Pneumococcal polysaccharide vaccine

The Pneumococcal polysaccharide vaccine is also known as the "Pneumonia vaccine" or "PPSV23". It is a prescription medication belonging to the vaccine class.

The pneumococcal polysaccharide vaccine is approved for effectively preventing invasive diseases caused by specific Streptococcus pneumoniae (S. pneumoniae) serotypes, particularly older adults over 65 and those with particular health conditions that increase susceptibility to these infections.

It is not part of India's routine immunization program but may be administered selectively, particularly for high-risk groups or adults.

The pneumococcal polysaccharide vaccine is injected intramuscularly, rapidly entering the bloodstream, distributing its components throughout the body, undergoing minimal metabolic processing, and gradually being eliminated to improve immune defence.

The common side effects of the Pneumococcal polysaccharide vaccine are redness, pain or swelling at the site where the shot was given, fever, and mild fatigue.

The Pneumococcal polysaccharide vaccine is available as a suspension for injection.

The Pneumococcal polysaccharide vaccine is available in the United States, Canada, Australia, Germany, the United Kingdom, France, Japan, China, India, and Brazil.

The Pneumococcal polysaccharide vaccine, belonging to the vaccine class, acts as an inactivated virus.

The Pneumococcal polysaccharide vaccine induces a robust immune response. The Pneumococcal Polysaccharide Vaccination 23 (PPSV23) is the first vaccination produced with capsular polysaccharides. About 85% to 90% of the pneumococcal disease strains in the US are represented by the polysaccharides in this substance, which come from 23 distinct serotypes of Streptococcus pneumoniae. It was between 50% and 80% effective in preventing invasive pneumococcal disease in adults.

Serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9V, 9N, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F of S. pneumoniae are among the variants that are included in PPSV23. PPSV23 is an efficient approach for lowering the prevalence of pneumococcal infections because of its wide coverage, especially among high-risk groups, including the elderly and people with underlying medical conditions.

The Pneumococcal polysaccharide vaccine is available as a suspension for injection.

Suspension for injection: To be administered parenterally, as applicable.

The Pneumococcal polysaccharide vaccine can be used as follows:

• To prevent diseases like pneumonia, meningitis, and bloodstream infections caused by the bacterium Streptococcus pneumoniae in older people and other groups at increased risk.
• To prevent pneumococcal infections in individuals with some medical issues.
• To immunize against certain Streptococcus pneumoniae strains in populations at increased risk.

The Pneumococcal polysaccharide vaccine can help support the following health benefits:

• Protection: Pneumococcal illnesses are caused by 23 different serotypes of Streptococcus pneumoniae, and PPSV23 contains polysaccharides derived from these strains. This broad protection means that those vaccinated are protected against various pneumococcal strains. It was developed to target the serotypes most frequently linked to severe infections.
• Prevention of pneumonia: A lung infection called pneumonia is more prevalent in older people, and those with underlying medical issues can result in hospitalisation, serious illness, and even death. Pneumococcal pneumonia is significantly reduced by PPSV23, helping prevent potentially dangerous and possibly fatal respiratory infections.
• Disease Severity in high-risk populations: Elderly people, those with long-term medical conditions (such as diabetes or cardiac disease), and people with weakened immune systems are more likely than other groups to get severe pneumococcal infections. To protect these high-risk populations against pneumococcal infections and the adverse effects that are connected with them, PPSV23 proves particularly beneficial.
• Invasive pneumococcal disease prevention: Meningitis and bacteremia, which can be fatal infections, are typically caused by the invasive bacteria Streptococcus pneumoniae. PPSV23 has effectively lowered the prevalence of these invasive pneumococcal infections, protecting high-risk populations, such as elderly people and people with low immune systems.
• Public Health: Pneumococcal infection prevalence is reduced by widespread immunisation with PPSV23, benefiting public health activities. Vaccination protects people, helps prevent epidemics, and lessens healthcare system burdens. This results in improved health outcomes reducing healthcare costs, and boosting the quality of life for society as a whole.

Pneumococcal polysaccharide vaccine is approved for its use in the following clinical indications:

• It is advised to have PPSV 23 for active immunization to prevent pneumococcal illness caused by the 23 serotypes of Streptococcus pneumoniae (1, 2, 4, 3, 5, 6B, 7F, 8, 9N and 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A and 19F, 20, 22F, 23F, and 33F).
• For those over 50, PPSV23 is indicated.
• Children two years old and at high risk of pneumococcal infection should also get PPSV 23 for children with high-risk diseases such as sickle cell disease, diabetes mellitus, chronic heart or lung disease, cerebrospinal fluid leakage, cochlear implants, anatomic or functional asplenia, or other immune-compromised disorders.

Parenterally: The Pneumococcal polysaccharide vaccine is given parenterally either into the deltoid muscle or lateral mid-thigh. It should not be injected into the GLUTEAL MUSCLE-like buttock areas. It should be administered intramuscularly or subcutaneously only and not intravenously or intradermally.

It can be only given by a healthcare professional in a hospital setting or during routine immunization programs.

