In essence, society’s attention has become focused on vaccination, focused solely on this health treatment. But TREATMENT is not what creates health, treatment is what changes or manages a persons’ symptoms of poor health. Instead of focusing solely on the treatment, there needs to be a shift. We need to evaluate the treatment in the context of the whole - what is working about the treatment? What needs improving? What is failing completely? How does the treatment affect evolution of the species? And how can health be supported moving forward so that the treatment is no longer needed?
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Vaccine Approval Is Fast Tracked - Part 3

 

I've titled this 4-Part article series "Vaccine Approval is Fast Tracked." In Part 2 of this series, I quoted the FDA and their criteria used when determining which new drugs qualify for a fast tracked review and approval process. On the FDA website, it states (emphasis mine):

Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need...Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapy.

 

Any drug being developed to treat or prevent a condition with no current therapy obviously is directed at an unmet need. If there are available therapies, a fast track drug must show some advantage over available therapy.

 

Also in Part 2, I explained that the Gardasil vaccine was a fast tracked agent, despite not actually meeting the FDA fast tracking criteria. With that said, though the title of this article series implies that all the other childhood vaccines were also fast tracked through the FDA review and approval process, I need to state here clearly that none of those childhood vaccines (that are used today), none of them were "fast tracked" as defined by the FDA, as far as I'm aware.

 

With that explained, I still believe it's reasonable to refer to all of the childhood vaccines as "fast tracked." I believe this because the safety monitoring period of every vaccine clinical trial was extremely brief. 

 

The Slate article "What the Gardasil Testing May have Missed," explained this clearly, saying, "In all the [Gardasil] trial locations, Merck also chose to restrict the reporting of adverse events—what the study protocol calls the “clinical follow-up for safety”—to just 14 days following each of the three Gardasil injections in the trial."  Slate goes on to quote Dr. Yoon Loke, a professor who studies drug side effects. The article states, "Of the short follow-up, Loke told me, "It's not going to pick up serious long-term issues, which is a pity. Presumably, the regulators believe that the vaccine is so safe that they don’t need to worry beyond 14 days.”

 

In Part 1 of this series, I explained how vaccine safety testing works, saying:

...for safety evaluation, the [trial] participants' health is not closely monitored over the entirety of the [years' long] trial. Rather, the safety monitoring period is usually reduced to 14 days, or less, following receipt of each dose of vaccine. That means...with three doses of vaccine [given], the participants' health will be closely monitored for 14 days x 3, for a combined total of 42 days over the entire four year time period. For many vaccines, the safety monitoring window is even less than 14 days, and participants are only monitored closely for one to seven days after each dose of vaccine.

 

The CDC subtly acknowledges that the Government views safety as less of a priority in vaccine testing and approval. The Government will recommend widespread use of a vaccine in an entire population, once the vaccine is proven effective,  despite there being only very limited safety data available for that vaccine. On the CDC's website, it states:

Observing vaccinated children for many years to look for long-term health conditions would not be practical, and withholding an effective vaccine from children while long-term studies are being done wouldn’t be ethical.

 

And therefore, because health outcomes are monitored for such a short period of time before launching the vaccine onto the entire population, I believe it's reasonable to refer to all vaccines as fast tracked drugs, hence the title for this article series.

 

As stated in Part 1 of this series, to learn which reactions researchers do look for in the vaccine safety studies, you need to review the vaccine package inserts provided by the manufacturers. In most vaccine clinical trials, the participants are monitored for minor, short term reactions. Below is a consolidated list from all the package inserts, of the various side effects that researchers specifically looked for in the trial participants, during the two week or less monitoriing period, in the various pre-licensing safety trials:

  • Fever / Chills

  • Sweating

  • Flushing

  • Malaise (feeling unwell)

  • Sore Throat

  • Rhinorrhea (excess mucous secretion from nose)

  • Ear Ache or Ear Infection

  • Upper Respiratory Infection

  • Cough

  • Irritability

  • Prolonged and Unusual Crying and/or High pitched Screaming (in young infants this can be indication of brain injury and swelling)

  • Fatigue / Drowsiness

  • Impaired Sleeping / Insomnia

  • Loss of Appetite

  • Abdominal Pain / Cramps

  • Nausea / Vomiting

  • Diarrhea

  • Hypersensitivity

  • Apnea (suspension of breathing)

  • Hypotonic-Hyporesponsive Episode (Collapse or shock-like state within 3 days of vaccination, which can involve cardiovascular or respiratory arrest)

  • Allergic Reaction / Anaphylaxis

  • Angioedema (swelling of the lower layer of skin and tissue just under the skin or mucous membranes. The swelling may occur in the face, eyes, lips, tongue, larynx, abdomen, or arms and legs.)

