Prevenar 13

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Pneumococcal Polysaccharide Conjugate Vaccine

Method of action: Immunostimulants, Vacciness

Treatment option: Middle Ear Infection, Pneumonia, Chronic Middle Ear Infection

Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Prevenar 13

What Type of Vaccine is Prevenar 13 (PCV13)?

Prevenar 13 is a specialized immunizing agent, formally classified as a pneumococcal polysaccharide conjugate vaccine (PCV13), which functions as an inactivated bacterial vaccine. This medicinal product is a sterile suspension for injection, designed for intramuscular administration. Its general purpose is to stimulate active immunity against disease caused by the bacterium Streptococcus pneumoniae. As a conjugate vaccine, the bacterial sugars are chemically linked to a carrier protein, a design feature intended to improve the quality of the immune response, particularly in infants and young children.

Composition: Why is Prevenar 13 Called "13-Valent"?

The term 13-valent signifies that the vaccine is a combination product containing purified polysaccharide antigens derived from thirteen clinically relevant pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). These polysaccharide components, which serve as the active ingredient, are chemically conjugated (linked) to a non-toxic Diphtheria CRM197 carrier protein. The final preparation is adsorbed onto aluminum phosphate, an adjuvant suspended in an aqueous solution, which is included to enhance the body's immune response.

What is the General Purpose of the Prevenar 13 Vaccine?

The primary general purpose of the Prevenar 13 vaccine is to prepare the immune system for future exposure to the bacteria. By administering the conjugated antigens, the vaccine stimulates the body to produce specific protective antibodies. This action establishes immunological memory, which is intended to protect vulnerable populations, such as infants and adults over 65, against invasive pneumococcal infection. This state of immunological readiness means that if the patient is later exposed to the bacteria, the body can more effectively recognize the threat, reducing the risk of developing serious pneumococcal disease.

Regulatory References

What side effects are possible with Prevenar 13 ?

Possible Side Effects and Safety Information

The following safety information for Prevenar 13 is strictly based on data compiled in official governmental regulatory documents (e.g., FDA Prescribing Information and EMA Summary of Product Characteristics).

Frequency-Classified Adverse Reactions

The safety profile is primarily defined by high-frequency, generally transient reactions, classified as follows:

Classification	Examples of Reactions
Very Common (Occurs in ge 1 in 10 people)	Pain, redness, swelling, or induration at the injection site; decreased appetite; irritability; drowsiness or increased sleep; fever.
Common (Occurs in ge 1 in 100 people)	Vomiting, diarrhea, rash, headache (in adults), fatigue.
Uncommon (Occurs in ge 1 in 1,000 people)	Seizures (including febrile seizures), urticaria.
Rare (Occurs in ge 1 in 10,000 people)	Hypotonic-hyporesponsive episode (HHE); apnea (in very premature infants); angioedema.

Serious Adverse Reactions

Official regulatory documents identify certain reactions with the potential for severe outcomes, which, though rare, warrant attention. These include Anaphylactic/Anaphylactoid Reactions (severe allergic reactions), Seizures, and Hypotonic-Hyporesponsive Episodes (HHE).

Safety-Related Restrictions and Precautions

Contraindications: Prevenar 13 must not be administered to individuals with a history of severe allergic reaction (anaphylaxis) to any component of the vaccine or to any diphtheria toxoid-containing vaccine.
Deferral: Vaccination should be postponed in individuals with an acute severe febrile illness.
Population Note: A specific risk of apnea is documented for very premature infants (le 28 weeks gestation) following primary immunization, which may necessitate respiratory monitoring.

General Safety Patterns

The frequency of local reactions (e.g., pain, swelling) may tend to increase after successive doses of the primary series. Most common local and systemic reactions typically resolve within 48 hours.

