Pneumococcal 13-valent conjugate vaccine

The Pneumococcal 13-valent conjugate vaccine (PCV13) is a prescription medication belonging to the vaccine class.

Pneumococcal 13-valent conjugate vaccine (PCV13) is approved for effectively preventing invasive diseases caused by specific Streptococcus pneumoniae (S. pneumoniae) serotypes, especially in vulnerable populations like children and the elderly.

It is usually used in national routine immunization programmes, especially in areas with a high risk of developing pneumonia and potentially severe lung infections.

The Pneumococcal 13-valent conjugate vaccine is administered via injection, and the antigens stimulate the immune system. There is no significant metabolism or elimination; instead, it prompts the body to produce antibodies for future protection against pneumococcal infections.

The common side effects of the Pneumococcal 13-valent conjugate vaccine include fever, muscle/joint pains, and injection site reactions (such as pain, erythema, swelling, or hard lumps).

The Pneumococcal 13-valent conjugate vaccine is available as a suspension for injection.

The pneumococcal 13-valent conjugate vaccine is available in the United States, Canada, the United Kingdom, Australia, Germany, France, Japan, and Brazil.

The Pneumococcal Conjugate Vaccine 13 (PCV13), belonging to the vaccine class, acts as an inactivated virus.

The Pneumococcal 13-valent conjugate vaccine (PCV13) induces a strong immune response. Purified capsular polysaccharides from 13 different pneumococcal serotypes are found in PCV13, and these polysaccharides are coupled to a carrier protein, usually CRM197. This conjugation process is vital to its effectiveness.

Particularly in young children and elderly individuals with weakened immune systems, PCV13 stimulates a higher immunological response by integrating the capsular polysaccharides with a carrier protein.

PCV13 targets explicitly the following serotypes: 1, 3, 4, 5, 6B, 6A, 7F, 9V, 14, 18C, 19A, 19F, and 23F. Since each of these serotypes is separately coupled to the CRM197 protein, it is a complete defence against invading illnesses brought on by Streptococcus pneumoniae.

This vaccine has shown to be very effective at preventing pneumococcal infections and the problems they might cause, such as bloodstream infections, meningitis, and pneumonia. As a result, it has a substantial impact on public health.

The Pneumococcal 13-valent conjugate vaccine is available as a suspension for injection.

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

The pneumococcal 13-valent conjugate vaccine can be used as follows:

• Prevents diseases like pneumonia, meningitis, and bloodstream infections caused by the bacterium Streptococcus pneumoniae in young children, older people, and other groups at increased risk.
• PCV13 helps reduce the need for antibiotics, which can help prevent the growth of bacterial strains which are resistant to antibiotics

The pneumococcal 13-valent conjugate vaccine can help support the following health benefits:

• Prevention: Infections caused by Streptococcus pneumoniae bacteria can be prevented effectively using PCV 13. This infection involves severe conditions, including meningitis, bacteremia, and pneumonia, particularly among those populations who are at risk such as young children, the elderly, and individuals with weakened immune systems. These groups are at a higher risk of pneumococcal infections, and the vaccine helps protect them from potentially life-threatening diseases.
• Antibiotic Resistance: Antibiotic-resistant bacterial strains, such as those causing pneumococcal infections, have emerged due to the overuse and abuse of antibiotics. The use of antibiotics for therapy is lowered by avoiding certain diseases by immunization. Thus, the growth and spread of antibiotic resistance are slowed, protecting these life-saving drugs' long-term efficacy.
• Disease Severity: PCV 13 may reduce the severity of the disease even in people who aren't entirely immune to pneumococcal infections. Since treatment can save hospitalizations, long-term complications, and mortality in individuals who acquire the condition, this disease severity reduction is essential. Vaccination enhances overall health outcomes by reducing the effects of the disease.
• Herd immunity: Public health benefits greatly from extensive PCV13 vaccinations. The possibility for severe pneumococcal infections ramifications among them is reduced and limiting the bacterium's spread. It protects the vaccinated person and those individuals with weaker immune systems, children, the elderly, and vulnerable populations.

