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Pneumococcal conjugate vaccine

October 21, 2023

Pneumococcal conjugate vaccine is a pneumococcal vaccine and a conjugate vaccine 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]

Pneumococcal conjugate vaccine
Prevenar 13
Vaccine description
TargetStreptococcus pneumoniae
Vaccine typeConjugate
Clinical data
Trade namesPrevnar 20, Prevnar 13, Synflorix, others; discontinued Prevnar (PCV7)
Other namesPCV, pneumococcal vaccine, capsular polysaccharides[1]
AHFS/Drugs.comMonograph
MedlinePlusa607021
License data
Pregnancy
category
Routes of
administration		Intramuscular
ATC code
Legal status
Legal status
Identifiers
ChemSpider
  • none
KEGG
  • D10455
  • D12205

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 Edit

Pneumosil Edit

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.[19][20]

Prevnar Edit

 
Prevnar vaccine

Prevnar 13 (PCV13) is produced by the Wyeth subsidiary of Pfizer and it replaces Prevnar (PCV7), the pneumococcal 7-valent conjugate vaccine (PCV7).[21][22] It is a tridecavalent vaccine because it contains thirteen serotypes of pneumococcus (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F).[23][8] 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 (PCV7), the pneumococcal 7-valent conjugate vaccine (PCV7).[21][24] 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.[25]

Prevnar (PCV7) is a heptavalent vaccine, meaning that it contains the cell capsule sugars of seven serotypes of the bacteria S. pneumoniae (4, 6B, 9V, 14, 18C, 19F, and 23F) conjugated with diphtheria proteins.[26] It was manufactured by Wyeth.[27][28] Prevnar (PCV7) was approved for use in the United States in February 2000,[27][29][30] and vaccination with Prevnar was recommended for all children younger than two years and for unvaccinated children between 24 and 59 months old who were at high risk for pneumococcal infections.[31]

Prevnar (PCV7) was produced from the seven most prevalent strains of Streptococcus pneumoniae bacteria in the U.S. The bacterial capsule sugars, a characteristic of these pathogens, are linked (conjugated) to CRM197, a nontoxic recombinant variant of diphtheria toxin (from cultures of Corynebacterium diphtheriae).[18] This produces a more robust immune response (in most healthy persons). Further, aluminum is also added to the vaccine serum because it is an adjuvant, meaning it further enhances the immune response.[18]

The vaccine's polysaccharide sugars are grown separately in soy peptone broths.[18] Through reductive amination, the sugars are directly conjugated to the protein carrier CRM197 to form the glycoconjugate.[18] CRM197 is grown in C. diphtheriae strain C7 in a medium of casamino acids and yeast extracts.[32][18]

The Prevnar (PCV7) seven-valent formulation (PCV7) contains serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F, and resulted in a 98% probability of protection against these strains, which caused 80% of the pneumococcal disease in infants in the U.S. PCV7 is no longer produced.[33]

Prevnar 13 (PCV13) was approved for medical use in the US in 2010.[34] PCV13 contains six additional strains (1, 3, 5, 6A, 19A and 7F).[35]

In June 2021, the U.S. Food and Drug Administration (FDA) approved the pneumococcal 20-valent conjugate vaccine, sold under the brand name Prevnar 20 (PCV20), for adults 18 years of age and older.[36][9] It is an icosavalent pneumococcal conjugate vaccine, which includes the serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F.[36][9] In February 2022, the European Medicines Agency approved PCV20 under the brand name Apexxnar.[15][37]

In April 2023, the FDA approved Prevnar 20 for the prevention of invasive disease caused by the 20 different serotypes of Streptococcus pneumoniae contained in the vaccine 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.[38]

Synflorix Edit

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,[39] and GSK received European Commission authorization to market Synflorix in March 2009.[40][12]

