

“The immune system is one of the most important systems protecting the mother against the environment and preventing damage to the fetus.” (study)

Maternal Immune Activation increases the risk of autism, schizophrenia, and seizure susceptibility.

Both vaccine inserts state “if vaccine is administered to immunocompromised persons, including persons receiving immunosuppressive therapy, the expected immune response may not be obtained.”

Check Your Titers

The CDC website states: “There are no blood tests that can tell you if you have enough antibodies in your body to protect yourself or your baby against whooping cough.”

This is a lie. There is a Pertussis Titers Test. You can have your titers checked for many diseases, and pertussis is one of them.

Before routine Tdap vaccination of pregnant women in 2012, and despite a heavily vaccinated population, 26% of infants at birth had protective levels of antibodies to pertussis from their mother having had previous natural infection.

“These women likely derived their antibody levels through pertussis infection, since none had a documented history of pertussis immunization.” (study)

Previous natural infection and breastfeeding would be more protective of newborns than vaccination, which is aiming to simulate natural infection, with unquantifiable risks to the unborn baby.

Adacel and Boostrix

  • Neither have been evaluated for carcinogenic or mutatenic potential, or impairment of fertility.
  • No Tdap vaccine is recommended to be administered less than five years after a Tdap or Dtap vaccine, per the insert.
  • Caution should be exercised when Tdap vaccines are administered to nursing mothers, per the inserts.
  • There are no adequate and well-controlled studies in pregnant women.

Increased Risk for Chorioamnionitis

An increased risk of diagnosed chorioamnionitis in women vaccinated with Tdap during pregnancy was previously detected at two Vaccine Safety Datalink (VSD) sites. Chorioamnionitis was recorded in 6.4% of women who received Tdap vaccination any time during pregnancy and 5.2% of women who did not (ARR [95% CI]: 1.23 [1.17, 1.28]) (Study Abstract)

That represents a 23% increase of chorioamnioitis incidence in Tdap vaccinated women over non-vaccinated.

Chorioamnionitis is a common complication of pregnancy associated with significant maternal, perinatal, and long-term adverse outcomes. Adverse maternal outcomes include postpartum infections and sepsis while adverse infant outcomes include stillbirth, premature birth, neonatal sepsis, chronic lung disease and brain injury leading to cerebral palsy and other neurodevelopmental disabilities. Research in the last two decades has expanded our understanding of the mechanistic links between intraamniotic infection and preterm delivery as well as morbidities of preterm and term infants. Recent and ongoing clinical research into better methods for diagnosing, treating and preventing chorioamnionitis is likely to have a substantial impact on short and long-term outcomes in the neonate.

From 1995-2010 the rate of chorioamnionitis more than doubled. Researchers at Kaiser found that the incidence of chorioamnionitis rose from 2.7 percent of births in 1995-96 to 6.0 percent of births in 2009-10. The influenza vaccine began to be recommended to pregnant women in 2004, and although the Tdap wasn’t recommended for all pregnant women for every pregnancy until 2012, it was approved to be used selectively in pregnant and postpartum women in 2006.

In 2008, the medical community issued this statement regarding Tdap during pregnancy:

“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.”

Scientific Articles

Safety of Tdap vaccine in pregnant women: an observational study

Evidence Concerning Pertussis Vaccines and Central Nervous System Disorders, Including Infantile Spasms, Hypsarrhythmia, Aseptic Meningitis, and Encephalopathy

Adverse event reports after tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccines in pregnant women

Atypical vanishing white matter disease with microcephaly and hepatosplenomegaly provoked after diphtheria pertussis tetanus vaccination

Pertussis Antibodies in Postpartum Women and Their Newborns

CDC Breaks Down Recent Study Linking Flu Vaccine, Miscarriage

Report To VAERS

VAERS stands for Vaccine Adverse Event Reporting System. It is a passive surveillance system.

Only 1-10% of adverse events are actually reported.

Let’s change that! You can file a report here.

