Polio Vaccine

Polio vaccine

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:

1-an immune deficiency (natural or due to cancer chemotherapy radiation, steroid therapy, or HIV infection)

2-fever or infection

3-an unusual reaction to this poliovirus vaccine, oral poliovirus vaccine, other medicines, foods, dyes, or preservatives.

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.

KEY TERMS

World Health Organization (WHO) —An international organization within the United Nations system that is concerned with world health and welfare.

Recent  Polio Vaccine

Trivalent polio vaccine (live attenuated) Sabin Strains

1.Name of the medicinal product.

Polio Sabin TM (Oral)

Poliomyelitis vaccine, live (Oral)

2. Qualitative and quantitative composition.

Polio Sabin TM (Oral) Vaccine is a stabilized preparation of live attenuated poliomyelitis viruses of the sabin strains type 1 (LSc,2ab), type 2 (P712 ch,2ab) and type 3 (Leon 12a,1b) propagated in MRC5 human diploid cells.

Polio Sabin TM meets the world health organization requirements for biological substances and for polio myelitis vaccine (oral).The appropriate formulation should be chosen in accordance with national recommendations. For example: WHO/ EPI recommends that each immunising dose of vaccine contains not less than : 10 6 TCID 50 for type 1, 10 5 TCID 50 for type 2 and 105.8 TCID 50 for type 3 live attenuated Sabin strains of  polioviruses. European Pharmacopoeia recommends  that each immunising dose of vaccine contains not less than: 106 TCID 50 for type 1, 105 TCID 50 for type 2 and 105.5 TCID 50 for type 3 live attenuated Sabin Strains of  Polioviruses.

3.Pharmaceutical form

Oral suspension.

4.Clinical Particulars

4.1 Therapeutic indications

Polio Sabin TM (oral) is indicated for active immunisation  of infants and susceptible children and adults against infection caused by polioviruses of type 1,2 and 3.

4.2 Posology and method of administration Posology.

In a multidose container , one immunising dose is contained in two drops. The drops are delivered from the special dropper supplied with the multidose glass vials or directly from the multidose  plastic tubes. As vaccination schemes vary from country to country ,the advised schedule for each country must be in accordance with the national recommendations.

Infants: The primary immunization course is three doses of  Polio Sabin TM (oral) may be given at birth provided it is realised that  the response is likely to be sub-optimal, and that three additional doses will be required later in life to give adequate protection. WHO recommends the following  schedule in endemic countries birth,6,10,14 weeks. In non-endemic areas the first dose can be given from 6 weeks with the first dose of  DTP.

Children and adults: In order to maintain the level of protection against polio virus infection, it is recommended to give a booster dose at the time of school entry and again on leaving school and Occasionally in adult life when a person  is likely to be exposed  to a  Method of administration.

Polio Sabin TM (Oral) is for oral use only.

The vaccine may be administered directly or mixed with beverages or foods provided that these do not contain substances that may inactivate polioviruses , such as preservations. Suitable vehicles aresimple syrup, milk, bread and a lump of sugar. Since the vaccine has a bitter salty taste, it may be given in syrup or on a lump of sugar, particularly when it is to be given to young children.Care should be taken not to contaminate a multidose dropper with saliva of the vaccine.

History of Vaccines and Polio Vaccine:

A vaccine tricks the body’s immune system into producing antibodies to fight a form of the virus that is not harmful. Then, if the person ever encounters the real and dangerous virus, the body is ready to prevent it from harming any cells.

An Idea in Search of a Method

If everyone in a room suddenly became exposed to the same disease in the same way at the same time, everyone would not be equally affected. One of the most important factors in determining how or whether a person gets sick is immunity—the human body’s own ability to prevent disease. It has been recognized for centuries that some diseases never reinfect a person after recovery. Smallpox was the first disease people tried to prevent by intentionally inoculating themselves with infected matter. Inoculation originated in India or China some time before 200 BC.This early Chinese print shows a vaccination needle From American Medical Association, The History of Inoculation and Vaccination for the Prevention and Treatment of Disease, 1913 The concept of immunization, or how to artificially induce the body to resist infection, received a big boost in 1796, when physician Edward Jenner inoculated a young boy in England and successfully prevented him from getting smallpox. Jenner used a lancet to scratch some infected material from a woman with cowpox (similar to smallpox) under the boy’s skin.

