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Polio vaccine

 
Children's Health Encyclopedia: Polio Vaccine
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Definition

The poliomyelitis (polio) vaccine protects against poliovirus infections. The vaccine helps the body produce antibodies (protective substances) that will prevent an individual from contracting polio. There are two forms of the vaccine that can be given; the one preferred is the inactivated poliovirus vaccine (IPV). IPV is preferred because it contains the inactivated or dead virus, which is considered safer for administration. The Sabin oral polio vaccine was made with a live but weakened virus, which gives the advantage of passive immunity for large groups (i.e. because it is easily passed on through the oral fecal route in households, schoolrooms, etc., even if only a portion of the community is immunized, everyone eventually develops immunity). The Sabin oral polio vaccine has the disadvantage of causing polio-like symptoms in some immune compromised hosts. Since 2000, the live virus vaccine is rarely used in the United States, but it is still being used in other countries.

Description

The purpose of any vaccine is to prevent disease. Mass immunizations in the United States have served to eradicate polio in the Americas. In 1988, the World Health Organization embarked upon a mission to eradicate polio by the year 2000. The intent was to immunize the world's children by methodically establishing sites where the masses could be reached. The mandate was to eradicate the virus by 2005. Most of the remaining virus can be found on the Indian subcontinent and Nigeria. Attempts to immunize children in Indian have met with good results, but Nigeria halted their immunization sites due to rumors that Western donors had tampered with the vaccine to spread HIV and cause sterility in Muslim males. Following a ban on the vaccine that lasted nearly one year, the virus spread across Nigeria to 10 African countries that were previously polio-free. The Muslim leaders in Nigeria lifted the ban in summer 2004. Immunization from the IPV triggers an excellent immune response and long-lasting immunity to all three poliovirus types.

General Use

The inactivated poliovirus vaccine is injected into a muscle or under the skin and is usually given by a health care professional in a hospital, clinic, or provider's office. The use of this vaccine must be officially recorded. Federal law requires that the vaccine manufacturer's name, the lot number of the vaccine, the name, address, and phone number of the person giving the vaccine, and the date of vaccine administration be recorded in a permanent medical record. For children, the vaccine is usually started at two months of age and given again at four months of age. The next dose should be given between six and 18 months of age with a final booster dose at age four to six years, for a total of four doses. Serious reactions to the inactivated poliovirus vaccine are rare in small children. It is necessary to receive all doses of the vaccine and there is no generic vaccine available.

Precautions

Individuals with an immune deficiency disease need to be counseled before taking the vaccine, and anyone with allergic reactions to prior vaccines and preservatives should be cautious. A provider may want to delay giving a child a dose of IPV or may not give it at all if the child has a known severe allergy to the antibiotics neomycin, streptomycin, or polymyxin B. A child who had a life-threatening reaction to a previous IPV should not receive another one.

There is no preparation necessary for the vaccine; however, if an individual is ill on the scheduled date, it is essential to make arrangements for a follow-up appointment as no dose can be missed.

Side Effects

Children receiving the inactivated poliovirus vaccine should be carefully observed for 24–72 hours after receiving the injection. If any serious side effects occur, the healthcare provider or an emergency service provider should be called immediately. For problems that may occur following the vaccine, parents are asked to call the vaccine adverse event reporting system toll-free at (800) 822–7967 to report them. The health care professional may administer a dose of a non-aspirin pain/fever reliever at the time of the vaccine and advise giving the medicine every four to six hours for 24 hours after the vaccine. This may serve to reduce pain and fever associated with the vaccine.

