Pneumococcal conjugate vaccine

Last updated

Pneumococcal conjugate vaccine
Prevenar 13.jpg
Prevenar 13
Vaccine description
Target Streptococcus pneumoniae
Vaccine type Conjugate
Clinical data
Trade names Prevnar 20, Prevnar 13, Synflorix, others; discontinued Prevnar (PCV7)
Other namesPCV, pneumococcal vaccine, capsular polysaccharides [1]
AHFS/Drugs.com Monograph
MedlinePlus a607021
License data
Pregnancy
category
Routes of
administration 		Intramuscular
ATC code
Legal status
Legal status
Identifiers
ChemSpider
  • none
KEGG

Pneumococcal conjugate vaccine is a pneumococcal vaccine made with the conjugate vaccine method and used to protect infants, young children, and adults against disease caused by the bacterium Streptococcus pneumoniae (pneumococcus). It contains purified capsular polysaccharide of pneumococcal serotypes conjugated to a carrier protein to improve antibody response compared to the pneumococcal polysaccharide vaccine. The World Health Organization (WHO) recommends the use of the conjugate vaccine in routine immunizations given to children. [16] [17]

Contents

Vaccine-mediated immunity is "conferred mainly by opsonophagocytic killing of S. pneumoniae." [18]

The most common side effects in children are decreased appetite, fever (only very common in children aged six weeks to five years), irritability, reactions at the site of injection (reddening or hardening of the skin, swelling, pain or tenderness), somnolence (sleepiness) and poor quality sleep. [11] [18] In adults and the elderly, the most common side effects are decreased appetite, headaches, diarrhea, fever (only very common in adults aged 18 to 29 years), vomiting (only very common in adults aged 18 to 49 years), rash, reactions at the site of injection, limitation of arm movement, arthralgia and myalgia (joint and muscle pain), chills and fatigue. [11] [18]

Brands

Capvaxive

Capvaxive is a pneumococcal 21-valent conjugate vaccine (PVC21) manufactured by Merck and was approved for medical use in the United States in June 2024. [19] [20] It is indicated for the active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in individuals 18 years of age and older; and the active immunization for the prevention of pneumonia caused by S. pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F,23A, 23B, 24F, 31, 33F, and 35B in individuals 18 years of age and older. [19]

Pneumosil

Pneumosil is a decavalent pneumococcal conjugate vaccine produced by the Serum Institute of India. It contains the serotypes 1, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F, and 23F, and was prequalified by WHO in January 2020. [21] [22]

Prevnar

Prevnar vaccine Vacuna-prevenar.jpg
Prevnar vaccine

Prevnar 20 (PCV20) is the third version of a vaccine produced by the Wyeth subsidiary of Pfizer. In April 2023, the FDA approved Prevnar 20 for the prevention of invasive disease caused by the 20 different serotypes of S. pneumoniae contained in the vaccine (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F) for individuals 6 weeks through 17 years of age; and for the prevention of otitis media (ear infection) caused by 7 of the serotypes of Streptococcus pneumoniae contained in the vaccine for children 6 weeks through 5 years of age. [23] In June 2023, the Advisory Committee on Immunization Practices (ACIP) approved PCV20 (Prevnar 20) for use in US children. [24] [25]

The second version, Prevnar 13 (PCV13), contained thirteen serotypes of pneumococcus (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). [26] [7] It replaced Prevnar, the pneumococcal heptavalent conjugate vaccine (PCV7). [27] [28] Prevnar 13 was approved for use in the European Union in December 2009. [11] In February 2010, Prevnar 13 was approved in the United States to replace Prevnar. [27] [29] After waiting for the outcome of a trial underway in the Netherlands, the Centers for Disease Control and Prevention (CDC) recommended the vaccine for adults over age 65 in August 2014. [30]

The first version, the heptavalent Prevnar (PCV7), was produced from the seven most prevalent strains of Streptococcus pneumoniae bacteria in the U.S. (4, 6B, 9V, 14, 18C, 19F, and 23F). Prevnar was approved for use in the United States in February 2000, [31] [32] [33] and vaccination with Prevnar was recommended for all children younger than 2 years and for unvaccinated children between 24 and 59 months old who were at high risk for pneumococcal infections. The formulation resulted in a 98% probability of protection against the constituent strains, which caused 80% of the pneumococcal disease in infants in the U.S. PCV7 is no longer produced. [34]

