Allopathy
Prescription Required
DCGI (Drugs Controller General of India)
Schedule C
Australia, Germany, the United States, Canada, the United Kingdom, Brazil and India.
The Pneumococcal Conjugate Vaccine 10 is called the "PCV 10". It is a prescription medication belonging to the vaccine class.
The pneumococcal conjugate vaccine is approved to prevent diseases caused by the bacterium Streptococcus pneumoniae. This includes conditions like pneumonia, invasive diseases (such as meningitis and sepsis), and acute otitis media (ear infections) in children. It is primarily used as a pediatric vaccine.
The Pneumococcal Conjugate Vaccine 10 (PCV10) is included in India's National Immunization Schedule (NIS).
The Pneumococcal Conjugate Vaccine 10 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.
Common side effects of the Pneumococcal Conjugate Vaccine 10 may include Pain, redness, swelling at the injection site, Mild fever, irritability or fussiness, decreased appetite, sleepiness or fatigue.
The Pneumococcal Conjugate Vaccine 10 is typically available as a liquid solution in vials or prefilled syringes for injection.
The Pneumococcal Conjugate Vaccine 10 is available in Australia, Germany, the United States, Canada, the United Kingdom, Brazil and India.
The Pneumococcal Conjugate Vaccine 10 (PCV10), belonging to the vaccine class, acts as an inactivated virus.
The Pneumococcal Conjugate Vaccine 10 (PCV10) targets ten specific serotypes (or strains) of Streptococcus pneumoniae. Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F represent different variants of the Streptococcus pneumoniae bacterium, distinguished by the specific characteristics of its outer capsule. The PCV 10 vaccine is designed to generate immunity against these ten selected serotypes, protecting against infections caused by these strains.
These substances, often called polysaccharides, initially have a limited immunogenic effect, especially in young infants. These polysaccharides are chemically bonded to a carrier protein, increasing their immunogenicity and enhancing the immune response. When administered, this vaccine stimulates the production of antibodies that act against the carrier protein and the polysaccharides. Due to this process, the body develops immunity and memory cells, enabling a prompt and effective response to the Streptococcus pneumoniae bacterium upon exposure and preventing the development of severe illnesses like pneumonia and meningitis.
The Pneumococcal Conjugate Vaccine 10 (PCV10) is a liquid solution in vials or prefilled syringes for injection.
It is to be administered intramuscularly, as applicable.
The Pneumococcal Conjugate Vaccine 10 (PCV10) can be used as follows:
- Prevents infections caused by ten specific serotypes (strains) of Streptococcus pneumoniae bacteria.
- Specifically, it targets pneumococcal diseases, including pneumonia, meningitis, and sepsis, which can be severe and life-threatening
The Pneumococcal Conjugate Vaccine 10 (PCV10) can help support the following health benefits:
- Provides immunization against ten specific serotypes of Streptococcus pneumoniae bacteria.
- Helps prevent severe pneumococcal infections, including pneumonia, meningitis, and sepsis.
- This is particularly important for infants, as they are more susceptible to these infections.
- Reduces the risk of complications and hospitalization associated with pneumococcal diseases.
- Contributes to herd immunity, protecting vulnerable populations who may not be able to receive the vaccine.
- Recommended for individuals with certain medical conditions or those at higher risk of pneumococcal infections.
- An essential tool in global efforts to control and prevent infectious diseases.
- Aims to decrease the overall burden of pneumococcal diseases in communities.
- A component of comprehensive vaccination strategies to promote public health and well-being.
Pneumococcal Conjugate Vaccine 10 (PCV10) is approved for its use in the following clinical indications:
- PCV10 may be recommended for adults with specific medical disorders or risk factors, such as those who are immunocompromised, have chronic illnesses, or are over a particular age.
- Individuals with cochlear implants have a higher risk of certain infections, including those caused by Streptococcus pneumoniae, making PCV vaccination essential.
- In some regions or specific populations, PCV may be recommended for older adults, especially those with certain health conditions that put them at higher risk for pneumococcal infections.
- PCV10 may be recommended for adults with specific medical disorders or risk factors, such as those who are immunocompromised, have chronic illnesses, or are over a particular age.
- Individuals with cochlear implants have a higher risk of certain infections, including those caused by Streptococcus pneumoniae, making PCV vaccination essential.
- If someone missed receiving the recommended doses of PCV during their infancy or childhood, catch-up vaccination may be recommended.
