DTaP/TDaP (Diphtheria, Tetanus and Pertussis)

• Diphtheria is a severe throat infection caused by a bacterium. The germ releases a toxin that irritates the lining of the throat and upper lungs and causes a severe cough and breathing difficulty.
• Specifically, the bacteria Corynebacterium diphtheriae does not necessarily cause clinical diphtheria, but rather a toxigenic virus (bacteriophage) that infects some of the bacteria.
• Diphtheria is diagnosed by sending a throat swab for lab testing. Incubation period: average of 2-5 days.
• Diphtheria is transmitted like the common cold (person to person, coughing and sneezing), and can range in severity from mild to serious.
• The diphtheria bacteria (Corynebacterium diphtheriae) will never be eradicated completely, as many people carry the bacteria on themselves harmlessly (without the toxin).
• Diphtheria can reoccur in individuals who have already had the disease.
• Most cases are mild or asymptomatic. The primary clue to diphtheria would be recent travel to a developing nation coupled with a white membrane visible in the nose or throat.
• MILD cases involve throat soreness and a visible white coating on the tonsils or in the nose, with no other visible symptoms. The illness will most likely run its course without any treatment.
•  If it worsens, a MODERATE case will progress to include labored breathing as the throat and airway become more swollen (the swelling is also visible in the neck glands). A child may be hospitalized in the ICU for IV treatment including antitoxins and antibiotics. Most children recover at this point without any long-term problems.
• A SEVERE case usually only occurs when diagnoses and treatment are delayed, allowing the germ’s toxin to do too much damage to the airway. 5-10% of cases are fatal in the US.

TREATMENT

• Antibiotics to kill the diphtheria bacteria, are used to treat the disease but have had little effect and appear to only assist in decreasing its spread from infected individuals. Source: (4) NVIC
• Antitoxin to neutralize the toxins secreted from the bacteria
• Survival rate in the 1930s was greater in those treated with “massive frequent doses” of Vitamin C through IV; conversely, vitamin C deficiency is related to an increased severity of diphtheria. Source: (1) Dissolving Illusions, pg. 204-205
• Some infected individuals may require hospitalization to maintain hydration and to monitor breathing and heart function.

HISTORY OF DIPHTHERIA (infection) IN THE U.S.

• From 1894 to 1920: the vaccine was introduced in 1920, yet the death rate in children in NYC declined 87% before the vaccine. Source: (2) Dissolving Illusions, pg. 202-203
• 1920: the toxoid vaccine was introduced, and there was a spike in mortality.
• 1921: there were 206,000 cases
• 1945: there were 19,000 cases (about 90% decline since 1921)
• The late 1940s: "A more rapid decrease began with the widespread use of diphtheria toxoid."
• From 1970 to 1979: there was an average of 196 reported cases per year
• 1980 to 2011: there were 55 total reported cases in the U.S., averaging 1 or 2 per year
• Since the year 2000: Only 6 reported cases

WHAT CAUSED THE DECLINE?

• In the U.S., diphtheria deaths dropped 98% from the year 1900 to the mid-1940s, right before the DTP vaccine was introduced.
• The decline in disease mortality was marked by the improvement in living conditions and industrialization (all quotes from Dissolving Illusion by Suzanne Humphries).
•  …extreme poverty, filth in all its forms, and overcrowding of large cities…are great promoters of contagion, resulting in epidemics, plagues, and pestilences; WHILE strict cleanliness, fresh air, pure water, and hygienic living tend greatly to restrict its spread and prevent these results. Source: (4) J.M. French, MD, “Infant Mortality and the Environment,” Popular Science, vol. 34, no. 10, December 1888, p. 228
• It is not by adding disease to disease that the evil of diphtheria will be combated, but it is by the removal of the dark, damp, ill-ventilated slums which infest our towns and cities; by letting light and air into the over-crowded and unsanitary dwellings of the poor, and by the inculcation of lessons of cleanliness and hygiene among the people. Source (5) Charles E. Page, MD, Diphtheria: Is the Prevailing Antitoxin Treatment Only Another Medical Delusion?” Medical Brief, A Monthly Journal of Scientific Medicine and Surgery, vol. XXXV, 1907, pp. 482-483.
•  The eradication of diphtheria…will be attained through the mass sanitary protection of the populace subconsciously practiced by the people at all times. Source: (6) James Gordon Cumming, MD, “Is the Control of Diphtheria Leading to Eradication?” Journal of the American Medical Association, vol. 78, no. 9, March 4, 1922, p. 632
•  Mortality due to tuberculosis, diphtheria, scarlet fever, whooping cough, measles, typhoid, puerperal fever, and infant gastroenteritis started to fall long before the introduction of immunization and/or antibiotics. The decline was probably due to a great extent to various factors linked to the steady rise in the standard of living: qualitative and quantitative improvements in nutrition; better public and personal hygiene; better housing and working conditions and improvements in education. Souce: (7) E. Guberan, “Tendances de la mortalite en Suisse,” Schweiz Med Wochenschr, vol. 110, 1980, p. 574.
• The diphtheria mortality rate is higher in those who are malnourished or alcoholic.