Smallpox inoculation devices

These smallpox inoculation devices illustrate both the simplicity of the idea and the complexity of the task. Left to right, from upper left corner: three examples of scab protectors (used after inoculation; early 20th century); two types of current disposable devices; bifurcated needles (a significant invention in 1968 because they used less vaccine and could be sterilized and reused); ivory vaccination points in glass carrier with wood shell (1900); vaccinator with metal carrying tube (19th century); spring lancet (1930s); glass and ivory points; round cowpox scab carrier (1860s, to transport vaccinating material); folding vaccinator (early 19th century); trigger vaccinator (1866); ivory-handled lancets with box (18th century); and drum vaccinator (19th century). The photograph shows a man with the distinctive smallpox blisters that often left permanent scars. Hugh Talman, photographer.

Can’t Catch This:

Immunity and Immunization

Lack of immunity to disease has helped to decide the fate of entire communities, from smallpox among the Indians in the New World to syphilitic soldiers in the Old. Most people have some amount of natural immunity. The human body can take care of itself in many circumstances—cuts, colds, and minor infections disappear without major upheaval. In other cases, the body has little or no naturally occurring immunity, so if you are exposed to diseases such as polio, influenza, smallpox, hepatitis, diphtheria, measles, or whooping cough, you will probably get sick with it, unless you have been immunized. Immunization refers to the artificial creation of immunity by deliberately infecting someone so that the body learns to protect itself. An important part of the history of immunization has been determining how to get the immunizing agent into the body. The skin, which keeps germs and schievous substances out, is also a barrier to getting medicines and vaccines into the tissue where they can work. Physicians have used varying methods to create immunity where there is none.This 1827 lithograph by Louis Leopold Boilly depicts a smallpox vaccination Courtesy of National Library of  Medicine Smallpox vaccinations in Mississippi Valley following a flooed, early 20th century.
The Skin Factor
While some scientists and physicians studied how the body worked and how to persuade it to fend off diseases, others puzzled over how to insert medicines and other substances such as vaccines. Having an effective vaccine that could produce sufficient immunity was useless without being able to get it into the body in a harmless way. Edward Jenner used a lancet and scratched two lines on James Phipps’s arm. Fifty years after Jenner, the hypodermic syringe became available. In 1885, scientist Louis Pasteur used one to vaccinate a young boy who had been bitten by a mad dog and was sure to die of rabies—the boy lived, and immunization took another giant step forward. As more immunizing agents became available, people saw the benefit of immunizing large groups, such as soldiers. During World War I, they were vaccinated against diphtheria; during World War II, typhus and tetanus.

The Future Has a Past

In the 19th century, use of the hypodermic syringe was limited by dependence on large needles that could rust or snap in two, glass barrels that cracked, and tips that leaked. Before disposable needles in the 1960s, needles needed to be sharpened and sterilized. Since then, technological improvements include sharper, thinner needles and safety features. Still, more than a few people would like to avoid a shot in the arm.Hypodermic injection remains the most common method of getting through the skin. But it is not the only technology for immunization. Engineers and scientists continue to search for alternative routes into the body, such as through the moth or nose. And continuing to solve the technological problems is critical for countries in which illness and death rates are high as a result of measles, maternal tetanus, and other preventable diseases.
A successful instrument or system must get the vaccine into the body with minimal disruption, and be cost-effective for use with billions of people. And perhaps the most important problem today—preventing reuse of syringes to avoid cross-contamination—was not even imagined in the 19th century.These devices represent different approaches to immunization Hugh Talman, photographer.These devices represent different approaches to immunization. Starting upper right: reusable glass syringe and plastic case (mid-20th century); two devices currently in development (one uses microneedles and the other, intradermal injection); pre-filled single-dose injection device (2004); nasal spray device that bypasses the skin (2004); disposable safety syringe (2004); disposable plastic syringe (1990s); disposable glass syringe (1980s); air-pressure gun (1970s); glass and metal antitoxin syringe (1930s); glass window syringe and case (1880s; note the thin wires used to keep the needle barrel open); Sharps container for disposal of used needles (1990s).

