Prevnar
Encyclopedia
Pneumococcal conjugate vaccine (PCV) is a vaccine
used to protect infant
s and young children against disease caused by the bacterium Streptococcus pneumoniae
(pneumococcus). There are currently three PCV vaccines available on the global market: Prevnar (called Prevenar in some countries), Synflorix and Prevnar 13.
Prevnar is a heptavalent vaccine, meaning that it contains the cell membrane
sugars of seven serotype
s of pneumococcus, conjugated with Diphtheria
proteins. It was manufactured by Wyeth
. In the United States
, vaccination with Prevnar is recommended for all children younger than 2 years, and for unvaccinated children between 24 and 59 months old who are at high risk for pneumococcal infections.
Synflorix is produced by GlaxoSmithKline
. It is a decavalent vaccine, meaning that it contains ten serotypes of pneumococcus (1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F) which are conjugated to a carrier protein. Synflorix received a positive opinion from the European Medicines Agency for use in the European Union in January 2009 and GSK received European Commission authorization to market Synflorix in March 2009.
Prevnar 13 is produced by Pfizer
. It is a triskaivalent vaccine, meaning that it contains thirteen serotypes of pneumococcus (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) which are conjugated to a carrier protein. Prevnar 13 was approved by the U.S. Food and Drug Administration
for immediate release to the public on February 24, 2010. It is to be given on the same schedule as was Prevnar.
bacteria
in the US. The bacterial capsule sugars, a characteristic of these pathogens, are linked to CRM197, a nontoxic recombinant variant of diphtheria
toxin (Corynebacterium diphtheriae
).
The vaccine's polysaccharide
sugars are grown separately in soy peptone broths. Through reductive amination, the sugars are directly conjugated to the protein carrier CRM197 to form the glycoconjugate. CRM197 is grown in Corynebacterium diphtheriae strain C7 in a medium of casamino acids and yeast extracts.http://www.rxlist.com/cgi/generic/prevnar.htm
The original 7-valent formulation contains serotypes 4,6B,9V,14,18C,19F, and 23F, and results in a 98% probability of protection against these strains, which caused 80% of the pneumococcal disease in infants in the US. In 2010, Pfizer introduced Prevnar 13 which contains six additional strains (i.e., 1, 3, 5, 6A, 19A and 7F), which protect against the majority of the remaining pneumococcal infections.
strains.
) must be used. Whilst this covers only seven strains out of more than ninety strains, these seven strains cause 80% to 90% of cases of severe pneumococcal disease, and it is considered to be nearly 100% effective against these strains.
) require as full protection as can be achieved using the 7-valent congugated vaccine, with the then more extensive 23-valent vaccine given after the second year of life:
, recommended the vaccine be administered to every infant and young child in the US. The resulting demand outstripped production, creating shortages not resolved until 2004. All children, according to current US vaccination schedule
s, should receive four doses, at two months, four months, six months, and again between one year and fifteen months of age.
in preventing invasive pneumococcal disease has been documented by a number of epidemiologic
studies. There is evidence that other people in the same household as a vaccinee also become relatively protected.
In fact, there is evidence that routine childhood vaccination reduces the burden of pneumococcal disease in adults and especially high-risk adults, such as those living with HIV
/AIDS
.
The vaccine is, however, primarily developed for the U.S. and European epidemiological situation, and therefore it has
only a limited coverage of serotypes causing serious pneumococcal infections in most developing countries.
Interestingly, rates of invasive pneumococcal disease among adults has also declined since the introduction of the vaccine. Although, it is more difficult to specifically attribute this decline in adults to the childhood pneumococcal conjugate vaccine since the adult pneumococcal 23-valent polysaccharide vaccine is also available.
While an overall decline in invasive pneumococcal disease is well documented, concerns have been raised regarding a potential increase in the rate of infections caused by serotypes not covered in the vaccine. Recent data suggest that serotype replacement is increasing (1.61- and 1.28-fold increase in children and adults) but remains minimal when compared to the significant reduction observed in the burden of this vaccine-preventable disease.
were evaluated. Rashes at the site of injection were noted in about one percent of children.