The dosage and duration of treatment should be as per the clinical judgement of the treating physician.

Suspension for injection: 0.5mL/syringe

Dosage Adjustment for Adult Patients

Immunization against Pneumococcal pneumoniae

65 and older: 0.5 mL IM once

If PPSV23 was given before the age of 65, give one additional dosage at least five years following the previous one.

optional, depending on the doctor's judgement

May administer one dose of PCV13 or PCV15 either at least a year before (preferred) or a year after (at least) PPSV23.

One PCV20 dosage may be administered at least a year after PPSV23.

individuals aged 19 to 64 with specific medical disorders, according to the ACIP recommendations

1 dose of PCV13 or PCV15, followed by 1 dose of PPSV23 at least a year later; repeat this regimen when one is over 65.

Booster doses may be required, especially for older adults.

The Pneumococcal polysaccharide vaccine is available as a suspension for injection.

The Pneumococcal polysaccharide vaccine should be used to protect against pneumococcal infections and related diseases, along with no appropriate dietary restrictions.

When administered, the Pneumococcal polysaccharide vaccine usually has little effect on dietary or food substances. Consuming regular foods and drinks before and after receiving the vaccine is safe.

However, staying fully hydrated and maintaining a balanced and healthy diet to support overall immune system function is always recommended, which can boost the effectiveness of vaccines.

The dietary restriction should be individualized as per patient requirements.

Pneumococcal polysaccharide vaccine may be contraindicated in the following conditions-

• Hypersensitivity (previous dose of vaccine or any of its components)
• Allergic to latex rubber
• 10 days of immunosuppressive therapy

The treating physician must closely monitor the patient and keep pharmacovigilance as follows.

• If the infant has a moderately critical acute sickness (with or without fever), administration of the vaccine should be postponed.
• Individuals with cancer or weakened immune systems with frequent close contact with a child receiving this vaccine may have a rare risk of pneumonia infection.
• Administer at least 2 weeks before the scheduled Splenectomy surgery.
• Patients with chronic renal failure, asplenia, HIV infection, cancer, or other illnesses linked to immunosuppression are now advised to receive a second dosage after five years.
• People with substantially impaired cardiovascular and pulmonary function should use caution and the appropriate level of treatment when a systemic response poses significant risks to patients.
• Patients with persistent cerebrospinal fluid (CSF) leaking due to congenital lesions, skull fractures, or neurosurgical operations may not be protected against pneumococcal meningitis by vaccination.

Caution is advised when consuming alcohol with the Pneumococcal polysaccharide vaccine.

There is no sufficient scientific evidence regarding the use and safety of the Pneumococcal polysaccharide vaccine in the breastfeeding population.

There is no sufficient scientific evidence traceable regarding the use and safety of the Pneumococcal polysaccharide vaccine for pregnant populations.

There is no sufficient scientific evidence regarding the use and safety of the Pneumococcal polysaccharide vaccine in concurrent use with any particular food.

The adverse reactions related to the Pneumococcal polysaccharide vaccine can be categorized as

• Common: Pain, redness or swelling at the site of injection and mild fever
• Less common: Moderate fever, fatigue, headache, muscle aches, and chills
• Rare: Severe allergic reactions (anaphylaxis)

Drug interactions with the Pneumococcal polysaccharide vaccination are usually minimal. It is often regarded as safe to give with the majority of drugs.

The most common clinically relevant drug interactions of the Pneumococcal polysaccharide vaccine are with immunosuppressive treatments such as radiation, antimetabolites, alkylating agents, cytotoxic medicines, and corticosteroids (used in dosages larger than therapeutic doses) may have diminished seroprotection to the pneumococcal vaccine.

The common side of the Pneumococcal polysaccharide vaccine includes the following-

• Pain, redness, warmth, a hard lump or tenderness at the injection site
• Muscle/joint aches
• Tiredness
• Headache
• Nausea
• Fatigue
• Weakness
• Fever
• Chills

The use of Pneumococcal polysaccharide vaccine should be prudent in the following group of special populations.

• Pregnancy: There is no sufficient scientific evidence traceable regarding the use and safety of the Pneumococcal polysaccharide vaccine for pregnant populations.

• Paediatrics: The pneumococcal polysaccharide vaccine (PPSV23) is not commonly given to paediatric populations due to its limited effectiveness in children. Instead, paediatric patients usually receive pneumococcal conjugate vaccinations (PCVs), such as PCV13, developed specifically for their age group and providing more vigorous defence against pneumococcal infections.

Dosage Adjustment for Paediatric Patients

Immunization to Streptococcus pneumoniae

Less than two years: No evidence of safety or effectiveness is established.

0.5 mL SC/IM for high-risk conditions in children under two years old with PCV13

All prescribed PCV13 doses should be given before PPSV23 immunization.

• Geriatrics: Pneumococcal polysaccharide vaccine (PPSV23) for elderly people is effective and safe. It reduces the risk of severe pneumococcal infections in elderly people, such as pneumonia and meningitis. Even though it could diminish effectiveness with time, it still offers beneficial protection. PPSV23 is a crucial preventative strategy for maintaining the health of older people, while its typical side effects are insignificant and severe reactions are rare.