SUMMARY: 

• Is it common? No. in the past 20 years, until 2023,  there have been 6 reported cases in the U.S. Source: (8) WHO  There have also been no deaths from diphtheria in U.S. children for at least 35 years.
• Is it serious? It can be. 
• Is it treatable? Yes.

DIPHTHERIA IN THE US NEWS

• 2014: Dayton, Ohio; Girl was fully vaccinated
• 2012: There was one case in 2012 that was “provisionally reported” and I could not find any info stating that it was confirmed, but it is listed on the WHO monitoring website.
•  2003: A 63-year-old PA man, never vaccinated against diphtheria, who started noticing symptoms while on a mission trip in Haiti. He was not properly diagnosed until 9 days after the onset of his symptoms and died after 17 days of illness due to cardiac complications. Source: (9) CDC Stacks

• Tetanus is an acute infectious disease caused by a bacterium called Clostridium tetani. I will briefly summarize it here, but a few great and lengthy posts have already been made about tetanus scenarios and can be found in our Quick Facts Blog.
• This bacterium is commonly found in soil, dust, and animal stool. The spores and bacteria's presence alone do not cause tetanus. It is only when the bacteria completes its life cycle and releases the toxin tetanospasmin that tetanus can occur.
• Tetanus is almost entirely preventable and not contagious (cannot be spread through human-to-human contact.) 
• Clostridium tetani releases a toxin that can cause paralysis; the first muscles that tend to be affected are the jaw muscles, which is why tetanus is also commonly referred to as lockjaw. It can also create difficulty in swallowing, muscle stiffness, and spasms throughout the body.
• The neurological symptoms of tetanus occur approximately one week after infection, which is the average life cycle of the spores.
• Tetanus is anaerobic by nature, meaning that it can only begin its life cycle in a place where there is no oxygen present. Most cuts bleed (are exposed to oxygen), and so tetanus is very rare in everyday life and injuries—the U.S. sees between 20-50 cases in adults any given year.

TETANUS: RISK TO BABIES

• Since the TDaP is given to children starting at two months old, I am sure you would like to know the actual risk of tetanus to your baby…
• Neonatal tetanus can occur very rarely in newborns via an infection of the umbilical cord stump. This happens more often in 3rd world countries but is exceedingly rare in the U.S. 
• Once babies are mobile, tetanus could in theory be more of a risk….but there has been an average of 0 cases per year for the past 25 years in children under 5 years old. 

TREATMENT (of general cuts)

• For any minor cut, the best thing to do is make sure you clean it with soap and water and let it bleed freely to flush out any bacteria.
•  If you have a deep cut, there is evidence that topical colloidal silver may help: “Topical silver (used on the skin) has some appropriate medical uses, such as in bandages and dressings to treat burns, skin wounds, or skin infections.”  Source: (10) PubMed Silver on Wounds 
• Finally, if you end up at the ER or doctor’s office with a cut that you were not able to adequately clean and treat on your own, there is a tetanus immune globulin injection (TIG) that can be given to inactivate any tetanus toxin that may develop. A TETANUS VACCINE AT THIS POINT IS USELESS, and there is not a tetanus-only vaccine so you would also be getting vaccinated against one or two other things unnecessarily.

DIAGNOSIS AND TREATMENT (of tetanus) 

Source: (11) CDC website

• Diagnosis: “Doctors can diagnose tetanus by examining the patient and looking for certain signs and symptoms. There are no hospital lab tests that can confirm tetanus.”
• Tetanus is a medical emergency requiring: Hospitalization, Immediate treatment with human tetanus immune globulin (TIG), Agents to control muscle spasms, Aggressive wound care, and Antibiotics

HISTORY OF TETANUS (infection) IN THE U.S.