Pneumococcal 13-valent conjugate vaccine is approved for its use in the following clinical indications:

• Pneumococcal vaccine 13-valent (PCV13) is indicated for active immunization for the prevention of pneumonia and other invasive disease that is produced by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
• Children six weeks up to five years of age: Prevention of IPD (invasive pneumococcal disease) caused by Streptococcus pneumoniae and for the prevention of otitis media
• 6 to 17 years old adults: Prevention of IPD caused by Streptococcus pneumoniae
• Adults over 18 years: Prevention of IPD and pneumonia caused by Streptococcus pneumoniae.

Parenterally: The Pneumococcal 13-valent conjugate vaccine is given parenterally either in mono or multiple doses. For children less than 2 years old, the vaccine is injected into the vastus lateralis in the anterolateral thigh. In contrast, for children more than 2 years and adults, it is injected into the deltoid muscle. 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 streptococcus pneumoniae

Adults aged 19 to 64 years: Adults with specific medical disorders are advised to use, according to ACIP recommendations.

Adults with a compromised immune system older than 65: Based on shared decision-making between the patient and the doctor, a vaccine may be necessary (i.e., it is no longer generally advised for all individuals older than 65).

Adults with specific medical issues, aged 19 to 64 years: 1 dose PCV13, 1 dose PPSV23, and repeat the therapy when aged 65 years old or older.

More than 65-year-old immunocompetent individuals:

Based on common clinical judgement

If both PCV13 and PPSV23 are given, PCV13 must be given first.

Both PCV13 and PPSV23 should be administered at least 1 year apart

Avoid giving medication during the same visit.

The Pneumococcal 13-valent conjugate vaccine is available as a suspension for injection.

The pneumococcal 13-valent conjugate vaccine should be used to protect against infections which is caused by bacterium Streptococcus pneumoniae, along with no appropriate dietary restrictions.

When administered, the pneumococcal 13-valent conjugate 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 13-valent conjugate vaccine may be contraindicated in the following conditions-

• Hypersensitivity (previous dose of vaccine or any of its components)
• Allergic to latex rubber
• History of Intussusception
• Pregnancy (often not advised unless a considerable risk of infection occurs)
• Guillain-Barré Syndrome (GBS)

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.
• Apnoea following immunization may occur in premature newborns. For early identification and prompt medical intervention, extend monitoring to 48 hours after vaccination.
• It is recommended not to reconstitute or dilute the vaccine before administration.

There is no sufficient scientific evidence regarding the use and safety of the Pneumococcal 13-valent conjugate vaccine in the breastfeeding population.

There is no sufficient scientific evidence regarding the use and safety of the Pneumococcal 13-valent conjugate vaccine in concurrent use with any particular food.

The adverse reactions related to the Pneumococcal 13-valent conjugate vaccine can be categorized as

• Common: Tenderness, erythema, lump, swelling at the site of injection, irritability, loss of appetite, fever more than100.4 F
• Less common: Nausea, diarrhoea, fatigue or vomiting,
• Rare: Altered sleep duration or unusual crying or persistent crying in infants.

The clinically relevant drug interactions of the Pneumococcal 13-valent conjugate vaccine are briefly summarized here:

• Immunosuppressants- The immunological response to Pneumococcal 13-valent conjugate vaccine may be suppressed by 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.
• Antipyretics: Following PCV 13 vaccinations, antipyretics reduce the immunological response to specific serotypes. However, further investigation is needed into this link.
• Other Vaccines- Multiple vaccinations, including the Pneumococcal 13-valent conjugate vaccine, given at the same time may increase the risk of adverse reactions. To reduce such a risk, medical professionals frequently adhere to vaccination regimens considering the time and space of vaccines.

The common side of the Pneumococcal 13-valent conjugate vaccine includes the following-

• Pain, swelling, redness, lump or tenderness at the injection site

• Muscle/joint aches
• Tiredness
• Headache
• Nausea
• Fatigue
• Diarrhoea
• Drowsiness
• Irritability
• Loss of appetite

The use of Pneumococcal 13-valent conjugate vaccine should be prudent in the following group of special populations

• Pregnancy:

Pregnancy Category: C. Safe during pregnancy, but when taken in high doses, use with caution if the benefits outweigh the risks.