Vaxneuvance Edit

Vaxneuvance is a pneumococcal 15-valent conjugate vaccine created by Merck that was approved for medical use in the United States in July 2021.[10][41] The vaccine was developed under the code name "V114".[42] It is identical to PCV13, except that it adds serotypes 22F and 33F.[43] 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."[43]

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.[10][41][44]

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.[45] The applicant for this medicinal product is Merck Sharp & Dohme B.V.[45] Vaxneuvance was approved for medical use in the European Union in December 2021.[13][14]

Schedule of vaccination Edit

Further information: Vaccination schedule

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.[46]

United Kingdom Edit

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.[47][48] 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.[48]

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:[48]

Vaccination schedule for children at special risk[48]
Age 2–6 months 7–11 months 12–23 months
Conjugated vaccine 3 × monthly dose 2 × monthly dose 2 doses, 2 months apart
Further dose in second year of life
23-valent vaccine Then after 2nd birthday single dose of 23-valent

United States Edit

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.[49][50]

The CDC updated the pneumococcal vaccine guidelines for adults 65 years of age or older in 2019.[51]

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).[52] If PCV15 is used, this should be followed by a dose of PPSV23.[52] 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).[52]

Efficacy Edit

 
United States incidence of invasive pneumococcal disease before and after introduction of the 7-valent and 13-valent pneumococcal vaccines.[53]

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.[54] Since approval, Prevnar's efficacy in preventing IPD has been documented by a number of epidemiologic studies.[55][56][57] There is evidence that other people in the same household as a vaccinee also become relatively protected.[58] 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.[59]

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.[60]

Adverse reactions Edit

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.[61] 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.[61] 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.[61]

Evidence supporting addition to routine vaccination schedules Edit

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.[55] 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.[62][63]

Rates of invasive pneumococcal disease among adults have also declined since the introduction of the vaccine.[55][63]

Vaccination in low-income countries Edit

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.[64] Approximately ninety percent of these deaths occur in the developing world.[64] Historically 15–20 years pass before a new vaccine reaches one quarter of the population of the developing world.[65]

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.[66]

Society and culture Edit

Legal status Edit

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.[67] The applicant for this medicinal product is Pfizer Europe MA EEIG.[67] Apexxnar was approved for medical use in the European Union in February 2022.[15][68]

Economics Edit

Prevnar 13 is Pfizer's best-selling product.[69] It had annual sales of US$5.85 billion in 2020.[69][70]

Research Edit

Merck is investigating a 21-valent vaccine (code named V116) against pneumococcus serotypes.[71] The vaccine is geared towards persons living with HIV.[71]

References Edit

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Further reading Edit

  • Centers for Disease Control and Prevention (2015). "Chapter 17: Pneumococcal Disease". In Hamborsky J, Kroger A, Wolfe S (eds.). Epidemiology and Prevention of Vaccine-Preventable Diseases (13th ed.). Washington, D.C.: Public Health Foundation.