  • Urticaria (Hives)

  • Rash

  • Dermatitis (eczema, itchy, red rash)

  • Lymphadenopathy (disease in lymph nodes producing swollen or enlarged lymph nodes)

  • Nodule formation (elevated areas of tissue or fluid inside or under the skin that feels hard and has a diameter greater than 0.5 cm)

  • Swelling (of limb, joint(s) or localized at injection site) 

  • Erythema (redness of the skin)

  • Ecchymosis (bleeding under the skin, causing bruising larger than 1cm)

  • Pruritus (undesirable feeling on skin, which provokes desire to scratch)

  • Paresthesia (sensation on the skin, tingling, prickling, burning, numbness)

  • Pain (at injection site, muscle pain, body ache, joint aches or headache)

  • Muscle Weakness or Stiffness

  • Hypotension (low blood pressure)

  • Vertigo, Dizziness, Lightheadedness, Fainting

  • Dysuria (painful urination)
     

Below, I provide a summary of the safety data for the approved Canadian childhood
vaccines (Link Here), focusing only on the clinical trial data where infants, children and adolescents participated, because they are the population that receives the bulk of vaccines and we know that the different age populations respond differently to drugs.

For the Government approved Canadian vaccines, I summarize BOTH the Canadian inserts and American inserts (if available).

 

Please note, I've listed and summarized the vaccines in an order which follows the Canadian and American childhood vaccine schedules. The headings denote each illness that have an applicable vaccine. Beneath each illness heading I explain the number of doses recommended, and the ages when this vaccine is given if you were to follow the recommended vaccination schedule. My summaries below provide and emphasize the information as follows:

  • the manufacturer (noted in brackets)

  • the number of clinical trial participants, (underlined)

  • the length of time that participants were monitored for (bolded)

  • the control substance that was used in the trial, (bolding for saline placebo only) 

  • any interesting information or warnings quoted directly from the manufacturer (italics)

 

Vaccine names are abbreviated below as follows:

  • Hep B - Hepatitis B

  • DTaP - Diphtheria, Tetanus, Acellular Pertussis (Whooping Cough)

  • DwPT / DPT - Diphtheria, Whole Cell Pertussis (Whooping Cough), Tetanus

  • TD - Tetanus and Diphtheria

  • IPV - Inactivated Polio Virus

  • OPV - Oral Polio Virus

  • HIB - Haemophilus Influenzae B

  • MMR - Measles, Mumps, Rubella

  • MMRV - Measles, Mumps Rubella, Varicella (Chicken Pox)

  • V - Varicella (Chicken Pox)

 

An important final point to make before moving on to the safety testing details explained in the vaccine package inserts, is to remind you of the obviousthe package inserts are prepared by the manufacturer. What's important about that point is that the manufacturer has the most to gain in convincing the public to use their product. Lets say there was no debate on the topic of vaccines, that would mean that the public truly does gain from vaccines, with improved public health, which includes improved long term health for the population. In that light, it could then be said that the manufacturer also gains from that improved health + they gain status, for being the creator and provider of that improved health + they gain profit for selling a product that improves health. Because the manufacturer has the most to gain, they also have the greatest motivation to show the strongest evidence available, in an effort to promote their product. Of course the manufacturers aren't going to list mediocre evidence "to prove" safety, if stronger evidence exists. That would make no sense. So, when you review the package insert summaries remember the obvious, this is the strongest evidence available to "prove" safety, for this specific vaccine.

 

 

Hepatitis B Vaccines:

  • 3 total doses given to American infants: on day 1 of life, at 2 and 6 months of age

  • 3 total doses given to Canadian infants: at 2, 4 and 6 months of age (New change to Alberta vaccination schedule effective May 1, 2018)

  • 3 total doses given to Canadian children: in grade 5 (I assume this series will end in 2028, when infants born in 2018 reach grade 5)

  • At risk Canadian infants may also be given a dose on their day of birth.

 

Brands available in Canada, for Hepatitis B vaccine include:

  • Recombivax HB (Merck) - On the Canadian insert there is no safety data provided for children. The insert states that the vaccine was tested on 1252 adults, who were monitored for 5 days post vaccination. Link Here On the American insert, it says the vaccine was tested for safety on 147 children (infant to less than 10 years of age - distribution of ages was not provided). The participants were monitored for some of the reactions listed above, during the 5 days following vaccination. The comparator 
    vaccine information (used as control) was not provided. The package insert states, "RECOMBIVAX HB has not been evaluated for its carcinogenic or mutagenic potential, or its potential to impair fertility."  FDA link Here The Canadian insert is silent on this.
     

  • Engerix-B (GSK) - the Canadian insert states the vaccine was tested on 5300 people. It didn't provide a description of ages, or how long the participants were monitored for. Link Here On the American insert it says the vaccine was tested on 5071 healthy adults, children and newborn infants (didn't provide the distribution through age groups). The participants were monitored for many of the above listed reactions during the 4 days following vaccination. The comparator vaccine information (used as control) was not provided. The insert states, "ENGERIX-B has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility." FDA link Here. The Canadian insert is silent on this.
     