, killing over 800,000 and up to a million children a year. Ninety percent of these deaths occur in the developing world. Historically 15–20 years pass before a new vaccine reaches one quarter of the population of the developing world. Pneumococcal vaccines Accelerated Development and Introduction Plan (PneumoADIP)
is a GAVI Alliance (GAVI)
funded project to accelerate the introduction of pneumococcal vaccinations into low-income countries through partnerships between countries, donors, academia, international organizations and industry. With action now, a projected 5.4 million child deaths can be prevented by 2030. In May 2007, 30 of the 72 GAVI
countries expressed interest in introducing pneumococcal conjugate vaccine between 2008 and 2010. These countries are Benin
, Burundi
, the Republic of Congo, Rep. of Côte d'Ivoire
, Djibouti
, the Democratic Republic of Congo, Ethiopia
, Ghana
, Guyana
, Honduras
, Indonesia
, Kenya
, Madagascar
, Malawi
, Mali
, Mongolia
, Nicaragua
, Pakistan
, Rwanda
, São Tomé and Príncipe
, Senegal
, Solomon Islands
, Sri Lanka
, Sudan
, The Gambia
, Timor Leste, Togo
, Uganda
, Yemen
, and Zambia
. In April 2009 the first of these countries, Rwanda, introduced Prevnar into its routine vaccination schedule. The use of this vaccine in Rwanda is expected to save thousands of children each year and dramatically reduce the economic burden of this disease. It is expected that GAVI will help to fund many other low-income introductions in the coming years.
In addition, Wyeth has been accused of conflict of interest in economic evaluations of Prevnar.
The selling price of conjugate vaccines is clearly very high. The WHO, pneumo ADIP and other associations are taking steps to make cheaper, more effective vaccines available with partners in countries such as India, and Brazil.
Authorities in the Netherlands banned use of one batch of Pfizer's Prevenar after three infants died within two weeks of receiving the anti-infection vaccination. A Pfizer
spokeswoman said that the three infants also received two unrelated other vaccines as part of routine immunizations. The Netherlands National Institute for Public Health and the Environment
was investigating the cause of the infants' deaths. Other batches of Prevenar will continue to be used. The Pfizer spokeswoman said preliminary investigations by the company and health authorities had found no link between the vaccinations and the deaths and that the company initiated the "quarantine" of the batch which contained 110,000 doses of Prevenar.http://web.archive.org/web/20091109191848/http://www.msnbc.msn.com/id/33671008/ns/health-infectious_diseases/
Concerns about serotype replacement have been circulating since the CDC published a study in 2006 http://www.ncbi.nlm.nih.gov/pubmed/16267772 More recently, it was confirmed that children vaccinated with 7-valent PCV pneumococcal conjugate vaccine showed an increased rate of carriage of serotype 19A: a new, more virulent and less treatable (antibiotic resistant) strain. The study showed that the increased carriage rates were dose-dependent. Healthy infants were vaccinated with three doses, two doses, or were unvaccinated for PCV. Journal of the American Medical Association (JAMA), Sept. 2010. http://www.ncbi.nlm.nih.gov/pubmed/20823436
Vaccine
A vaccine is a biological preparation that improves immunity to a particular disease. A vaccine typically contains an agent that resembles a disease-causing microorganism, and is often made from weakened or killed forms of the microbe or its toxins...
used to protect infant
Infant
A newborn or baby is the very young offspring of a human or other mammal. A newborn is an infant who is within hours, days, or up to a few weeks from birth. In medical contexts, newborn or neonate refers to an infant in the first 28 days after birth...
s and young children against disease caused by the bacterium Streptococcus pneumoniae
Streptococcus pneumoniae
Streptococcus pneumoniae, or pneumococcus, is Gram-positive, alpha-hemolytic, aerotolerant anaerobic member of the genus Streptococcus. A significant human pathogenic bacterium, S...