Adacel Package Insert

Pregnancy Category C

“Animal reproduction studies have not been conducted with Adacel vaccine. It is also not known whether Adacel vaccine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Adacel vaccine should be given to a pregnant woman only if clearly needed. Animal fertility studies have not been conducted with Adacel vaccine. The effect of Adacel vaccine on embryo-fetal and pre-weaning development was evaluated in two developmental toxicity studies using pregnant rabbits. Animals were administered Adacel vaccine twice prior to gestation, during the period of organogenesis (gestation day 6) and later during pregnancy on gestation day 29, 0.5 mL/rabbit/occasion (a 17-fold increase compared to the human dose of Adacel vaccine on a body weight basis), by intramuscular injection. No adverse effects on pregnancy, parturition, lactation, embryo-fetal or preweaning development were observed. There were no vaccine related fetal malformations or other evidence of teratogenesis noted in this study.”

Ingredients

Each 0.5-mL dose of Adacel® (Sanofi Pasteur) contains 5 Lf tetanus toxoid, 2 Lf diphtheria toxoid, and acellular pertussis antigens (2.5 µg detoxified PT, 5 µg FHA, 3 µg pertactin, 5 µg FIM). Other ingredients per 0.5-mL dose include 1.5 mg aluminum phosphate (0.33 mg aluminum) as the adjuvant, ≤5 µg residual formaldehyde, <50 ng residual glutaraldehyde, and 3.3 mg (0.6% v/v) 2-phenoxyethanol (not as a preservative).

Nursing Mothers

“It is not known whether Adacel vaccine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Adacel vaccine is given to a nursing woman.”

Drug Interactions

“When Adacel vaccine was administered concomitantly with trivalent inactivated influenza vaccine (TIV) to adults 19-64 years of age, a lower antibody response was observed for pertactin antigen as compared to Adacel vaccine administered alone.”

Schedule

“There are no data to support repeat administration of Adacel vaccine.”

“Five years should have elapsed since the recipient’s last dose of tetanus toxoid, diphtheria toxoid and/or pertussis containing vaccine and the administration of Adacel vaccine.”

Postmarketing Surveillance

Immune system disorders: Anaphylactic reaction, hypersensitivity reaction (angioedema, edema, rash, hypotension)

Nervous system disorders: Paraesthesia, hypoesthesia, Guillain-Barré syndrome, brachial neuritis, facial palsy, convulsion, syncope, myelitis

Cardiac disorders: Myocarditis

Skin and subcutaneous tissue disorders: Pruritus, urticaria

Musculoskeletal and connective tissue disorders: Myositis, muscle spasm

General disorders and administration site conditions: Large injection site reactions (>50 mm), extensive limb swelling from the injection site beyond one or both joints Injection site bruising, sterile abscess

Boostrix Package Insert

Pregnancy Category B

“A developmental toxicity study has been performed in female rats at a dose approximately 40 times the human dose (on a mL/kg basis) and revealed no evidence of harm to the fetus due to BOOSTRIX. Animal fertility studies have not been conducted with BOOSTRIX. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, BOOSTRIX should be given to a pregnant woman only if clearly needed. In a developmental toxicity study, the effect of BOOSTRIX on embryo-fetal and pre-weaning development was evaluated in pregnant rats. Animals were administered INFANRIX by intramuscular injection once prior to gestation and BOOSTRIX by intramuscular injection during the period of organogenesis (gestation Days 6, 8, 11, and 15), 0.1 mL/rat/occasion (approximately 40-fold excess relative to the projected human dose of BOOSTRIX on a body weight basis). The antigens in INFANRIX are the same as those in BOOSTRIX, but INFANRIX is formulated with higher quantities of these antigens. No adverse effects on pregnancy, parturition, lactation parameters, and embryo-fetal or pre-weaning development were observed. There were no vaccine-related fetal malformations or other evidence of teratogenesis.

Ingredients

Each 0.5-mL dose of Boostrix® (GlaxoSmithKline) is formulated to contain 5 Lf of tetanus toxoid, 2.5 Lf of diphtheria toxoid, 8 µg of inactivated PT, 8 µg of FHA, and 2.5 µg of pertactin (69 kiloDalton outer membrane protein). Each 0.5-mL dose contains aluminum hydroxide as adjuvant (not more than 0.39 mg aluminum by assay), 4.5 mg of sodium chloride, ≤100 µg of residual formaldehyde, and ≤100 µg of polysorbate 80 (Tween 80).

Nursing Mothers

“It is not known whether BOOSTRIX is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when BOOSTRIX is administered to a nursing woman.”