External links Edit

October 21, 2023
pneumococcal, conjugate, vaccine, pneumococcal, vaccine, conjugate, vaccine, used, protect, infants, young, children, adults, against, disease, caused, bacterium, streptococcus, pneumoniae, pneumococcus, contains, purified, capsular, polysaccharide, pneumococc. Pneumococcal conjugate vaccine is a pneumococcal vaccine and a conjugate vaccine 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 Pneumococcal conjugate vaccinePrevenar 13Vaccine descriptionTargetStreptococcus pneumoniaeVaccine typeConjugateClinical dataTrade namesPrevnar 20 Prevnar 13 Synflorix others discontinued Prevnar PCV7 Other namesPCV pneumococcal vaccine capsular polysaccharides 1 AHFS Drugs comMonographMedlinePlusa607021License dataUS DailyMed PneumococcalPregnancycategoryAU B1 2 3 4 Routes ofadministrationIntramuscularATC codeJ07AL02 WHO Legal statusLegal statusAU S4 Prescription only 2 4 5 CA only Schedule D 6 7 US only 8 9 10 EU Rx only 11 12 13 14 15 In general Prescription only IdentifiersChemSpidernoneKEGGD10455D12205Vaccine 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 Contents 1 Brands 1 1 Pneumosil 1 2 Prevnar 1 3 Synflorix 1 4 Vaxneuvance 2 Schedule of vaccination 2 1 United Kingdom 2 2 United States 3 Efficacy 4 Adverse reactions 5 Evidence supporting addition to routine vaccination schedules 6 Vaccination in low income countries 7 Society and culture 7 1 Legal status 7 2 Economics 8 Research 9 References 10 Further reading 11 External linksBrands EditPneumosil Edit 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 19 20 Prevnar Edit nbsp Prevnar vaccinePrevnar 13 PCV13 is produced by the Wyeth subsidiary of Pfizer and it replaces Prevnar PCV7 the pneumococcal 7 valent conjugate vaccine PCV7 21 22 It is a tridecavalent vaccine because it contains thirteen serotypes of pneumococcus 1 3 4 5 6A 6B 7F 9V 14 18C 19A 19F and 23F 23 8 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 PCV7 the pneumococcal 7 valent conjugate vaccine PCV7 21 24 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 25 Prevnar PCV7 is a heptavalent vaccine meaning that it contains the cell capsule sugars of seven serotypes of the bacteria S pneumoniae 4 6B 9V 14 18C 19F and 23F conjugated with diphtheria proteins 26 It was manufactured by Wyeth 27 28 Prevnar PCV7 was approved for use in the United States in February 2000 27 29 30 and vaccination with Prevnar was recommended for all children younger than two years and for unvaccinated children between 24 and 59 months old who were at high risk for pneumococcal infections 31 Prevnar PCV7 was produced from the seven most prevalent strains of Streptococcus pneumoniae bacteria in the U S The bacterial capsule sugars a characteristic of these pathogens are linked conjugated to CRM197 a nontoxic recombinant variant of diphtheria toxin from cultures of Corynebacterium diphtheriae 18 This produces a more robust immune response in most healthy persons Further aluminum is also added to the vaccine serum because it is an adjuvant meaning it further enhances the immune response 18 The vaccine s polysaccharide sugars are grown separately in soy peptone broths 18 Through reductive amination the sugars are directly conjugated to the protein carrier CRM197 to form the glycoconjugate 18 CRM197 is grown in C diphtheriae strain C7 in a medium of casamino acids and yeast extracts 32 18 The Prevnar PCV7 seven valent formulation PCV7 contains serotypes 4 6B 9V 14 18C 19F and 23F and resulted in a 98 probability of protection against these strains which caused 80 of the pneumococcal disease in infants in the U S PCV7 is no longer produced 33 Prevnar 13 PCV13 was approved for medical use in the US in 2010 34 PCV13 contains six additional strains 1 3 5 6A 19A and 7F 35 In June 2021 the U S Food and Drug Administration FDA approved the pneumococcal 20 valent conjugate vaccine sold under the brand name Prevnar 20 PCV20 for adults 18 years of age and older 36 9 It is an icosavalent pneumococcal conjugate vaccine which includes the serotypes 1 3 4 5 6A 6B 7F 8 9V 10A 11A 12F 14 15B 18C 19A 19F 22F 23F and 33F 36 9 In February 2022 the European Medicines Agency approved PCV20 under the brand name Apexxnar 15 37 In April 2023 the FDA approved Prevnar 20 