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Can Meningococcal vaccine cause injury & death?


vaccine injury death

The Institute of Medicine (IOM) has acknowledged that there is individual susceptibility to vaccine reactions for genetic, biological and environmental reasons, but that vaccine providers cannot accurately predict prior to a vaccine’s administration who will suffer complications, injury or death from vaccination.1 However, a person who has previously had a serious reaction to a vaccination or is acutely or chronically ill should become informed about all potential risks associated with vaccination and discuss any concerns with a trusted health care professional before receiving a meningococcal vaccine or any other vaccine.

According to the CDC, at least 50 percent of individuals receiving meningococcal vaccines targeting meningococcal serogroups A, C, Y, and W-135 (Menactra or Menveo) experience mild side effects such as pain or redness at the injection site and a small number also report joint pain and muscle aches following vaccination. Additionally the CDC warns that persons receiving any vaccine may collapse (faint), experience a severe allergic reaction, severe pain and limited mobility to the vaccinated limb, and even serious injury and death.2

Adverse events reported by Sanofi Pasteur in the Menactra vaccine product insert include: injection site redness, pain, and swelling; irritability; diarrhea; drowsiness; anorexia; headache; fatigue; vomiting; abnormal crying; loss of appetite; rash; joint pain; chills; anaphylaxis; wheezing; upper airway swelling; difficulty breathing; hypotension; itching; hives; lymph node swelling; Guillain-Barre syndrome; convulsions; dizziness; facial palsy; vasovagal syncope; paresthesia; transverse myelitis; acute disseminated encephalomyelitis; muscle pain; and extensive swelling of the injected limb and injection site.3

Adverse events reported by Novartis Vaccines and Diagnostics (GlaxoSmithKline) in the pre-licensing clinical trials of Menveo vaccine include: injection site tenderness, swelling, and redness; sleepiness; irritability; persistent crying; changes in eating habits; diarrhea; vomiting; fever; rash; headache; joint and muscle pain; malaise; nausea; chills; dehydration; gastroenteritis; Kawasaki’s Disease; acute disseminated

encephalomyelitis; appendicitis; pneumonia; staphylococcal infection; dehydration; tonic and febrile convulsion; limb injury; varicella; road traffic accidents; vitello-intestinal duct remnant; Cushing’s syndrome; viral hepatitis; pelvic inflammatory disease; intentional multiple drug overdose; simple partial seizure; suicidal depression and suicide attempts. Among infants and young children under 2 years of age, two deaths were reported within 28 days of vaccination. Deaths were listed as sepsis and sudden death. Adverse events reported following the licensing of Menveo vaccine have included: anaphylaxis; falls; head injury; vaccination site cellulitis, pain, redness, persistent itching, swelling, and inflammation; extensive swelling of the vaccinated limb; fatigue; malaise; fever; ear pain; hearing impairment; vestibular disorder; vertigo; eyelid ptosis; increased body temperature; increased Alanine aminotransferase; bone and joint pain; skin exfoliation; oropharyngeal pain; balance disorder; facial paresis; dizziness; syncope; tonic convulsions; headache; and Bell’s palsy. In a post marketing safety study, the administration of Menveo vaccine concomitantly with Tdap and HPV vaccine was noted to significantly increase the risk of Bell’s palsy within 84 days of vaccine administration.4 5

A 2017 published study of Menveo vaccine by researchers who examined adverse reaction reports submitted to the Vaccine Adverse Events Reporting System (VAERS) between 2010 and 2015 noted additional medical conditions following vaccination to include Guillain-Barre syndrome, facial nerve palsy, seizures, intracranial hypertension, acute disseminated encephalomyelitis, chronic inflammatory demyelinating polyradiculopathy, migraine, headache, hypotonia/motor delay, polyneuritis, neuromyopathy, anaphylaxis, allergic reactions, drug eruption, vasovagal syncope, myocarditis and pericarditis, appendicitis, viral meningitis, streptococcal pneumonia, Steven Johnson Syndrome, erythema multiforme, fibromyalgia, pyomyositis, muscular weakness, juvenile idiopathic arthritis, psychiatric disorders, gastrointestinal disorders, glioma, osteosarcoma, Kawasaki’s disease, idiopathic thrombocytopenic purpura (ITP), and hyperthyroidism.6

In the comprehensive report evaluating scientific evidence, Adverse Effects of Vaccines: Evidence and Causality7, published in 2012 by the Institute of Medicine (IOM), nine reported vaccine adverse events following meningococcal serogroup A, C, Y, and W-135 vaccination were evaluated by a physician committee.8 These adverse events included encephalitis, encephalopathy, multiple sclerosis, chronic headache, Guillain-Barre Syndrome, acute disseminated encephalomyelitis, chronic inflammatory disseminated polyneuropathy, anaphylaxis, and transverse myelitis.