Overdose and Emergency Response

The official regulatory documents indicate that an overdose of Prevenar 13 is classified as unlikely due to the product’s presentation in a pre-filled syringe. Reports of overdose have occurred primarily in infants and children, typically defined by the administration of subsequent doses closer than recommended to the previous one. In such documented cases, the resulting manifestations are consistent with the common adverse events observed during the standard vaccination schedule.

These manifestations include fever, irritability, decreased appetite, and localized injection site reactions such as tenderness and redness. However, the regulatory profile explicitly addresses the risk of severe systemic outcomes that require immediate attention. Immediate medical attention must be sought if any signs of a severe hypersensitivity reaction, such as an anaphylactic event, occur following administration.

Regulatory guidelines mandate that appropriate medical treatment and supervision must be readily available to manage these rare, life-threatening events. Management of overdose-related symptoms is supportive, as no specific antidote is documented in the official labeling. Additionally, a specific monitoring requirement exists for very premature infants (born at or before 28 weeks of gestation): the potential risk of apnoea must be considered, and respiratory monitoring for 48 to 72 hours should be employed during the primary immunization series.

Therapeutic Uses of Prevenar 13

Prevenar 13 is commonly used to help manage the risk of severe infectious diseases caused by Streptococcus pneumoniae. This use is considered relevant across domains where additional symptomatic support is needed. The use of Prevenar 13 is relevant for addressing the risk of invasive disease, pneumonia, and acute otitis media caused by Streptococcus pneumoniae in various age groups.

Main Therapeutic Benefits

Prevention of Severe Systemic Illness

The vaccine is commonly used across conditions presenting with acute episodes to address the risk of Invasive Pneumococcal Disease (IPD), including meningitis and septicaemia. The primary benefit supports the patient during difficult episodes by easing distress associated with severe systemic illness in vulnerable populations, including infants and adults over 65. It plays a role in managing symptoms related to organ-specific functional stress.

Targeting Pneumonia and Pediatric Symptoms

The use of the vaccine also plays a role in managing symptoms related to organ-specific functional stress by helping to manage the risk of pneumonia, a serious lung infection, caused by the 13 serotypes covered by the product. In children, it may also assist with managing symptoms that create noticeable interference with daily comfort, and is relevant for easing symptoms associated with recurrent Acute Otitis Media (middle ear infections).

“The vaccine’s use is applied in scenarios where additional management of discomfort is required by providing foundational protection against serious bacterial infection.”

Quick Fact: Relief for Invasive Symptom Strain

Quick Fact: Relief for Invasive Symptom Strain The vaccine provides support that helps ease the overall symptom burden by being relevant for managing the risk of symptoms related to systemic imbalance, specifically those linked to severe infections like meningitis and septicaemia. It is commonly used when symptoms create noticeable physiological strain and interference with daily functioning. The use of Prevenar 13 assists with maintaining a sense of stability when symptoms are more noticeable.

Regulatory References

European Medicines Agency (EMA) public assessment report

Eligibility and Restrictions for Use

Eligibility Profile: Who Can and Cannot Use Prevenar 13

This section outlines the official population eligibility and non-eligibility for Prevenar 13 (Pneumococcal Polysaccharide Conjugate Vaccine, 13-valent), as defined by government regulatory agencies.

Populations Allowed (Eligible)

Age Group	Eligibility Status
Infants and Children	ge 6 weeks of age through 17 years
Adults	ge 18 years of age and older

Populations Not Allowed or Requiring Restriction

Status	Population/Condition	Restriction Detail
Contraindicated	Individuals with known hypersensitivity to any component (active substance, excipients, or diphtheria toxoid).	Must not be used.
Temporary Deferral	Subjects with an acute, severe febrile illness.	Must be postponed until recovery.
Conditional Use	Individuals with coagulation disorders (e.g., thrombocytopaenia).	Use with caution (intramuscular route); may use subcutaneously if benefits outweigh risks.
Conditional Use	Very premature infants (le 28 weeks gestation).	Requires consideration of apnoea risk and respiratory monitoring for 48–72 hours.
Use Not Established	Children below the age of 6 weeks.	Safety and effectiveness have not been established.

