Pneumococcal vaccine

Last updated

Pneumococcal vaccine
Pneumovax.jpg
23-valent pneumococcal polysaccharide vaccine by MSD as it is marketed in Japan.
Vaccine description
Target Streptococcus pneumoniae
Vaccine type Conjugate
Clinical data
AHFS/Drugs.com Monograph
ATC code
Legal status
Legal status
  • US: ℞-only
  • In general: ℞ (Prescription only)
Identifiers
ChemSpider
  • none

Pneumococcal vaccines are vaccines against the bacterium Streptococcus pneumoniae . [1] Their use can prevent some cases of pneumonia, meningitis, and sepsis. [1] There are two types of pneumococcal vaccines: conjugate vaccines and polysaccharide vaccines. [1] They are given by injection either into a muscle or just under the skin. [1]

Contents

The World Health Organization (WHO) recommends the use of the conjugate vaccine in the routine immunizations given to children. [1] This includes those with HIV/AIDS. [1] The recommended three or four doses are between 71 and 93% effective at preventing severe pneumococcal disease. [1] The polysaccharide vaccines, while effective in healthy adults, are not effective in children less than two years old or those with poor immune function. [1]

These vaccines are generally safe. [1] With the conjugate vaccine about 10% of babies develop redness at the site of injection, fever, or change in sleep. [1] Severe allergies are very rare. [1]

Whole cell vaccinations were developed alongside characterisation of the subtypes of pneumococcus from the early 1900s. [2]

The first pneumococcal vaccine was developed in the 1980s. [1] It is on the World Health Organization's List of Essential Medicines. [3]

Recommendations

13-valent pneumococcal conjugate vaccine (Prevnar 13) produced by Pfizer Japan in 2013. Prevenar13 Suspension Liquid for Injection.jpg
13-valent pneumococcal conjugate vaccine (Prevnar 13) produced by Pfizer Japan in 2013.

Worldwide

Pneumococcal vaccines Accelerated Development and Introduction Plan (PneumoADIP) is a program to accelerate the evaluation and access to new pneumococcal vaccines in the developing world. PneumoADIP is funded by the Global Alliance for Vaccines and Immunization (GAVI). Thirty GAVI countries have expressed interest in participating by 2010. PneumoADIP aims to save 5.4 million children by 2030. [4]

A pilot Advance Market Commitment (AMC) to develop a vaccine against pneumococcus was launched by GAVI in June 2009 as a strategy to address two of the major policy challenges to vaccine introduction: a lack of affordable vaccines on the market, and insufficient commercial incentives to develop vaccines for diseases concentrated in developing countries. Under the terms of an AMC, donors make a legally binding guarantee that, if a future vaccine is developed against a particular disease, they will purchase a predetermined amount at an agreed-upon price. The guarantee is linked to safety and efficacy standards that the vaccine must meet and is structured in a way to allow several firms to compete to develop and produce the best possible new product. AMCs reduce risk to donor governments by eliminating the need to fund individual research and development projects that may never produce a vaccine. If no company produces a vaccine that meets the predetermined standards, governments (and thus their taxpayers) spend nothing. For the bio-pharmaceutical industry, AMCs create a guaranteed market, with a promise of returns that would not normally exist. For developing countries, AMCs provide funding to ensure that those vaccines will be affordable once they have been developed. It is estimated that the pneumococcal AMC could prevent more than 1.5 million childhood deaths by 2020. [5] [ third-party source needed ]

Doctors Without Borders has criticized GAVI's pneumococcal AMC for not encouraging innovation, discouraging competition from new market entrants, and raising vaccine costs. They said that it had allowed Pfizer and GlaxoSmithKline to maintain a duopoly, while making it more difficult for the Serum Institute of India to sell their cheaper vaccine. The duopoly allowed price discrimination; somewhat higher prices for GAVI, and unaffordable prices (about ten time the GAVI price) for middle-income countries too rich for GAVI aid. [6] The pneumococcal program (unlike previous market-shaping programs from GAVI [7] [ third-party source needed ]) did not include any mechanism for increasing competition. [8]