•  “In the United States, reported mortality due to tetanus has declined at a constant rate since the early 1900s, and documented tetanus incidence has declined since the mid-to-late 1940s when national reporting of tetanus cases began.” 
• Several factors have contributed to the decline in tetanus morbidity and mortality, apart from a vaccine. “Other factors include improved wound care and post-exposure use of tetanus immune globulin (TIG), either for prophylaxis in wound management or for treatment of tetanus. In addition, increased rural-to-urban migration with consequent decreased exposure to tetanus spores may also have contributed to the decline in tetanus mortality noted during the first half of the 20th century.” (Source: https://www.cdc.gov/vaccines/pubs/surv-manual/chpt16-tetanus.html#f1)

SUMMARY

•  Is it common? No
•  Is it serious? Yes 
•  Is it treatable? Yes
• This is a great summary from Dr. Paul Thomas in The Vaccine Friendly Plan: “Tetanus is an acute soil-borne bacterial infection. It is not an infectious disease, and it cannot be spread from one [person] to another. It is usually contracted from deep puncture wounds (nails, factory equipment), infected needles, and contaminated animal feces. We see about 29 cases a year out of 3000 million people living in the United States.” (p. 161)

TETANUS IN THE U.S. NEWS

• 2017: Unvaccinated 6-year-old in Oregon, Source: (12) ABC News, Teatnus in Unvaccinated Boy 
• This is pretty much the only news piece on tetanus because it is the worst-case scenario and the media ran with it. As stated earlier, there are virtually no cases in children in the U.S. and it is even rare that a child will die from tetanus in the U.S

• Pertussis is a respiratory illness commonly known as whooping cough, caused by a type of bacteria called Bordetella pertussis that infects the upper lungs.
• It is transmitted like the common cold and can last three months.
• Symptoms begin similar to the common cold, with the cough eventually worsening to prolonged coughing fits that can last from 30 seconds to two minutes. The cough can become so severe that it is hard to breathe, which leads to the telltale gasps that sound like a “whoop.” This whooping sound is not usually present in infants under 1. There is a lot of variability in the severity of the illness.
• MILD cases are the most common and are more of a nuisance than a health risk. These are characterized by sporadic coughing fits (one every few hours) and will most likely not be any other obvious symptoms or breathing difficulties. The individual will feel generally well in between the coughing fits. There may be a lingering cough for a month or two due to damage to the airways from coughing.
• MODERATE cases involve coughing fits that can cause an infant or young child to turn blue, which may warrant hospitalization for observation and oxygen treatment. Pneumonia is a rare complication from a moderate case of pertussis. In an older child or adult, the coughing fits may lead to some rib fractures due to coughing too hard. 
• SEVERE cases can occur in younger infants (3 months or less), especially when diagnosis and treatment are delayed. Treatment in the ICU is necessary, for supplemental oxygen, suctioning of secretions, and IV fluids in the case of dehydration. Seizures, encephalitis, and brain damage are the most severe complications. The fatality for an infant treated in the hospital is 1% (there are less than 20 deaths per year).
• Probability of a serious case of pertussis: pertussis is typically only severe in a child under 3 months of age, and it is even rare for an exclusively breastfed infant who is not in daycare. “Otherwise healthy babies over six months of age with whooping cough, should not worry any parent if they understand the principles and protocols to deal with the infection, and are well equipped and organized,“ Dr. Suzanne Humphries. 
• Pertussis is diagnosed mainly by the cough description and can be confirmed with a lab test/nasal swab.
• Infection may lead to lifelong immunity. One recent study suggests that after natural infection, on average, whooping cough immunity lasts at least 30 years and perhaps as long as 70 years.  as compared to vaccine immunity, which may wane in 4-6 years after receiving all recommended doses. Source: (13) University of Maryland, Whooping Cough Immunity Study

TREATMENT

• Without official treatment, most mild cases of pertussis will go undiagnosed and will resolve on their own.
• CONVENTIONAL TREATMENT: Oral antibiotics are given for a mild case. More severe cases can also be treated with supplemental oxygen, hospitalization, additional antibiotics for pneumonia, and IV fluids for dehydration. It is questionable whether the antibiotics are very effective in reducing the symptoms and duration of infection (“Although antibiotics were effective in eliminating B. pertussis, they did not alter the subsequent clinical course of the illness. There is insufficient evidence to determine the benefit of prophylactic treatment of pertussis contacts.” Source: (14) PubMed Antibiotics for Whooping Cough
• NATURAL TREATMENT AT HOME: HIGH-DOSE VITAMIN C PROTOCOL The basic premise of this treatment in regards to whooping cough is that within 8 hours or so, there will be a significant reduction in the severity and duration of coughing fits, as the antioxidants of vitamin C help to neutralize the pertussis toxins so they can clear from the body and allow the immune system to do its job more efficiently. It may take just as long to fight pertussis, but there will be fewer symptoms. 
• SUZANNE HUMPHRIES VITAMIN C PROTOCOL FOR WHOOPING COUGH “Successful treatment [of pertussis] will require diligence and an adult rocking very young infants, at the peak of infection, 24 hours for several days.” Please read this wealth of information on Suzanne Humphries's website, which also contains a lot of information about pertussis in general and combats the conventional medicine approach to treatment. The basic starting formula for dosing is (weight in pounds divided by 2.2) times 375 = the 24-hour dose, in mg per kg. This amount can be adjusted based on observation and bowel tolerance. It is recommended to keep dosing for at least 4 weeks. Source: (15) Dr. Suzanne Humphries Vitamin C Protocol

HISTORY OF PERTUSSIS (infection) IN THE U.S.