Pregnancy and Lactation: Use in pregnant women is based on limited data and should only be considered if the potential benefit outweighs the potential risk. It is unknown whether the vaccine is excreted in human milk during lactation.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory information for Prevenar 13 documents interactions primarily focused on the resulting immunological response and physical co-administration rules rather than metabolic or transporter-mediated drug interactions.

Interaction Type	Documented Interaction Entity or Statement
Immunological Interference	Immunosuppressive therapies (e.g., corticosteroids, alkylating agents, antimetabolites, cytotoxic agents, irradiation) may lead to a suboptimal immune response to the vaccine, as stated in official labeling.
Antipyretic Impact	Prophylactic oral administration of acetaminophen has been documented to reduce the antibody response to some vaccine serotypes following the third infant dose in specific studies.
Prior Vaccination Timing	Prior receipt of PPSV23 (Pneumococcal Polysaccharide Vaccine) within a one-year interval results in diminished immune responses to Prevenar 13 in adults, establishing a mandatory separation window.

Procedural and Physical Restrictions

When Prevenar 13 is administered at the same time as other injectable vaccines, the regulatory labels mandate that the vaccines must always be administered with different syringes and given at separate injection sites. The product must not be mixed with any other vaccines or products in the same syringe. Individuals with altered immunocompetence due to immunosuppressive treatment are explicitly noted as a population where a suboptimal response is a specific consideration.

Mechanism of Action

How Prevenar 13 Works: Mechanism of Action

Targeting Components and Conjugate System

This mechanism involves presenting specific polysaccharide components from 13 bacterial serotypes, chemically linked to a carrier protein (CRM197). This conjugation is necessary because it converts the polysaccharide component into a highly immunogenic antigen, causing the immune system to recognize the target components and initiate a specific immune activation cascade.

Immune Pathway Activation and Signaling

The presented conjugate molecules engage the adaptive immune system by stimulating a crucial signaling sequence involving T-cells and B-cells. This signaling leads to the rapid proliferation and differentiation of B-cells, which are the immune cells responsible for producing targeted antibodies.

Physiological Outcome: Memory and Antibody Generation

The mechanistic cascade results in two key physiological effects: the formation of long-lived immune memory cells and the generation of specific circulating IgG antibodies. The antibodies bind to the target components, facilitating their rapid clearance by white blood cells (opsonophagocytosis), and the memory cells support the systemic generation and long-term maintenance of immune recognition.

Dosage and Administration Information

How to Use Prevenar 13

Prevenar 13 is administered according to standardized, age-dependent schedules. Its use is strictly procedural, involving a specified route, fixed dosage volume, and preparation requirements as outlined in the product information.

Official Administration Guidelines

Instruction	Detail
Route of Administration	Intramuscular (IM) injection only. Administration sites are the anterolateral aspect of the thigh for infants or the deltoid muscle for older children and adults.
Standard Dose Volume	A fixed volume of 0.5 mL is used for each injection across all approved age groups.
Preparation Requirements	The pre-filled syringe must be shaken vigorously immediately before use to ensure the suspension is homogeneous. The product should be inspected and must not be used if the suspension cannot be achieved.

Official Dosing Schedules

Population	Frequency and Schedule	Use Pattern
Infants (Routine)	A four-dose series is administered, typically at 2, 4, 6, and 12 through 15 months of age.	Primary doses require separation by an interval of 4 to 8 weeks, and the final dose must be given at least 2 months after the preceding dose.
Adults (18+ Years)	A single 0.5 mL dose.	The regimen consists of a single injection, and official guidelines do not establish the need for revaccination in this population.

Procedural Structure

The usage protocol defines specific handling constraints. The vaccine is not to be mixed with any other products in the same syringe. For children who missed their initial doses, standard clinical protocols include specific catch-up schedules and dose counts based on their current age, such as a single dose for unvaccinated children between 24 months and 17 years.