  • Twinrix Jr. (GSK) (Canadian insert) - the vaccine is approved for use in the childhood population, age 1-18 years old. The insert provided very few details regarding the safety studies that have been conducted. It stated that in the pediatric population, Twinwrix was tested on 800 participants and 778 participants (ages not specified). Those two groups received 3 total doses each, based on two different vaccine schedules. The participants were monitored for some of the above listed reactions. It does not say how long participants were monitored for. Link Here
     

  • Infanrix - Hexa - see description in the DTaP section below

DTaP Vaccines (Combination of three vaccines in one vial, for illnesses Diptheria, Tetanus, Pertussis):

  • 6 total doses given to each Canadian and American infants and children, administered at: ages 2, 4, 6 and 18 months of age, at 4-6 years of age, and in grade 9

 

Available brands in Canada, for DTaP vaccines include:

  • Pediacel (Sanofi Pasteur) Canadian Insert) - is a combination of 5 vaccines in one vial, for the illnesses DTaP, IPV, HIB. It was tested on 339 Infants (at 2, 4, & 6 months of age) and 301 of these infants were later immunized as toddlers (18 months). The participants were monitored for some of the above listed reactions during the 24 hours after vaccination. Control information was not provided. The package insert states, "The potential risk of apnea and the need for respiratory monitoring for 48 – 72 hours should be considered when administering the primary immunization series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity." The package insert also states, "Sudden infant death syndrome (SIDS) has occurred in infants following administration of DTaP vaccines. By chance alone, some cases of SIDS can be expected to follow receipt of PEDIACEL®." You will often hear health officials state that vaccines do not cause SIDS deaths. SIDS is the cessation of breathing, usually during sleep, which results in death, and an admitted vaccine side effect is apnea - the suspension of breathing. If vaccination can cause the suspension of breathing, why can't it also cause the cessation of breathing. It needs to also be noted that recently there was a vaccine court ruling that determined a child's SIDS death was in fact likely caused by the infant's recent vaccination. The insert also states, "the following events are contraindications to administration of a pertussis containing vaccine. "Encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) within 7 days of a previous dose of a pertussis-containing vaccine that is not attributable to another identifiable cause." Encephalopathy means brain injury, and so the package insert is warning  that vaccination may cause brain injury, which may not be reversible. The package also insert states, "A review by the IOM found evidence for a causal relation between tetanus toxoid and both brachial neuritis and Guillain-Barré syndrome." Link Here.
     

  • Infanrix (GSK) (American Insert) - has been tested in several clinical trials on a total of 29,243 infants receiving the primary series (3 doses in infancy), of which 6081 of those infants then went on to receive  a 4th dose in childhood, and 1,764 received a 5th dose. A US study observed 335 infants (at 2, 4 and 6 months of age), who received the test Infanrix vaccine with Engerix-B, IPV, HIB and Pneumococcal vaccines administered at the same time. The participants were monitored for some of the above listed reactions during the 4 days following vaccination. Control information was not provided. It was also tested as a booster dose in 810 children (age 15-18 months). MMR, pneumococcal, and HIB vaccines were administered simultaneously with the test Infanrix vaccine. The children were monitored for some of the above listed reactions in the 4 days following vaccination. No control information was provided. It was tested as a booster on 1053 children (age 4-6). IPV and MMR vaccines were administered simultaneously with the test Infanrix vaccine. The children were monitored for some of the above listed reactions in the 4 days following vaccination. No control information was provided. In an Italian Trial, 4,696 infants (at 2, 4, and 6 months of age) received Infanrix, and 4,678 infants received a whole cell DTwP vaccine as control. (The whole cell DTwP vaccine is no longer used in North America as it is no longer deemed to be safe enough for our infants). All infants were monitored for 48 hours, and the insert states that infants who received Infanrix vaccine experienced significantly fewer severe reactions as compared to infants who received the DTwP vaccine. Serious adverse events reported in the Infanrix group were, 5 fevers greater than 104°, 6 episodes of persistent crying for 3 hours or longer, and 1 seizure. In a German study which involved 22,505 infants (at 3, 4 and 5 months of age), a diary card was sent home to record reactions during the 28 days following vaccination. A subset of 2,457 of those infants were given a diary card to monitor their reactions over 3 months, (from day 1 with the 1st dose to 30 days following the 3rd dose). Those studies that list an extended monitoring period (28 days and 3 months) were likely gathering unsolicited event information, where the onus falls onto the parents (not researchers) to record possible side effects. The package insert states, "Apnea following intramuscular vaccination has been observed in some infants born prematurely." The package insert states, "INFANRIX has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility." Insert from FDA website Link Here
     

