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
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.
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)
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.
- 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.”