Recent Clinical Evidence

Research evidence / Overview of Studies for Prevenar 13

The information here is derived from official regulatory reviews and major scientific publications, describing the evidence collected through clinical trials and post-licensure studies. This overview is intended to describe the available research, not to provide clinical guidance or recommendations.

Evidence for Use in Preventing Severe Systemic Infection (Invasive Pneumococcal Disease)

For older adults, research examined this outcome in a large-scale, controlled study (Randomized, Placebo-Controlled Trial) that monitored thousands of individuals. Studies observed patterns related to the occurrence of IPD within the groups receiving the vaccine compared to the control groups in the efficacy trial for older adults. Separately, studies exploring the vaccine's use in infants and children mainly focus on measuring the body’s functional antibody responses (a type of immune marker) against the 13 serotypes. Immunogenicity studies reported that antibody concentrations in infants and children one month after the primary series were comparable to levels historically observed in effective vaccination.

What remains uncertain is the long-term duration of these measured antibody responses. Furthermore, outcomes related to confirmed IPD in younger, healthy adults (18-64 years) are largely inferred from immunogenicity studies, as a large efficacy trial examining this clinical endpoint was not conducted for this specific age group. Research also indicates that the measured immune responses in certain severely immunocompromised populations were inconsistent.

Evidence for Use in Preventing Pneumonia

The research base for preventing pneumonia caused by the vaccine's serotypes has been primarily established through a major, long-term, controlled study observed in a large population of older adults aged 65 and above. This trial was designed to measure the rate of first episodes of confirmed Vaccine-Type Community-Acquired Pneumonia (VT-CAP). The adult RCT reported patterns in the occurrence of VT-CAP over the observation period in the groups receiving the vaccine versus the control group. Research explored outcomes related only to pneumonia caused by the vaccine serotypes; no evidence is available regarding the effect on pneumonia caused by non-vaccine serotypes or other pathogens.

Evidence for Use in Preventing Acute Otitis Media

Research was evaluated in infants and young children to study the vaccine’s role concerning Acute Otitis Media (AOM). Immunogenicity studies reported that measured antibody levels were comparable to those of a previously studied vaccine with established AOM data. Clinical studies reported on the occurrence rates of AOM caused by a defined subset of the 13 serotypes in the observed pediatric populations. A key limitation is that clinical evidence of protection against AOM has been established for only seven of the 13 serotypes included in the vaccine, meaning dedicated clinical outcome evidence is not established by clinical outcome trials for all 13 serotypes. Data for certain groups remain insufficient.

What is Still Uncertain About the Research for Prevenar 13

Clinical endpoints for IPD and pneumonia in healthy adults between 18 and 64 years old are largely inferred from immunogenicity data, meaning dedicated clinical outcome trials are not established for this group. Additionally, evidence is limited regarding the effect on diseases caused by non-vaccine serotypes, and long-term effects beyond the intermediate trial follow-up periods are not fully established across all studied populations. Research is ongoing to address these gaps and provide further insight into observed patterns.

Frequently Asked Questions (FAQ)

Common questions about Prevenar 13 (FAQ)

Q: Is Prevenar 13 a flu shot or is it different?

Prevenar 13 is a pneumococcal conjugate vaccine designed to protect against specific bacterial strains of Streptococcus pneumoniae. The influenza (flu) vaccine, on the other hand, is designed to protect against the influenza virus. These are two different vaccines that target different pathogens, though official guidelines indicate that co-administration with other vaccines is generally permissible.

Q: What is the difference between Prevenar 13 and Pneumovax 23?

Prevenar 13 (PCV13) is a 'conjugate' vaccine, which is designed to stimulate T-cell dependent immune memory. Pneumovax 23 (PPSV23) is a 'polysaccharide' vaccine. While both protect against pneumococcal bacteria, they cover a different number of strains—13 for PCV13 and 23 for PPSV23. Official guidance specifies the recommended order and time interval for giving these two vaccines to adults.

