Can Polio vaccine cause injury and 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.  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 poliovirus vaccine or any other vaccine.

The poliovirus vaccine is commonly administered in a combination vaccine which includes the diphtheria, tetanus, and acellular pertussis vaccine (DTaP), hepatitis B and Haemophilus influenzae type b (Hib) vaccines. It is important to review the manufacturer product insert prior to receiving a combination vaccine that contains the poliovirus vaccine.

Adverse reactions reported by vaccine manufacturers as listed in the vaccine product inserts:

Pediarix (Diphtheria and tetanus toxoids and acellular pertussis, hepatitis B recombinant and inactivated poliovirus vaccine manufactured by GlaxoSmithKline.)

• Frequently Reported Adverse Events: Local injection site reactions (pain, redness, or swelling); fussiness, high fever (Pediarix is associated with higher rates of feverrelative to separately administered vaccines. The prevalence of fever was highest on the day of and the day following vaccination.)
• Serious Reported Adverse Events: High fever requiring medical attention (In a safety study that evaluated medically attended fever after Pediarix or separately administered vaccines when co-administered with 7-valent pneumococcal and Hib conjugate vaccines, infants who received Pediarix had a higher rate of medical encounters for fever within the first 4 days following the first vaccination); febrile and afebrile convulsions (seizures); gastroenteritis; bronchiolitis; asthma; diabetes mellitus; and chronic neutropenia; anaphylactic reactions (hives, swelling, difficulty breathing, hypotension or shock); and demyelinating diseases.

Kinrix (Diphtheria and tetanus toxoids, acellular pertussis and inactivated poliovirus vaccine manufactured by GlaxoSmithKline.)

• Frequently Reported Adverse Events: Injection site pain, including redness, swelling and increase in arm circumference; drowsiness; fever; loss of appetite.
• Serious Reported Adverse Events:Gastroenteritis; dehydration; and cellulitis. After licensure (post-marketing), reported adverse event have also included apnea, collapse or shock-like state (hypotonic-hyporesponsive episode), convulsions (with or without fever), injection site vesicles, pruritus (intense itching), allergic reactions, including anaphylaxis, urticaria, angioedema, lympadenopathy, and thrombocytopenia.

Quadracel (Diphtheria and tetanus toxoid, acellular pertussis and inactivated poliovirus vaccine manufactured by Sanofi Pasteur.)

• Frequently Reported Adverse Events: Injection site pain, including redness, swelling and increase in arm circumference; malaise; muscle pain; headache.
• Serious Reported Adverse Events: After licensure (post-marketing), reported adverse event have also included cyanosis, convulsions (with or without fever), injection site abscess, injection site cellulitis, pallor, screaming, allergic reactions, including anaphylaxis, urticaria, and dyspnea.

Pentacel (Diphtheria and tetanus toxoids and acellular pertussis, inactivated poliovirus and Haemophilus b conjugate (tetanus toxoid conjugate) vaccine manufactured by Sanofi Pasteur.)

• Frequently Reported Adverse Events: Systemic reactions that occurred in clinical trials in more than 50 percent of participants following any dose included: fussiness/irritability and inconsolable crying; fever; injection site reactions, including tenderness, abscess and increase in arm circumference.
• Serious Reported Adverse Events: Cases of encephalopathy and death also occurred during clinical trials. After licensure (post marketing), there have been reports of febrile and afebrile convulsions (seizures), bronchiolitis, gastroenteritis, dehydration, pneumonia, lethargy/somnolence, hypotonic/hyporesponsive episode (collapse), apnea, cyanosis, and asthma.

VAXELIS (Diphtheria and tetanus toxoids and acellular pertussis, inactivated poliovirus, Haemophilus b conjugate, and hepatitis B recombinant vaccine manufactured by MCM Vaccine Company.)

• Frequently Reported Adverse Events: Systemic reactions that occurred in clinical trials following any dose included: injection site redness, swelling, and pain, fever, crying, decreased appetite, irritability, vomiting, and somnolence
• Serious Reported Adverse Events: In the two U.S. clinical trials, 6 deaths were reported but were determined by trial investigators not to be caused by VAXELIS. These deaths included sepsis, asphyxia, hydrocephalus, unknown cause, and two cases of sudden infant death syndrome. 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.

IPOL (inactive poliovirus (Monkey Kidney Cell) manufactured by Sanofi Pasteur)

• Frequently Reported Adverse Events: Local injection site reactions (pain, redness, and induration); fever; sleepiness; irritability; fussiness; crying; anorexia; vomiting; and fatigue;
• Serious Reported Adverse Events: convulsion, including febrile convulsion; somnolence; paresthesia; headache; injection site rash and mass; agitation; lymphadenopathy; anaphylactic reaction and anaphylactic shock; hypersensitivity; rash; urticaria; arthralgia; myalgia; and death.