In the Prevnar vaccines, the bacterial cell capsule sugars, a characteristic of these pathogens, are linked (conjugated) through reductive amination to CRM197, a nontoxic recombinant variant of diphtheria toxin. CRM197 is derived from the C7 strain of Corynebacterium diphtheriae grown in a medium of casamino acids and yeast extracts. [18] [35] Bacteria bearing the vaccine's polysaccharide sugars are grown separately in soy peptone broths. The resulting glycoconjugate [18] produces a more robust immune response in most healthy persons. Aluminum is also added to the vaccine as an adjuvant, further enhancing the immune response. [18]

Synflorix

Synflorix (PCV10) is produced by GlaxoSmithKline. It is a decavalent vaccine and thus 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 (EMA) for use in the European Union in January 2009, [36] and GSK received European Commission authorization to market Synflorix in March 2009. [37] [12]

Vaxneuvance

Vaxneuvance is a pneumococcal 15-valent conjugate vaccine created by Merck that was approved for medical use in the United States in July 2021. [9] [38] The vaccine was developed under the code name "V114". [39] It is identical to PCV13, except that it adds serotypes 22F and 33F. [40] These two serotypes are particularly important because, after "widespread use of the PCV13...[vaccine] in many countries," these two serotypes are now "among leading serotypes causing IPD in children and adults." [40]

Vaxneuvance is indicated for the active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in adults 18 years of age and older. [9] [38] [41]

On 14 October 2021, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Vaxneuvance, intended for prophylaxis against pneumococcal pneumonia and associated invasive disease. [42] The applicant for this medicinal product is Merck Sharp & Dohme B.V. [42] Vaxneuvance was approved for medical use in the European Union in December 2021. [13] [14]

Schedule of vaccination

As with all immunizations, whether it is available or required, and under what circumstances, varies according to the decisions made by local public health agencies.

Children under the age of two years fail to mount an adequate response to the 23-valent adult vaccine, and so a pneumococcal conjugate vaccine is used. While 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. [43]

United Kingdom

The UK childhood vaccination schedule for infants born after 31 December 2019, consists of a primary course of one dose at twelve weeks of age with a second dose at one year of age. [44] [45] For infants born before 1 January 2020 and those in Scotland, the childhood vaccination schedule consists of a primary course of two doses at eight and sixteen weeks of age with a final third dose at one year of age. [45]

Children at special risk (e.g., sickle cell disease and asplenia) require as full protection as can be achieved using the conjugated vaccine, with the more extensive polysaccharide vaccine given after the second year of life: [45]

Vaccination schedule for children at special risk [45]
Age2–6 months7–11 months12–23 months
Conjugated vaccine3 × monthly dose2 × monthly dose2 doses, 2 months apart
Further dose in second year of life
23-valent vaccineThen after 2nd birthday single dose of 23-valent

United States

In 2001, the Centers for Disease Control and Prevention (CDC), upon advice from its Advisory Committee on Immunization Practices (ACIP), recommended the vaccine be administered to every infant and young child in the United States. The resulting demand outstripped production, creating shortages not resolved until 2004. All children, according to the U.S. vaccination schedule, should receive four doses, at two months, four months, six months, and again between one year and fifteen months of age. [46] [47]

The CDC updated the pneumococcal vaccine guidelines for adults 65 years of age or older in 2019. [48]

In October 2021, the CDC recommended that adults 65 years of age or older who have not previously received a pneumococcal conjugate vaccine or whose previous vaccination history is unknown should receive a pneumococcal conjugate vaccine (either PCV20 or PCV15). [49] If PCV15 is used, this should be followed by a dose of PPSV23. [49] The CDC recommended that adults aged 19 to 64 years with certain underlying medical conditions or other risk factors who have not previously received a pneumococcal conjugate vaccine or whose previous vaccination history is unknown should receive a pneumococcal conjugate vaccine (either PCV20 or PCV15). [49]

The CDC published revised and consolidated guidelines in September 2023, for adults aged 19 years of age and older. [50]

Efficacy

United States incidence of invasive pneumococcal disease before and after introduction of the 7-valent and 13-valent pneumococcal vaccines. US incidence of invasive streptococcal disease before and after vaccine introduction.jpg
United States incidence of invasive pneumococcal disease before and after introduction of the 7-valent and 13-valent pneumococcal vaccines.

