April 12, 2020

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The Manufacturer Inserts - Summarized

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. I summarize BOTH the Canadian inserts and American inserts (if available).

 

Please note, I've listed and summarized the vaccines below in an order which follows the Canadian and American childhood vaccine schedules. 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)

 

Below is a consolidated list of the various side effects that researchers specifically looked for in the trial participants, usually during the two week or less monitoring time period. The side effects listed below are called "solicited events" within the package insert:

  • 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)
     

 

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 Type B

  • MMR - Measles, Mumps, Rubella

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

  • V - Varicella (Chicken Pox)

 

 

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) OR 3 total doses given to Canadian children: in grade 5 (this childhood series will end in 2028, when infants born in 2018 reach grade 5 as babies born in 2018 received this series in infancy)

  • 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, 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 as side effects are more severe). 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 - 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 -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 - 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 - 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 child