(pneumococcus). There are currently three PCV vaccines available on the global market: Prevnar (called Prevenar in some countries), Synflorix and Prevnar 13.
Prevnar is a heptavalent vaccine, meaning that it contains the cell membrane
Cell membrane
The cell membrane or plasma membrane is a biological membrane that separates the interior of all cells from the outside environment. The cell membrane is selectively permeable to ions and organic molecules and controls the movement of substances in and out of cells. It basically protects the cell...
sugars of seven serotype
Serotype
Serotype or serovar refers to distinct variations within a subspecies of bacteria or viruses. These microorganisms, viruses, or cells are classified together based on their cell surface antigens...
s of pneumococcus, conjugated with Diphtheria
Diphtheria
Diphtheria is an upper respiratory tract illness caused by Corynebacterium diphtheriae, a facultative anaerobic, Gram-positive bacterium. It is characterized by sore throat, low fever, and an adherent membrane on the tonsils, pharynx, and/or nasal cavity...
proteins. It was manufactured by Wyeth
Wyeth
Wyeth, formerly one of the companies owned by American Home Products Corporation , was a pharmaceutical company. The company was based in Madison, New Jersey, USA...
. In the United States
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
, vaccination with Prevnar is recommended for all children younger than 2 years, and for unvaccinated children between 24 and 59 months old who are at high risk for pneumococcal infections.
Synflorix is produced by GlaxoSmithKline
GlaxoSmithKline
GlaxoSmithKline plc is a global pharmaceutical, biologics, vaccines and consumer healthcare company headquartered in London, United Kingdom...
. It is a decavalent vaccine, meaning that it contains ten serotypes of pneumococcus (1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F) which are conjugated to a carrier protein. Synflorix received a positive opinion from the European Medicines Agency for use in the European Union in January 2009 and GSK received European Commission authorization to market Synflorix in March 2009.
Prevnar 13 is produced by Pfizer
Pfizer
Pfizer, Inc. is an American multinational pharmaceutical corporation. The company is based in New York City, New York with its research headquarters in Groton, Connecticut, United States...
. It is a triskaivalent vaccine, meaning that it contains thirteen serotypes of pneumococcus (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) which are conjugated to a carrier protein. Prevnar 13 was approved by the U.S. Food and Drug Administration
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
for immediate release to the public on February 24, 2010. It is to be given on the same schedule as was Prevnar.
Prevnar
The original Prevnar was produced from the seven most prevalent strains of Streptococcus pneumoniaeStreptococcus pneumoniae
Streptococcus pneumoniae, or pneumococcus, is Gram-positive, alpha-hemolytic, aerotolerant anaerobic member of the genus Streptococcus. A significant human pathogenic bacterium, S...
bacteria
Bacteria
Bacteria are a large domain of prokaryotic microorganisms. Typically a few micrometres in length, bacteria have a wide range of shapes, ranging from spheres to rods and spirals...
in the US. The bacterial capsule sugars, a characteristic of these pathogens, are linked to CRM197, a nontoxic recombinant variant of diphtheria
Diphtheria
Diphtheria is an upper respiratory tract illness caused by Corynebacterium diphtheriae, a facultative anaerobic, Gram-positive bacterium. It is characterized by sore throat, low fever, and an adherent membrane on the tonsils, pharynx, and/or nasal cavity...
toxin (Corynebacterium diphtheriae
Corynebacterium diphtheriae
Corynebacterium diphtheriae is a pathogenic bacterium that causes diphtheria. It is also known as the Klebs-Löffler bacillus, because it was discovered in 1884 by German bacteriologists Edwin Klebs and Friedrich Löffler .-Classification:Four subspecies are recognized: C. diphtheriae mitis, C....
).