  • Infanrix-IPV (GSK) (Canadian Insert) -  is a combination of 4 vaccines in one vial, for the illnesses DTaP, IPV. It was tested on children (number not specified) aged 15 months to 20 months. This vaccine was tested as a booster dose. The participants were monitored for 48 hours following vaccination. Infanrix-IPV was tested on children who were also given a HIB vaccine at the same time. The reactions experienced by the children who received the Infanrix-IPV + HIB vaccine were less frequent, when compared against the reactions experienced by children who received a control of DTP-IPV + HIB vaccine. (It needs to be noted that DTP (the control), which is sometimes also called DTwP or DwPT, is no longer considered safe enough to use on American and Canadian infants). The vaccine was also tested on 2200 infants, and the participants were monitored for some of the above listed reactions. The ages of those 2200 infants, the length of time that their health was monitored for, and the control information was not provided. The package insert states, "The potential risk of apnea and the need for respiratory monitoring for 48-72h should be considered when administering the primary immunization series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity." The insert states, "adequate animal reproduction studies are not available." Link Here On the FDA website, the package insert for the American Infanrix vaccine states, "INFANRIX has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility."  Link Here The Canadian insert is silent on this.
     

  • Infanrix-IPV/HIB (GSK) (Canadian Insert) - is a combination of 5 vaccines in one vial, for the illnesses DTaP, IPV, HIB. The vaccine was tested through 6100 primary immunization doses administered (at 2, 4, & 6 months of age), and 2900 booster doses administered (in second year of life). It does not state the number of participants, but recognizing that infants receive three doses in the first year of life, I estimate approximately 2000 infants participated in the primary study. The participants were monitored for several of the reactions listed above. It does not specify how long the participants were monitored for, or what was used as control. The vaccine was also tested on 3500 subjects (age not specified). Participants were monitored for some of the above listed reactions, but it does not say how long participants were monitored for. The insert states, "The potential risk of apnea and the need for respiratory monitoring for 48-72h should be considered when administering the primary immunization series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity." The package insert states, "Experience with INFANRIX and other INFANRIX based combinations have not revealed any cases of encephalopathy or permanent neurologic damage causally linked to vaccination. While acute encephalopathy and permanent neurologic damage have not been reported to be causally linked nor in temporal association with administration of INFANRIX®-IPV/Hib, data are limited at this time." (It is important to note that whole cell DTP vaccines became widely used 70 years ago, and due to safety concerns were replaced with DTaP vaccines 20 years ago. Recognizing the extensive history of use, there is no reason why 70 & 20 years later, data should still be limited). The insert also says, "Studies suggest that, when given whole-cell DTP vaccine, infants and children with a history of convulsions in first-degree family members (i.e. siblings and parents) have a 2.4-fold increased risk for neurologic events compared to those without such histories." (They are providing data on the former DTP vaccine, which is no longer used, because the warning may still apply to the re-formulated DTaP vaccines that are used today). On the FDA website, the package insert for the American Infanrix vaccine states, "INFANRIX has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility." Link Here The Canadian insert is silent on this.
     

  • Infanrix-Hexa (GSK) (Canadian Insert) - is a combination of 6 vaccines in one vial, for the illnesses DTaP, IPV, HIB, Hep B. It was tested on 267 infants. The participants were monitored for some of the above listed reactions during the 8 days following vaccination. The control group received a combination of other vaccines (Infanrix + Engerix-B + OPV administered at the same time). Reactions were also monitored in 16,000 participants (ages not specified). The data given does not provide the time frame that the participants were monitored for, or which other vaccines were injected simultaneously or what was used as control. The insert states, "The potential risk of apnea and the need for respiratory monitoring for 48-72h should be considered when administering the primary immunization series to very preterm infants (born after at least 24 weeks of gestational age) and particularly for those with a previous history of respiratory immaturity." Seizure (with or without fever) was listed as occurring in less than 0.01% of the population (1 in 10,000 infants). The package insert states, "While acute encephalopathy and permanent neurologic damage have not been reported to be causally linked nor in a temporal association with administration of INFANRIX hexa data is limited at this time." The insert also states, "Studies suggest that when given whole-cell DTP vaccine, infants and children with a history of convulsions in first-degree family members (i.e., siblings and parents) have a 2.4-fold increased risk for neurologic events compared to those without such histories." The insert also states, "adequate animal reproduction studies are not available." Link Here. On the FDA website, the package insert for the American Infanrix vaccine states, "INFANRIX has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility." Link Here The Canadian insert is silent on this.
     