Parenterally: The Pneumococcal Conjugate Vaccine 10 (PCV10)is given parenterally. It is injected intramuscularly into the anterolateral part of the thigh in children under 2 years and into the deltoid muscle in children over two years.
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 treating physician's clinical judgment.
Liquid solution for injection: 0.5 ml per dose
Dosage Adjustment for Adult Patients
Adults may require different dosages of PCV10 according to their own health status, potential risks, and regional recommendations.
Adults who are at higher risk
• The recommended dosage for adults is typically a single 0.5 mL dose of PCV10.
The Pneumococcal Conjugate Vaccine 10 (PCV10) is a liquid solution in vials or prefilled syringes for injection.
The Pneumococcal Conjugate Vaccine 10 (PCV10) typically does not have specific dietary restrictions. However, it is advisable to maintain regular hydration levels before and after vaccination, as this can support the body's immune response. Individuals with known allergies to vaccine components should inform their healthcare provider beforehand to ensure proper precautions are taken. After receiving the vaccine, a brief observation period may be recommended to monitor for any immediate allergic reactions or side effects. Unless advised otherwise, individuals can continue their medications and supplements before and after receiving the PCV 10 vaccine.
Pneumococcal Conjugate Vaccine 10 (PCV10) may be contraindicated in the following conditions:
• Immediate severe allergic reaction (anaphylaxis) to a previous PCV 10 or its components dose.
• Pre-existing medical conditions, especially severe immunodeficiency or immunosuppressive therapy, may warrant consultation before vaccination.
• Fever or moderate to severe illness during planned vaccination may require postponement.
The treating physician must closely monitor the patient and keep pharmacovigilance as follows.
• Individuals with a history of severe allergic reactions to any component of PCV 10 should not receive the vaccine.
• If an individual has experienced a severe allergic reaction to a previous dose of PCV 10, further doses should not be administered.
• PCV 10 may have reduced effectiveness in individuals with certain immunodeficiency disorders or those receiving immunosuppressive therapy.
• In the presence of a fever or acute illness, vaccination may be deferred until after recovery.
• Individuals with bleeding disorders may need special precautions when receiving an intramuscular injection. The vaccine should be cautiously administered and pressure applied to the injection site.
• An individual having a history of Guillain-Barré Syndrome (GBS) should be cautious while administrating.
• Limited data are available on the safety of PCV 10 during pregnancy and breastfeeding, so benefits and potential risks should be considered on a case-by-case basis.
• If more than one type of pneumococcal vaccine is indicated, specific recommendations regarding timing and sequence should be followed.
Alcohol Warning
There is no evidence to suggest that alcohol would significantly impact the effectiveness or safety of PCV 10. However, excessive consumption of alcohol can weaken the immune system over time, potentially affecting the body's response to vaccines. Therefore, it's always advisable to consume alcohol in moderation, especially during vaccination.
Breast Feeding Warning
There is no sufficient scientific evidence regarding the use and safety of the Pneumococcal Conjugate Vaccine 10 (PCV10) in the breastfeeding population.
Pregnancy Warning
There is no sufficient scientific evidence traceable regarding the use and safety of the Pneumococcal Conjugate Vaccine 10 (PCV10) for pregnant populations.
Food Warning
There is no sufficient scientific evidence regarding the use and safety of the Pneumococcal Conjugate Vaccine 10 (PCV10) in concurrent use with any particular food.
The adverse reactions related to the Pneumococcal Conjugate Vaccine 10 (PCV10) can be categorized as:
- Common: Soreness, redness, swelling at the injection site and mild fever
- Less Common: Irritability or fussiness (especially in infants and young children), decreased appetite, sleepiness or fatigue (particularly in infants).
- Rare: Severe allergic reactions (Anaphylaxis).
The clinically relevant drug interactions of the Pneumococcal Conjugate Vaccine 10 (PCV10) are briefly summarized here:
Chemotherapy: Immune systems may be compromised in chemotherapy patients. Their reaction to PCV10 and other vaccinations may be compromised as a result. Medical professionals may change immunization schedules or suggest greater vaccine doses to increase vaccine efficacy.
Other vaccines: PCV10 is frequently given with other vaccinations, such as the Hib vaccine or other standard childhood immunizations. Different injection sites are often used when administering numerous immunizations at once to reduce any possible interactions.
Immunosuppressive Drugs: Individuals receiving immunosuppressive drugs, such as corticosteroids or drugs used following organ transplants, may exhibit a diminished immune response to vaccinations like PCV10. This indicates that the vaccination may not be as effective in such individuals.