The Humanitarian Mechanism makes the pneumococcal vaccine available to humanitarian actors (but not governments) at a lower than normal price during humanitarian emergencies. [9]

Belgium

The national vaccination program started vaccinating newborns in 2004 with the 7-valent pneumococcal conjugate vaccine (PCV 7). This was changed into the 13-valent conjugate (PCV 13) in 2011. The switch to the 10-valent conjugate (PCV 10) was made in July 2015 in Flanders and May 2016 in Wallonia. [10] In late 2020 a start was made with the vaccination of care home residents with the 23-valant pneumococcal polysaccharide vaccine (PPV 23). [11]

Canada

Health Canada's general recommendations are 13-valent pneumococcal conjugate vaccine (PCV 13) vaccine for children aged 2 months to 18 years and 23-valent pneumococcal polysaccharide vaccine (PPV 23) vaccine for adults. [12]

India

In May 2017, the Government of India decided to include pneumococcal conjugate vaccine in its Universal Immunization Programme. [13]

The Netherlands

The national vaccination program started including the pneumococcal vaccine for newborns in April 2006. [14]

The Health Council advised in 2018 that those who are over the age of 60 should also be vaccinated on a 5-year recurring schedule. The resulting program from this, NPPV, started at the end of 2020. [15]

Health authorities reported in December 2020 that former COVID-19 patients also have an indication for this vaccine because of the damage their lungs incurred. Vaccinating this group is not part of the NPPV program. [16]

South Africa

The 7- and 13-valent pneumococcal conjugate vaccines (PCV7 and PCV13) were introduced into the national Expanded Program on Immunization (EPI) in South Africa in 2009 and 2011, respectively. South Africa became the first African country – and the first nation in the world with a high HIV prevalence – to introduce PCV7 into its routine immunization program. [17] Rates of invasive pneumococcal disease (IPD) – including cases caused by antibiotic-resistant bacteria – have fallen substantially in South Africa following the introduction of PCV7. Among children under two years of age, the overall incidence of IPD declined nearly 70% after PCV introduction, and rates of IPD caused by bacteria specifically targeted by the vaccine decreased nearly 90%. [18] Due to the indirect protection conferred by herd immunity, a significant decline in IPD in children and in unvaccinated adults has also been shown. [18]

Pneumovax 23 is used for all ages and, according to the enclosed patient information leaflet, has a reported 76% to 92% protective efficacy (pneumococcal types 1, 2, 3, 4, 5, 6B**, 7F, 8, 9N, 9V**, 10A, 11A, 12F, 14**, 15B, 17F, 18C, 19A**, 19F**, 20, 22F, 23F** and 33F** are included, where ** indicates drug-resistant pneumococcal infections; these are the 23 most prevalent or invasive pneumococcal types of Streptococcus pneumoniae).[ medical citation needed ]

United Kingdom

It was announced in February 2006, that the UK government would introduce vaccination with the conjugate vaccine in children aged 2, 4 and 13 months. [19] [20] This included changes to the immunisation programme in general. [21] In 2009, the European Medicines Agency approved the use of a 10 valent pneumococcal conjugate vaccine for use in Europe. [22] The 13-valent pneumococcal vaccine was introduced in the routine immunization schedule of the UK in April 2010.[ citation needed ]

United States

Diagram with visual representation of the current indications for both the Prevnar and the Pneumovax. Pneumococcal%25 20vaccine%25 20guidelines.jpg
Diagram with visual representation of the current indications for both the Prevnar and the Pneumovax.