Pneumococcal 13-valent conjugate vaccine is usually considered safe during pregnancy; it is mostly advised when there is a significant risk of bacterium Streptococcus pneumoniae exposure. Unless the risk of exposure is very high, routine vaccinations are commonly not recommended during pregnancy.

• Paediatrics:

PCV13 is a crucial paediatric vaccine that protects against severe pneumococcal diseases, including pneumonia and meningitis. Giving multiple doses boosts a child's immune system, providing ongoing protection against these potentially fatal diseases.

Dosage Adjustment for Paediatric Patients

Immunization to Streptococcus pneumoniae

Aged 12 to 15 months (Routine vaccination): 0.5 mL intramuscularly in 4-dose series at ages 2, 4, and 6 months

Aged 6 weeks to 5 years (Routine vaccination): 0.5 mL intramuscularly in 4-dose series at ages 2, 4, and 6 months

The first dose may be administered as early as age 6 weeks.

The time between the first and second doses and the second and third doses is 4 to 8 weeks.

Administer the fourth dosage at least two months following the third dose, at 12 to 15 months.

Administer a single extra dose of 13-valent PCV (PCV13) to children between the ages of 14 and 59 months who have already received an age-appropriate series of 7-valent PCV (PCV7).

Catch-up immunization: Administer one dose of PCV13 to all healthy children between the ages of 24 and 59 months who have not received all the recommended vaccinations.

• Geriatrics:

There is no sufficient scientific evidence traceable regarding the use and safety of the Pneumococcal 13-valent conjugate vaccine for geriatric populations.

• Lactating mothers:

There is no sufficient scientific evidence traceable regarding the use and safety of the Pneumococcal 13-valent conjugate 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 13-valent conjugate vaccine rarely occurs because healthcare professionals administer it according to specific or precise dosing guidelines.

There is no specific antidote or treatment for excessive Pneumococcal 13-valent conjugate 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 13-valent conjugate vaccine:

PCV13 vaccines have a physiological mechanism that plays a role in their pharmacodynamics. After being administered, PCV13 prompts B cells to produce antibodies specific to each pneumococcal serotype it targets. These antibodies protect by identifying and disarming the bacterium. Additionally, memory cells develop, ensuring a quick and effective reaction when exposed to the same serotypes in the future. For long-lasting protection, this immunological memory is essential. In particular, in susceptible groups like children and the elderly, PCV13's pharmacodynamics show its ability to effectively promote the immune system and provide protection against invasive illnesses caused on by Streptococcus pneumoniae.

Pharmacokinetics of Pneumococcal 13-valent conjugate vaccine:

• Absorption: Pneumococcal 13-valent conjugate vaccines are typically administered directly into the muscle tissue, bypassing the absorption from the gastrointestinal tract.
• 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, PCV13 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 PCV13 infections and related diseases.

• Daniels, Calvin C et al. "A Review of Pneumococcal Vaccines: Current Polysaccharide Vaccine Recommendations and Future Protein Antigens." The Journal of paediatric pharmacology and Therapeutics: JPPT : the official journal of PPAG vol. 21,1 (2016): 27-35. doi:10.5863/1551-6776-21.1.27.
• Marra, Fawziah, and Nirma Khatri Vadlamudi. “Efficacy and Safety of the Pneumococcal Conjugate-13 Valent Vaccine in Adults.” Aging and disease vol. 10,2 404-418. 1 Apr. 2019, doi:10.14336/AD.2018.0512
• Huang, Liping et al. “PCV13 Paediatric Routine Schedule Completion and Adherence Before and During the COVID-19 Pandemic in the United States.” Infectious diseases and therapy vol. 11,6 (2022): 2141-2158. doi:10.1007/s40121-022-00699-5

• Inform the caregivers of the schedule for administering the Pneumococcal 13-valent conjugate 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 13-valent conjugate vaccine.
• Tell the patients about common side effects like pain or redness at the site of injection and potential mild fever or irritability, which usually subside within a few days.
• Assure caregivers that PCV13 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.

https://medicalguidelines.msf.org/en/

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

https://www.indianpediatrics.net/oct2014/

https://www.cdc.gov/pneumococcal/vaccination.html

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