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Can Hib Vaccine Cause Injury?

Can Hib vaccine cause injury?
Image source: CDC PHIL

According to the CDC, mild side effects such as redness, warmth, or swelling where the shot was given have been reported in connection with administration of Hib vaccines. Fever may occur as well and last two to three days. Other adverse events that may occur include allergic reaction, severe shoulder pain, fainting, and death.1

In pre-licensing clinical trials, the severity of adverse reactions varied depended on which vaccine was given, as well as the additional vaccines administered simultaneously. Some of the events reported by the manufacturers included:

ActHIB — tenderness, erythema, swelling, induration, fever, irritability, drowsiness, anorexia, unusual or persistent crying, vomiting, and seizure with apnea. Reported side effects post marketing have included convulsions, anaphylaxis, peripheral edema, extensive limb swelling, pruritus, and rash.2 Initial pre-licensing clinical safety studies of ActHIB compared the vaccine against other vaccines such as hepatitis B, while other studies involved ActHIB to be administered in addition to multiple vaccines including the DTP vaccine.3 Additional clinical studies on ActHIB involved the solicitation of adverse events when the vaccine was administered along with DTaP, IPV (polio), PCV7, and hepatitis B vaccines. No clinical studies involved a comparison of ActHIB against a true placebo.4

HIBERIX —redness, pain and swelling at injection site, fever, fussiness, irritability, loss of appetite, restlessness, sleepiness, diarrhea, vomiting, seizure, bilateral pneumonia; Reported side effects post marketing have included extensive swelling of the vaccinated limb, anaphylactic reactions, angioedema, convulsions, hypotonic-hyporesponsive episode, syncope, apnea, rash, urticaria, somnolence. Pre-licensing clinical trials of HIBERIX did not involve the use of a true placebo and most trials involved the testing of HIBERIX against another licensed Hib vaccine in combination with multiple additional vaccines. For example, one pre-licensing clinical safety study compared HIBERIX to another U.S. licensed Hib vaccine administered along with PEDIARIX vaccine (combination DTaP, inactivated polio, and hepatitis B vaccine). Study participants who received HIBERIX or another U.S. licensed Hib vaccine also received a dose of PEDIARIX and a dose of PCV13 (13-valent pneumococcal vaccine) at all three doses AND a dose of ROTARIX live oral rotavirus vaccine at dose 1 and 2. Study participants receiving PEDIARIX also received a dose of PCV13 and a dose of ENGERIX-B (Hepatitis B vaccine) when indicated, dependent on whether a dose of hepatitis B vaccine was administered at birth.5

PedvaxHIB —irritability, sleepiness, injection site pain/soreness, injection site swelling/induration, injection site erythema,  prolonged crying (more than 4 hours), unusual high-pitched crying, vomiting, diarrhea, pain, crying, otitis media, rash, upper respiratory infection, seizures, tracheitis, thrombocytopenia, urticaria; potential adverse events may also include early onset of Hib disease and Guillain-Barre syndrome (GBS); Reported side effects post marketing have included lymphadenopathy, febrile seizures, angioedema, and injection site abscess. Pre-licensing clinical trials of liquid PedvaxHIB compared the vaccine to lyophilized PedvaxHIB with most children in each study group receiving the DTP and oral polio vaccine in addition to PedvaxHIB. No pre-licensing clinical trials involved the comparison of PedvaxHIB against a true placebo.6

Pentacel — irritability, fussiness, inconsolable crying, injection site redness, swelling, tenderness, increase in arm circumference (dose 4), fever, lethargy, hypotonic hyporesponsive episodes (HHE), seizures, febrile seizures, bronchiolitis, dehydration, pneumonia, gastroenteritis, asthma, pneumonia, encephalopathy, and four deaths attributed to asphyxia due to suffocation, head trauma, sudden infant death syndrome (SIDS), and neuroblastoma. Reported side effects post marketing have included cyanosis, vomiting, diarrhea, extensive swelling of injected limb including swelling that involved adjacent joints, invasive Hib disease (classified as vaccine failure), rash, urticarial, meningitis, rhinitis, viral infection, decreased appetite, somnolence, hypotonic hyporesponsive episodes, depressed level of consciousness, screaming, apnea, cough, erythema, skin discoloration, and pallor. In pre-licensing clinical safety trials of Pentacel, there were no true placebo studies and most clinical trials compared the product against multiple vaccines including DTaP (diphtheria, tetanus, and acellular pertussis vaccine), polio vaccine, and ActHIB (Hib conjugated vaccine). In addition to the administration of Pentacel or the control vaccine(s), study participants also received PCV7 (7-valent pneumococcal vaccine, hepatitis B vaccine, and in some trials, measles, mumps, rubella (MMR) and varicella vaccines were also administered. Additionally, one pre-licensing clinical safety studies did not have a control group and involved the evaluation of adverse events reported following the fourth dose of Pentacel.7