for the prevention of invasive disease caused by the 20 different serotypes of Streptococcus pneumoniae contained in the vaccine 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 38 Synflorix Edit 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 39 and GSK received European Commission authorization to market Synflorix in March 2009 40 12 Vaxneuvance Edit Vaxneuvance is a pneumococcal 15 valent conjugate vaccine created by Merck that was approved for medical use in the United States in July 2021 10 41 The vaccine was developed under the code name V114 42 It is identical to PCV13 except that it adds serotypes 22F and 33F 43 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 43 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 10 41 44 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 45 The applicant for this medicinal product is Merck Sharp amp Dohme B V 45 Vaxneuvance was approved for medical use in the European Union in December 2021 13 14 Schedule of vaccination EditFurther information Vaccination schedule 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 46 United Kingdom Edit 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 47 48 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 48 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 48 Vaccination schedule for children at special risk 48 Age 2 6 months 7 11 months 12 23 monthsConjugated vaccine 3 monthly dose 2 monthly dose 2 doses 2 months apartFurther dose in second year of life23 valent vaccine Then after 2nd birthday single dose of 23 valentUnited States Edit 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 49 50 The CDC updated the pneumococcal vaccine guidelines for adults 65 years of age or older in 2019 51 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 52 If PCV15 is used this should be followed by a dose of PPSV23 52 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 52 Efficacy Edit nbsp United States incidence of invasive pneumococcal disease before and after introduction of the 7 valent and 13 valent pneumococcal vaccines 53 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 54 Since approval Prevnar s efficacy in preventing IPD has been documented by a number of epidemiologic studies 55 56 57 There is evidence that other people in the same household as a vaccinee also become relatively protected 58 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 59 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 60 Adverse reactions EditLocal 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 61 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 61 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 61 Evidence supporting addition to routine vaccination schedules EditAfter 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 55 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 62 63 Rates of invasive pneumococcal disease among adults have also declined since the introduction of the vaccine 55 63 Vaccination in low income countries EditPneumococcal 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 64 Approximately ninety percent of these deaths occur in the developing world 64 Historically 15 20 years pass before a new vaccine reaches one quarter of the population of the developing world 65 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 66 Society and culture EditLegal status Edit 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 67 The applicant for this medicinal product is Pfizer Europe MA EEIG 67 Apexxnar was approved for medical use in the European Union in February 2022 15 68 Economics Edit Prevnar 13 is Pfizer s best selling product 69 It had annual sales of US 5 85 billion in 2020 69 70 Research EditMerck is investigating a 21 valent vaccine code named V116 against pneumococcus serotypes 71 The vaccine is geared towards persons living with HIV 71 References Edit Updates to the Prescribing Medicines in Pregnancy database Therapeutic Goods Administration TGA 21 December 2022 Archived from the original on 3 April 2022 Retrieved 2 January 2023 a b Vaxneuvance APMDS Therapeutic Goods Administration TGA 24 January 2022 Archived from the original on 5 February 2022 Retrieved 5 February 2022 Updates to the Prescribing Medicines in Pregnancy