In 8 of the 9 meningococcal vaccine-related adverse events evaluated, the IOM committee concluded that there was inadequate evidence to support or reject a causal relationship between meningococcal vaccine and the reported adverse event, primarily because there was either an absence of methodologically sound published studies or too few quality studies to make a determination.9 The IOM committee, however, concluded that the scientific evidence “convincingly supports” a causal relationship between anaphylaxis and meningococcal vaccine. 10

According to the CDC, approximately 50 percent of meningococcal serogroup B (BEXSERO or TRUMENBA) vaccine recipients experience mild side effects that may include pain, redness, and swelling to the injection site, headache, joint or muscle pain, fever or chills, diarrhea or nausea, and fatigue. The CDC also warns that persons receiving any vaccine may collapse (faint), experience a severe allergic reaction, severe pain and limited mobility to the vaccinated arm, and even serious injury and death.11

Adverse events reported by Novartis Vaccines and Diagnostics (GlaxoSmithKline) in the pre-licensing clinical trials of BEXSERO vaccine included: redness, pain, and swelling at the injection site; muscle and joint pain; fatigue; nausea; headache; fever; nasopharyngitis; upper respiratory infection; anaphylaxis; juvenile arthritis; acute thyroiditis; bacterial meningitis; appendicitis, muscular weakness, generalized and submandibular lymphadenopathy, rhabdomyolysis; septic shock; pneumonia; and generalized Tonic-Clonic seizure. Four deaths were reported during pre-licensing clinical trials, however, study investigators declared them to be unrelated to vaccination. These deaths included suicide, drowning, motor vehicle accident, and the death of a 7 week old infant from post-natal respiratory complications. The infant’s mother had received her last dose of the vaccine approximately 9-10 months prior to the infant’s birth.12 Adverse events reported following FDA approval of BEXSERO have included: vasovagal responses to injection; syncope; allergic reaction; rash; eye swelling; extensive swelling of the vaccinated limb; blisters around or at the injection site; and persistent injection site nodule.13

In the United Kingdom, where BEXSERO (4CMenB) has been routinely administered in a three dose series to infants at 8 weeks, 16 weeks, and between 12-13 months since September 2015, researchers have found that fever related hospitalizations within 3 days of vaccination have increased significantly when the vaccine is administered at 8 and 16 weeks.14

Adverse events reported by Wyeth Pharmaceuticals (Pfizer)  in the pre-licensing clinical trials of TRUMENBA vaccine included: pain, swelling, and redness at the injection site; headache; fever; vomiting and diarrhea; fatigue; chills; muscle and joint pain; nervous system disorders; ligament strain; oropharyngeal pain; eye disorders; severe vertigo, chills, and headache; severe vomiting with fever; anaphylaxis; hydrocephalus; post-infectious arthritis; deep vein thrombosis; Type 2 diabetes mellitus; contact dermatitis; decreased appetite; migraine; asthma; hypothyroidism; scoliosis; Crohn's disease; exacerbation of psoriasis; celiac disease; exacerbation of celiac disease; autoimmune thyroiditis; acute idiopathic thrombocytopenia purpura (ITP); Sydenham’s chorea; IgA nephropathy; hyperthyroidism; rheumatoid arthritis; Bell’s Palsy; lymphoid tissue hyperplasia; psychiatric disorders; appendicitis; cellulitis; depression; thymic disorder; extremity weakness; appendicitis; nodular fasciitis; epiphysiolysis; bipolar disorder; leg and wrist fracture; abdominal pain; hemorrhoids; and biliary dyskinesia. One death resulting from a motor vehicle accident was reported during pre-licensing clinical trials.15 16 Adverse events reported following FDA approval of TRUMENBA vaccine have included: syncope; hypersensitivity reactions; and anaphylactic reactions.17

As of January 31, 2019, there have been more than 31,330 reports of meningococcal vaccine reactions, hospitalizations, injuries and deaths following meningococcal vaccinations made to the federal Vaccine Adverse Events Reporting System (VAERS), including 174 related deaths, 3,092 hospitalizations, and 437 related disabilities. However, the numbers of vaccine-related injuries and deaths reported to VAERS may not reflect the true number of serious health problems that occur develop after meningococcal vaccination.