Prevnar-7 is designed to stop seven of about ninety pneumococcal serotypes which have the potential to cause invasive pneumococcal disease (IPD). In 2010, a 13-valent vaccine was introduced. Each year, IPD kills approximately one million children worldwide. [52] Since approval, Prevnar's efficacy in preventing IPD has been documented by a number of epidemiologic studies. [53] [54] [55] There is evidence that other people in the same household as a vaccinee also become relatively protected. [56] 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. [57]

The vaccine is, however, primarily developed for the U.S. and European epidemiological situation, and therefore it has a limited coverage of serotypes causing serious pneumococcal infections in most developing countries. [58]

Adverse reactions

Local reactions such as pain, swelling, or redness occur in up to 50% of those vaccinated with PCV13; of these, 8% are considered severe. Local reactions are more likely after the 4th dose than the earlier doses. [59] In clinical trials, fever greater than 100.4 F (38 C) was reported at a rate of 24–35% following any dose in the primary series and nonspecific symptoms such as decreased appetite or irritability occur in up to 80% of recipients. [59] In a vaccine safety datalink study, febrile seizures occurred in roughly 1 in 83,000 to 1 in 6,000 children given PCV 13, and 1 in 21,000 to 1 in 2,000 of those who were given PCV13 and trivalent influenza vaccine at the same time. [59]

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 of less than two years of age. [53] 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. [60] [61]

Rates of invasive pneumococcal disease among adults have also declined since the introduction of the vaccine. [53] [61]

Vaccination in low-income countries

Evolution of pneumococcal and rotavirus vaccine coverage from 2006 to 2022 in Gavi and non-Gavi countries. Gavi countries are the 54 Gavi 5.0 eligible countries. Coverage data are WHO/UNICEF estimates of the percentage of infants who have received three doses of Pneumococcal conjugate vaccine. Pneumococcal and rotavirus vaccine coverage (Gavi and non-Gavi countries).svg
Evolution of pneumococcal and rotavirus vaccine coverage from 2006 to 2022 in Gavi and non-Gavi countries. Gavi countries are the 54 Gavi 5.0 eligible countries. Coverage data are WHO/UNICEF estimates of the percentage of infants who have received three doses of Pneumococcal conjugate vaccine.

Pneumococcal disease is the leading vaccine-preventable killer of young children worldwide, according to the World Health Organization (WHO). It killed more than 500,000 children younger than five years of age in 2008 alone. [62] Approximately ninety percent of these deaths occur in the developing world. [62] Historically 15–20 years pass before a new vaccine reaches one quarter of the population of the developing world. [63]

Pneumococcal vaccines Accelerated Development and Introduction Plan (PneumoADIP) was 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. GAVI continues this work and as of March 2013, 25 GAVI-eligible and supported countries have introduced the pneumococcal conjugate vaccine. Further, 15 additional GAVI countries have plans to introduce the vaccine into their national immunization program and 23 additional countries have approved GAVI support to introduce the vaccine. [64]

Society and culture

On 16 December 2021, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Apexxnar, intended for prophylaxis against pneumococcal pneumonia and associated invasive disease. [65] The applicant for this medicinal product is Pfizer Europe MA EEIG. [65] Apexxnar was approved for medical use in the European Union in February 2022. [15] [66]

Economics

Prevnar 13 was Pfizer's best-selling product [67] with annual sales of US$5.85 billion in 2020. [67] [68]

Research

Merck is investigating a 21-valent vaccine (code named V116) against pneumococcus serotypes. [69] The vaccine is geared towards persons living with HIV. [69]

The vaccine is recommended for people with immune-mediated inflammatory diseases in the UK. [70] A UK database study found that compared with not having a pneumococcal vaccine, being vaccinated was associated with a 30% reduced risk of hospitalisation due to pneumonia and a 40% reduced risk of death from pneumonia. Another database study found that vaccination was not associated with disease flare ups among people with lupus, rheumatoid arthritis and spondylarthritis, which is a common reason for vaccine hesitancy in this group. [71] [72] [73]

Related Research Articles

<i>Streptococcus pneumoniae</i> Species of bacterium

Streptococcus pneumoniae, or pneumococcus, is a Gram-positive, spherical bacteria, alpha-hemolytic member of the genus Streptococcus. S. pneumoniae cells are usually found in pairs (diplococci) and do not form spores and are non motile. As a significant human pathogenic bacterium S. pneumoniae was recognized as a major cause of pneumonia in the late 19th century, and is the subject of many humoral immunity studies.

<span class="mw-page-title-main">DPT vaccine</span> Combination vaccine

The DPT vaccine or DTP vaccine is a class of combination vaccines to protect against three infectious diseases in humans: diphtheria, pertussis, and tetanus (lockjaw). The vaccine components include diphtheria and tetanus toxoids, and either killed whole cells of the bacterium that causes pertussis or pertussis antigens. The term toxoid refers to vaccines which use an inactivated toxin produced by the pathogen which they are targeted against to generate an immune response. In this way, the toxoid vaccine generates an immune response which is targeted against the toxin which is produced by the pathogen and causes disease, rather than a vaccine which is targeted against the pathogen itself. The whole cells or antigens will be depicted as either "DTwP" or "DTaP", where the lower-case "w" indicates whole-cell inactivated pertussis and the lower-case "a" stands for "acellular". In comparison to alternative vaccine types, such as live attenuated vaccines, the DTP vaccine does not contain any live pathogen, but rather uses inactivated toxoid to generate an immune response; therefore, there is not a risk of use in populations that are immune compromised since there is not any known risk of causing the disease itself. As a result, the DTP vaccine is considered a safe vaccine to use in anyone and it generates a much more targeted immune response specific for the pathogen of interest.