database Therapeutic Goods Administration TGA 21 December 2022 Archived from the original on 3 April 2022 Retrieved 2 January 2023 a b https www tga gov au resources auspmd prevenar 20 Archived 5 January 2023 at the Wayback Machine bare URL Prevenar 20 Pfizer Australia Pty Ltd Therapeutic Goods Administration TGA 13 January 2023 Archived from the original on 27 March 2023 Retrieved 9 April 2023 Summary Basis of Decision SBD for Vaxneuvance Health Canada 25 February 2022 Archived from the original on 29 May 2022 Retrieved 29 May 2022 Summary Basis of Decision Prevnar 20 Health Canada 31 August 2022 Archived from the original on 29 September 2022 Retrieved 22 September 2022 a b Prevnar 13 pneumococcal 13 valent conjugate vaccine injection suspension DailyMed Archived from the original on 21 August 2021 Retrieved 20 August 2021 a b c Prevnar 20 pneumococcal 20 valent conjugate vaccine injection suspension DailyMed Archived from the original on 21 August 2021 Retrieved 20 August 2021 a b c Vaxneuvance pneumococcal 15 valent conjugate vaccine crm197 protein adsorbed injection suspension DailyMed Archived from the original on 21 August 2021 Retrieved 20 August 2021 a b c d Prevenar 13 EPAR European Medicines Agency EMA 26 March 2020 Archived from the original on 26 February 2021 Retrieved 26 March 2020 Text was copied from this source which is c European Medicines Agency Reproduction is authorized provided the source is acknowledged a b Synflorix EPAR European Medicines Agency EMA 17 September 2018 Archived from the original on 8 January 2021 Retrieved 13 July 2020 a b Vaxneuvance EPAR European Medicines Agency EMA 12 October 2021 Archived from the original on 18 January 2022 Retrieved 17 January 2022 Text was copied from this source which is c European Medicines Agency Reproduction is authorized provided the source is acknowledged a b Vaxneuvance Union Register of medicinal products Archived from the original on 11 January 2022 Retrieved 11 January 2022 a b c Apexxnar EPAR European Medicines Agency EMA 14 December 2021 Archived from the original on 3 March 2022 Retrieved 2 March 2022 World Health Organization 2019 Pneumococcal conjugate vaccines in infants and children under 5 years of age WHO position paper February 2019 Wkly Epidemiol Rec 94 8 85 104 hdl 10665 310970 Summary of WHO Position Paper on Pneumococcal conjugate vaccines in infants and children under 5 years of age February 2019 PDF who int 21 April 2019 Archived from the original PDF on 8 March 2022 a b c d e f g h PREVNAR 20 pneumococcal 20 valent conjugate vaccine injection suspension Wyeth Pharmaceutical Division of Wyeth Holdings LLC Philadelphia PA 19101 US Wyeth Pharmaceuticals LLC A subsidiary of Pfizer Inc June 2021 p 11 Archived from the original on 5 September 2022 Retrieved 9 August 2022 a href Template Cite web html title Template Cite web cite web a CS1 maint date and year link CS1 maint location link Gavi supported pneumococcal conjugate vaccines profiles to support country decision making PDF GAVI 2019 Archived PDF from the original on 19 May 2020 Retrieved 8 April 2020 Pneumosil the new pneumococcal vaccine achieves WHO prequalification a key step toward improving access and affordability Press release Serum Institute of India PR Newswire 28 January 2020 Archived from the original on 17 April 2021 Retrieved 8 April 2020 a b FDA Approves Pneumococcal Disease Vaccine with Broader Protection Press release 24 February 2010 Archived from the original on 11 September 2010 Retrieved 9 September 2010 nbsp This article incorporates text from this source which is in the public domain Pfizer And Wyeth Become One Working Together For A Healthier World Pfizer Press release 15 October 2009 Archived from the original on 15 December 2022 Retrieved 15 December 2022 Prevnar 13 U S Food and Drug Administration FDA 1 March 2018 STN 125324 Archived from the original on 27 November 2019 Retrieved 27 September 2019 nbsp This article incorporates text from this source which is in the public domain Prevnar 13 U S Food and Drug Administration FDA 12 March 2010 Archived from the original on 12 March 2010 Retrieved 27 November 2019 a href Template Cite web html title Template Cite web cite web a CS1 maint unfit URL link nbsp This article