IMPORTANT SAFETY INFORMATION & USE
IMPORTANT SAFETY
INFORMATION & USE
PREVNAR 20Ⓡ
(Pneumococcal 20-valent Conjugate Vaccine)
IMPORTANT SAFETY INFORMATION FOR PREVNAR 20
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Prevnar 20 should not be given to anyone who has had a severe allergic reaction to any component of Prevnar 20 or to diphtheria toxoid.
- Individuals with weakened immune systems may have a lower immune response. Safety data are not available for these groups.
- A temporary pause in breathing after getting the vaccine has been observed in some infants who were born prematurely. For premature infants, talk to your healthcare provider about the infant's medical status when deciding to get vaccinated with Prevnar 20.
- In individuals 2, 4, 6, and 12 through 15 months of age vaccinated with a 4-dose schedule, the most common side effects reported at a rate of >10% were irritability, pain at the injection site, drowsiness, decreased appetite, injection site redness, injection site swelling, and fever.
- In individuals 15 months through 17 years of age vaccinated with a single dose, the most common side effects reported at a rate of >10% were irritability, pain at the injection site, drowsiness, fatigue, muscle pain, decreased appetite, injection site swelling, injection site redness, headache, and fever.
- In individuals 18 years and older, the most common side effects reported at a rate of >10% were pain at the injection site, muscle pain, fatigue, headache, and joint pain. Also, injection site swelling was common in individuals 18 years through 59 years of age.
- Ask your healthcare provider about the risks and benefits of Prevnar 20. Only a healthcare provider can decide if Prevnar 20 is right for you or your child.
Please click here for Prevnar 20 Full Prescribing Information.
Patients should always ask their healthcare providers for medical advice about adverse events. You are encouraged to report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit http://www.vaers.hhs.gov or call 1‐800‐822‐7967.
What is PREVNAR 20?
Prevnar 20 is a vaccine approved for:
- the prevention of invasive disease caused by 20 Streptococcus pneumoniae strains (1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F) in individuals 6 weeks and older.
- the prevention of otitis media (middle ear infection) caused by 7 of the 20 strains in individuals 6 weeks through 5 years.
- active immunization for the prevention of pneumonia caused by Streptococcus pneumoniae strains 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in individuals 18 years of age and older.
The indication for the prevention of pneumonia caused by S. pneumoniae serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F in individuals 18 years of age and older is approved based on immune responses. Continued approval may depend on a supportive study.
Patients should always ask their healthcare providers for medical advice about adverse events. You are encouraged to report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit http://www.vaers.hhs.gov or call 1‐800‐822‐7967.