Pharmaceutical Name

Trade (marketing or proprietary) name: IPOL®

Generic (nonproprietary or active ingredient) name: Poliovirus Vaccine Inactivated

Indication and Usage

Reason the product has been approved for sale on the market.

Per the FDA, IPOL vaccine is indicated for active immunization of infants (as young as 6 weeks of age), children, and adults for the prevention of poliomyelitis caused by poliovirus Types 1, 2, and 3.

Manufacturer Insert

Ingredients

Also known as “excipients” for vaccines.

Inactivated forms of three types of poliovirus: Type 1 (Mahoney), Type 2 (MEF-1), and Type 3 (Saukett). Each of the three strains of poliovirus is individually grown in vero cells, a continuous line of monkey kidney cells cultivated on microcarriers. The cells are grown in Eagle MEM modified medium, supplemented with newborn calf bovine serum tested for adventitious agents prior to use, originated from countries free of bovine spongiform encephalopathy. For viral growth, the culture medium is replaced by M-199, without calf bovine serum. This culture technique and improvements in purification, concentration, and standardization of poliovirus antigen produce a more potent and consistent immunogenic vaccine than the inactivated poliovirus vaccine (IPV) available in the US prior to 1988 (see polio vaccine history in History section).

Each dose (0.5 mL) of trivalent vaccine is formulated to contain 40 D antigen units of Type 1, 8 D antigen units of Type 2, and 32 D antigen units of Type 3 poliovirus. For each lot of IPOL vaccine, D-antigen content is determined in vitro using the D-antigen ELISA assay. IPOL vaccine is produced from vaccine concentrates diluted with M-199 medium. Also present are 0.5% of 2-phenoxyethanol and a maximum of 0.02% of formaldehyde per dose as preservatives. Neomycin, streptomycin, and polymyxin B are used in vaccine production; and, although purification procedures eliminate measurable amounts, less than 5 ng neomycin, 200 ng streptomycin, and 25 ng polymyxin B per dose may still be present. The residual calf bovine serum albumin is less than 50 ng/dose in the final vaccine.

Limitations of Effectiveness

Per the manufacturer, “As with any vaccine, vaccination with IPOL vaccine may not protect 100% of individuals.”

Contraindications

Per the FDA, contraindications are conditions in a recipient that increases the risk for a serious adverse reaction. Product should not be administered when a patient has a listed contraindication.

• IPOL vaccine is contraindicated in persons with a history of hypersensitivity to any component of the vaccine, including 2-phenoxyethanol, formaldehyde, neomycin, streptomycin, and polymyxin B.
• No further doses should be given if anaphylaxis or anaphylactic shock occurs within 24 hours of administration of one dose of vaccine.
• Vaccination of persons with an acute, febrile illness should be deferred until after recovery; however, minor illness, such as mild upper respiratory infection, with or without low grade fever, are not reasons for postponing vaccine administration.

Warnings and Precautions

Per the FDA, warnings are clinically significant adverse reactions or risks. According to the CDC, a precaution is a condition in a recipient that might increase the risk for a serious adverse reaction, might cause diagnostic confusion, or might compromise the effectiveness of the product. In general, a product should be deferred when a precaution is present.

Neomycin, streptomycin, polymyxin B, 2-phenoxyethanol, and formaldehyde are used in the
production of this vaccine. Although purification procedures eliminate measurable amounts of these substances, traces may be present, and allergic reactions may occur in persons sensitive to these substances.

Systemic adverse reactions reported in infants receiving IPV concomitantly at separate sites or combined with DTP (the product used before DTAP was adopted on the schedule) have been similar to those associated with administration of DTP alone. Local reactions are usually mild and transient in nature.

Although no causal relationship between IPOL vaccine and Guillain-Barré Syndrome (GBS) has been established, GBS has been temporally related to administration of another inactivated poliovirus vaccine. Deaths have been reported in temporal association with the administration of IPV.

Immunodeficient patients or patients under immunosuppressive therapy may not develop a protective immune response against paralytic poliomyelitis after administration of IPV.

Special care should be taken to ensure that the injection does not enter a blood vessel.

Syncope (fainting) has been reported following vaccination with IPOL. Procedures should be in place to avoid injury from fainting.

Manufacturer-Listed Adverse Reactions

Per the CDC, adverse reactions are an undesirable medical condition that has been demonstrated to be caused by a vaccine. Evidence for the causal relation is usually obtained through randomized clinical trials, controlled epidemiologic studies, isolation of the vaccine strain from the pathogenic site, or recurrence of the condition with repeated vaccination (i.e., rechallenge); synonyms include side effect and adverse effect.

