IMOVAX Polio® Ipol® Vaccine Description 2022
Sanofi Pasteur's single-antigen inactivated poliovirus vaccine (IPV) Imovax Polio®; Ipol® is highly purified, with enhanced potency, says the U.S. FDA. The IPOL is a sterile suspension consisting of three types of poliovirus that have been chemically killed: Type 1 (Mahoney), Type 2 (MEF-1), and Type 3 (Saukett).
In addition, some combination vaccines (different vaccines contained in the same dose) contain IPV, such as Pentacel (DTaP-IPV/Hib), and IPOL is the IPV included in the children's vaccine series Pentacel and Quadracel.
Children in the USA should get an IPV to protect against poliomyelitis, according to the U.S. CDC's 2022 vaccination schedule. In addition, children traveling to a country where there is a risk of contracting poliovirus should complete the series before departure, says the CDC. Most adults do not need a polio vaccine booster because they were vaccinated as children.
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IPV Vaccine Overview
The U.S. CDC vaccine committee (ACIP) reviewed a presentation on October 19, 2022, that says IPV induces some nasopharyngeal mucosal immunity but limited intestinal immunity. IPV induces effective humoral immunity and prevents paralysis with about 90% seroprotection after 2 doses.
The U.S. CDC says Fractional IPV (fIPV) is administered intradermally using one-fifth of the regular dose. The use of fIPV has been recommended by WHO as a response strategy for VDPV2 outbreaks. In July 2017, the WHO/PAHO published a Practical Guide to support countries in planning and implementing fIPV in the routine immunization schedule. Currently, fIPV is not recognized as a dose to satisfy immunization requirements in the U.S.
IMOVAX IPOL Indication
Polio immunization has been available in the USA since 1955 and has been part of the U.S. CDC's routine childhood immunization schedule for decades. The IPOL vaccine is indicated for active immunization of infants (as young as six weeks), children, and adults to prevent poliomyelitis caused by poliovirus types 1, 2, and 3.
Unimmunized adults who are potentially exposed to wild poliovirus and have not been adequately immunized should receive polio vaccination. In addition, persons with previous wild poliovirus disease who are incompletely immunized or unimmunized should be given additional doses of the IPOL vaccine if they fall into one or more categories listed. The following categories of adults are at an increased risk of exposure to wild polioviruses: Travelers to regions or countries where poliomyelitis is endemic or epidemic; Healthcare workers in close contact with patients who may be excreting polioviruses; Laboratory workers handling specimens that may contain polioviruses.
IMOVAX IPOL Dosage
IPOL is administered intramuscularly or subcutaneously. Single-antigen IPV is distributed in single-dose syringes or 10-dose vials. The recommended dose for both children and adults is 0.5 mL. It can be administered by the intramuscular or subcutaneous route, using a needle length appropriate for the age and size of the person receiving the vaccine.
IMOVAX IPOL Active Substance
IPOL Vaccine Active substance: Inactivated Poliovirus type 1 (Mahoney) 40D antigen units Inactivated Poliovirus type 2 (MEF-1) 8D antigen units Inactivated Poliovirus type 3 (Saukett) 32D antigen units.
Polio Virus Shedding
The inactivated poliovirus vaccine (IPV) protects people against all three types of poliovirus and does not contain live virus, so people who receive this vaccine do not shed the virus and cannot infect others, and the vaccine cannot cause disease, says the U.S. CDC. However, IPV does not stop transmission of the virus. The OPV is used wherever a polio outbreak needs to be contained, even in countries that rely exclusively on IPV, such as the U.S., for their routine immunization program.
Poliomyelitis is a highly infectious disease caused by a virus that can invade the nervous system and cause total paralysis in hours. The virus enters the body through the mouth and replicates in the intestine. Initial symptoms are fever, fatigue, headache, vomiting, neck stiffness, and limb pain. One in 200 infections leads to irreversible paralysis (usually in the legs). Among those paralyzed, 5% to 10% die when their breathing muscles become immobilized, says the World Health Organization.
IMOVAX IPOL Vaccine News 1987 - 2022
October 12, 2022 - The Lancet published an analysis that stated: Polio outbreak risk can be exacerbated in countries using inactivated polio vaccine, which offers excellent protection against paralysis but is less effective than an oral vaccine against poliovirus shedding, potentially allowing circulation without detection of paralytic cases for long periods of time.
October 5, 2022 - Cattaraugus County, New York, Public Health Director Dr. Kevin D. Watkins is urging county residents who are not vaccinated against polio to get vaccinated. At this time, there have been no cases of polio in upstate New York.
September 28, 2022 - New York State Health Commissioner Dr. Mary T. Bassett declared poliovirus an imminent threat to public health in New York State, thereby expanding the availability of funding and resources to support local health departments in establishing immunization clinics, deploying vaccines to health care partners, and conducting outreach to unvaccinated and under-vaccinated New Yorkers to increase immunization rates particularly in the areas affected by the virus and among children.
September 28, 2022 - HEALTH ADVISORY: Update #3 Regarding Poliovirus in New York State. If an adult at risk has reason to believe they were not vaccinated and records cannot be easily and quickly obtained, then treat them as if they are not vaccinated. All children and adolescents (up through 17 years of age) who are unvaccinated or undervaccinated should be brought up to date with all routine CDC-recommended IPV doses. This is particularly urgent if they live, work, attend school, or have frequent social interactions with communities where poliovirus has been repeatedly detected in wastewater (currently Rockland, Orange, and Sullivan Counties).