  • Quadracel (Sanofi Pasteur) (Canadian Insert) - is a combination of 4 vaccines in one vial for the illnesses DTaP, IPV. 113 infants were tested (at 2, 4, & 6 months of age), with 104 of these infants later vaccinated again as toddlers at 18 months of age. The participants were monitored for some of the above listed reactions during the 24 hours following vaccination. Control vaccine information was not provided. It was also tested on 800 children (4-6 years) who were monitored for some of the above listed reactions during the following 48-96 hours post vaccination. The package insert states, "The potential risk of apnea and the need for respiratory monitoring for 48 – 72 hours should be considered when administering the primary immunization series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity." The package insert states, "the following events are contraindications to administration of any pertussis-containing vaccine...Encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) within 7 days of a previous dose of a pertussis-containing vaccine that is not attributable to another identifiable cause." The insert also states, "A review by the US Institute of Medicine (IOM) found evidence for a causal relationship between tetanus toxoid and both brachial neuritis and Guillain-Barré syndrome." Canadian Insert Here On the FDA website, the package insert for the American Quadracel vaccine states, "Quadracel has not been evaluated for carcinogenic or mutagenic potential or impairment of fertility." Link Here The Canadian insert is silent on this. 
     

  • Quadracel (Sanofi Pasteur) (American Insert) - A study conducted in Puerto Rico, tested Quadracel on 2733 children (4-6 years). A control group of 621 children received Daptacel + IPOL vaccines instead. All participants received MMR and Varicella vaccines at the same time. The participants were monitored for some of the above listed reactions during the 7 days following vaccination. Participants could report unsolicited adverse events for 28 days following vaccination, and participants were monitored for serious adverse events during the 6 months following vaccination. During the 28 day period, 0.1% of Quadracel recipients and 0.2% of Daptacel+IPOL recipients experienced serious adverse events (not detailed). During the 6 month period, 0.8% of Quadracel recipients (21 of 2733) and 0.5% Daptacel+IPOL recipients (3 of 621) experienced a serious adverse event (not detailed). The insert states that none of the adverse events were assessed as related to vaccination. (A never vaccinated control group was not monitored during this period, to see if they too experienced serious medical events at a rate of 0.1-0.2% in 28 days or 0.5-0.8% in 6 months). The package insert states, "Quadracel has not been evaluated for carcinogenic or mutagenic potential or impairment of fertility." FDA Link Here
     

  • Adacel (Sanofi Pasteur) (Canadian Insert) - was tested on 298 children (less than 4 years of age) and 1508 adolescents. The participants were monitored for some of the above listed reactions during the 14 days after vaccination. The reactions experienced by the children were compared to reactions experienced in Quadracel vaccine recipients (children) and Td vaccine recipients (adolescents and adults). The insert states, "Two serious adverse events were reported during Study Td506 which were considered related to the vaccination: a case of severe migraine with unilateral facial paralysis, and a diagnosis of nerve compression in the neck and left arm." The package insert also states, "Encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) within 7 days of a previous dose of a pertussis-containing vaccine not attributable to another identifiable cause is a contraindication to vaccination with any pertussis-containing vaccine, including ADACEL." The insert also states, "A review by the US Institute of Medicine (IOM) found evidence for a causal relation between tetanus toxoid and both brachial neuritis and Guillain-Barré syndrome. Canadian insert Here On the FDA website, the package insert for the American Adacel vaccine states, "Adacel vaccine has not been evaluated for carcinogenic or mutagenic potential or impairment of fertility." Link Here The Canadian insert is silent on this.
     

  • Adacel (Sanofi Pasteur) (American Insert) - the vaccine was tested in 5 trials involving a total of 4,695 adolescents (10-17 years) and 2,448 adults (18-64 years). In one trial, the participants were monitored for some of the above listed reactions during the 14 days following vaccination. Reactions were compared to a control group that received a Td vaccine. Data was also gathered for adverse events necessitating medical support, starting on day 14, until 6 months after vaccination. The reports were made by interview at a 28 day follow-up and 6 month follow-up telephone call. Two serious adverse events occurred within 28 days following vaccination. They were one severe migraine with unilateral facial paralysis and one diagnosis of nerve compression in neck and left arm. Serious adverse events during the 6 month period were reported as occurring in 1.5% of Adacel recipients and 1.4% of Td recipients (not detailed). The vaccine was also tested in 1806 adolescents (11-17 years) who were monitored for some of the above listed reactions during the 14 days following vaccination. Participants could report unsolicited events during the 28 days after vaccination, and participants were monitored for serious events during that time. In a Canadian trial, the vaccine was tested on 762 adolescents and adults. Their reactions were compared to recipients who received a TD vaccine. The reactions were deemed similar to those experienced in four prior American trials. The package insert states, "Adacel vaccine has not been evaluated for carcinogenic or mutagenic potential or impairment of fertility." FDA Link Here
     