Virus, Vaccines, Verification

World War II accelerated vaccine development. Fear of a repetition of the 1918–19 world epidemic of influenza focused urgent attention on all viral diseases, while commercial production of antibiotics taught researchers to grow viruses with less microbe contamination. Also, investigators paid closer attention to vaccine safety and effectiveness through clinical studies before release of a vaccine to the public, especially after the yellow fever vaccine apparently caused hepatitis B in many U.S. soldiers in 1942.The U.S. Army hospital in Royat, France, during the World War I influenza epidemic Courtesy of National Library of Medicine

Early Research

Polio vaccine is made from the actual virus. For both research and production, vaccine makers needed to grow large quantities of virus. Influenza virus had been grown in chicken eggs, but this method did not polio. So researchers sought other materials in which to grow poliovirus.
In 1936, Albert Sabin and Peter Olitsky at the Rockefeller Institute demonstrated that poliovirus could grow in human embryonic brain tissue, but they feared that this method might risk central nervous system damage in those who received the vaccine. The advantage of embryonic tissue, however, was that it grew quickly.
Left: Copy of page from Thomas Wellerís notebook, March 30, 1948, describing the experiment for which he, John Enders, and Frederick Robbins won the Nobel Prize in 1954 Courtesy of Watson Publishing International.
Right: Thomas Weller, Frederick Robbins, and John Enders receiving the Nobel Prize in Stockholm, for “the cultivation of the poliomyelitis viruses in tissue culture,” 1954

A Nobel Prize

In March 1948, John Enders, Thomas Weller, and Frederick Robbins used human embryonic skin and muscle tissue, grown in a nutrient mix with antibiotics, to prove poliovirus could infect tissue other than nerve cells. Their confirmation meant that researchers could now grow enough poliovirus to create large quantities of vaccine. The three scientists won the Nobel Prize in Physiology or Medicine in 1954, the year polio vaccine had its first large clinical trial. Neither Jonas Salk nor Albert Sabin received a Nobel Prize for their work in creating vaccines.From John Enders’s lab, 1948: flasks in which poliovirus grew in monkey kidney tissue, and the wooden roller used to test tubes containing the growing virus slowly and continuously.

The Salk Vaccine

The chief advantage of Salk’s killed virus vaccine was safety. If made properly, it could not cause disease. Its chief disadvantage was that the formaldehyde used in its manufacture caused the immune system to recognize killed virus differently from live virus, possibly risking a shortened period of immunity. Results of trials with small numbers of children in 1952 encouraged the National Foundation for Infantile Paralysis to adopt Salk’s vaccine for a large-scale trial in 1954. Salk called his vaccine “Pittsburgh vaccine,” but reporters named it “Salk.”

Left: Vaccine bottles and 5-cc syringe used by Jonas Salk in the 1954ñ55 clinical trials.

Right: Jonas Salk in his lab at the University of Pittsburgh, 1954 Courtesy of March of Dimes.

Some of the thousands of children who received free vaccine in the weeks following the announcement, waiting in segregated lines Courtesy of Memphis Commercial Appeal.

Sabin and Salk

While the large-scale clinical trial with Salk vaccine went ahead in 1954, Albert Sabin continued developing his live-virus vaccine. Like many researchers of the day, Sabin strongly disagreed with Salk’s approach of using injected, “killed” virus. He believed that long-term immunity could only be achieved with a live, attenuated—or weakened—virus. In the race to develop a safe and effective polio vaccine, accidents occurred with both types. In 1955, for instance, insufficiently killed virus in the vaccine from Cutter Laboratories in Berkeley, California, infected some 200 children; many were paralyzed and several died. But the global end to polio transmission would have been inconceivable without both the “killed” (Salk) and “live” (Sabin) vaccines. Neither Jonas Salk nor Albert Sabin patented their vaccines; they donated the rights as gifts to humanity.

The Sabin Vaccine

An important feature of Sabin’s oral polio vaccine was that immediately after vaccination, people shed weakened virus in their fecal waste. This boosted immunity for others in the community and gradually reduced the number of people susceptible to poliomyelitis.Between 1963 and 1999, Sabin live vaccine largely replaced Salk killed vaccine everywhere in the world. However, because the live virus in the vaccine occasionally became strong enough to cause actual disease, Salk killed-type vaccine has replaced the live type in the United States.“I have studied the effects of our new lots of polio vaccine in 100 adult volunteers and during the next few days shall give it to my wife and 2 children as well as to our neighbors and their children.”

—Albert Sabin, 1957

Sabin and the Cold War

Because Salk vaccine was used so extensively in the United States, Sabin had to go overseas in the late 1950s to find people for his clinical trials, in the Belgian Congo and, on a massive scale, in the Soviet Union. An American was able to conduct an extensive polio vaccine trial in the Soviet Union at the height of the cold war because the fear of polio was stronger than political differences. “After getting satisfactory results of tests of your vaccine in 20,000 children we are going to prepare from your strains (1956) material for vaccination of 2ñ3 million people more, and after thorough laboratory tests of this vaccine, to use it in our country in 1959.”