September 26, 2022 - Due to a recent confirmed poliovirus case in New York, a bordering state, the New Jersey Department of Health (NJDOH) requests that healthcare provider offices and pharmacies consider stocking IPV to increase access for people seeking vaccination.
September 13, 2022 - The U.S. CDC confirmed the WHO added the USA to a list of countries where circulating vaccine-derived poliovirus has been identified in 2022.
August 4, 2022 - The New York State Department of Health stated: "This unprecedented circulation of polio in our community must be stopped. Any unvaccinated children and adults should receive a first polio immunization immediately."
April 26, 2022 - The rise of vaccine-derived polio cases has almost tripled from 2019 to 2020.
March 27, 2022 - 'Two Drops' campaign will be kicked off in Israel after health officials confirmed the first case of the potentially debilitating disease in the country in over 30 years.
October 11, 2021 - Due to a case of polio being reported in the Rivne region of Ukraine, a Rapid Response Vaccination program has been put in place. All children under the age of 5 will be given an IPV polio vaccine regardless of previous vaccination. The TEB and Emergency Situations Commission also decided that unvaccinated children will not be admitted to a school. Instead, other forms of education will be provided for such children.
June 14, 2021 - The Ministry of Public Health of Afghanistan, the WHO, and UNICEF launched the third national polio immunization campaign. Following a challenging year in 2020, the polio program has intensified efforts to eradicate wild poliovirus type 1 (WPV1) and circulating vaccine-derived poliovirus type 2 (cVDPV2) outbreaks exacerbated due to disruptions to polio campaigns because of the COVID-19 pandemic. So far, WPV1 and cVDPV2 outbreaks have been contained in all accessible areas of the country.
March 4, 2021 - The U.S. CDC issued a Travel Alert, which said, 'There are polio outbreaks in several countries in Asia. The CDC recommends that all travelers to these countries be vaccinated fully against polio. In addition, before traveling to these countries, adults who completed their routine polio vaccine series as children should receive a single, lifetime adult booster dose of polio vaccine.
December 9, 2020 - According to the latest Global Polio Eradication Initiative report, four countries reported additional polio cases involving vaccine-derived polio. Pakistan: five WPV1 positive environmental samples, six cVDPV2 cases, and eight cVDPV2 positive environmental samples; Central African Republic: one cVDPV2 case; Chad: nine cVDPV2 cases; Somalia: one cVDPV2 case.
December 9, 2020 - Scientists evaluated the two nOPV2 candidates in parallel clinical studies in adults, young children, and infants in two different countries to assess their safety and immunogenicity compared with the licensed Sabin mOPV2 designed to replace them. Designed to be more genetically stable than the licensed Sabin oral vaccine, the new vaccine appears safe. In addition, according to the research published in The Lancet, it provides similar immune responses when tested in healthy adults, children, and infants.
November 13, 2020 - The WHO issued an Emergency Use Listing recommendation for the type 2 novel oral polio vaccine (nOPV2).
June 4, 2020 - The world's largest company devoted exclusively to the research and manufacture of vaccines has discontinued their Poliovax vaccine production, which is produced using a cell line from an aborted child.
December 11, 2019 - FDA: Poliovirus Vaccine Inactivated (Monkey Kidney Cell). IPOL vaccine is indicated for active immunization of infants (as young as six weeks of age), children, and adults to prevent poliomyelitis caused by poliovirus types 1, 2, and 3.
March 25, 2015 - Sanofi Pasteur announced that the U.S. FDA approved the use of Quadracel™ (Diphtheria and Tetanus Toxoids and Acellular Pertussis Absorbed and Inactivated Poliovirus; DTaP-IPV) vaccine for active immunization against diphtheria, tetanus, pertussis, and poliomyelitis in children 4 through 6 years of age.
December 11, 1987 - Recommendations of the CDC Immunization Practices Advisory Committee Poliomyelitis Prevention: Enhanced-Potency Inactivated Poliomyelitis Vaccine -- Supplementary Statement.
IMOVAX IPOL Clinical Trials
IPOL has been tested in multiple clinical trials. Click here to review all the trials.
The primary objective of this Pase III trial is to compare IMOVAX Polio to the current Chinese standard of care (OPV) that is administered following a schedule of 2-3-4 months. The objective is to demonstrate that after the three doses primary series, in terms of seroprotection rates, IMOVAX Polio is not inferior to OPV. The safety of IPV will be assessed after each IPV dose.
Clinical Safety Evaluation Phase 3 Study of the Sanofi Pasteur's Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) Administered as a Single Booster Dose at 18 Months of Age in Healthy Chinese Children, and as the First Dose of Primary Vaccination at 2 Months of Age in Healthy Chinese Infants.
The primary objective of this Phase 2 study is to demonstrate the non-inferiority of fractional doses of IMOVAX Polio administered intradermally versus full doses of IMOVAX Polio administered intramuscularly in terms of seroprotection rates (polio types 1, 2 and 3) one month after the three-dose primary vaccination administered at 6-10-14 weeks of age.