<span class="mw-page-title-main">Conjugate vaccine</span> Type of vaccine

A conjugate vaccine is a type of subunit vaccine which combines a weak antigen with a strong antigen as a carrier so that the immune system has a stronger response to the weak antigen.

<span class="mw-page-title-main">Pneumococcal polysaccharide vaccine</span> Pneumonia vaccine

Pneumococcal polysaccharide vaccine, sold under the brand name Pneumovax 23, is a pneumococcal vaccine that is used for the prevention of pneumococcal disease caused by the 23 serotypes of Streptococcus pneumoniae contained in the vaccine as capsular polysaccharides. It is given by intramuscular or subcutaneous injection.

<span class="mw-page-title-main">HPV vaccine</span> Class of vaccines against human papillomavirus

Human papillomavirus (HPV) vaccines are vaccines intended to provide acquired immunity against infection by certain types of human papillomavirus (HPV). The first HPV vaccine became available in 2006. Currently there are six licensed HPV vaccines: three bivalent, two quadrivalent, and one nonavalent vaccine All have excellent safety profiles and are highly efficacious, or have met immunobridging standards. All of them protect against HPV types 16 and 18, which are together responsible for approximately 70% of cervical cancer cases globally. The quadrivalent vaccines provide additional protection against HPV types 6 and 11. The nonavalent provides additional protection against HPV types 31, 33, 45, 52 and 58. It is estimated that HPV vaccines may prevent 70% of cervical cancer, 80% of anal cancer, 60% of vaginal cancer, 40% of vulvar cancer, and show more than 90% effectiveness in preventing HPV-positive oropharyngeal cancers. They also protect against penile cancer. They additionally prevent genital warts, with the quadrivalent and nonavalent vaccines providing virtually complete protection. The WHO recommends a one or two-dose schedule for girls aged 9–14 years, the same for girls and women aged 15–20 years, and two doses with a 6-month interval for women older than 21 years. The vaccines provide protection for at least five to ten years.

<span class="mw-page-title-main">Zoster vaccine</span> Vaccine to prevent shingles

A zoster vaccine is a vaccine that reduces the incidence of herpes zoster (shingles), a disease caused by reactivation of the varicella zoster virus, which is also responsible for chickenpox. Shingles provokes a painful rash with blisters, and can be followed by chronic pain, as well as other complications. Older people are more often affected, as are people with weakened immune systems (immunosuppression). Both shingles and postherpetic neuralgia can be prevented by vaccination.

<span class="mw-page-title-main">Pneumococcal vaccine</span> Vaccine to prevent infection by the bacteria Stretococcus pneumoniae

Pneumococcal vaccines are vaccines against the bacterium Streptococcus pneumoniae. Their use can prevent some cases of pneumonia, meningitis, and sepsis. There are two types of pneumococcal vaccines: conjugate vaccines and polysaccharide vaccines. They are given by injection either into a muscle or just under the skin.

<span class="mw-page-title-main">Hib vaccine</span> Haemophilus influenzae type B vaccine

The Haemophilus influenzae type B vaccine, also known as Hib vaccine, is a vaccine used to prevent Haemophilus influenzae type b (Hib) infection. In countries that include it as a routine vaccine, rates of severe Hib infections have decreased more than 90%. It has therefore resulted in a decrease in the rate of meningitis, pneumonia, and epiglottitis.

The rotavirus vaccine is a vaccine used to protect against rotavirus infections, which are the leading cause of severe diarrhea among young children. The vaccines prevent 15–34% of severe diarrhea in the developing world and 37–96% of the risk of death among young children due to severe diarrhea. Immunizing babies decreases rates of disease among older people and those who have not been immunized.

Pneumococcal infection is an infection caused by the bacterium Streptococcus pneumoniae.

Meningococcal vaccine refers to any vaccine used to prevent infection by Neisseria meningitidis. Different versions are effective against some or all of the following types of meningococcus: A, B, C, W-135, and Y. The vaccines are between 85 and 100% effective for at least two years. They result in a decrease in meningitis and sepsis among populations where they are widely used. They are given either by injection into a muscle or just under the skin.