The vaccine's polysaccharide
Polysaccharide
Polysaccharides are long carbohydrate molecules, of repeated monomer units joined together by glycosidic bonds. They range in structure from linear to highly branched. Polysaccharides are often quite heterogeneous, containing slight modifications of the repeating unit. Depending on the structure,...
sugars are grown separately in soy peptone broths. Through reductive amination, the sugars are directly conjugated to the protein carrier CRM197 to form the glycoconjugate. CRM197 is grown in Corynebacterium diphtheriae strain C7 in a medium of casamino acids and yeast extracts.http://www.rxlist.com/cgi/generic/prevnar.htm
The original 7-valent formulation contains serotypes 4,6B,9V,14,18C,19F, and 23F, and results in a 98% probability of protection against these strains, which caused 80% of the pneumococcal disease in infants in the US. In 2010, Pfizer introduced Prevnar 13 which contains six additional strains (i.e., 1, 3, 5, 6A, 19A and 7F), which protect against the majority of the remaining pneumococcal infections.
Synflorix
Synflorix contains antigen from ten pneumococcal serotypes: the seven that are contained in Prevnar, plus serotypes 1, 5, and 7F. Eight of the ten serotypes are linked to a protein carrier derived from non-typeable Haemophilus influenzaeHaemophilus influenzae
Haemophilus influenzae, formerly called Pfeiffer's bacillus or Bacillus influenzae, Gram-negative, rod-shaped bacterium first described in 1892 by Richard Pfeiffer during an influenza pandemic. A member of the Pasteurellaceae family, it is generally aerobic, but can grow as a facultative anaerobe. H...
strains.
Schedule of vaccination
Children under the age of two years fail to mount an adequate response to the 23-valent adult vaccine, and so the 7-valent Pneumococcal Conjugated Vaccine (PCV) (e.g. PrevnarPrevnar
Pneumococcal conjugate vaccine is a vaccine used to protect infants and young children against disease caused by the bacterium Streptococcus pneumoniae...
) must be used. Whilst this covers only seven strains out of more than ninety strains, these seven strains cause 80% to 90% of cases of severe pneumococcal disease, and it is considered to be nearly 100% effective against these strains.
United Kingdom
The UK childhood vaccination schedule consists of a primary course of two doses at 2 and 4 months of age with a final third dose aged 13 months.Special risk-group
Children at special risk (e.g., sickle cell disease and aspleniaAsplenia
Asplenia refers to the absence of normal spleen function and is associated with some serious infection risks. Hyposplenism is used to describe reduced splenic functioning, but not as severely affected as with asplenism.-Congenital:...
) require as full protection as can be achieved using the 7-valent congugated vaccine, with the then more extensive 23-valent vaccine given after the second year of life:
| Age | 2–6 months | 7–11 months | 12–23 months | ||
| Conjugated vaccine | 3 x monthly dose | 2 x monthly dose | Further dose in second year of life | ||
| 23-valent vaccine | Then after 2nd birthday single dose of 23-valent | ||||
United States
In 2001, the Centers for Disease Control (CDC), upon advice from its Advisory Committee on Immunization PracticesAdvisory Committee on Immunization Practices
The Advisory Committee on Immunization Practices provides advice and guidance on effective control of vaccine-preventable diseases in the U.S. civilian population. The ACIP develops written recommendations for routine administration of vaccines to the pediatric and adult populations, along with...
, recommended the vaccine be administered to every infant and young child in the US. The resulting demand outstripped production, creating shortages not resolved until 2004. All children, according to current US vaccination schedule
Vaccination schedule
A vaccination schedule is a series of vaccinations, including the timing of all doses, which may be either recommended or compulsory, depending on the country of residence....
s, should receive four doses, at two months, four months, six months, and again between one year and fifteen months of age.