  • Adacel-Polio (Sanofi Pasteur) (Canadian Insert) - was tested in 7 clinical trials that spanned a total of 644 children (age 3-7 years) and 992 adolescents and adults (age 11-60). The length of time that the participants were monitored for was not clearly defined, though from one table it appears that three of the studies followed the participants for 7 and 14 days. In the children studies, reactions to Adacel-Polio, were stated to be comparable to reactions observed in children who received an Adacel vaccine. The package insert states, "A review by the US Institute of Medicine (IOM) found evidence for a causal relation between tetanus toxoid and both brachial neuritis and Guillain-Barré syndrome." The insert is silent on whether or not the vaccine was tested for carcinogenic or mutagenic potential, or the potential to impair fertility. Link Here
     

  • Boostrix (GSK) (Canadian Insert) - was tested in two trials on 1243 subjects. Of those subjects, a total of  211 children (under 10 years of age) and 448 adolescents (10 - 17 years of age) received Boostrix, while 119 adolescents received either Td or aP vaccines as control. The participants were monitored for some of the above listed reactions during the 15 days after vaccination, and those reactions experienced by Boostrix recipients were deemed comparable to the control groups. The vaccine was also tested on 839 children (age 4-9 years) and 1931 children, adolescents, and adults (over 10 years of age). It lists the rate of occurrence of some of the above listed reactions, but does not specify how long participants were monitored for. On the FDA website, the package insert for the American Boostrix vaccine states, "Boostrix has not been evaluated for carcinogenic or mutagenic potential or impairment of fertility." Link Here The Canadian insert is silent on this.
     

  • Boostrix (GSK) (American Insert) - was tested in various clinical trials on a total of 4,949 adolescents (10-18 years). Of these adolescents, 1341 of them received a meningococcal vaccine at the same time. In one US study, 3,080 adolescents who received Boostrix, were compared to a control group of 1,034 adolescents who received Td vaccine. All participants were monitored for some of the above reactions in the 14 days following vaccination. Participants could also report unsolicited events for 31 days following vaccination. Unsolicited events were reported as occurring in 25.4% of Boostrix recipients and 24.5% of Td recipients. As well, participants were monitored for non-routine medical visits, ER visits, onset of new chronic illness, and serious adverse events, for 6 months following vaccination. In a German study, 319 children (10-12 years) were monitored for 15 days for some of the solicited events listed above, and for 31 days for unsolicited reactions. Participants were also monitored for 6 months after vaccination, for ER visits, onset of new chronic illness, and serious adverse events. Regarding serious adverse events, the insert states, "In the US and German adolescent safety studies, no serious adverse events were reported to occur within 31 days of vaccination. During the 6-month extended safety evaluation period, no serious adverse events that were of potential autoimmune origin or new onset and chronic in nature were reported to occur." (That phrasing leaves questions for me. Does that mean that participants with existing chronic autoimmune conditions which were previously stable, those stable conditions became worse following vaccination?) The insert goes on to state, "In non-US adolescent studies in which serious adverse events were monitored for up to 37 days, one subject was diagnosed with insulin-dependent diabetes 20 days following administration of BOOSTRIX. No other serious adverse events of potential autoimmune origin or that were new onset and chronic in nature were reported to occur in these studies." The inset states, "BOOSTRIX has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility." FDA link Here
     

  • Boostrix-Polio (GSK) (Canadian Insert) - was tested on 908 children (age 4-9), who were monitored for several of the above listed reactions. It did not say how long they were monitored for, or if there was a comparison to control. The vaccine was also tested on 1931 subjects over 10 years of age (did not provide the distribution of children, adolescents and adults in that group). A detail of the rate of reactions was provided. The insert states, "Although an isolated and slight retardation of some ossification parameters was observed among dTpa-IPV treated [rat] fetuses on Day 20 gestation, no sustained effects were observed after parturition." The insert is silent on whether or not the vaccine was tested for carcinogenic or mutagenic potential, or the potential to impair fertility. Link Here
     