incorporates text from this source which is in the public domain Advisory Committee on Immunization Practices Votes to Recommend Pfizer s Prevnar 13 Vaccine in Adults Aged 65 Years and Older MarketWatch com 13 August 2014 Archived from the original on 4 March 2016 Retrieved 27 April 2017 Prevnar U S Food and Drug Administration FDA 25 May 2022 Archived from the original on 1 September 2022 Retrieved 22 September 2022 a b Prevnar U S Food and Drug Administration FDA 24 August 2009 Archived from the original on 22 July 2017 Retrieved 29 September 2022 Pneumococcal 7 valent Conjugate Vaccine Diphtheria CRM197 Protein Wyeth 2006 Archived from the original on 15 June 2006 February 17 2000 Approval Letter U S Food and Drug Administration FDA Archived from the original on 10 July 2009 nbsp This article incorporates text from this source which is in the public domain Pneumococcal Vaccination What Everyone Should Know U S Centers for Disease Control and Prevention CDC 24 January 2022 Archived from the original on 12 November 2019 Retrieved 15 December 2022 nbsp This article incorporates text from this source which is in the public domain American Academy of Pediatrics Committee on Infectious Diseases Policy statement recommendations for the prevention of pneumococcal infections including the use of pneumococcal conjugate vaccine Prevnar pneumococcal polysaccharide vaccine and antibiotic prophylaxis Pediatrics 106 2 Pt 1 362 366 August 2000 doi 10 1542 peds 106 2 362 PMID 10920169 Prevnar Pneumococcal 7 valent Conjugate drug description prescription drugs and medications at RxList Archived from the original on 11 December 2007 Retrieved 21 November 2007 WHO SAGE evidence to recommendations table PDF Archived PDF from the original on 9 May 2021 Retrieved 6 April 2020 Prevnar 13 U S Food and Drug Administration FDA 24 February 2010 Archived from the original on 22 July 2017 Retrieved 15 December 2022 Centers for Disease Control Prevention CDC March 2010 Licensure of a 13 valent pneumococcal conjugate vaccine PCV13 and recommendations for use among children Advisory Committee on Immunization Practices ACIP 2010 PDF MMWR Morbidity and Mortality Weekly Report 59 9 258 261 PMID 20224542 Archived PDF from the original on 18 June 2022 Retrieved 29 September 2022 a b Prevnar 20 U S Food and Drug Administration FDA 10 June 2021 Archived from the original on 10 June 2021 Retrieved 20 June 2021 nbsp This article incorporates text from this source which is in the public domain European Medicines Agency Approves Pfizer s 20 Valent Pneumococcal Conjugate Vaccine Against Invasive Pneumococcal Disease and Pneumonia in Adults EU Apexxnar U S Prevnar 20 Pfizer Press release 15 February 2022 Archived from the original on 7 June 2022 Retrieved 9 June 2022 FDA Roundup April 28 2023 U S Food and Drug Administration 28 April 2023 Archived from the original on 29 April 2023 Retrieved 29 April 2023 nbsp This article incorporates text from this source which is in the public domain EMEA Document PDF Emea europa eu Archived from the original PDF on 19 February 2009 Retrieved 27 April 2017 GSK Release Gsk com Press release Archived from the original on 4 August 2009 Retrieved 27 April 2017 a b Vaxneuvance U S Food and Drug Administration FDA 30 July 2021 Archived from the original on 21 August 2021 Retrieved 20 August 2021 nbsp This article incorporates text from this source which is in the public domain GRADE 15 valent pneumococcal conjugate vaccine PCV15 in series with 23 valent pneumococcal conjugate vaccine PPSV23 for adults aged 65 years CDC www cdc gov 27 January 2022 Archived from the original on 9 August 2022 Retrieved 9 August 2022 a b Stacey HL Rosen J Peterson JT Williams Diaz A Gakhar V Sterling TM et al 2019 Safety and immunogenicity of 15 valent pneumococcal conjugate vaccine PCV 15 compared to PCV 13 in healthy older adults Human Vaccines amp Immunotherapeutics 15 3 530 539 doi 10 1080 21645515 2018 1532249 PMC 6605726 PMID 30648919 Merck Announces U S FDA Approval of Vaxneuvance Pneumococcal 15 valent Conjugate Vaccine for the Prevention of Invasive Pneumococcal Disease in individuals 6 weeks of age and older Caused by 15 Serotypes Press release Merck 16 July 2021 Archived from the original on 21 August 