Pentacel was first licensed in Canada in May of 1997, and data reported from Canada was evaluated by the FDA as part of the licensing process.8 In Canada, between May 1, 1997 and April 30, 2006, there were 245 medically confirmed adverse events reported to the manufacturer, with 237 adverse events reports submitted by health care authorities and providers and 8 reports pulled from literature. There were also 43 adverse events reported from health care consumers. Adverse events included: vomiting; diarrhea; cyanosis; eye rolling; injection site reactions including pain, inflammation, mass, and abscess; fever, irritability; edema, including peripheral edema; decreased vaccine response and vaccine failure; sudden infant death syndrome; sudden death; viral infection; rhinitis; meningitis; decreased appetite; seizures; hypotonic-hyporesponsive episode; somnolence; hypotonia; lethargy; encephalopathy; depressed level of consciousness; rash, including maculo-papular; skin discoloration; urticaria; and pallor. 14 deaths were reported following the administration of Pentacel and causes included Sudden Infant Death Syndrome (5 cases), unknown causes (4 cases), invasive Hib disease (2 cases), sepsis (1 case), convulsions (1 case), congenital anomaly (1 case).9

In addition to the deaths that occurred during the Pentacel clinical trials, deaths following the administration of other pentavalent vaccines have also been reported. In a March 2012 open letter to Dr. Margaret Chan, then director general of the World Health Organization, the letter’s authors called attention to the deaths connected with the pentavalent (DPT + Hib + Hepatitis B) vaccine in India, Sri Lanka, Bhutan, and Pakistan10 and noted the cause of the problem to be unrelated to the brand, manufacturer or lot of the vaccine, while stating that:

“It appears to be a form of ‘hypersensitivity reaction’ as described in the post mortem report on one of the children in Kerala. The vaccine can be administered to many patients without problems and there is no available method at present to predict which infant will react adversely.”11

Several studies on a Hib containing pentavalent vaccine used in South Asia and India have reported an elevated risk of death following vaccination,12 13 with several physicians publicly rejecting the use of the pentavalent vaccine.14 15

In a pediatric safety and use review of Pentacel presented in March of 2010, Dr. Jane Woo with the FDA discussed reported adverse reactions related to the vaccine following the June 2008 FDA approval. At the meeting, Dr. Woo reported that 775 adverse reactions, 170 of which were considered serious including 26 deaths, had been reported to VAERS in connection with Pentacel between June 20, 2008 (when Pentacel was licensed) and October 31, 2009. Deaths were attributed to SIDS (almost half of the reported cases), congenital/genetic conditions, respiratory infections, positional asphyxia, anoxic encephalopathy, cardiac arrest of undetermined etiology, dilated and hypertrophic cardiomyopathy, two deaths of undetermined cause, one death with no records obtainable, and two deaths with information pending.16 17 Dr. Woo stated that the number of cases of SIDS were not concerning and went on to quote the Institute of Medicine (IOM), which had previously concluded that evidence favors rejection of a causal relationship between exposure to multiple vaccines and SIDS. 18   