Efficacy
Prevnar is designed to stop seven of about ninety pneumococcal serotypes which have the potential to cause invasive pneumococcal disease. Each year, IPD kills approximately one million children worldwide.http://www.slate.com/id/2168854/pagenum/all/ Since approval, Prevnar's efficacyVaccine efficacy
Vaccine efficacy is defined as the reduction in the incidence of a disease among people who have received a vaccine compared to the incidence in unvaccinated people...
in preventing invasive pneumococcal disease has been documented by a number of epidemiologic
Epidemiology
Epidemiology is the study of health-event, health-characteristic, or health-determinant patterns in a population. It is the cornerstone method of public health research, and helps inform policy decisions and evidence-based medicine by identifying risk factors for disease and targets for preventive...
studies. There is evidence that other people in the same household as a vaccinee also become relatively protected.
In fact, there is evidence that routine childhood vaccination reduces the burden of pneumococcal disease in adults and especially high-risk adults, such as those living with HIV
HIV
Human immunodeficiency virus is a lentivirus that causes acquired immunodeficiency syndrome , a condition in humans in which progressive failure of the immune system allows life-threatening opportunistic infections and cancers to thrive...
/AIDS
AIDS
Acquired immune deficiency syndrome or acquired immunodeficiency syndrome is a disease of the human immune system caused by the human immunodeficiency virus...
.
The vaccine is, however, primarily developed for the U.S. and European epidemiological situation, and therefore it has
only a limited coverage of serotypes causing serious pneumococcal infections in most developing countries.
Evidence supporting addition to routine vaccination schedules
After introduction of the pneumococcal conjugate vaccine in 2000, several studies described a decrease in invasive pneumococcal disease in the United States. One year after its introduction, a group of investigators found a 69% drop in the rate of invasive disease in those age less than 2 years of age. By 2004, all-cause pneumonia admission rates had declined by 39% (95% CI 22–52) and rates of hospitalizations for pneumococcal meningitis decreased by 66% (95% CI 56.3-73.5) in children younger than 2.Interestingly, rates of invasive pneumococcal disease among adults has also declined since the introduction of the vaccine. Although, it is more difficult to specifically attribute this decline in adults to the childhood pneumococcal conjugate vaccine since the adult pneumococcal 23-valent polysaccharide vaccine is also available.
While an overall decline in invasive pneumococcal disease is well documented, concerns have been raised regarding a potential increase in the rate of infections caused by serotypes not covered in the vaccine. Recent data suggest that serotype replacement is increasing (1.61- and 1.28-fold increase in children and adults) but remains minimal when compared to the significant reduction observed in the burden of this vaccine-preventable disease.
Clinical study
Prevnar was administered to nearly 20,000 children prior to licensure, and the side effectsAdverse effect (medicine)
In medicine, an adverse effect is a harmful and undesired effect resulting from a medication or other intervention such as surgery.An adverse effect may be termed a "side effect", when judged to be secondary to a main or therapeutic effect. If it results from an unsuitable or incorrect dosage or...
were evaluated. Rashes at the site of injection were noted in about one percent of children.
Vaccination in Low-Income Countries
Pneumococcal disease is the leading vaccine-preventable killer of young children worldwide, according to the World Health Organization (WHO)World Health Organization
The World Health Organization is a specialized agency of the United Nations that acts as a coordinating authority on international public health. Established on 7 April 1948, with headquarters in Geneva, Switzerland, the agency inherited the mandate and resources of its predecessor, the Health...
, killing over 800,000 and up to a million children a year. Ninety percent of these deaths occur in the developing world. Historically 15–20 years pass before a new vaccine reaches one quarter of the population of the developing world. Pneumococcal vaccines Accelerated Development and Introduction Plan (PneumoADIP)
PneumoADIP
Pneumococcal vaccines Accelerated Development and Introduction Plan is a small, dedicated team based at Johns Hopkins Bloomberg School of Public Health and is supported by a $30 million grant from the Global Alliance for Vaccines and Immunization...
is a GAVI Alliance (GAVI)
Global Alliance for Vaccines and Immunization
The GAVI Alliance is a public-private global health partnership committed to saving children’s lives and protecting people’s health by increasing access to immunisation in poor countries...