In the United States, a heptavalent pneumococcal conjugate vaccine (PCV 7) (e.g. Prevnar, called Prevenar in some countries [24] ) was recommended for all children aged 2–23 months and for at-risk children aged 24–59 months in 2000. The normal four-dose series is given at 2, 4, 6 and 12–14 months of age. In February 2010, a pneumococcal conjugate vaccine which protects against an additional six serotypes was introduced (PCV 13/brand name: Prevnar 13) and can be given instead of the original Prevnar. [25] [26] On 10 June 2021, a pneumococcal conjugate vaccine which protects against 20 serotypes was approved with the brand name Prevnar 20. [27] In April 2023, the FDA approved the use of Prevnar 20 vaccine to prevent pneumococcal disease in children aged six weeks to 17 years. [28] [29] [30]

Mechanism

Polysaccharide vaccine

The pneumococcal polysaccharide vaccine most commonly used today [ citation needed ] consists of purified polysaccharides from 23 serotypes (1, 2, 3, 4, 5, 6b, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F). [31] Immunity is induced primarily through stimulation of B-cells which release IgM [31] without the assistance of T cells. [32]

This immune response is less robust than the response provoked by conjugated vaccines, which has several consequences. The vaccine is ineffective in children less than 2 years old, presumably due to their less mature immune systems. [31] Non-response is also common amongst older adults. [31] Immunity is not lifelong, so individuals must be re-vaccinated at age 65 if their initial vaccination was given at age 60 or younger. [31] Since no mucosal immunity is provoked, the vaccine does not affect carrier rates, promote herd immunity, or protect against upper or lower respiratory tract infections. [31] Finally, provoking immune responses using unconjugated polysaccharides from the capsules of other bacteria, such as H. influenzae, has proven significantly more difficult. [31]

Conjugated vaccine

The pneumococcal conjugate vaccine consists of capsular polysaccharides covalently bound to the diphtheria toxoid CRM197, which is highly immunogenic but non-toxic. [31] This combination provokes a significantly more robust immune response by recruiting CRM197-specific type 2 helper T cells, which allow for immunoglobulin type switching (to produce non-IgM immunoglobulin) and production of memory B cells. [31] Among other things, this results in mucosal immunity and the eventual establishment of lifelong immunity after several exposures. [31] The main drawbacks to conjugated vaccines are that they only provide protection against a subset of the serotypes covered by the polysaccharide vaccines.[ medical citation needed ] depitte, J.; Gove, Sandy; Breiman, Robert F.

Research

Due to the geographic distribution of pneumococcal serotypes, additional research is needed to find the most efficacious vaccine for developing-world populations. In a previous study, the most common pneumococcal serotypes or groups from developed countries were found to be, in descending order, 14, 6, 19, 18, 9, 23, 7, 4, 1 and 15. In developing countries, the order was 6, 14, 8, 5, 1, 19, 9, 23, 18, 15 and 7. [33] In order to further pneumococcal vaccine research and reduce childhood mortality, five countries and the Bill & Melinda Gates Foundation established a pilot Advance Market Commitment for pneumococcal vaccines worth US$1.5 billion. Advance Market Commitments are a new approach to public health funding designed to stimulate the development and manufacture of vaccines for developing countries. [34]

There is research into producing vaccines than can be given into the nose rather than by injection. [35] [36] It is believed that this improves vaccine efficacy and also avoids the need for injection.[ medical citation needed ]

The development of serotype-specific anticapsular monoclonal antibodies has also been researched in recent years. These antibodies have been shown to prolong survival in a mouse model of pneumococcal infection characterized by a reduction in bacterial loads and a suppression of the host inflammatory response. [37] [38] Additional pneumococcal vaccine research is taking place to find a vaccine that offers broad protection against pneumococcal disease. [39]

As of 2017, pneumonia vaccines target up to 23 forms of the bacterium that cause pneumonia with a new version under development covering 72 strains of the bacterium. [40] [ needs update ]

Related Research Articles

<span class="mw-page-title-main">Herd immunity</span> Concept in epidemiology

Herd immunity is a form of indirect protection that applies only to contagious diseases. It occurs when a sufficient percentage of a population has become immune to an infection, whether through previous infections or vaccination, thereby reducing the likelihood of infection for individuals who lack immunity.

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

Streptococcus pneumoniae, or pneumococcus, is a Gram-positive, spherical bacteria, alpha-hemolytic member of the genus Streptococcus. They 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.

Asplenia refers to the absence of normal spleen function and is associated with some serious infection risks. Hyposplenism is used to describe reduced ('hypo-') splenic functioning, but not as severely affected as with asplenism.

