Polio Vaccine Safety

Overview

Polio, or poliomyelitis, is a disabling and potentially life-threatening disease caused by the poliovirus. There are three types of poliovirus:

• Type 1: this type and vaccine-derived polioviruses (VDPVs) still circulate in some parts of the world.
• Type 2: declared eradicated in September 2015.
• Type 3: declared eradicated in October 2019.

Available vaccines & manufacturer package inserts

Inactivated polio vaccine (IPV) is the only polio vaccine that has been given in the United States since 2000. It is given by a shot in the arm or leg, depending on the person’s age.

• The FDA approved IPOL for use in infants (as young as 6 weeks of age), children, and adults for the prevention of poliomyelitis caused by poliovirus Types 1, 2, and 3.
  • This vaccine is mainly used as a travel vaccine for adults.
• The FDA approved Pentacel (Pentacel 242 and Pentacel 520) in 2008 for use in infants and children ages 6 weeks through 4 years for the prevention of diphtheria, tetanus, pertussis, poliomyelitis and invasive disease caused by Haemophilus influenzae type b.
• The FDA approved VAXELIS in 2018 for use in children ages 6 weeks through 4 years the prevention of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae type b.
• The FDA approved Quadracel [Quadracel 243 and Quadracel 521) in 2015 for use in children ages 4 through 6 years as a fourth or fifth dose in the inactivated poliovirus vaccination series whose previous vaccine doses have been with Pentacel, DAPTACEL, and/or VAXELIS to prevent poliomyelitis.
• The FDA approved KINRIX in 2008 for use in children ages 4 through 6 years as the fourth dose in the inactivated poliovirus vaccination series whose previous DTAP vaccine doses have been with INFANRIX and/or PEDIARIX for the first 3 doses and INFANRIX for the fourth dose to prevent poliomyelitis.
• The FDA approved PEDIARIX in 2002 for use in children ages 6 weeks through 6 years to prevent diphtheria, tetanus, pertussis, infection caused by all known subtypes of hepatitis B virus, and poliomyelitis.

Who should & should not get the vaccine

CDC recommends that all children get four doses of IPV as part of their routine childhood vaccination schedule. Adults who know or suspect that they are unvaccinated or incompletely vaccinated against polio should complete their polio vaccination series with IPV. Certain groups should not receive the vaccine.

Common side effects

• Decreased appetite (Vaxelis, Kinrix, Pediarix).
• Drowsiness (Vaxelis, Kinrix, Pediarix).
• Fever.
• Fussiness/irritability.
• Headache (Quadracel).
• Injection site pain, redness, swelling and slight increase in muscle size.
• Persistent crying.
• Vomiting (Vaxelis).

Vaccines, like any medicine, can have side effects. Many people who get the polio vaccine have no side effects at all. The most common side effects are usually mild—such as soreness where the shot was given—and go away on their own.

A closer look at the safety data

Findings from vaccine safety monitoring systems and scientific studies have shown that polio vaccines have a favorable safety profile – the body of scientific evidence overwhelmingly supports their safety. One study focused on adverse events after IPV administration reported to the US Vaccine Adverse Event Reporting System (VAERS). The study showed that there were few adverse events reported for more than 250 million doses given between 2000 and 2012.1

How CDC monitors vaccine safety

CDC and the Food and Drug Administration (FDA) are committed to ensuring that vaccines provided to the public are safe and effective. Once vaccines are licensed or authorized for emergency use in the United States, CDC and FDA continuously monitor them through several safety systems.

Resources