funded project to accelerate the introduction of pneumococcal vaccinations into low-income countries through partnerships between countries, donors, academia, international organizations and industry. With action now, a projected 5.4 million child deaths can be prevented by 2030. In May 2007, 30 of the 72 GAVI
Global Alliance for Vaccines and Immunization
The GAVI Alliance is a public-private global health partnership committed to saving children’s lives and protecting people’s health by increasing access to immunisation in poor countries...
countries expressed interest in introducing pneumococcal conjugate vaccine between 2008 and 2010. These countries are Benin
Benin
Benin , officially the Republic of Benin, is a country in West Africa. It borders Togo to the west, Nigeria to the east and Burkina Faso and Niger to the north. Its small southern coastline on the Bight of Benin is where a majority of the population is located...
, Burundi
Burundi
Burundi , officially the Republic of Burundi , is a landlocked country in the Great Lakes region of Eastern Africa bordered by Rwanda to the north, Tanzania to the east and south, and the Democratic Republic of the Congo to the west. Its capital is Bujumbura...
, the Republic of Congo, Rep. of Côte d'Ivoire
Côte d'Ivoire
The Republic of Côte d'Ivoire or Ivory Coast is a country in West Africa. It has an area of , and borders the countries Liberia, Guinea, Mali, Burkina Faso and Ghana; its southern boundary is along the Gulf of Guinea. The country's population was 15,366,672 in 1998 and was estimated to be...
, Djibouti
Djibouti
Djibouti , officially the Republic of Djibouti , is a country in the Horn of Africa. It is bordered by Eritrea in the north, Ethiopia in the west and south, and Somalia in the southeast. The remainder of the border is formed by the Red Sea and the Gulf of Aden at the east...
, the Democratic Republic of Congo, Ethiopia
Ethiopia
Ethiopia , officially known as the Federal Democratic Republic of Ethiopia, is a country located in the Horn of Africa. It is the second-most populous nation in Africa, with over 82 million inhabitants, and the tenth-largest by area, occupying 1,100,000 km2...
, Ghana
Ghana
Ghana , officially the Republic of Ghana, is a country located in West Africa. It is bordered by Côte d'Ivoire to the west, Burkina Faso to the north, Togo to the east, and the Gulf of Guinea to the south...
, Guyana
Guyana
Guyana , officially the Co-operative Republic of Guyana, previously the colony of British Guiana, is a sovereign state on the northern coast of South America that is culturally part of the Anglophone Caribbean. Guyana was a former colony of the Dutch and of the British...
, Honduras
Honduras
Honduras is a republic in Central America. It was previously known as Spanish Honduras to differentiate it from British Honduras, which became the modern-day state of Belize...
, Indonesia
Indonesia
Indonesia , officially the Republic of Indonesia , is a country in Southeast Asia and Oceania. Indonesia is an archipelago comprising approximately 13,000 islands. It has 33 provinces with over 238 million people, and is the world's fourth most populous country. Indonesia is a republic, with an...
, Kenya
Kenya
Kenya , officially known as the Republic of Kenya, is a country in East Africa that lies on the equator, with the Indian Ocean to its south-east...
, Madagascar
Madagascar
The Republic of Madagascar is an island country located in the Indian Ocean off the southeastern coast of Africa...
, Malawi
Malawi
The Republic of Malawi is a landlocked country in southeast Africa that was formerly known as Nyasaland. It is bordered by Zambia to the northwest, Tanzania to the northeast, and Mozambique on the east, south and west. The country is separated from Tanzania and Mozambique by Lake Malawi. Its size...
, Mali
Mali
Mali , officially the Republic of Mali , is a landlocked country in Western Africa. Mali borders Algeria on the north, Niger on the east, Burkina Faso and the Côte d'Ivoire on the south, Guinea on the south-west, and Senegal and Mauritania on the west. Its size is just over 1,240,000 km² with...