  • Imovax-Polio (Sanofi Pasteur) (Canadian Insert) - is a combination of 4 vaccines in one vial, for illnesses DTaP, IPV). This vaccine was tested on 395 participants (ages not specified. The participants were monitored for some of the above listed reactions. It did not say how long the participants were monitored for, or what vaccines were administered at the same time, or which comparator vaccine was used as control. The vaccine was also tested on 205 children (ages not specified), who were monitored for rates of fever. No other details were provided. The insert says the vaccine was also tested on 324 children (ages not specified) who received Imovax-Polio with or without DPT vaccine. The study concluded that Imovax-Polio was as well tolerated as when DPT was administered alone (DPT is no longer used in the US or Canada because of the severe side effects). The package insert states, "Although no causal relationship between IMOVAX® Polio and Guillain-Barré syndrome (GBS) has been established, GBS has been temporally related to administration of another inactivated poliovirus vaccine. An extensive review by the (US) Institute of Medicine of adverse events associated with vaccination suggested that no serious adverse events have been associated with IPV. Although no causal relationship has been established, deaths have occurred in temporal association after vaccination of infants with IPV." The package insert states, "No clinical trials with inactivated poliomyelitis vaccine have been conducted on pregnant women. Although there is no convincing evidence documenting adverse effects of inactivated poliomyelitis vaccine on the pregnant woman or the developing fetus, it is prudent on theoretical grounds to avoid vaccinating pregnant women." But, The National Advisory Committee on Immunization (NACI) says you can disregard the manufacturer's warning completely, because the package insert goes on to state, "The National Advisory Committee on Immunization (NACI) states that IPV is not contraindicated in pregnancy, but its administration should be delayed until after the first trimester, if possible, to minimize any theoretical risk. If risk of exposure is imminent, IPV should be given and is always the vaccine of choice except for outbreak control." In other words, they are saying, "Don't worry that we have no scientific data to refute the manufacturer's warning, our recommendation which is based on our belief, is that you and your baby will be okay! YAY! Vaccines for everyone!" The insert is silent on whether or not the vaccine was tested for carcinogenic or mutagenic potential, or the potential to impair fertility. Link Here

Polio

  • 5 total doses given to Canadian infants and children: at 2, 4, 6 & 18 months of age, and at 4-6 years of age

  • 4 total doses given to American infants and children: at 2, 4 & 6-18 months of age, and at 4-6 years of age

 

The brands available in Canada, for Polio are:

  • Td Polio Adsorbed (Sanofi Pasteur) (Canadian Insert) - is a combination of 3 vaccines in one vial, for illnesses Td, IPV). This vaccine is approved for use in children 7 years of age and older. This vaccine was tested on 40 participants (ages not specified) who had previously been vaccinated against diphtheria, tetanus, and polio. The participants were monitored for some of the above listed reactions during the 3 days following vaccination. The inset states, "A review by the US Institute of Medicine (IOM) found evidence for a causal relation between tetanus toxoid and both brachial neuritis and Guillain-BarrÈ syndrome. If Guillain-BarrÈ Syndrome occurred within 6 weeks of immunization with a previous dose of vaccine containing tetanus toxoid, the decision to give subsequent doses of Td POLIO ADSORBED or any vaccine containing tetanus toxoid should be based on careful consideration of the potential benefits and possible risks."  The insert is silent on whether or not the vaccine was tested for carcinogenic or mutagenic potential, or the potential to impair fertility. Link Here


Also, refer to the DTaP section above, for the DTaP combo vaccines that also contain Polio vaccination. These vaccines include:

  • Infanrix Hexa

  • Infanrix-IPV/Hib 

  • Infanrix-IPV

  • Quadracel

  • Pediacel

  • Adacel-Polio

  • Boostrix-Polio

  • Imovax-Polio

Haemophilus Influenzae Type B (HIB)

  • 4 total doses given to Canadian infants at: 2, 4, 6 & 18 months of age

  • 4 total doses given to American infants at: 2, 4, 6 & 12-18 months of age
     

The brands available in Canada for HIB are:

 

  • Act-HIB (Sanofi Pasteur) (Canadian Insert) - Very general information is provided on this insert, with few specific clinical trial details explained. The insert states that the vaccine has been tested in multiple clinical trials, carried out in multiple countries, involving more than 110,000 infants and children. The insert states that in almost all of the trials, the Act-HIB vaccine was injected with DPT or DTaP vaccines, and that reactions to Act-HIB were deemed comparable to reactions seen in participants who received DPT vaccine alone. In a later section of the insert where it provides a little more detail about the safety trials, the insert explains one specific safety trial (the number of participants is not specified). The insert then explains that participants received either Act-HIB + DPT vaccine at separate injection sites, or placebo + DPT vaccine given at separate injection sites. The participants in that trial were monitored for some of the above listed reactions during the 24 hours following vaccination. In that same section, the insert goes on to  mention a few other safety trials, specifying the number of participants enrolled in those various safety studies. The numbers of participants listed in that summary are as follows: 215 infants, 186 toddlers (18-months old), 68 infants, 62 toddlers (18-months old), and 66 toddlers (18-months old). So, if we are to believe that 110,000 infants and children did participate in various pre-licensing safety trials like the package insert alludes to, I question why the insert only highlights and details safety trial data involving a few very small groups of children, ranging from 62 participants to 215 participants. Based on those very low participant numbers, I suspect that the bulk of that "110,000 participants" number, were most likely a result of a post marketing observational study completed after the vaccine was licensed and was being used on a mass scale. If so, that 110,000 number is not actually reflective of the number of participants who were monitored during the more targeted and focused pre-licensing safety trials. The insert states, "No evaluation of Act-HIB® has been made with respect to its potential for carcinogenesis or mutagenesis." It is says that it's unknown whether the Act-HIBvaccine can cause fetal harm or affect fertility. The insert states, "The potential risk of apnea and the need for respiratory monitoring for 48 – 72 hours should be considered when administering the primary immunization series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity." Link Here
     

