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PREVNAR 20™ (pneumococcal 20-valent conjugate vaccine)
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
PREVNAR 20™ Quick Finder
Highlights
Indications and Usage
1 INDICATIONS AND USAGE
Prevnar 20™ is a vaccine indicated for active immunization for the prevention of pneumonia and invasive disease caused by Streptococcus...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
For intramuscular administration only.
2.1 Preparation
Do not mix Prevnar 20 with other...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
Prevnar 20 is a suspension for intramuscular injection available in a 0.5 mL single-dose pre-filled syringe.
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Contraindications
4 CONTRAINDICATIONS
Severe allergic reaction (e.g., anaphylaxis) to any component of Prevnar 20 or to diphtheria toxoid [see Description (11)].
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Management of Acute Allergic Reactions
Appropriate medical treatment and supervision used to manage immediate allergic reactions must...
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Adverse Reactions
6 ADVERSE REACTIONS
In adults 18 through 59 years of age, the most commonly reported solicited adverse reactions >10% were pain at the injection site (>70%), muscle pain (>50%), fatigue (>40%), headache (>30...
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Drug Interactions
7 DRUG INTERACTIONS
7.1 Prior Vaccination with PNEUMOVAX 23
Receipt of PPSV23 1 to 5 years prior to Prevnar 20 resulted in diminished OPA geometric mean titers (GMTs...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
All pregnancies have a...
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Description
11 DESCRIPTION
Prevnar 20, Pneumococcal 20-valent Conjugate Vaccine is a sterile suspension of saccharides of the capsular antigens of S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A,...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Protection against pneumococcal disease is conferred mainly by opsonophagocytic killing of S....
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Prevnar 20 has not been evaluated for the potential to cause carcinogenicity,...
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Clinical Studies
14 CLINICAL STUDIES
14.1 Prevnar 13 Adult Efficacy Data
Efficacy and effectiveness of Prevnar 13 are relevant to Prevnar 20, since the vaccines are manufactured...
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
Pre-filled Syringe, 1 Dose (10 per package) – NDC 0005-2000-10.
Pre-filled Syringe, 1 Dose (1 per package) – NDC 0005-2000-02.
After shipping, Prevnar 20 may arrive at...
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Medication Guide
17 PATIENT COUNSELING INFORMATION
Prior to administration of this vaccine, inform the individual of the following:
- The potential benefits and risks of immunization with Prevnar 20...
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Report Adverse Event
To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at(800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.