, Mongolia
Mongolia
Mongolia is a landlocked country in East and Central Asia. It is bordered by Russia to the north and China to the south, east and west. Although Mongolia does not share a border with Kazakhstan, its western-most point is only from Kazakhstan's eastern tip. Ulan Bator, the capital and largest...
, Nicaragua
Nicaragua
Nicaragua is the largest country in the Central American American isthmus, bordered by Honduras to the north and Costa Rica to the south. The country is situated between 11 and 14 degrees north of the Equator in the Northern Hemisphere, which places it entirely within the tropics. The Pacific Ocean...
, Pakistan
Pakistan
Pakistan , officially the Islamic Republic of Pakistan is a sovereign state in South Asia. It has a coastline along the Arabian Sea and the Gulf of Oman in the south and is bordered by Afghanistan and Iran in the west, India in the east and China in the far northeast. In the north, Tajikistan...
, Rwanda
Rwanda
Rwanda or , officially the Republic of Rwanda , is a country in central and eastern Africa with a population of approximately 11.4 million . Rwanda is located a few degrees south of the Equator, and is bordered by Uganda, Tanzania, Burundi and the Democratic Republic of the Congo...
, São Tomé and Príncipe
São Tomé and Príncipe
São Tomé and Príncipe, officially the Democratic Republic of São Tomé and Príncipe, is a Portuguese-speaking island nation in the Gulf of Guinea, off the western equatorial coast of Central Africa. It consists of two islands: São Tomé and Príncipe, located about apart and about , respectively, off...
, Senegal
Senegal
Senegal , officially the Republic of Senegal , is a country in western Africa. It owes its name to the Sénégal River that borders it to the east and north...
, Solomon Islands
Solomon Islands
Solomon Islands is a sovereign state in Oceania, east of Papua New Guinea, consisting of nearly one thousand islands. It covers a land mass of . The capital, Honiara, is located on the island of Guadalcanal...
, Sri Lanka
Sri Lanka
Sri Lanka, officially the Democratic Socialist Republic of Sri Lanka is a country off the southern coast of the Indian subcontinent. Known until 1972 as Ceylon , Sri Lanka is an island surrounded by the Indian Ocean, the Gulf of Mannar and the Palk Strait, and lies in the vicinity of India and the...
, Sudan
Sudan
Sudan , officially the Republic of the Sudan , is a country in North Africa, sometimes considered part of the Middle East politically. It is bordered by Egypt to the north, the Red Sea to the northeast, Eritrea and Ethiopia to the east, South Sudan to the south, the Central African Republic to the...
, The Gambia
The Gambia
The Republic of The Gambia, commonly referred to as The Gambia, or Gambia , is a country in West Africa. Gambia is the smallest country on mainland Africa, surrounded by Senegal except for a short coastline on the Atlantic Ocean in the west....
, Timor Leste, Togo
Togo
Togo, officially the Togolese Republic , is a country in West Africa bordered by Ghana to the west, Benin to the east and Burkina Faso to the north. It extends south to the Gulf of Guinea, on which the capital Lomé is located. Togo covers an area of approximately with a population of approximately...
, Uganda
Uganda
Uganda , officially the Republic of Uganda, is a landlocked country in East Africa. Uganda is also known as the "Pearl of Africa". It is bordered on the east by Kenya, on the north by South Sudan, on the west by the Democratic Republic of the Congo, on the southwest by Rwanda, and on the south by...
, Yemen
Yemen
The Republic of Yemen , commonly known as Yemen , is a country located in the Middle East, occupying the southwestern to southern end of the Arabian Peninsula. It is bordered by Saudi Arabia to the north, the Red Sea to the west, and Oman to the east....
, and Zambia
Zambia
Zambia , officially the Republic of Zambia, is a landlocked country in Southern Africa. The neighbouring countries are the Democratic Republic of the Congo to the north, Tanzania to the north-east, Malawi to the east, Mozambique, Zimbabwe, Botswana and Namibia to the south, and Angola to the west....