—Dr. Mikhail Chumakov to Albert Sabin, letter of December 26, 1958

In the first five months of 1959, ten million children in the Soviet Union received the Sabin oral vaccine. Albert Sabin received a medal in gratitude from the Russian government during the height of the cold war.

Left: Albert Sabin with Dr. Victor Zhdanov, Soviet deputy minister of health, 1958 Courtesy of Heloisa Sabin

Right: Albert Sabin’s medal, box and vial of Russian oral vaccine, matchbox advertising the vaccine campaign, two photographs of Sabin with Russian scientists, 1956-1958 Medal courtesy of University of Cincinnati, Cincinnati Medical Heritage Center, Academic Information Technology and Libraries; other items courtesy of Heloisa Sabin
Killed or Live Vaccine?
Albert Sabin and other researchers, including John Enders and Hilary Koprowski, had argued that long-term immunity to polio could only be achieved with a live though greatly weakened virus, and that it must follow the same route of infection as wild-type poliovirus—through the mouth, and infecting intestinal tissue. Weakening the virus required passing it through a succession of animals—rats, mice, or monkeys. This allowed it to become more virulent for these hosts, and less so for humans. Hilary Koprowski carried out the first successful trial of weakened virus vaccine in February 1950.
The National Foundation for Infantile Paralysis chose Dr. Thomas Francis Jr. at the University of Michigan to implement the first mass polio vaccine trial in 1954. More than 300,000 people, mostly volunteers, including physicians, nurses, schoolteachers, public health officials, and community members, carried out the work. Polio Pioneer card given to each child, along with a piece of candy, 1954.

Polio Pioneers:

In 1954, almost 75 percent of reported poliomyelitis cases occurred in people under twenty years of age, and 50 percent in children under ten. The trial’s study population, then, targeted some 1.8 million children in the first three grades of elementary school at 215 test sites. In the double-blind experiment, 650,000 children received vaccine, 750,000 received a placebo (a solution made to look like vaccine, but containing no virus), and 430,000 served as controls and had neither. All were “Polio Pioneers.”
Randall Kerr gets the first shot, Franklin Sherman Elementary School, Fairfax, Virginia, April 26, 1954 Courtesy of March of Dimes. The study called for all children receiving vaccine or placebo to have three intramuscular injections over a five-week period. About 2 percent of the children also gave blood samples to verify their immune response.
Data from all 1,829,916 clinical trial participants were entered on IBM punch cards and tabulated. The study evaluated every scrap of evidence, from the registration methods of the participants to laboratory procedures to statistical analysis.
“The news that began to pour out over the radio in the gym on April 12, 1955, the tenth anniversary of Roosevelt’s death, was news only in detail. That the field trials of the Salk vaccine would prove in some measure successful had been anticipated. Indeed, the assistant to the director at the previous hospital had remarked to me in November, ‘Too bad you didn’t wait a year. The vaccine sure looks good.”

The March of  Dimes:

President Franklin Roosevelt established the National Foundation for Infantile Paralysis in 1938. Its hugely successful fund-raising campaigns collected enough money to fund John Enders’s laboratory, where poliovirus was first grown in nonneural tissue; both Jonas Salk’s and Albert Sabin’s vaccine development; the 1954–55 field trial of Salk vaccine; and the supply of free vaccine to thousands of children afterward.
In 1958, the foundation changed its focus to premature birth and the prevention of birth defects. In 1979, the organization officially changed its name to the March of Dimes. Its work continues today, under the slogan “Saving babies, together.”

Rotary International

Chicago lawyer Paul Harris called together a group of civic-minded professionals in February 1905 to found the first “Rotary” Club—taking its name from rotating meetings in members’ homes and offices. By 1922, Rotary Clubs existed around the world, prompting the name change to Rotary International. Rotarians were well-represented at the United Nations Charter Conference and have maintained their UN ties ever since. In 1985, Rotary International committed itself to immunizing all children against poliomyelitis. This organization, with 1.2 million members in 166 countries, has been the largest private-sector contributor to the polio eradication campaign worldwide.

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Special Tanks to : Dr. Tariq W.H.O Pakistan (Member of National surveillance Team Pakistan)