Schedule

“There are no data to support repeat administration of BOOSTRIX.”

Five years should elapse between the last dose of the recommended series of Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP) and/or Tetanus and Diphtheria Toxoids Adsorbed For Adult Use (Td) vaccine and the administration of BOOSTRIX.”

Postmarketing Surveillance

Blood and Lymphatic System Disorders: Lymphadenitis, lymphadenopathy.

Immune System Disorders: Allergic reactions, including anaphylactic and anaphylactoid reactions.

Cardiac Disorders: Myocarditis

General Disorders and Administration Site Conditions: Extensive swelling of the injected limb, injection site induration, injection site inflammation, injection site mass, injection site pruritus, injection site nodule, injection site warmth, injection site reaction.

Musculoskeletal and Connective Tissue Disorders: Arthralgia, back pain, myalgia.

Nervous System Disorders: Convulsions (with and without fever), encephalitis, facial palsy, loss of consciousness, paraesthesia, syncope.

Skin and Subcutaneous Tissue Disorders: Angioedema, exanthem, Henoch-Schönlein purpura, rash, urticaria.

VAERS Reports after Tdap

The following accounts are randomly taken from a VAERS search January 2013-March 2018 for the Tdap or DTaP (allowing for mistaken reports) vaccine during pregnancy:

“I was given the TDAP vaccine while pregnant and immediately felt sick to my stomach. That day I developed a low fever, chills, shaking, vomiting (once), body aches and pains, and nausea. This lasted for 72 hours. I missed work for 4 days and no medicated would sooth the symptoms. Doctor’s told me it was “”coincidence”” despite my symptoms being labeled as possible side effects for about 1/100 people! I was not given informed consent.” (690716-1)

“4 days after receiving the Tdap vaccination I began having pre-term contractions (28 weeks gestation). I was sent to the hospital at 5pm where I received medication to stop contractions and was sent home later that evening. The following morning around 6am the contractions started again and I went to the hospital where doctors were again able to control and cease contractions with medication. I was prescribed Nifedipine, taken orally every 4 hours to further control my contractions, which I was experiencing daily. I took Nifedipine from 28 weeks to 37 weeks gestation in order to control contractions and delay delivery of the baby. Up until the Tdap vaccination, my pregnancy was healthy and without complications. My actual delivery was a 8 lb. 15 oz. baby. This was my first pregnancy.”(720912-1)

“I was vaccinated at 27 weeks pregnant. I could not fully lift my arm again for 15 months because there was severe pain when I tried to lift my arm above my head. There is still pain in my arm three years later. My unborn child did not move for three weeks after I was vaccinated. He is now 2.5 years old and he is developmentally delayed and showing signs of autism.” (691390-1)

“I had an uncomplicated, healthy pregnancy prior to being vaccinated at 36 weeks along. My due date was 4/1/2015 but I was induced on 3/18/2015 due to gestational hypertension and pre-eclampia. My son was born on 3/19/2015 weighing only 5lbs 8oz. I was given terbutaline prior to delivery and my son had hypoglycemia. Initial glucose was 55 but repeat glucose around 4 hours of life was 26. He was symptomatic with jitteriness, thus he was given formula and transferred to the Intermediate Special Care Nursery for further management. In the ISCN he did require a tube feeding. He also had jaundice past the mid chest. I was never able to breastfeed again after him being in the ISCN. He has been sick since the day he was born (allergies, ear infections, cough, respiratory issues) and also delayed.” (727841-1)

“Pt G3P2 at 28.5 weeks with EDD of 12/22/17. Went to OB office on 10/3/17 for routine OB apt at 28.4 weeks. Pt was feeling well, feeling fetal movement, pt’s fingerstick blood sugar was 138, Tdap was given per routine office policy. Later that evening, pt began to feel achy and had a low-grade fever of 99 degrees. Pt called MD at approx. 0230 on 10/4/17 to report possible spontaneous rupture of membranes. MD told her it was most likely not her water and to note if it kept coming out. Pt came to triage at hospital at approximately 0830 after feeling certain her water had broken and starting to be in some pain. AmniSure was positive and foul smell noted. Pt was 3cm at this time with no fetal heart tones found. Pt delivered fetal demise 10/4/17 at 1043 am. Baby weighed 1480g, or 3lbs. 4oz.” (716402-1)