The common side of Pneumococcal Conjugate Vaccine 10 (PCV10) includes the following-
• Pain, redness, or swelling at the injection site
• Mild fever
• Irritability or fussiness (especially in infants and young children)
• Temporary decrease in appetite
• Sleepiness or fatigue (particularly in infants)
• Pregnancy: There is no sufficient scientific evidence traceable regarding the use and safety of the Pneumococcal Conjugate Vaccine 10 (PCV10)for pregnant populations.
• Pediatric: PCV 10 is a crucial component of childhood immunization schedules. It is recommended for infants and young children to protect against severe pneumococcal infections, which can be particularly dangerous in this age group.
Dosage Adjustment for Paediatric Patients
It is recommended as three primary doses (the 3p+0 schedule) or, as an alternative, two primary doses plus a booster (the 2p + 1 schedule).
Child from 6 weeks to < 12 months:
3p+0 schedule include administraion of 3 doses four weeks apart at 6, 10 and 14 weeks of age
2p+1 schedule includes administration of 2 doses eight weeks apart and a booster dose between 9 and 15 months. In this schedule, the booster dose of the pneumococcal vaccine may be given along with the measles vaccine and Vitamin A supplementation.
Children who are at risk:
Child from 12 months to < 2 years: 2 catch-up dose(s) 8 weeks separated
Child from 2 to 5 years: a single dose
• Geriatric: While PCV 10 is primarily targeted towards infants and young children, in some regions, healthcare providers may recommend it for certain elderly individuals, especially those with specific health conditions or risk factors that make them more susceptible to pneumococcal infections.
• Lactating Mothers: There is no sufficient scientific evidence regarding the use and safety of the Pneumococcal Conjugate Vaccine 10 (PCV10) in the lactating mothers population.
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 Pneumococcal Conjugate Vaccine 10 (PCV10) 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 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 Conjugate Vaccine 10 (PCV10)
The pharmacodynamics of the Pneumococcal Conjugate Vaccine 10 (PCV10) centre on its ability to stimulate the immune system. The vaccine stimulates the production of specific antibodies by incorporating pieces of the Streptococcus pneumoniae bacterium coupled with a carrier protein. These antibodies combat the Streptococcus pneumoniae strains contained in the vaccine, fostering a targeted immune response. Concurrently, PCV 10 prompts the generation of memory B-cells, the antigenic material, establishing a rapid and robust defence mechanism upon future exposure to the actual bacteria. This immune reaction reduces severe pneumococcal infections, such as pneumonia, meningitis, and sepsis, caused by the targeted serotypes. The ultimate goal of PCV 10 is to confer lasting protection against these potentially life-threatening diseases.
Pharmacokinetics of Pneumococcal Conjugate Vaccine 10 (PCV 10):
• Absorption: PCV 10 is administered through an intramuscular injection, directly introducing it into the muscle tissue. This route bypasses absorption through the gastrointestinal tract, as would be the case with oral medications.
• Distribution: Instead of being distributed throughout the body like a drug, the components of PCV 10 (pieces of the Streptococcus pneumoniae bacterium combined with a carrier protein) work locally at the injection site to stimulate an immune response.
Unlike drugs, PCV 10 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 bacterium pneumococcal infections and related diseases.
• Berman-Rosa, Melissa et al. "Efficacy and Effectiveness of the PCV-10 and PCV-13 Vaccines Against Invasive Pneumococcal Diseases." Pediatrics vol. 145,4 (2020): e20190377. doi:10.1542/peds.2019-0377
• Tomas Mrkvan, Stephen I. Pelton, Javier Ruiz-Guiñazú, Arto A. Palmu & Dorota Borys (2018) Effectiveness and impact of the 10-valent pneumococcal conjugate vaccine, PHiD-CV: review of clinical trials and post-marketing experience, Expert Review of Vaccines, 17:9, 797-818, DOI: 10.1080/14760584.2018.1516551
• de Oliveira LH, Camacho LAB, et al. (2016) Impact and Effectiveness of 10 and 13-Valent Pneumococcal Conjugate Vaccines on Hospitalization and Mortality in Children Aged > 5 Years in Latin American Countries: A Systematic Review. PLOS ONE 11(12): e0166736. https://doi.org/10.1371/journal.pone.0166736
- Inform the caregivers of the schedule for administering the Pneumococcal Conjugate Vaccine 10 (PCV10) 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 Pneumococcal conjugate vaccine (PCV) 10 dosage.
- 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 Conjugate Vaccine 10 (PCV10) 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. 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