<span class="mw-page-title-main">Katherine O'Brien</span> Canadian-born pediatric physician (born 1963)

Katherine "Kate" L. O'Brien is a Canadian American pediatric infectious disease physician, epidemiologist, and vaccinologist who specializes in the areas of pneumococcal epidemiology, pneumococcal vaccine trials and impact studies, and surveillance for pneumococcal disease. She is also known as an expert in infectious diseases in American Indian populations. O’Brien is currently the Director of the World Health Organization's Department of Immunization, Vaccines and Biologicals.

<span class="mw-page-title-main">GAVI</span> Global health organization

GAVI, officially Gavi, the Vaccine Alliance is a public–private global health partnership with the goal of increasing access to immunization in poor countries. In 2016, Gavi channeled more than half of total donor assistance for health, and most donor assistance for immunization, by monetary measure.

<span class="mw-page-title-main">George Siber</span> Medical researcher and vaccine expert

George Rainer Siber is a Canadian-American medical researcher and vaccinologist.

CRM197 is a non-toxic mutant of diphtheria toxin, currently used as a carrier protein for polysaccharides and haptens to make them immunogenic. There is some dispute about the toxicity of CRM197, with evidence that it is toxic to yeast cells and some mammalian cell lines.

A respiratory syncytial virus vaccine, or RSV vaccine, is a vaccine that protects against respiratory syncytial virus. RSV affects an estimated 64 million people and causes 160,000 deaths worldwide each year.

<span class="mw-page-title-main">Ruth Link-Gelles</span> American epidemiologist

Ruth Link-Gelles is an American epidemiologist. She works for the United States Centers for Disease Control and Prevention (CDC) and serves as a Commander in the United States Public Health Service Commissioned Corps.

Necrotizing pneumonia (NP), also known as cavitary pneumonia or cavitatory necrosis, is a rare but severe complication of lung parenchymal infection. In necrotizing pneumonia, there is a substantial liquefaction following death of the lung tissue, which may lead to gangrene formation in the lung. In most cases patients with NP have fever, cough and bad breath, and those with more indolent infections have weight loss. Often patients clinically present with acute respiratory failure. The most common pathogens responsible for NP are Streptococcus pneumoniae, Staphylococcus aureus, Klebsiella pneumoniae. Diagnosis is usually done by chest imaging, e.g. chest X-ray or CT scan. Among these, a CT scan is the most sensitive test, which shows loss of lung architecture and multiple small thin walled cavities. Often cultures from bronchoalveolar lavage and blood may be done for identification of the causative organism(s). It is primarily managed by supportive care along with appropriate antibiotics. However, if a patient develops severe complications like sepsis or fails to medical therapy, surgical resection is a reasonable option for saving life.

Live recombinant vaccines are biological preparations that stimulate immune responses to a pathogen through the use of genetically modified live bacteria or viruses. These live pathogens are biologically engineered to express exogenous antigens in the cytoplasm of target cells, thereby triggering immune responses. This form of vaccine combines the beneficial features of attenuated and recombinant vaccines, providing the long-lasting immunity of attenuated vaccines’ with recombinant vaccines’ genetically engineered precision and safety.

Trudy Virginia Noller Murphy is an American pediatric infectious diseases physician, public health epidemiologist and vaccinologist. During the 1980s and 1990s, she conducted research at Southwestern Medical School in Dallas, Texas on three bacterial pathogens: Haemophilus influenzae type b (Hib), Streptococcus pneumoniae (pneumococcus), and methicillin-resistant Staphylococcus aureus (MRSA). Murphy's studies advanced understanding of how these organisms spread within communities, particularly among children attending day care centers. Her seminal work on Hib vaccines elucidated the effects of introduction of new Hib vaccines on both bacterial carriage and control of invasive Hib disease. Murphy subsequently joined the National Immunization Program at the Centers for Disease Control and Prevention (CDC) where she led multi-disciplinary teams in the Divisions of Epidemiology and Surveillance and The Viral Hepatitis Division. Among her most influential work at CDC was on Rotashield™, which was a newly licensed vaccine designed to prevent severe diarrheal disease caused by rotavirus. Murphy and her colleagues uncovered that the vaccine increased the risk of acute bowel obstruction (intussusception). This finding prompted suspension of the national recommendation to vaccinate children with Rotashield, and led the manufacturer to withdraw the vaccine from the market. For this work Murphy received the United States Department of Health and Human Services Secretary's Award for Distinguished Service in 2000, and the publication describing this work was recognized in 2002 by the Charles C. Shepard Science Award from the Centers for Disease Control and Prevention.

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