• In 1914, a whole-cell pertussis vaccine was invented, but it was not very accessible. The national vaccination program in the U.S. began in the 1940s, which is when pertussis was combined with diphtheria and tetanus into the DTP shot and made more widely available. Source: (16) PubMed; History of the disease and current prevention failure
• By the 1940s (when the vaccine was introduced), the death rate of whooping cough had already fallen by 99% from its peak in the 1800s.
• More specifically, the death rate of whooping cough in 1900 was 12.2 per 100,000 people. In 1948, the death rate was .8/100,000. This shows a decline of about 90-95% in 48 years, before the wide use of vaccination.
• Since the introduction of the vaccine—from the late 1940s to around 1957, the death rate was still decreasing at a similar rate as before the vaccine.
• Incidents (not deaths) of pertussis infection have been steadily increasing since the 1980s (about 9/100,000 per year), despite widespread immunization.

WHAT CAUSED THE DECLINE?

• The widely held belief is that pertussis, and its death rate, were successfully controlled by the introduction of routine childhood immunizations. Is this the truth?
• According to data from the U.S., as well as from Wales and England, the death rate from whooping cough declined by well over 90% before the use of a vaccine.
• When the vaccine was introduced, the death rate didn’t change, but the disease rate did appear to decline. How much of that decline is attributed to the vaccine?
• One explanation could be that, as the vaccination rate increased, the ability of the medical field to properly recognize and diagnose whooping cough decreased. Diagnosing pertussis is difficult, especially in the vaccinated population which is more likely to be asymptomatic.
• Another thing to note is that deaths from all diseases were on the decline in the 1930s/1940s, even those that were not treatable by antibiotics or vaccines—this could be due to the overall improvement in the standard of living, sanitation, nutrition, living and working conditions, etc. (please refer to the diphtheria post for a few lengthy quotes citing this).
• Especially once the vaccine was changed from DTP to DTaP, which is safer but less effective, the occurrence of whopping cough has become even more widespread.
• Another important thing to note—the case definition of whooping cough was refined in the 1990s, eliminating many cases that would have previously been diagnosed as pertussis—leading to believe that the vaccine was more effective at eliminating pertussis.
• Finally, remember that whopping cough cases are on the rise—the vaccine has failed its initial promise to provide lifelong immunity. It does not offer lifelong protection, and the protection from DTaP wanes after 5-10 years on average, with a significant decline in antibodies after just one year. Source: (15) C.U. Meyer et al, Cellular Immunity in Adolescents and Adults following Acellular Pertussis Vaccine Administration. Source: (17) Clinical and Vaccine Immunology, *vol. 14, no. 3, March 2007, pp. 288-292

SUMMARY

• Is it common? Yes
• Is it serious? It can be, for infants under three months, particularly if they are in daycare and not breastfed.
• Is it treatable? Yes
• Further, the vaccine has not been successful at preventing the infection and spread of pertussis.

PERTUSSIS IN THE US NEWS

• The trend you will notice as you pay attention to pertussis in the media is that the vaccine is not that effective.
• March 2019: “The pertussis vaccine is not optimal… we're frantically researching to make a better one” This article also lists a few schools affected by whooping cough outbreaks. Source: (18) USA Today, Whooping Cough Vaccine is less effective  
• Dec 2019: Whooping Cough outbreak in Texas school despite 100% vaccination rate Source: (17) Fox News, Texas school closed for Whooping Cough Outbreak Despite 100% Vaccination rate 
• Dec 2019: County in Oregon sees increase in cases (doesn’t mention vaccination rate but does mention that vaccine efficacy wanes over time) Source: (18) OPB News Clackman Co. Whooping Cough Outbreak
• Jan 2020: Jefferson County in Missouri sees most cases of pertussis in a decade (63 cases. The local epidemiologist said, “For our county, we have a very high vaccination rate." Source: (19) My Leader Paper;  Whooping Cough Cases
• 2010 California Pertussis Epidemic: highest number of cases in more than 60 years; most serious cases occurred in infants under 3 months; most of the pediatric cases were vaccinated according to CDC recommendation (9% were completely unvaccinated against pertussis), suggesting waning immunity of the DTaP vaccine. Source: (20) Pubmed; CA Pertussis Epidemic 

• The vaccine does not prevent the spread of diphtheria, tetanus, or pertussis. The vaccine contains neutralized germ toxins, and our immune systems respond to those toxins and create antibodies. This means that if/when a vaccinated individual is infected, they are less likely to feel sick and could be asymptomatic carriers who still catch and pass the germs.