“We had a healthy and normal pregnancy up until this vaccine was administered at 34 weeks. We experienced fetal demise and endured the stillbirth of our son shortly after receiving it. 3lb 2.6oz and 18″” long at birth.” (728995-1)

“19 days after I got the vaccine my baby passed away in my womb. I delivered her the next evening at 3lbs 11 oz . I have MTHFR gene as well. I am not sure the vaccine caused her death but wanted to provide this information. I also have an 8 year old son with one kidney I received the vaccine as well. (Don’t believe vaccine caused kidney).” (703658-1)

“I was pregnant and received the Tdap vaccine on 10/24. On 10/29 my daughter was stillborn.”(684510-1)

“Had a perfect pregnancy until this point; no nausea, had energy, had not fallen ill once or had any complications. I was healthy and well pre-pregnancy as well. Within a week of these vaccinations, I broke out into an upper-body rash, developed a horrid cold, lost a lot of my mental clarity and was constantly fatigued for weeks. I only began experiencing healing/reversal of these symptoms when I finished breastfeeding (after the birth of my baby, obviously) and began detoxing. Even so, my immune system has been significantly weaker and I went from being a healthy woman who became sick about once a year, on average, to being a woman who almost always is dealing with some sort of ailment. I had a VERY minor form of Tourette Syndrome – after the shots, I went from perhaps 1-2 tics an hour to having one about every other minute. The increase in severity was frighteningly drastic. My doctor has since said that it is more than likely a reaction to the aluminum in the shots.” (724986-1)

“33 weeks pregnant. Due October 6, 2016. Healthy pregnancy. Ultrasound on 8/20/2016 at Prenatal visions showed perfectly healthy baby, placenta and fluid levels. Went into pre-term labor exactly 24 hours after vaccine. Contractions continued every 6-8 minutes for 7 days before delivering a premature baby.” (725673-1)

“36 weeks pregnant at time of vaccines. 38 weeks pregnant when gave birth. Went into hospital because I had not felt baby move and was feeling really hot, was told there was no heartbeat for baby.” (656455-1)

“Full term fetal demise – ultrasound determined that within the week after receiving TDaP vaccine, fetal demise occurred. Exact time unclear.” (501467-1)

“Patient received TDAP and flu vaccine on 10/11/13. Reported decreased fetal movements next day presented on 10/14/13. Baby showed distress and was emergently delivered by C/S. Baby had severe acidosis with PH 6.9.” (508537-1)

“Pt had localized pain and swelling to inj site, high fever, nausea and vomiting, became very tachycardic as did the baby (pt was 31 weeks preg).” (534304-1)

“I recieved the TDAP Shot on Monday… I noticed a reduction in fetal movement I went in to my doctors on friday morning and after an ultrasound no fetal heart beat was found and I was told my baby had died. Later Friday afternoon I was admitted to the hospital and they induced labor. I delivered the baby early in the morning on August 2 2014. Prior to the TDAP shot I was having a “”text book”” pregnancy and the Baby had always been active and strong.” (549463-1)

“Bottoms of feet started to become numb, overall weakness around 11/29/14. 11/30/14 hands started to become numb and numbness started ascending up legs. Admitted into hospital 12/1/14 unable to walk unassisted. OBGYN and Neurologist decided to deliver baby at 38 weeks. Paralysis continued up to torso. Admitted into ICU for almost 2 weeks, Neurologist confirmed Guillain Barre Syndrome, moved to Intensive Rehab Unit on 12/15/14 – 3/20/15. Participated in physical, occupational, and speech therapy. Outpatient rehab until May 2015.”(609339-1)

“Patient presented to Labor and Delivery triage the morning of March 11th, 2016 with low back pain and extremity pain. No motor loss or sensory loss. Return to triage March 14th with same sxms but now with addition of lower ext greater than upper ext weakness with paresthesias. Stat MRI was WNL, EMG by Neurology confirmed Guillain Barre. Patient had worsening protection of airway. STAT LTCS done under general anesthesia. Patient as of today (3/21/2016) remains on ventilation and in ICU, stable.” (628151-1)

“Stillbirth of daughter during pregnancy.” (651141-1)

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