Side effects that usually do not require immediate medical attention, unless they persist and are bothersome, include:

  • fussiness
  • decreased appetite
  • low-grade fever (102°F [39° C] or less)
  • pain, tenderness, redness, swelling, or a "knot" at the injection site
  • fatigue
  • vomiting

Side effects that should be reported as soon as possible are:

  • limp, pale, or less alert child
  • difficulty breathing, shortness of breath, or wheezing
  • difficulty swallowing
  • high fever (103°F [39.4°C] or more)
  • inconsolable crying for three hours or more
  • seizures (convulsions)
  • severe skin rash, hives, or itching
  • swelling of eyes or face
  • unusual sleepiness

Interactions

Before administering the vaccine, the healthcare provider should be informed as to whether the recipient has any of the following conditions:

  • an immune deficiency (natural or due to cancer chemotherapy radiation, steroid therapy, or HIV infection)
  • fever or infection
  • an unusual reaction to this poliovirus vaccine, oral poliovirus vaccine, other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breastfeeding

Prevention

While it is important to mention these items to the physician, they are not necessarily contraindications for the vaccine. The provider also needs to know what medicines an individual is taking, including non-prescription medicines, nutritional supplements, herbal products, tobacco, and whether or not he or she is a user of illegal drugs or a frequent user of drinks with caffeine or alcohol. Any of these may affect the way the vaccine works.

Risks

There have been no adverse effects from IPV reported to date. However, IPV induces only little immunity in the intestinal tract. If an individual is infected with the wild-type poliovirus, the virus can multiply in the intestines and be shed in stools, ultimately heightening the risk of viral circulation within the community. This scenario is unlikely in the United States.

Parental Concerns

Parents need to be aware of any existing allergies in their families that might cause a reaction from vaccines and their preservatives, and they need to be observant of a child for the first 24–72 hours after receiving the vaccine. Traveling to other parts of the world may necessitate a booster vaccine if the polio virus is known to be present in that vicinity.

See also Polio.

Resources

Books

2004 Childhood and Adolescent Immunization Schedule. Atlanta: GA, Centers for Disease Control and Prevention, 2004. www.cdc.gov/nip/recs/childschedule.htm#Printable

Periodicals

Osterrieth, Paul. "Oral polio vaccine: fact vs. fiction." Vaccine 22 (2004): 1831–35. www.elsevier.com/locate/vaccine

Organizations

March of Dimes Birth Defects Foundation. National Office, 1275 Mamaroneck Avenue, White Plains, NY 10605. www.modimes.org/

Web Sites

"Polio Vaccine." .

World Health Organization. Global Polio Eradication Progress 2000. www.polioeradication.org/

[Article by: Linda K. Bennington, MSN, CNS]


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Wikipedia: Polio vaccine
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Home > Library > Miscellaneous > Wikipedia
Polio vaccine
Vaccine description
Target disease Polio virus
Type Killed/Inactivated
Identifiers
CAS number  ?
ATC code J07BF01 J07BF02 J07BF03
PubChem  ?
Therapeutic considerations
Pregnancy cat.

C (both OPV and IPV)
Legal status

Administered by or under the supervision of a health care professional.
Routes Parenteral (IPV), Oral drops (OPV)

Two polio vaccines are used throughout the world to combat poliomyelitis (or polio). The first was developed by Jonas Salk and first tested in 1952. Announced to the world by Salk on April 12, 1955, it consists of an injected dose of inactivated (dead) poliovirus. An oral vaccine was developed by Albert Sabin using attenuated poliovirus that he had received from Hilary Koprowski. Human trials of Sabin's vaccine began in 1957 and it was licensed in 1962.[1] Because there is no long term carrier state for poliovirus in immunocompetent individuals, polioviruses have no non-primate reservoir in nature, and survival of the virus in the environment for an extended period of time appears to be remote. Therefore, interruption of person-to person transmission of the virus by vaccination is the critical step in global polio eradication.[2] The two vaccines have eradicated polio from most countries in the world,[3][4] and reduced the worldwide incidence from an estimated 350,000 cases in 1988 to 1652 cases in 2007.[5][6][7]

Contents

Development

In the generic sense, vaccination works by priming the immune system with an 'immunogen'. Stimulating immune response, via use of an infectious agent, is known as immunization. The development of immunity to polio efficiently blocks person-to-person transmission of wild poliovirus, thereby protecting both individual vaccine recipients and the wider community.[2]