• Lactating mothers: There is no sufficient scientific evidence traceable regarding the use and safety of the Pneumococcal polysaccharide vaccine for lactating mother populations.

Dosage Adjustment in Kidney Impairment

There are no specific dosage adjustments provided.

Dosage Adjustment in Hepatic Impairment

There are no specific dosage adjustments provided.

Overdosage of the Pneumococcal polysaccharide vaccine rarely occurs because healthcare professionals administer it according to specific doses based on age and medical guidelines.

There is no specific antidote or treatment for excessive Pneumococcal polysaccharide vaccine intake. Medical attention should be sought immediately when an overdose is suspected, followed by close monitoring for any adverse effects or allergic reactions. Supportive therapy should also be given, addressing any symptoms that persist or worsen. Physical treatment might be added if necessary.

Pharmacodynamics of Pneumococcal polysaccharide:

Pneumococcal polysaccharide vaccines have a physiological mechanism that plays a role in their pharmacodynamics, involving their interaction with the immune system. The Streptococcus pneumoniae polysaccharide vaccine (PPSV23) comprises polysaccharides from numerous serotypes associated with this pathogen, which causes B cells to develop antibodies against them. When they come into contact with the bacterial capsular polysaccharides, these antibodies recognize and attach to them while circulating through the bloodstream. As a result of this immune reaction, the bacteria are more effectively eliminated, and white blood cells are more effectively able to phagocytose them, eventually destroying the pathogen. PPSV23 responds effectively. However, it does not create a persistent immunological memory; thus, booster doses could be necessary. This vaccine lessens the risk of pneumococcal infections, particularly in high-risk populations like the elderly and people with underlying medical disorders.

Pharmacokinetics of Pneumococcal polysaccharide vaccine:

• Absorption: Pneumococcal polysaccharide vaccines are injected, usually intramuscularly or subcutaneously, and are then absorbed. The vaccine is injected into the body, bypassing the digestive system and immediately entering circulation.
• Distribution: After being administered, the vaccine's active ingredients enter the bloodstream and trigger an immunological response against the targeted serotypes. They circulate throughout the body, where specific antibodies and memory cells are produced promptly due to the vaccine's active ingredients, which help prevent infections from recurring.

Unlike drugs, Pneumococcal polysaccharide vaccines don't involve metabolism or elimination processes because vaccines contain inert viral proteins, not active drugs. The vaccine's effectiveness comes from the body's immune response and antibody production, which provides long-term defence against pneumococcal infections and related diseases.

• Sikjær, Melina Gade et al. "Vaccine effectiveness of the Pneumococcal polysaccharide vaccine and conjugated vaccines in elderly and high-risk populations in preventing invasive pneumococcal disease: a systematic search and meta-analysis." European Clinical Respiratory Journal vol. 10,1 2168354. 20 Jan. 2023, doi:10.1080/20018525.2023.2168354.
• Ghia, Canna Jagdish, and Gautam Rambhad. “Pneumococcal Vaccine Recommendations for Old-Age Home Indian Residents: A Literature Review.” Gerontology & geriatric medicine vol. 8 23337214221118237. 1 Sep. 2022, doi:10.1177/23337214221118237
• Wang, Yang et al. "Effectiveness and practical uses of 23-valent Pneumococcal polysaccharide vaccine in healthy and special populations." Human Vaccines & Immunotherapeutics vol. 14,4 (2018): 1003 1012.doi:10.1080/21645515.2017.1409316

• Inform the caregivers of the schedule for administering the Pneumococcal polysaccharide vaccine doses, including the number of doses, the intervals between them, and any catch-up doses, if applicable.
• Inform the vaccination recipient, their parents, or their guardians whether they had any side effects from a prior dosage of the Pneumococcal polysaccharide vaccine.
• Tell the patients about common side effects like pain, redness or swelling at the administered site and potential mild fever or irritability, which usually subside within a few days.
• Assure caregivers that Pneumococcal polysaccharide immunizations are generally safe, with only minor, short side effects. Encouraging them to immediately report any unexpected or severe responses to the healthcare physician and, whenever applicable, to use reporting systems like the Vaccine Adverse Event Reporting System (VAERS)
• Inform caregivers of the recommended immunization schedule, which usually consists of two or three doses, depending on the vaccine brand used. Also, mention the ages at which the doses should be administered and give the Vaccine Information Statements, which must be disclosed before immunization by the National Childhood Vaccine Injury Act of 1986 about the Centres for Disease Control and Prevention (CDC) website (www.cdc.gov/vaccines), these resources are freely accessible.

http://www.cdc.gov/vaccines/schedules/hcp/index.html

https://www.cdc.gov/vaccines/hcp/vis/vis-statements/ppv.html

https://www.ncbi.nlm.nih.gov/books/NBK507794/

https://www.indianpediatrics.net/oct2014/785 figure1.pdf