First, let’s summarize the risks of each infection and the likelihood of a baby contracting them.

• TETANUS is not an infectious disease and generally does not affect infants or children, as you might have read in the tetanus unit post.
• DIPHTHERIA has been eradicated from the United States, and there have been no childhood deaths from diphtheria in over 35 years. The chance of catching diphtheria is less than 1 in 100 million.
• PERTUSSIS is common and not going away anytime soon, vaccinated or not. However, it is very rarely deadly in children over 3 months of age.
• All three of these are treatable.
• Pertussis is the main reason this vaccine exists in the U.S. and the main reason a vaccine (either DTaP or TDaP) is pushed so heavily on pregnant mothers, babies, and anyone surrounding them really. So, is it truly safe and effective?

SAFETY of DTaP

• On the package inserts: “On very rare occasions, severe (anaphylactic) allergic reactions may occur after vaccination, including hives, swelling of the face and throat, difficulty breathing, a fast heartbeat, dizziness, and weakness.”
• DTaP vaccines were not tested against placebos.
• DTaP vaccine-induced encephalitis: 1 in 1,000
• DTaP vaccine serious events (1995-2017 from CDC Wonder): 6576
• DTaP vaccine mortality (in 2014 from CDC Wonder): 221
• DTaP vaccine mortality (1995-2014 from CDC Wonder): 916
• Thousands of parents have reported SIDS following DTaP or the combination of 2/4 month vaccines via VAERS
• Combo Vaccine reactions: 1 in 1,000 babies will have non-stop crying for 3 or more hours
• NVICP Injury Table: Anaphylaxis, Brachial Neuritis, Encephalopathy, Vasovagal syncope

Risks of the vaccine: 

• Redness, soreness, swelling, and tenderness where the shot is given are common after DTaP.
• Fever, fussiness, tiredness, poor appetite, and vomiting sometimes happen 1 to 3 days after DTaP vaccination.
• More serious reactions, such as seizures, non-stop crying for 3 hours or more, or high fever (over 105°F) after DTaP vaccination happen much less often. Rarely, the vaccine is followed by swelling of the entire arm or leg, especially in older children when they receive their fourth or fifth dose.
• Long-term seizures, coma, lowered consciousness, or permanent brain damage happen extremely rarely after DTaP vaccination.
• As with any medicine, there is a very remote chance of a vaccine causing a serious injury or death.

Source: (21) HRSA vaccine table; (22)CDC Vaccine Side Effects 

EFFICACY of DTaP, specifically the Pertussis component 

• “Vaccinated persons become susceptible to pertussis disease approximately 5-10 years following vaccination.” Source: (23) Dalya Guris, Peter M. Strebel, Barbara Bardenheier, Muireann Brennan, Raffi Tachdjian, et al.
• “Changing Epidemiology of Pertussis in the United States: Increasing Reported Incidence Among Adolescents and Adults, 1990-1996,” Clinical Infectious Diseases, vol. 28, 1999, p. 1235.
• Pertussis can give up to 30 years of natural immunity, while the vaccine is shown to be only 30-80% effective initially, and after 12 years loses 95% efficacy.
• Because of linked-epitope suppression, all children who were primed by DTaP vaccines will be more susceptible to pertussis throughout their lifetimes, and there is no easy way to decrease this increased lifetime susceptibility. Since 1997, the DTaP vaccination policy has created a cohort of people (the number of which is expanding yearly) who are more susceptible to repeated clinical illness with B pertussis infection than are DTaP-vaccinated children. There is no feasible way to make this cohort less susceptible. Source: (24) Pediatric Infectious Disease Society, The 112-Year Odessy of Pertussis and the Pertussis Vaccine, Mistakes Made and Implications for the Future 
• The effectiveness of the vaccine is an insignificant question. The highest incidence of the disease is among previously vaccinated children in the 8-12 year range. In the 2-7 and 8-12 age groups, there was no significant difference in attack rates between fully vaccinated and under/unvaccinated children. Source: (25) Maxwell A. Witt; Paul H. Katz, MD, MPH; and David J. Witt, MD, Unexpectedly Limited Durability of Immunity Following Acellular Pertussis Vaccination in Preadolescents in a North American Outbreak 
• “Unexpectedly Limited Durability of Immunity Following Acellular Pertussis Vaccination in Pre-Adolescents in a North American Outbreak,” Clinical Infectious Diseases, March 15, 2012.