In 1936, Maurice Brodie, a research assistant at New York University, attempted to produce a formaldehyde-killed polio vaccine from ground-up monkey spinal cords. His initial attempts were hampered by the difficulty of obtaining enough virus. Brodie first tested the vaccine on himself and several of his assistants. He then gave the vaccine to three thousand children, many of whom developed allergic reactions, but none developed immunity to polio.[8] Philadelphia pathologist John Kollmer also claimed to have developed a vaccine that same year, but it too produced no immunity and was blamed for causing a number of cases, some of them fatal.[9]

Mass polio vaccination in Columbus, Georgia during the early days of the National Polio Immunization Program.

A breakthrough came in 1948 when a research group headed by John Enders at the Children's Hospital Boston successfully cultivated the poliovirus in human tissue in the laboratory.[10] This development greatly facilitated vaccine research and ultimately allowed for the development of vaccines against polio. Enders and his colleagues, Thomas H. Weller and Frederick C. Robbins, were recognized in 1954 for their labors with a Nobel Prize in Physiology or Medicine.[11] Other important advances that led to the development of polio vaccines were: the identification of three poliovirus serotypes (Poliovirus type 1 — PV1, or Mahoney; PV2, Lansing; and PV3, Leon); the finding that prior to paralysis, the virus must be present in the blood; and the demonstration that administration of antibodies in the form of gamma-globulin protects against paralytic polio.[6][12]

In 1952 and 1953, the U.S. experienced an outbreak of 58,000 and 35,000 polio cases, respectively, up from a typical number of some 20,000 a year. Amid this U.S. polio epidemic, millions of dollars were invested in finding and marketing a polio vaccine by commercial interests, including Lederle Laboratories in New York under the direction of H. R. Cox. Also working at Lederle was Polish-born virologist and immunologist Hilary Koprowski, who claims to have created the first successful polio vaccine, in 1950. His vaccine, however, a live attenuated virus taken orally, was still in the research stage and would not be ready for use until five years after Jonas Salk's polio vaccine (a dead injectable vaccine) had reached the market.

The development of two polio vaccines led to the first modern mass inoculations. The last cases of paralytic poliomyelitis caused by endemic transmission of wild virus in the United States occurred in 1979, with an outbreak among the Amish in several Midwest states.[13] A global effort to eradicate polio, led by the World Health Organization, UNICEF, and The Rotary Foundation, began in 1988 and has relied largely on the oral polio vaccine developed by Albert Sabin.[14] The disease was entirely eradicated in the Americas by 1994.[15] Polio was officially eradicated in 36 Western Pacific countries, including China and Australia in 2000.[16][17] Europe was declared polio-free in 2002.[18] As of 2008, polio remains endemic in only four countries: Nigeria, India, Pakistan, and Afghanistan.[5] Although poliovirus transmission has been interrupted in the much of the world, transmission of wild poliovirus does continue and creates an ongoing risk for the importation of wild poliovirus into previously polio-free regions. If importations of poliovirus occurs, outbreaks of poliomyelitis may develop, especially in areas with low vaccination coverage and poor sanitation. As a result, high levels of vaccination coverage must be maintained.[15]

Inactivated vaccine

The first effective polio vaccine was developed in 1952 by Jonas Salk at the University of Pittsburgh. The Salk vaccine, or inactivated poliovirus vaccine (IPV), is based on three wild, virulent reference strains, Mahoney (type 1 poliovirus), MEF-1 (type 2 poliovirus), and Saukett (type 3 poliovirus), grown in a type of monkey kidney tissue culture (Vero cell line), which are then inactivated with formalin.[6] The injected Salk vaccine confers IgG-mediated immunity in the bloodstream, which prevents polio infection from progressing to viremia and protects the motor neurons, thus eliminating the risk of bulbar polio and post-polio syndrome.