In 1994, the Institute of Medicine (IOM) reported that there was compelling scientific evidence to establish a causal relationship between the oral poliovirus vaccine (OPV) and paralytic and non-paralytic polio. The committee also affirmed that OPV could cause vaccine-strain polio in the contacts of vaccinated individuals. Additionally, the IOM committee also favored acceptance of an association between OPV and Guillain-Barre Syndrome (GBS). An immune mediated painful and disabling neurological disorder that can occur after viral infection or vaccination, GBS involves inflammation of the peripheral nervous system and can cause temporary or permanent paralysis that may lead to death. The committee, however, reported that there was insufficient evidence to accept or reject a causal relationship between the inactivated, injectable poliovirus vaccine (IPV) and GBS. A potential association between poliovirus vaccines, both OPV and IPV, and transverse myelitis, a rare neurological condition which causes spinal inflammation, was also evaluated in this report. Committee members reported that the evidence was insufficient to accept or reject a causal relationship between OPV and transverse myelitis and that there was no evidence to determine a relationship between IPV and this serious neurological condition. 

Vaccine-acquired paralytic polio (VAPP) was associated with OPV immediately following the vaccine’s introduction. When OPV was in use in the U.S., VAPP was estimated to occur at a rate of one case per 2.4 million doses, or one case per 750,000 doses, if OPV was administered as the first dose. On June 17, 1999, the CDC’s Advisory Committee on Immunization Practices (ACIP) voted to stop the use of OPV in the U.S., by January of 2000.  OPV, however, remains in use globally, and is the vaccine primarily used in global campaigns that are focused on eradicating polio. 

In addition to VAPP, OPV can also cause vaccine-derived poliovirus (VDPV). OPV is a live virus vaccine and individuals who receive the vaccine will shed vaccine-strain poliovirus in the stool for several weeks following vaccination. In areas with poor sanitation, the vaccine-strain virus can spread within a community for an extended period. When this occurs, the vaccine-strain polio virus will undergo genetic changes and, in some cases, transform into circulating VDPV (cVDPV) and cause paralysis. Public health officials report that cVDPV occurs in under-vaccinated communities or due to poorly administered vaccination programs. 

In 2019, the majority of reported paralytic polio cases were caused by outbreaks of type 2 cVDPV (cVDPV2) which were reported in Niger, Nigeria, Cameroon, Benin, Ghana, Ethiopia, Somalia, China, Myanmar, Kenya, Central African Republic (CAR), Angola, Somalia, and Papua New Guinea, Indonesia. 

The U.S. government recognizes the following as OPV vaccine injuries –  

• Paralytic polio occurring within 30 days of vaccine administration in an immunocompetent individual
• Paralytic polio occurring within 6 months of vaccine administration in an immunodeficient individual
• Paralytic polio in a vaccine-associated case within the community
• Vaccine-strain polio infection occurring within 30 days of vaccine administration in an immunocompetent individual
• Vaccine-strain polio infection occurring within 6 months of vaccine administration in an immunodeficient individual
• Vaccine-strain polio infection associated case within the community

The U.S. government recognizes the following as IPV vaccine injuries –  

• Anaphylaxis occurring within four hours of vaccine administration
• Shoulder injury related to vaccine administration within 48 hours of receiving the vaccine
• Vasovagal syncope within one hour of vaccine administration

As of June 30, 2023, there have been 24,887 adverse events reported following OPV including 1,045 deaths (nearly 90 percent in children under age six). There have also been more than 82,060 reports of adverse events associated with IPV containing vaccines including 1,716 deaths. However, the number of vaccine-related injuries and deaths reported to VAERS may not reflect the true number of serious health problems that occur after polio 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.          

As of August 1, 2023, there had been 310 claims filed in the federal Vaccine Injury Compensation Program (VICP) for injuries and deaths following OPV containing vaccines, including 28 deaths and 282 serious injuries. There had been 516 claims for injuries and deaths following IPV containing vaccines, including 75 deaths and 441 serious injuries. Of that number, the U.S. Court of Claims administering the VICP has compensated 241 children and adults, who have filed claims for polio vaccine associated injury and death. 

SV40 and Poliovirus vaccine

In 1960, Dr. Bernice Eddy discovered that the rhesus monkey kidney cells used to make the first injectable poliovirus vaccine, and the first experimental oral polio vaccines, could cause cancer when injected into lab animals. Later that year, the cancer-causing virus in the rhesus monkey kidney cells was identified as simian virus 40 (SV40), the 40th monkey virus to be discovered. Public health officials, who were aware of the virus and its potential to cause cancer, chose not to make this information public. Further, they allowed the contaminated vaccine to be injected into millions of Americans between 1955 and 1963. 

The U.S. government and vaccine manufacturers have reported that all SV40 tainted poliovirus vaccines were removed from the market by 1963; however, there is evidence that SV40 was still present in the OPV and administered to children from 1963 through the 1990’s.     

In 2002, the Institute of Medicine (IOM) concluded that “the biological evidence is strong that SV40 is a transforming virus” and that “the biological evidence is of moderate strength that SV40 exposure could lead to cancer in humans under natural conditions”. It also concluded that "the evidence is inadequate to accept or reject a causal relationship between SV40-containing polio vaccines and cancer."   SV40 associated cancers include - brain cancers, bone cancers, malignant mesothelioma, and non-Hodgkin's lymphoma.    

The 2002 IOM committee recommended that additional research be completed to determine whether a causal relationship exists between SV40 and cancer, but they have not published any further reports on this subject. U.S public health officials have acknowledged that live SV40 contaminated both inactivated and live polio vaccines between 1955 and 1963, but they continue to deny that SV40 causes cancer in humans. 

IMPORTANT NOTE: NVIC encourages you to become fully informed about Polio and the Polio 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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