Q: Does Prevenar 13 protect against all types of pneumonia?

No. Official information clarifies that protection is limited specifically to pneumonia caused by the 13 types of Streptococcus pneumoniae bacteria contained within the vaccine. It does not provide protection against pneumonia caused by other types of pneumococcal bacteria or by other microorganisms such as viruses.

Q: Why do some people need a booster shot of Prevenar 13?

The fourth dose in the infant series is sometimes referred to as a booster, according to official schedules. Additionally, a specific four-dose series is outlined in official guidelines for certain patient populations, such as those who have received a haematopoietic stem cell transplant, following their initial doses.

Q: Can people with a known egg allergy get Prevenar 13?

According to official regulatory guidance, an allergy to eggs is not listed as a contraindication for Prevenar 13. Official product information states that contraindications include a history of severe allergic reaction (anaphylaxis) to any component of the vaccine or to diphtheria toxoid.

Q: How quickly does Prevenar 13 start working after the injection?

Immunogenicity studies typically assess the immune response approximately one month (28 to 42 days) after the final scheduled dose in a series. Official product information does not specify a precise number of days required to establish full protective immunity.

Q: Are there any long-term side effects associated with Prevenar 13 that I should know about?

Official product labeling does not list specific long-term adverse effects in its safety profile, which summarizes data from clinical trials and post-marketing reports. The safety profile is defined by reactions classified by frequency (e.g., Very Common, Common, Uncommon, Rare) and is continually monitored through post-marketing surveillance.

Q: Is the Prevenar 13 injection painful?

Pain or tenderness at the injection site is listed in the official safety information as a Very Common adverse reaction. This means that pain or tenderness is a common experience following the injection.

Q: Do you still need to get the yearly flu shot if you have had Prevenar 13?

Yes, Prevenar 13 and the influenza (flu) vaccine are two different vaccines that protect against different diseases (bacteria versus virus). Official public health guidelines recommend that the need for the yearly flu vaccine should be assessed independently of PCV13 status.

Q: Why do doctors recommend Prevenar 13 for people with certain chronic conditions?

Official guidelines indicate that the vaccine may be used in individuals with underlying conditions, such as certain heart, lung, or immune system disorders. These populations are considered to be at an elevated risk of severe pneumococcal disease.

Q: Can Prevenar 13 be administered to people who have had a splenectomy?

Official guidelines specifically address the use of PCV13 in patients with asplenia or a history of splenectomy, as they are considered to be at an elevated risk of serious pneumococcal disease and may benefit from vaccination.

Q: How effective is Prevenar 13 in preventing invasive pneumococcal disease?

Clinical studies in older adults reported a reduction in the occurrence of vaccine-type Invasive Pneumococcal Disease (IPD) in those who received the vaccine. For infants and children, the effectiveness is supported by studies showing a strong immune response (antibody levels) that correlates with protection against the disease.

Q: Does the brand name 'Prevenar' differ from 'Prevnar' in different countries?

Yes, the brand name for this pneumococcal conjugate vaccine varies by region. The vaccine is typically known as Prevnar 13 in the United States and Prevenar 13 in most other international markets, including those in Europe.

How should Prevenar 13 be stored and disposed of?

Storage and Disposal of Prevenar 13

The storage and handling of Prevenar 13 (pneumococcal 13-valent conjugate vaccine) are governed by specific regulatory requirements to ensure product stability.

Official Storage Requirements

Condition	Requirement
Temperature	Store refrigerated between 2 C to 8 C (36 F to 46 F).
Freezing	Do not freeze. The product must be discarded if it has been frozen.
Light Protection	The vaccine requires protection from light and must be kept in its original package.
Child Safety	Store out of the sight and reach of children.

Disposal Instructions

Unused or expired Prevenar 13 and all related waste materials must be disposed of in accordance with local regulations for pharmaceutical waste. The product must not be disposed of via household waste or wastewater.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.