A Somali boy is injected with inactivated poliovirus vaccine (Mogadishu, 1993)

In 1954, the vaccine was tested at Arsenal Elementary School and the Watson Home for Children in Pittsburgh, Pennsylvania. Salk's vaccine was then used in a test called the Francis Field Trial, led by Thomas Francis; the largest medical experiment in history. The test began with some 4,000 children at Franklin Sherman Elementary School in McLean, Virginia, and would eventually involve 1.8 million children, in 44 states from Maine to California.[19] By the conclusion of the study, roughly 440,000 received one or more injections of the vaccine, about 210,000 children received a placebo, consisting of harmless culture media, and 1.2 million children received no vaccination and served as a control group, who would then be observed to see if any contracted polio.[20] The results of the field trial were announced April 12, 1955 (the tenth anniversary of the death of Franklin D. Roosevelt; see Franklin D. Roosevelt's paralytic illness). The Salk vaccine had been 60 - 70% effective against PV1 (poliovirus type 1), over 90% effective against PV2 and PV3, and 94% effective against the development of bulbar polio.[21] Soon after Salk's vaccine was licensed in 1955 children's vaccination campaigns were launched. In the U.S, following a mass immunization campaign promoted by the March of Dimes, the annual number of polio cases fell to 5,600 by 1957.[22] By 1961 only 161 cases were recorded in the United States.[23]

An enhanced-potency IPV was licensed in the United States in November 1987, and is currently the vaccine of choice in the United States.[13] The first dose of polio vaccine is given shortly after birth, usually between 1–2 months of age, a second dose is given at 4 months of age.[13] The timing of the third dose depends on the vaccine formulation but should be given between 6–18 months of age.[24] A booster vaccination is given at 4 to 6 years of age, for a total of four doses at or before school entry.[25] In some countries, a fifth vaccination is given during adolescence.[24] Routine vaccination of adults (18 years of age and older) in developed countries is neither necessary nor recommended because most adults are already immune and have a very small risk of exposure to wild poliovirus in their home countries.[13]

In 2002 a pentavalent (5-component) combination vaccine (called Pediarix) containing IPV was approved for use in the United States. The vaccine also contains combined diphtheria, tetanus, and acellular pertussis vaccines (DTaP) and a pediatric dose of hepatitis B vaccine.[13] In the UK, IPV is combined with tetanus, diphtheria, pertussis and Haemophilus influenzae type b vaccines.[24] When the current formulation of IPV is used, 90% or more of individuals develop protective antibody to all three serotypes of poliovirus after two doses of inactivated polio vaccine (IPV), and at least 99% are immune to poliovirus following three doses. The duration of immunity induced by IPV is not known with certainty, although a complete series is thought to provide protection for many years.[26]

Oral vaccine

This 1963 poster featured CDC’s national symbol of public health, the "Wellbee", encouraging the public to receive an oral polio vaccine.

Oral polio vaccine (OPV) is a live-attenuated vaccine, produced by the passage of the virus through non-human cells at a sub-physiological temperature, which produces spontaneous mutations in the viral genome.[27] Oral polio vaccines were developed by several groups, one of which was led by Albert Sabin. Other groups, led by Hilary Koprowski and H.R. Cox, developed their own attenuated vaccine strains. In 1958, the National Institutes of Health created a special committee on live polio vaccines. The various vaccines were carefully evaluated for their ability to induce immunity to polio, while retaining a low incidence of neuropathogenicity in monkeys. Based on these results, the Sabin strains were chosen for worldwide distribution.[20]

There are 57 nucleotide substitutions which distinguish the attenuated Sabin 1 strain from its virulent parent (the Mahoney serotype), two nucleotide substitutions attenuate the Sabin 2 strain, and 10 substitutions are involved in attenuating the Sabin 3 strain.[6] The primary attenuating factor common to all three Sabin vaccines is a mutation located in the virus's internal ribosome entry site (or IRES)[28] which alters stem-loop structures, and reduces the ability of poliovirus to translate its RNA template within the host cell.[29] The attenuated poliovirus in the Sabin vaccine replicates very efficiently in the gut, the primary site of infection and replication, but is unable to replicate efficiently within nervous system tissue. OPV also proved to be superior in administration, eliminating the need for sterile syringes and making the vaccine more suitable for mass vaccination campaigns. OPV also provided longer lasting immunity than the Salk vaccine.