VAXELIS – injection site pain, swelling, and redness, crying, fever, irritability, decreased appetite, vomiting, somnolence, and death. As VAXELIS is not currently available for use in the United States, post-marketing data on serious adverse events are limited to those events considered to have a causal link to the vaccines containing the antigens of VAXELIS. These include anaphylaxis, hypersensitivity, seizures, including febrile seizures, and excessive swelling of the injected limb.19 6 in 1 (hexavalent) vaccines have been in use outside of the United States for several years and numerous studies have linked their use to an increase in infant deaths.20 21 22 23 24 In the two U.S. pre-licensing clinical trials, 6 deaths were reported in infants who received VAXELIS and included sepsis, asphyxia, hydrocephalus, unknown cause, and two cases of sudden infant death syndrome. The number of deaths that occurred during the VAXELIS pre-licensing clinical trials outside of the United States was not provided as part of the vaccine product insert. Pre-licensing clinical trials of VAXELIS compared infants who received VAXELIS concomitantly with RotaTeq (rotavirus vaccine) and Prevnar 13 (13-valent pneumococcal conjugate vaccine) against infants who received Pentacel (DTaP-IPV-HIB), and RECOMBIVAX-HB (hepatitis B, recombinant vaccine) concomitantly with RotaTeq and Prevnar 13. The safety and effectiveness of VAXELIS was evaluated in six clinical trials involving only 5,251 infants between the ages of 43 and 99 days of age at the time of enrollment. Only two clinical trials took place in the United States and involved 3,380 infants between the ages of 46 and 98 days. Information on solicited adverse events included injection site pain, redness, and swelling, fever, irritability, decreased appetite, somnolence, vomiting and crying were recorded by parents for only five days following vaccination. 68 (2 percent) infants who received VAXELIS were reported to have experienced a serious adverse event within 30 days of vaccination, however, only four of these serious adverse events were attributed to VAXELIS. Three infants experienced serious fever and one infant had a life threatening event that included vomiting followed by lethargy and pallor. The VAXELIS product insert does not provide any further information on the serious adverse events reported post vaccine administration that were considered by the vaccine manufacturer to be unrelated to the administration of VAXELIS. While VAXELIS is FDA approved for use in infants and children between the ages of 6 weeks and 4 years of age, the safety of VAXELIS was only evaluated in infants and children between 6 weeks and 15 months and the effectiveness of VAXELIS was only evaluated in infants between 6 weeks and 6 months of age. Pre-licensing clinical trials did not examine the effectiveness of VAXELIS in infants and children between 6 months and 4 years of age or the safety of VAXELIS for use in children between 15 months and 4 years of age. The FDA granted approval of the vaccine for use in this older population based on pre-licensing clinical trial data involving only younger children. Currently, there are no studies to support the safety of VAXELIS for use in children between the ages of 15 months and 4 years of age.25

Using the MedAlerts search engine, as of May 31, 2019, there have been more than 80,552 reports of Hib vaccine reactions, hospitalizations, injuries and deaths following Hib vaccinations made to the federal Vaccine Adverse Events Reporting System (VAERS), including 2,694 related deaths, 16,327 hospitalizations, and 1,623 related disabilities. Nearly 88% of HIB vaccine-related adverse events occurred in children three years old and under. Of these Hib-vaccine related deaths reported to VAERS, nearly 94% of the deaths occurred in children under three years of age. Of these reported deaths, 2,040 occurred in infants under the age of 6 months.

Even though the National Childhood Vaccine Injury Act of 1986 legally required pediatricians and other vaccine providers to report serious health problems following vaccination to federal health agencies (VAERS), many doctors and other medical workers giving vaccines to children and adults fail to report vaccine-related health problem to VAERS. There is evidence that only between one and 10 percent of serious health problems that occur after use of prescription drugs or vaccines in the U.S. are ever reported to federal health officials, who are responsible for regulating the safety of drugs and vaccines and issue national vaccine policy recommendations.26 27 28 29 30

As of July 1, 2019, there had been 159 claims filed in the federal Vaccine Injury Compensation Program (VICP) for injuries and deaths following HIB vaccination, including 33 deaths and 126 serious injuries. Of that number, the U.S. Court of Claims administering the VICP has compensated 51 children and adults who have filed for Hib vaccine injuries.31

In the comprehensive report evaluating scientific evidence, Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality,32 published in 1994 by the Institute of Medicine (IOM), reported vaccine adverse events following administration of Haemophilus influenzae vaccines were evaluated by a physician committee. These adverse events included Guillain-Barre Syndrome, transverse myelitis, thrombocytopenia, early susceptibility to H. influenzae type b, anaphylaxis, and death. In most cases, after evaluating the available literature, the IOM was unable to accept or reject a causal relation between Hib vaccines and the reported side effect due to a lack of evidence. The committee, however, favored a causal association between unconjugated PRP vaccine (unconjugated PRP vaccines are no longer approved for use in the U.S.) and the increased risk of early onset H. influenzae disease in children older than 18 months who received an unconjugated PRP vaccine as their first Hib vaccine. The committee also favored rejection of an association between early onset Hib disease and conjugated Hib vaccines (conjugated Hib vaccines are the only FDA approved Hib vaccines available in the U.S.) Additionally, the IOM favored rejection of a causal relation between death from early-onset Hib disease and conjugated Hib vaccines. 33 Hib vaccines were not evaluated as part of the Institute of Medicine’s 2012 comprehensive report Adverse Effects of Vaccines: Evidence and Causality.34

No Hib conjugate or Hib combination vaccines have ever been evaluated for their carcinogenic or mutagenic potential, or for impairment of fertility.35

IMPORTANT NOTE: NVIC encourages you to become fully informed about Haemophilus Influenzae Type B (Hib) and the Hib vaccine by reading all sections in the Table of Contents, which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

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1 CDC Haemophilus Influenzae Type b (Hib) VIS Apr. 2, 2015

2 FDA ActHIB Product Insert Dec. 20, 2018

3 FDA Summary for Basis for Regulatory Action - ActHIB No Date

4 FDA ActHIB Product Insert Dec. 20, 2018

5 FDA Hiberix Product Insert Apr. 30, 2018

6 FDA Haemophilus B Conjugate Vaccine (Meningococcal Protein Conjugate) Apr. 27, 2011

7 FDA Pentacel Product Insert Mar. 16, 2017

8 FDA Pentacel Clinical Safety Review June 13, 2008

9 Ibid

10 Puliyel J, Shiva M, Dabade G, et al. Open Letter to DG, WHO — Pentavalent Vaccine Related Deaths in India. All India Drug Action Network (AIDAN). March 12, 2012.