<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.

An advance market commitment (AMC) is a promise to buy or subsidise a product if it is successfully developed. AMCs are typically offered by governments or private foundations to encourage the development of vaccines or treatments. In exchange, pharmaceutical companies commit to providing doses at a fixed price. This funding mechanism is used when the cost of research and development is too high to be worthwhile for the private sector without a guarantee of a certain quantity of purchases.

<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">Vaccination schedule</span> Series of vaccinations

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. A vaccine is an antigenic preparation used to produce active immunity to a disease, in order to prevent or reduce the effects of infection by any natural or "wild" pathogen. Vaccines go through multiple phases of trials to ensure safety and effectiveness.

<span class="mw-page-title-main">Meningococcal disease</span> Often life-threatening bacterial infection

Meningococcal disease describes infections caused by the bacterium Neisseria meningitidis. It has a high mortality rate if untreated but is vaccine-preventable. While best known as a cause of meningitis, it can also result in sepsis, which is an even more damaging and dangerous condition. Meningitis and meningococcemia are major causes of illness, death, and disability in both developed and under-developed countries.

Artificial induction of immunity is immunization achieved by human efforts in preventive healthcare, as opposed to natural immunity as produced by organisms' immune systems. It makes people immune to specific diseases by means other than waiting for them to catch the disease. The purpose is to reduce the risk of death and suffering, that is, the disease burden, even when eradication of the disease is not possible. Vaccination is the chief type of such immunization, greatly reducing the burden of vaccine-preventable diseases.

<span class="mw-page-title-main">Pneumococcal conjugate vaccine</span> Vaccine against Strep pneumoniae

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.

<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.

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

NmVac4-A/C/Y/W-135 is the commercial name of the polysaccharide vaccine against the bacterium that causes meningococcal meningitis. The product, by JN-International Medical Corporation, is designed and formulated to be used in developing countries for protecting populations during meningitis disease epidemics.

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.

Maria Deloria Knoll is an expert in the fields of epidemiology, disease surveillance, vaccine trial conduct, and biostatistics. She currently serves as associate director of Science at the International Vaccine Access Center (IVAC), an organization dedicated to accelerating global access to life-saving vaccines, at the Johns Hopkins Bloomberg School of Public Health in Baltimore, Maryland.

Orin Levine is an epidemiologist known for his work in the fields of international public health, child survival, and pneumonia. He is currently the director of vaccine delivery at the Bill & Melinda Gates Foundation in Seattle, US. In the past he was the executive director of the International Vaccine Access Center (IVAC), the co-chair of the Pneumococcal Awareness Council of Experts (PACE), and is a professor at The Johns Hopkins Bloomberg School of Public Health in the Department of International Health. He is also an adjunct assistant professor of epidemiology at The Rollins School of Public Health at Emory University in Atlanta. Additionally, he is currently president of the American Society of Tropical Medicine and Hygiene (ASTMH) Council on Global Health. He resides in Washington, D.C.

<span class="mw-page-title-main">Pneumococcal Awareness Council of Experts</span>

The Pneumococcal Awareness Council of Experts (PACE) is a project of the Sabin Vaccine Institute and is composed of global experts in infectious diseases and vaccines. Established in December 2006, The Council seeks to raise awareness among policymakers and aims to secure global commitments to prevent pneumococcal disease, a leading infectious killer of children and adults worldwide. The Council works in collaboration and partnership with countries, NGOs, academia and industry.

<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 medical researcher and vaccine expert with 49 years of experience in developing numerous vaccines, therapeutic antibodies, and diagnostic agents for infectious diseases.

<span class="mw-page-title-main">Shabir Madhi</span> South African physician and professor

Shabir Ahmed Madhi, is a South African physician who is professor of vaccinology and director of the South African Medical Research Council Respiratory and Meningeal Pathogens Research Unit at the University of the Witwatersrand, and National Research Foundation/Department of Science and Technology Research Chair in Vaccine Preventable Diseases. In January 2021, he was appointed Dean of the Faculty of Health Sciences at the University of the Witwatersrand.

References

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