In 1961, type 1 and 2 monovalent oral poliovirus vaccine (MOPV) was licensed, and in 1962, type 3 MOPV was licensed. In 1963, trivalent OPV (TOPV) was licensed, and became the vaccine of choice in the United States and most other countries of the world, largely replacing the inactivated polio vaccine.[8] A second wave of mass immunizations led to a further dramatic decline in the number of polio cases. Between 1962 and 1965 about 100 million Americans (roughly 56% of the population at that time) received the Sabin vaccine. The result was a substantial reduction in the number of poliomyelitis cases, even from the much reduced levels following the introduction of the Salk vaccine.[30]

OPV is usually provided in vials containing 10-20 doses of vaccine. A single dose of oral polio vaccine (usually two drops) contains 1,000,000 infectious units of Sabin 1 (effective against PV1), 100,000 infectious units of the Sabin 2 strain, and 600,000 infectious units of Sabin 3. The vaccine contains small traces of antibiotics— neomycin and streptomycin—but does not contain preservatives.[31] One dose of OPV produces immunity to all three poliovirus serotypes in approximately 50% of recipients.[13] Three doses of live-attenuated OPV produce protective antibody to all three poliovirus types in more than 95% of recipients. OPV produces excellent immunity in the intestine, the primary site of wild poliovirus entry, which helps prevent infection with wild virus in areas where the virus is endemic.[25] The live virus used in the vaccine is shed in the stool and can be spread to others within a community, resulting in protection against poliomyelitis even in individuals who have not been directly vaccinated. IPV produces less gastrointestinal immunity than does OPV, so persons who receive IPV are more easily infected with wild poliovirus. In regions without wild poliovirus, inactivated polio vaccine is the vaccine of choice.[25] In regions with higher incidence of polio, and thus a different relative risk between efficacy and reversion of the vaccine to a virulent form, live vaccine is still used. The live virus also has stringent requirements for transport and storage, which are a problem in some hot or remote areas. As with other live-virus vaccines, immunity initiated by OPV is probably lifelong.[26]

Iatrogenic (vaccine-induced) polio

A major concern about the oral polio vaccine (OPV) is its known ability to revert to a form that can achieve neurological infection and cause paralysis.[32] Clinical disease, including paralysis, caused by vaccine-derived poliovirus (VDPV) is indistinguishable from that caused by wild polioviruses.[33] This is believed to be a rare event, but outbreaks of vaccine-associated paralytic poliomyelitis (VAPP) have been reported, and tend to occur in areas of low coverage by OPV, presumably because the OPV is itself protective against the related outbreak strain.[34][35]

Doses of oral polio vaccine are added to sugar cubes for use in a 1967 vaccination campaign in Bonn, Germany

As the incidence of wild polio diminishes, nations transition from use of the oral vaccine back to the injected vaccine because the direct risk of iatrogenic polio (VAPP) due to OPV outweighs the indirect benefit of immunization via subclinical transmission of OPV. When IPV is used, reversion is not possible but there remains a small risk of clinical infection upon exposure to reverted OPV or wild polio virus. Following the widespread use of polio vaccines in the mid-1950s, the incidence of poliomyelitis declined rapidly in many industrialized countries. The use of OPV was discontinued in the United States in 2000 and in 2004 in the UK, but it continues to be used around the globe.[13][24]