IPOL may cause: Erythema (redness of skin or mucus membranes), Induration (thickening or hardening of soft tissues), Agitation, and Pain at the injection site. Fevers over 102°F. Irritability, Sleepiness, Fussiness, and Crying. Although no causal relationship has been established, deaths have occurred in temporal association after vaccination of infants with IPV. Although no causal relationship between IPOL vaccine and Guillain-Barré Syndrome GBS has been established, GBS has been temporally related to administration of another inactivated poliovirus vaccine. Lymphadenopathy (abnormal lymph nodes), Type I hypersensitivity including allergic reaction, anaphylactic reaction, and anaphylactic shock. Arthralgia (joint pain), Myalgia (muscle pain), Convulsion, Febrile convulsion, Headache, Paresthesia (burning, pricking sensation in your limbs, arms, and skin), Somnolence (drowsiness), Syncope (fainting), Rash, and Urticaria (hives).

Specific Populations

Pregnancy

Animal reproduction studies have not been conducted with IPOL vaccine. It is also not known whether IPOL vaccine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. IPOL vaccine should be given to a pregnant woman only if clearly needed.

Breastfeeding

It is not known whether IPOL vaccine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when IPOL vaccine is administered to a nursing woman.

Fertility

Long-term studies in animals to evaluate carcinogenic potential or impairment of fertility have not been conducted.

Pediatric

Safety and effectiveness of IPOL vaccine in infants below six weeks or age have not been established.

Drug Interactions

Per the manufacturer, “If the third dose of IPOL vaccine is given between 12 to 18 months of age, it may be desirable to administer this dose with Measles, Mumps, and Rubella (MMR) vaccine and/or other vaccines using separate syringes at separate sites, but no data on the immunological interference between IPOL vaccine and these vaccines exist.”

Immunological interference refers to the phenomenon where the immune response to one antigen (such as a vaccine component) is altered, suppressed, or enhanced due to the simultaneous presence of another antigen or immunological factor.

According to the 2025 CDC Recommended Schedule, other vaccines that may be administered the same time as IPOL during 12-18 months of age are as follows: Hepatitis B, Hib, PCV15/PCV20, Covid-19, Influenza, MMR, Varicella, Hepatitis A, and DTAP.

History

The manufacturer addresses importance historical challenges of the polio vaccines in America. Here is a brief timeline per the manufacturer, the CDC, and the Smithsonian:

April 12, 1955: The first edition of the inactivated polio vaccine (injection) was introduced by Jonas Salk. At the time, the annual incidence of paralytic disease was 11.4 cases per 100,000 people in the United States. For comparison, in 2021, the incidence rate for melanoma (skin cancer) was 23 cases per 100,000 people. [https://gis.cdc.gov/Cancer/USCS/#/AtAGlance/]

April 24, 1955:

https://www.cdc.gov/vaccine-safety/historical-concerns

From the National Archives:

https://www.archives.gov/files/records-mgmt/rcs/schedules/departments/department-of-health-and-human-services/rg-0088/daa-0088-2018-0007_sf115.pdf

1961: The oral polio vaccine (drops in the mouth), which intentionally contained a live, weakened polio virus was introduced by Albert Sabin.

Per the National Museum of American History from the Smithsonian, shedding was known and encouraged.

[https://wayback.archive-it.org/3340/20230929181055/https://americanhistory.si.edu/polio/virus-and-vaccine/two-vaccines]

1968: The first edition of the inactivated polio vaccine was phased out, and only the oral live polio vaccine was used.

https://www.cdc.gov/mmwr/preview/mmwrhtml/00045949.htm

https://www.cdc.gov/vaccines/pubs/pinkbook/polio.html

Between 1980 – 1994: Out of the 127 paralytic polio cases reported in the United States, 119 were from vaccine associated paralytic poliomyelitis (VAPP).

1997: A second edition of the inactivated polio vaccine was introduced to the market.

1999: To eliminate VAPP, an all inactivated polio vaccine (injection) schedule was adopted. Oral polio vaccine was no longer recommended. However, according to the CDC, those who receive the inactivated polio vaccine can shed both the wild and vaccine poliovirus strains.

https://www.cdc.gov/vaccines/pubs/pinkbook/polio.html

What is informed consent?

Alternatives

If you have a listed contraindication/warning/precaution or have decided to delay or decline the inactivated polio vaccine, please read Chapter 20 in The Unvaccinated Child: A Treatment for Parents and Caregivers for helpful information on preventing and treating polio.