11 Ibid

12 Sreedhar S, Antony A, and Poulose N Study on the effectiveness and impact of pentavalent vaccination program in India and other south Asian countries Hum Vaccin Immunother. 2014 Jul 1; 10(7): 2062–2065.

13 Puliyel J, Kaur J, Puliyel A, et al. Deaths reported after pentavalent vaccine compared with death reported after diphtheria-tetanus-pertussis vaccine: An exploratory analysis Med J DY Patil Vidyapeeth 2018 May 18; 11(2) 99-105

14 Devraj R Doctors Resist Deadly Vaccine Inter Press Service News Agency Feb 8, 2014

15 Express News Service More children died after getting Pentavalent vaccine than DPT, says study The New Indian Express Mar. 16, 2018

16 FDA Transcript of the Pediatric Advisory Committee Meeting Mar. 22, 2010

17 Woo, J Post-Approval Adverse Event Review: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine (Pentacel®) Office of Biostatistics and Epidemiology Center for Biologics Evaluation and Research US Food and Drug Administration Mar. 22, 2010

18 FDA Transcript of the Pediatric Advisory Committee Meeting Mar. 22, 2010

19 FDA VAXELIS Product Insert Dec. 21, 2018

20 Matturri L, Del Corno G, Lavezzi AM Sudden infant death following hexavalent vaccination: a neuropathologic study. Curr Med Chem. 2014 Mar;21(7):941-6.

21 Ottaviani G, Lavezzi AM, Matturri L. Sudden infant death syndrome (SIDS) shortly after hexavalent vaccination: another pathology in suspected SIDS? Virchows Arch. 2006 Jan;448(1):100-4

22 von Kries R, Toschke AM, Strassburger K, et al. Sudden and unexpected deaths after the administration of hexavalent vaccines (diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, Haemophilius influenzae type b): is there a signal? Eur J Pediatr. 2005 Feb;164(2):61-9

23 Zinka B, Rauch E, Buettner A, et al. Unexplained cases of sudden infant death shortly after hexavalent vaccination. Vaccine. 2006 Jul 26;24(31-32):5779-80.

24 Puliyel J, Sathyamala C Infanrix hexa and sudden death: a review of the periodic safety update reports submitted to the European Medicines Agency. Indian J Med Ethics. 2018 Jan-Mar;3(1):43-47

25 FDA VAXELIS Product Insert Dec. 21, 2018

26 Kessler DA, the Working Group, Natanblut S, et al. A New Approach to Reporting Medication and Device Adverse Effects and Product Problems. JAMA. 1993;269(21):2765-2768.

27 FDA. Kessler DA. Introducing MEDWatch: A New Approach to Reporting Medication and Device Adverse Effects and Product Problems. Reprint from JAMA. June 9, 1993.

28 Braun M. Vaccine adverse event reporting system (VAERS): usefulness and limitations. Johns Hopkins Bloomberg School of Public Health

29 Rosenthanl S, Chen R. The reporting sensitivities of two passive surveillance systems for vaccine adverse events. Am J Public Health 1995; 85: pp. 1706-9.

30 AHRQ Electronic Support for Public Health–Vaccine Adverse Event Reporting System (ESP:VAERS) Dec 1, 2007-Sep. 30, 2010

31 U.S. Department of Health and Human Services. National Vaccine Injury Compensation Program Data—May 1, 2019. National Vaccine Injury Compensation Program. May. 1, 2019

32 Institute of Medicine Committee to Review Adverse Effects of Vaccines. Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality. Washington, DC: The National Academies Press. 1994 Chap. 9 Haemophilis influenzae Type b vaccines. P 236-273

33 Ibid

34 Institute of Medicine Committee to Review Adverse Effects of Vaccines. Adverse Effects of Vaccines: Evidence and Causality. (Evaluating Biological Mechanisms for Adverse Events: Increased Susceptibility). Washington, DC: The National Academies Press. 2012.

35 FDA Vaccines Licensed for Use in the United States Apr. 26, 2019

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