The rate of vaccine-associated paralytic poliomyelitis (VAPP) varies by region but is generally about 1 case per 750,000 vaccine recipients.[36] VAPP is more likely to occur in adults than in children. In immunodeficient children, the risk of VAPP is almost 7,000 times higher, particularly for persons with B-lymphocyte disorders (e.g., agammaglobulinemia and hypogammaglobulinemia), which reduce the synthesis of protective antibodies.[33] The World Health Organization considers the benefits of vaccination to far outweigh the risk of vaccine derived polio. Outbreaks of vaccine derived polio have been stopped by multiple rounds of high-quality vaccination, in order to immunize the entire population.[37]

Outbreaks of VAPP occurred independently in Belarus (1965–66), Canada (1966–68), Egypt (1983–1993), Hispaniola (2000–2001), Philippines (2001), Madagascar (2001–2002),[38] and in Haiti (2002), where political strife and poverty have interfered with vaccination efforts.[39] In 2006 an outbreak of vaccine-derived poliovirus occurred in China.[40] Cases have been reported from Cambodia (2005–2006), Myanmar (2006–2007), Iran (1995, 2005–2007), Syria, Kuwait and Egypt.[41] Since 2005, The World Health Organization has been tracking vaccine-caused polio in northern Nigeria caused by a mutation in live oral polio vaccines.[42]

Contamination concerns

In 1960, it was determined that the rhesus monkey kidney cells used to prepare the poliovirus vaccines were infected with the SV40 virus (Simian Virus-40).[43] SV40, also discovered in 1960, is a naturally occurring virus that infects monkeys. In 1961, SV40 was found to cause tumors in rodents.[44] More recently, the virus was found in certain forms of cancer in humans, for instance brain and bone tumors, mesotheliomas, and some types of non-Hodgkin's lymphoma.[45][46] However, it has not been determined that SV40 causes these cancers.[47]

SV40 was found to be present in stocks of the injected form of the polio vaccine (IPV) in use between 1955 to 1963.[43] It is not found in the OPV form.[43] Over 98 million Americans received one or more doses of polio vaccine between 1955 to 1963 when a proportion of vaccine was contaminated with SV40; it has been estimated that 10–30 million Americans may have received a dose of vaccine contaminated with SV40.[43] Later analysis suggested that vaccines produced by the former Soviet bloc countries until 1980, and used in the USSR, China, Japan, and several African countries, may have been contaminated; meaning hundreds of millions more may have been exposed to SV40.[48]

In 1998, the National Cancer Institute undertook a large study, using cancer case information from the Institutes SEER database. The published findings from the study revealed that there was no increased incidence of cancer in persons who may have received vaccine containing SV40.[49] Another large study in Sweden examined cancer rates of 700,000 individuals who had received potentially contaminated polio vaccine as late as 1957; the study again revealed no increased cancer incidence between persons who received polio vaccines containing SV40 and those who did not.[50] The question of whether SV40 causes cancer in humans remains controversial however, and the development of improved assays for detection of SV40 in human tissues will be needed to resolve the controversy.[47]

During the race to develop an oral polio vaccine several large scale human trials were undertaken. By 1958, the National Institutes of Health had determined that OPV produced using the Sabin strains were the safest.[20]/ Between 1957 and 1960, however, Hilary Koprowski continued to administer his vaccine around the world. In Africa, the vaccines were administered to roughly one million people in the Belgian territories, now the Democratic Republic of the Congo, Rwanda and Burundi.[51][52] The results of these human trials have been controversial,[53] and accusations in the 1990s arose that the vaccine had created the conditions necessary for transmission of SIV from chimpanzees to humans, causing HIV/AIDS. These hypotheses have, however, been refuted.[51] By 2004, cases of poliomyelitis in Africa had been reduced to just a small number of isolated regions in the western portion of the continent, with sporadic cases elsewhere. However, recent opposition to vaccination campaigns has evolved,[54][55] often relating to fears that the vaccine might induce sterility.[56] The disease has since resurged in Nigeria and in several other African nations, which epidemiologists cite is due to refusals by certain local populations to allow their children to receive the polio vaccine.[57]

References

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