2021 Retrieved 20 August 2021 via Business Wire a b Vaxneuvance Pending EC decision European Medicines Agency EMA 13 October 2021 Archived from the original on 18 October 2021 Retrieved 15 October 2021 Text was copied from this source which is c European Medicines Agency Reproduction is authorized provided the source is acknowledged Childhood Pneumococcal Disease 21 March 2006 Archived from the original on 25 October 2006 information on the disease and the Prevnar vaccine from the Victoria State Australia government Includes possible side effects NHS vaccinations and when to have them 31 July 2019 Archived from 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pneumococcal colonization among unvaccinated household members Clinical Infectious Diseases 47 8 989 996 doi 10 1086 591966 PMID 18781875 Siemieniuk RA Gregson DB Gill MJ November 2011 The persisting burden of invasive pneumococcal disease in HIV patients an observational cohort study BMC Infectious Diseases 11 314 doi 10 1186 1471 2334 11 314 PMC 3226630 PMID 22078162 Barocchi MA Censini S Rappuoli R April 2007 Vaccines in the era of genomics the pneumococcal challenge Vaccine 25 16 2963 2973 doi 10 1016 j vaccine 2007 01 065 PMID 17324490 a b c Gierke R Wodi P Kobayashi M Hall E Hamborsky J Pinkbook Pneumococcal Epidemiology of Vaccine Preventable Diseases U S Centers for Disease Control and Prevention CDC Archived from the original on 1 September 2022 Retrieved 10 December 2017 Grijalva CG Nuorti JP Arbogast PG Martin SW Edwards KM Griffin MR April 2007 Decline in pneumonia admissions after routine childhood immunisation with pneumococcal conjugate vaccine in the USA a time series analysis Lancet 369 9568 1179 1186 doi 10 1016 S0140 6736 07 60564 9 PMID 17416262 S2CID 26494828 a b Tsai CJ Griffin MR Nuorti JP Grijalva CG June 2008 Changing epidemiology of pneumococcal meningitis after the introduction of pneumococcal conjugate vaccine in the United States Clinical Infectious Diseases 46 11 1664 1672 doi 10 1086 587897 PMC 4822508 PMID 18433334 a b O Brien KL Wolfson LJ Watt JP Henkle E Deloria Knoll M McCall N et al September 2009 Burden of disease caused by Streptococcus pneumoniae in children younger than 5 years global estimates Lancet 374 9693 893 902 doi 10 1016 S0140 6736 09 61204 6 PMID 19748398 S2CID 18964449 PneumoADIP Need for PneumoADIP Pneumoasdip com Archived from the original on 27 August 2021 Retrieved 27 April 2017 Johns Hopkins Bloomberg School of Public Health International Vaccine Access Center 2013 VIMS Report Global vaccine introduction PDF Jhsph edu Archived PDF from the original on 3 March 2016 Retrieved 27 April 2017 a b Apexxnar Pending EC decision European Medicines Agency EMA 15 December 2021 Archived from the original on 17 December 2021 Retrieved 18 December 2021 Text was copied from this source which is copyright European Medicines Agency Reproduction is authorized provided the source is acknowledged Apexxnar Product information Union Register of medicinal products Archived from the original on 4 March 2023 Retrieved 3 March 2023 a b Pfizer Inc 2020 Form 10 K Annual Report PDF Pfizer Archived PDF from the original on 23 March 2021 Retrieved 21 August 2021 Herper M 24 August 2020 In the race for a Covid 19 vaccine Pfizer turns to a scientist with a history of defying skeptics and getting results Stat News Archived from the original on 21 December 2020 Retrieved 2 December 2020 a b Safety and Immunogenicity of V116 in Adults Living With Human Immunodeficiency Virus HIV V116 007 STRIDE 7 ClinicalTrials gov 26 May 2022 Archived from the original on 9 August 2022 Retrieved 29 September 2022 Further reading EditCenters for Disease Control and Prevention 2015 Chapter 17 Pneumococcal Disease In Hamborsky J Kroger A Wolfe S eds Epidemiology and Prevention of Vaccine Preventable Diseases 13th ed Washington D C Public Health Foundation External links Edit Pneumococcal Conjugate Vaccine Information Statement U S Centers for Disease Control and Prevention CDC February 2022 Portals nbsp Medicine nbsp Viruses Retrieved from https en wikipedia org w index php title Pneumococcal conjugate vaccine amp oldid 1178617619, wikipedia, wiki, book, books, library,

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