The most common DTaP vaccine given at well-baby visits is Pentacel (DTaP, polio, and Hib) or Pediarix (DTaP, polio, and Hepatitis B). The full ingredient lists of the vaccines will be at the end of this post, but first I want to briefly highlight some of the more concerning ingredients. If you want more information on any of these particular ingredients, please search the group for tons of resources!

ALUMINUM ADJUVANTS

• The purpose of aluminum in vaccines is to trigger an immune response. It is effective to this end, but is it safe to be injected?
• Did the FDA study aluminum in vaccines to determine a safe amount? No, not really at all. The evidence for aluminum safety in vaccines is based on three very small research studies that look at injected aluminum in human subjects and the potential internal toxicity—two were IV infusions and one used vaccinations.
• The study that looked at vaccines is also the most recent, from 2013. It was a pilot study examining 15 preterm babies receiving their 2-month shots in the NICU. Effects of routine vaccination on aluminum and essential element levels in preterm infants. Source: (27) JAMA Pediatrics, Effect of Routine Vaccination on Aluminum 
• How did the FDA originally determine the safe level of injected aluminum? For all intents and purposes, the level they settled on is arbitrary and convenient—they looked at the schedule and how much aluminum was in each vaccine already, and set the limit at what the current highest aluminum content was.
• The following quote is from Dr. Bob Sears’ The Vaccine Book: “Several years ago, the FDA decided to set a maximum allowable limit for how much aluminum would be allowed in any one vaccine. That limit is 850 micrograms. They don’t put a limit on giving multiple aluminum-containing vaccines on the same day. How did they decide on 850? That number of micrograms just so happens to be the amount of aluminum in the Pediarix brand of DTaP/hep B/polio combination vaccine. The FDA decided not to allow any future vaccines to exceed that limit. However, there was not one shred of research data used to set the limit. And the FDA announced in 2011 that they would allow exceptions to this limit if a product manufacturer could demonstrate its safety.” 
• A side note: injection vs ingestion is something that you should also look into when discussing aluminum. Aluminum is present everywhere in our environment, and when swallowed in typical daily amounts it is thought to be harmless because very little is absorbed into the body this way. Dr. Suzanne Humphries points out that when you ingest aluminum, only 0.2-1.5% gets absorbed into your blood; when aluminum is injected into the muscle, your blood absorbs 100% of it. The study showing this was performed on animals, but in the absence of any human studies, it is reasonable and rational to assume our bodies are somewhat similar.) Check out our blog post HERE. 

FORMALDEHYDE

• A preservative, a known toxic chemical, with recognized carcinogenic effects via the EPA, OSHA, and CPSC. Formaldehyde is also known to cause kidney damage and genetic damage. Most research deals with formaldehyde that is inhaled rather than injected. Here is a blog post we did about it with tons of sources. 

POLYSORBATE 80

• A common chemical that is used as an emulsifier in foods. The FDA generally considers it safe in small quantities, but “recent research in mice suggests that this chemical causes metabolic dysfunction and may be a contributing factor in the increase in chronic inflammatory diseases and metabolic disorders.” Some consumer advocates are concerned that polysorbate 80 may be to blame for rising rates of bowel disease. There is little information on the safety of injecting polysorbate 80, and a 2005 case study discovered that injected polysorbate 80 can trigger anaphylactic shock.

GLUTARALDEHYDE

• A chemical that is toxic, corrosive to body tissues, and may be fatal if inhaled. 
• Can cause severe eye, nose, throat, and lung irritations, along with headaches, drowsiness, and dizziness.
• Poisonous if ingested, and known to cause birth defects in experimental animals. 
• The effects of direct injection into the blood to bypass the process of ingestion are unknown. 
• It is often used to clean medical equipment.

2-PHENOXYETHANOL

• A preservative. Research has found that it is harmful if swallowed, inhaled, or absorbed through the skin. It can potentially cause reproductive defects and is severely irritating to the eyes and skin. Read more on our blog.