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. 18 19 20 21 22

As of April 1, 2019, there have been 75 claims filed so far in the federal Vaccine Injury Compensation Program (VICP) for 2 deaths and 73 injuries that occurred after meningococcal vaccination. Of that number, the U.S. Court of Claims administering the VICP has compensated 43 children and adults, who have filed claims for meningococcal vaccine injury.23

In addition to reactions and injuries following meningococcal vaccination, administration errors resulting in adverse events have also been reported. Menactra (MCV4/MenACWY-D) meningococcal conjugate vaccine is approved to be administered intramuscularly (IM) while Menomune meningococcal polysaccharide vaccine is approved to given subcutaneously (SC). Following FDA approval of Menactra vaccine, multiple reports surfaced in regards to the incorrect administration of Menactra vaccine by subcutaneous injection. In September of 2006, the CDC issued a report regarding the over 100 reported vaccine errors involving Menactra vaccine misadministration. Twelve reports resulted in adverse events, however, all were considered to be non-serious. The CDC conducted a study examining immune responses from individuals who received the incorrectly administered vaccine and determined vaccine acquired antibodies to be acceptable and did not recommend revaccination. In this report, the CDC reminded vaccine providers to review all vaccine product inserts prior to administering any vaccine.24

In February of 2016, the CDC issued a second report detailing meningococcal vaccine administration errors, this time involving the Menveo (MenACWY-CRM) meningococcal conjugate vaccine. Menveo vaccine is supplied in two separate vials and must be combined prior to vaccine administration. However, between March 1, 2010 and September 22, 2015, 407 reports of Menveo vaccine misadministration were submitted to the Vaccine Adverse Events Reporting System (VAERS). Reported errors included vaccine providers administering only the liquid MenCYW-135 component of the vaccine or otherwise administering only the lyophilized MenA component by reconstituting it in liquids such as saline, sterile water, or even with another vaccine. Fifteen percent of vaccine administration errors involving Menveo resulted in adverse events that included redness to the injection, fever and pain. The CDC also admitted that as a passive surveillance system, VAERS likely only captured a fraction of meningococcal vaccine misadministration error and many more additional cases were likely to have occurred. Again, vaccine providers were advised to review and follow the instructions provided in the vaccine product insert and on the vial labels prior to administration.25

NVIC “Quick Facts” is not a substitute for becoming fully informed about Meningococcal disease, meningitis and the Meningococcal vaccine. NVIC recommends consumers read the more complete information following the "Quick Facts", as well as the vaccine manufacturer product information inserts, and speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child.

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References

1 Institute of Medicine Committee to Review Adverse Effects of Vaccines. Adverse Effects of Vaccines: Evidence and Causality. Evaluating Biological Mechanisms of Adverse Events (p. 57-102), Increased Susceptibility (p. 82). Washington, DC: The National Academies Press 2012.

2 CDC Meningococcal ACWY VIS Aug. 24, 2018

3 FDA Menactra Product Insert Apr. 27, 2018

4 FDA Menveo Product Insert Oct. 4, 2018

5 Tseng HF, Sy LS, Ackerson BK et al. Safety of Quadrivalent Meningococcal Conjugate Vaccine in 11- to 21-Year-Olds. Pediatrics. 2017 Jan;139(1). pii: e20162084.

6 Myers TR, McNeil MM, Ng CS et al. Adverse events following quadrivalent meningococcal CRM-conjugate vaccine (Menveo®) reported to the Vaccine Adverse Event Reporting system (VAERS), 2010-2015. Vaccine. 2017 Mar 27;35(14):1758-1763

7 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

8 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. Chap. 11, p 599 - 614

9 Ibid

10 Ibid

11 CDC Serogroup B Meningococcal (MenB) VIS Aug. 9, 2018

12 FDA Clinical Review, January 23, 2015 - BEXSERO Jan. 23, 2015

13 FDA BEXSERO Product Insert May 31, 2018

14 Murdoch H, Wallace L, Bishop J et al. Risk of hospitalisation with fever following MenB vaccination: self-controlled case series analysis. Arch Dis Child. 2017 Oct;102(10):894-898

15 FDA Clinical Review - TRUMENBA Oct. 29, 2014

16 FDA Clinical Review of 125549/17 - TRUMENBA Apr. 14, 2016

17 FDA TRUMENBA Product Insert Mar. 14, 2018

18 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.

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

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

21 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.

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

23 U.S. Department of Health and Human Services. National Vaccine Injury Compensation Program Data—April 1, 2019. National Vaccine Injury Compensation Program. Apr. 1, 2019

24 CDC Inadvertent Misadministration of Meningococcal Conjugate Vaccine --- United States, June--August 2005 MMWR Sep 22, 2006; 55(37);1016-1017

25 CDC Notes from the Field: Administration Error Involving a Meningococcal Conjugate Vaccine — United States, March 1, 2010–September 22, 2015 MMWR Feb. 19, 2016; 65(6);161–162


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