. In April 2009 the first of these countries, Rwanda, introduced Prevnar into its routine vaccination schedule. The use of this vaccine in Rwanda is expected to save thousands of children each year and dramatically reduce the economic burden of this disease. It is expected that GAVI will help to fund many other low-income introductions in the coming years.
Sales
Prevnar is among Wyeth's top revenue producers, with sales in 2005 of $1.5 billion, up 43 percent from 2004.Wyeth Annual reportControversy
Controversy has arisen regarding pneumococcal vaccine advertisements aired by Wyeth in Poland and Saudi Arabia. A television commercial for Prevnar, showing a dying child and its mother, was banned in Poland by the main pharmaceutical inspector (GIF), Zofia Ulz, on April 3, 2007. According to Ulz, the ad was designed to provoke fear to attract customers. Wyeth responded by asserting the tactic was used to increase awareness of the potential danger represented by pneumococcal infections.In addition, Wyeth has been accused of conflict of interest in economic evaluations of Prevnar.
The selling price of conjugate vaccines is clearly very high. The WHO, pneumo ADIP and other associations are taking steps to make cheaper, more effective vaccines available with partners in countries such as India, and Brazil.
Authorities in the Netherlands banned use of one batch of Pfizer's Prevenar after three infants died within two weeks of receiving the anti-infection vaccination. A Pfizer
Pfizer
Pfizer, Inc. is an American multinational pharmaceutical corporation. The company is based in New York City, New York with its research headquarters in Groton, Connecticut, United States...
spokeswoman said that the three infants also received two unrelated other vaccines as part of routine immunizations. The Netherlands National Institute for Public Health and the Environment
Netherlands National Institute for Public Health and the Environment
The Netherlands National Institute for Public Health and the Environment , is a Dutch research institute that is an independent agency of the Dutch Ministry of Health, Welfare and Sport....
was investigating the cause of the infants' deaths. Other batches of Prevenar will continue to be used. The Pfizer spokeswoman said preliminary investigations by the company and health authorities had found no link between the vaccinations and the deaths and that the company initiated the "quarantine" of the batch which contained 110,000 doses of Prevenar.http://web.archive.org/web/20091109191848/http://www.msnbc.msn.com/id/33671008/ns/health-infectious_diseases/
Concerns about serotype replacement have been circulating since the CDC published a study in 2006 http://www.ncbi.nlm.nih.gov/pubmed/16267772 More recently, it was confirmed that children vaccinated with 7-valent PCV pneumococcal conjugate vaccine showed an increased rate of carriage of serotype 19A: a new, more virulent and less treatable (antibiotic resistant) strain. The study showed that the increased carriage rates were dose-dependent. Healthy infants were vaccinated with three doses, two doses, or were unvaccinated for PCV. Journal of the American Medical Association (JAMA), Sept. 2010. http://www.ncbi.nlm.nih.gov/pubmed/20823436
See also
- Streptococcus pneumoniaeStreptococcus pneumoniaeStreptococcus pneumoniae, or pneumococcus, is Gram-positive, alpha-hemolytic, aerotolerant anaerobic member of the genus Streptococcus. A significant human pathogenic bacterium, S...
- PneumoniaPneumoniaPneumonia is an inflammatory condition of the lung—especially affecting the microscopic air sacs —associated with fever, chest symptoms, and a lack of air space on a chest X-ray. Pneumonia is typically caused by an infection but there are a number of other causes...
- PneumoADIPPneumoADIPPneumococcal vaccines Accelerated Development and Introduction Plan is a small, dedicated team based at Johns Hopkins Bloomberg School of Public Health and is supported by a $30 million grant from the Global Alliance for Vaccines and Immunization...
- Pneumococcal polysaccharide vaccinePneumococcal polysaccharide vaccinePneumococcal polysaccharide vaccine — the latest version is known as Pneumovax 23 — is the first pneumococcal vaccine, the first vaccine derived from a capsular polysaccharide, and an important landmark in medical history...