ALL INGREDIENTS IN DTaP VACCINES

• Pentacel (DTaP-IPV/Hib) ingredients: 1.5mg aluminum phosphate as the adjuvant, Polysorbate 80 (approx. 10 ppm), Sucrose, Formaldehyde, Glutaraldehyde, Bovine serum albumin, 2-phenoxyethanol, Neomycin, Polymyxin B sulfate, Mueller’s growth medium, Mueller-Miller casamino acid medium (without beef heart infusion), Stainer-Scholte medium (modified by the addition of casino acids and dimethyl-beta-cyclodextrin), MRC-5 human diploid cell lines, CMRL 1969 medium (supplemented with calf serum)

• Pediarix (DTaP-HepB-IPV) ingredients: Formaldehyde, Glutaraldehyde, Aluminum hydroxide, Aluminum phosphate, Lactalbumin hydrolysate, Polysorbate 80, Neomycin sulfate, Polymyxin B, Yeast protein, Calf serum, Fenton medium (containing bovine extract), Modified Latham medium (derived from bovine casein), Modified Stainer-Scholte liquid medium, Vero (monkey kidney) cells

• Daptacel (DTaP): Aluminum Phosphate, Formaldehyde, Glutaraldehyde, 2-phenoxyethanol, Stainer-Scholte medium, Modified Mueller’s growth medium, Modified Mueller-Miller casamino acid medium (without beef heart infusion), dimethyl 1-beta-cyclodextrin, ammonium sulfate

• Infanrix (DTaP): Formaldehyde, Glutaraldehyde, Aluminum hydroxide, Polysorbate 80, Fenton medium (containing bovine extract), Modified Latham medium (derived from bovine casein), Modified Stainer-Scholte liquid medium

• Kinrix (DTaP-IPV): Formaldehyde, Glutaraldehyde, Aluminum Hydroxide, Vero (monkey kidney) cells, Calf serum, Lactalbumin hydrolysate, Polysorbate 80, neomycin sulfate, polymyxin B, Fenton medium (containing bovine extract), modified Latham medium (derived from bovine casein), Modified Stainer-Scholte liquid

• TLDR SUMMARY: Basically, efficacy is assumed and overestimated with this vaccine, while safety is overlooked and downplayed. 
• The Tdap vaccine is offered to pregnant women in the third trimester. CDC recommends pregnant women get the whooping cough vaccine between 27 and 36 weeks of each pregnancy. Source: (28) CDC Pertussis and Pregnancy 
• Pregnancy and vaccination Source: (29) CDC Vaccines & Pregnancy 

WHY IS IT RECOMMENDED?

• The Tdap is given in the 3rd trimester to supposedly protect you from pertussis (whooping cough) and to pass along some of that protection to your baby.
• However, the Tdap vaccine does not prevent the spread of the disease, or even prevent you from catching the disease. All it does is lessen the effects and symptoms of one who has been vaccinated. This is probably more dangerous to a baby, because someone may be sick from whooping cough and not know it, and unknowingly pass it on to your baby if they come in contact. Source: (30) Pubmed, Acellular pertussis vaccines protect against disease but fail to prevent infection and transmission in a nonhuman primate model

IS IT EFFECTIVE?

• There is limited information about the effectiveness of Tdap during pregnancy, but the effectiveness that they claim is measured by looking at the antibodies present in the newborn in a handful of studies.
• A 2017 review of 15 published articles, including 2 randomized controlled trials and 13 observational studies determined that while vaccination boosted maternal antibodies, evidence was lacking on whether or not this had any impact on reducing the incidence of pertussis, serious complications from pertussis, or death in infants. Source: (31) National Vaccine Information Center, Whooping Cough 

Sources IT SAFE?

• Generally speaking, Tdap vaccines have not been tested against a true placebo. The “control” group received either Td or another Tdap vaccine.
• Both vaccines are made with aluminum adjuvants. 
• Many women have claimed miscarriage/stillbirth/fetal demise or preterm labor after this vaccine.
• This vaccine has not been tested for safety in pregnancy or tested for what effects it may have on the baby, and the manufacturers warn against their use for pregnant mothers since their safety has never been established.

Sources: (32) National Vaccine Information Center, Vaccination in Pregnancy; (33) Science Direct (34) Children’s Health Defense, Unlicensed and Untested 

Furthermore, the FDA has never approved a vaccine specifically for use in pregnancy to protect the infant Source: (35) FDA, Transparency Basics  (they have since deleted this page but you can access this slide presentation they did on the FDA archives. It has the same info.

From the package inserts:

• On very rare occasions, severe (anaphylactic) allergic reactions may occur after vaccination, including hives, swelling of the face and throat, difficulty breathing, a fast heartbeat, dizziness, and weakness.
• Section 5.3: “A review by the Institute of Medicine (IOM) found evidence for a causal relationship between receipt of tetanus toxoid and both brachial neuritis and Guillain-Barré syndrome.”
• Section 8.1: “Animal reproduction studies have not been conducted with the Adacel vaccine. It is also not known whether the 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 needed.”
• Section 8.3 “It is not known whether the Adacel vaccine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when the Adacel vaccine is given to a nursing woman.”
• Section 13.1: “This vaccine has not been evaluated for carcinogenic or mutagenic potential or impairment of fertility.”

Package inserts can all be found below. For more information on how to read an insert - and why to read them, check out our article here. 