  • Act-HIB (Sanofi Pasteur) (American Insert) - The details are very sparse in this insert, and it appears that the insert phrases information very poorly and provides incorrect information. The insert states, "More than 7,000 infants and young children (≤2 years of age) have received at least one dose of 19 ActHIB vaccine during US clinical trials. Of these, 1,064 subjects 12 to 24 months of age who 20 received ActHIB vaccine alone reported no serious or life threatening adverse reactions." Wow! That statement could be read to mean that the majority of the participants, approximately 6,000 them, did experience a serious or life threatening adverse reaction to the vaccine. I believe their statement is actually alluding to the reality that few of the subjects participated in safety testing, and that approximately 6,000 of them participated in vaccine effectiveness testing only. It states that 110 children (15-20 months) received 3 doses of Act-HIB or a competitor HIB vaccine at 2, 4 & 6 months of age. Again, there's something wrong here. How can children who are 15-20 months of age be enrolled in an infancy study. Did they teleport those toddlers back in time so those toddlers could receive this vaccine at 2, 4, and 6 months of age? I doubt it, so I assume they've incorrectly stated the age of the participants. Whatever age those participants were, the children were monitored for some of the above listed reactions during the 48 hours following vaccination. The insert says that 1454 infants received 3 doses of Act-HIB at 2, 4 & 6 months of age. Of those participants, 418 of them also received a fourth dose at 15-18 months of age. In that trial, the Act-HIB vaccine was administered simultaneously with routine childhood vaccines, which included either Daptacel, Polio, Prevnar, Hep B, or combinations of those. The participants were monitored for some of the above listed reactions during the 3 days following vaccination. The insert states, "In Study P3T06, within 30 days following any of Doses 1-3 of DAPTACEL + IPOL + ActHIB vaccines, 50 of 1,455 (3.4%) participants experienced a serious adverse event. One SAE of seizure with apnea occurring on the day of vaccination with the first dose of the three vaccines was determined by the investigators as possibly related." And Section 13.1 of the insert states, "ActHIB vaccine has not been evaluated for its carcinogenic or mutagenic potential or impairment of fertility." Link to FDA site Here
     

  • Hiberix (GSK) (Canadian Insert) - The details provided in the Adverse Events Reactions section are extremely sparse. This section provided 2 sentences of background, which read, "The following frequencies were based on the analysis of approximately 3000 infants enrolled in study Hib-097 and of approximately 1200 infants enrolled in study DTPa- HBV-IPV-011." From there, they provided a legend, and a short 12 line list that encompassed 12 potential side effects, all of which I've listed above. No information was provided for the placebo or comparator vaccine used, or how long the participants were monitored for following vaccination. The insert states, "The potential risk of apnea and the need for respiratory monitoring for 48- 72h should be considered when administering the primary immunization series to very premature infants (born 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity." Section 13.1 of the American insert states, "HIBERIX has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility." Link to FDA website Here The Canadian insert is silent on  this. Link Here
     

  • Hiberix (GSK) (American Insert) - The insert states that 2963 infants (2, 4 & 6 months old) were vaccinated with 3 total doses of Hiberix at those ages. A separate group of 520 control participants received a competitor HIB vaccine also at 2, 4 & 6 months of age, and a third group of 520 control participants received a DTaP-IPV/HiB vaccine at 2, 4 & 6 months of age. For the Hiberix group and competitor group, the participants received routine vaccines simultaneously, including Pediarix + Prevnar vaccines during doses 1, 2 & 3, and Roatarix vaccine with doses 1 & 2. The DTaP-IPV/Hib group received routine vaccine simultaneously, including Prevnar 13 + Engerix B vaccines with doses 1, 2 & 3, and Rotarix vaccines with doses 1 & 2. The participants were monitored for some of the above listed reactions during the 4 days following vaccination. The insert explains that the vaccine was tested in 7 additional trials conducted in various countries. 530 children (11-25 months) received a booster dose of Hiberix with simultaneous routinely recommended vaccines of their country. 478 control participants received one of two possible competitor Hib vaccines. It does not say how long the participants were monitored for, nor did it provide a table or description explaining the reactions experienced. In a German study, a booster dose of Hiberix was tested on 371 children (mean age 16 months). Hiberix was administered simultaneously with DTaP-HBV-IPV vaccine. The participants were monitored for some of the above listed reactions during the 4 days following vaccination. The insert states, "In Study 1, one of 2,963 subjects who received HIBERIX and coadministered vaccines given at 2, 4, and 6 months of age experienced a SAE which was in temporal association with vaccination and had no alternative plausible causes (convulsion on Day 14 after Dose 1)." The insert states, &quo