• Adacel Insert 
• Boostrix Insert 

VAERS Report on Tdap and Fetal Demise:

• Check out the VAERS website to pull a report with the most current numbers. Instructions to access: read the disclaimer, and click the “I Agree” button at the bottom of the page. Click the top left tab that says “request form,” then wait for the results to load.
• Apparent contradictions in recommendations of timing the vaccine…Per the package inserts, there is no data to support repeat administration of either Tdap vaccine. The package inserts also say that at least 5 years should pass between the last time a vaccine was given containing tetanus toxoid, diphtheria toxoid, and/or pertussis-containing toxoid. Yet, Tdap is still recommended for each pregnancy, no matter if you got it the last time you were pregnant.
• In January 2019, the FDA approved Sanofi’s Adacel vaccine as the first Tdap vaccine approved for repeat use in the U.S. “8 years or more after the first vaccination”…yet the CDC still recommends a single dose of Tdap during each pregnancy, regardless of time since last vaccination received. Source: (36) Sanofi, Tdap News
• “The most recent change [in Tdap recommendations], which was included in the 2013 Immunization Schedule, is the recommendation for Tdap administration during each pregnancy, preferably between 27 and 36 weeks of gestation and regardless of time since the last Tdap or Td.” Source: (37) American College of Obstetricians, Committee on Obstetric Practice Immunization and Emerging Infections Expert Work Group

• When the U.S. vaccination program began in the 1940s, vaccines for diphtheria, tetanus, and pertussis were some of the first available. The first combined DPT vaccine became available in the United States in 1948.
• This type of combined shot used a whole-cell pertussis vaccine, which was associated with many adverse reactions including acute neurological reactions, seizures, permanent brain damage (encephalopathy), and death. In 1964, the AAP recommended the use of an aluminum-precipitated form of the DTP vaccine; the aluminum adjuvant made the vaccine more effective by way of increasing a person’s antibody response to the toxoids in the combination vaccine.
• (Decades later, in the mid-1990s, the whole-cell vaccine would be replaced with an acellular version that resulted in fewer adverse reactions.)

Here is a brief timeline of the DTP/DTaP vaccine:

• 1974: The World Health Organization included DPT in the list of vaccines recommended for its new Expanded Program on Immunization for developing countries.
• 1975: Japan stopped using DPT in response to safety concerns, then reinstated it only for children over the age of 2.
• 1981: Japan introduced the first acellular pertussis vaccine.
• 1982: DPT: Vaccine Roulette documentary was created by Lea Thompson highlighting the damaging effects of DPT.
• 1985: DPT: A Shot In The Dark by Harris Coulter published. National Vaccine Information Center (NVIC) was founded.
• 1986: The National Childhood Vaccine Injury Act passed, giving pharmaceutical companies a partial product liability shield. This Act came about because the parents of DPT-injured children were suing the vaccine manufacturers for its damages, and the number of lawsuits was growing to the point that vaccine manufacturers were threatening to stop the sales of vaccines in the U.S. This Act restricted lawsuits against vaccine manufacturers and negligent doctors. NVIC worked with Congress to subsequently set up the National Vaccine Injury Compensation Program (“vaccine court”).
• In 2011, a U.S. Supreme Court decision that inaccurately interpreted the National Childhood Vaccine Injury Act of 1986 removed a provision and completely shielded pharmaceutical companies from all liability for harm caused by any vaccine.
• 1991: The FDA approved the first acellular DTaP for use in the U.S. However, it took until 1996 for this vaccine to be granted approval for use on infants in children for all the recommended doses. (From 1991-1996, it was only approved for children aged 15 months to 6 years
• 1997: Whooping Cough: Acellular Vaccine Recommended combined diphtheria, tetanus, and pertussis (whooping cough) vaccine, DTaP, that used an acellular pertussis vaccine, replaced the DTP vaccination on the U.S. Recommended Childhood Immunization Schedule. The acellular vaccine used only parts of the pertussis pathogen in order to generate immunity and it resulted in fewer side effects than the whole-cell vaccine that had been used in DTP. Eventually, the United States would cease the use of DTP completely in favor of DTaP.
• 2017: Study finds that DPT is associated with increased mortality. Source: (40) The Vaccine Reaction, Increased Infant Mortality 

Sources:

• (41) NCBI 
• (42) NCBI, Pertussis and Rubella Vaccines: A Brief Chronology
• (43) History of Vaccines 
• (44) History of Vaccines 
• (45) NCBI, Diphtheria, pertussis (whooping cough), and tetanus vaccine induced recurrent seizures and acute encephalopathy in a pediatric patient: Possibly due to pertussis fraction
• (46) NCBI Pub Med