Pneumococcal Vaccine Safety

Pneumococcal Disease and How to Protect Against It

Pneumococcal disease is an infection caused by Streptococcus pneumoniae bacteria, sometimes referred to as pneumococcus. Pneumococcus can cause many types of illnesses, including ear and sinus infections, pneumonia, and bloodstream infections. You can protect against pneumococcal disease with safe, effective vaccination.

Pneumococcal Vaccine Side Effects

Pneumococcal vaccines are very safe and effective at preventing pneumococcal disease. Vaccines, like any medicine, can have side effects. The most common side effects from pneumococcal vaccines are mild and last 1 or 2 days.

Very rarely, severe (anaphylactic) allergic reactions may occur after vaccination.

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Available Pneumococcal Vaccines

There are two pneumococcal vaccines approved for use in the United States:

• Prevnar13 (PCV13) [PDF – 584 KB]: The Food and Drug Administration (FDA) approved this vaccine in 2010 for use in children and in 2011 for use in adults. PCV13 replaced a previous pneumococcal vaccine, PCV7. PCV13 protects against the 13 types of pneumococcal bacteria that cause the most severe illness among children and adults. It is recommended for routine use among children younger than 5 years of age and adults 65 years of age and older. It is also recommended to help prevent pneumococcal disease in individuals 6 through 64 years of age with certain medical conditions that place them at increased risk for pneumococcal disease.
• Pneumovax 23 (PPSV23) [PDF – 259 KB]: FDA approved this vaccine in 1983. It protects against 23 types of pneumococcal bacteria. Pneumovax 23 is recommended for all adults 65 years of age and older and for those 2 years and older who are at increased risk for pneumococcal disease. 

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How CDC Monitors Pneumococcal Vaccine Safety

CDC and FDA monitor the safety of vaccines after they are licensed.  Any problems detected with these vaccines will be reported to health officials, health care providers, and the public. Needed action will be taken to ensure the public’s health and safety.

CDC uses three systems to monitor vaccine safety:

• The Vaccine Adverse Event Reporting System (VAERS) – an early warning system that helps CDC and FDA monitor problems following vaccination.  Anyone can report suspected vaccine reactions and issues to VAERS.
• The Vaccine Safety Datalink (VSD) – a collaboration between CDC and several health care organizations that allows ongoing monitoring and proactive searches of vaccine-related data.
• The Clinical Immunization Safety Assessment (CISA) Project – a partnership between CDC and several medical centers that conduct clinical research on vaccine-associated health risks in certain groups of people.

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A Closer Look at the Safety Data

• A 2004 study found most VAERS reports in the first 2 years after licensure of 7-valent pneumococcal conjugate vaccine (PCV7) were minor known side effects.
• Two large 2013 studies (Jackson et al; Jackson et al) conducted in the United States and Europe in adults aged 50 years and older compared PCV13 with PPSV23. Common adverse events reported with PCV13 were pain, redness, and swelling at the injection site; limited movement of the injected arm; tiredness; headache; chills; decreased appetite; generalized muscle pain; and joint pain.  Similar reactions were observed in adults who received PPSV23.
• A 2012 study showed that children who received both 2010-2011 trivalent influenza (flu) vaccine and PCV13 at the same doctor visit had a higher risk of fever-related seizures (febrile seizures).

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More Resources

• Pneumococcal Vaccine Information Statement
• Pneumococcal Vaccine: Who Should Not Be Vaccinated
• Pneumococcal Vaccination: Who Needs It?
• U.S. Vaccine Abbreviations [PDF – 196 KB]

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Related Scientific Articles

Centers for Disease Control and Prevention. Licensure of 13-valent pneumococcal conjugate vaccine for adults aged 50 years and older. MMWR. 2012 Jun 1;61(21):394-5.
 

Hak E, Grobbee DE, Sanders EA, et al. Rationale and design of CAPITA: A RCT of 13-valent conjugated pneumococcal vaccine efficacy among older adults. Neth J Med. 2008;66:378–83.
 

Jackson LA, Gurtman A, van Cleeff M, et al. Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine compared to a 23-valent pneumococcal polysaccharide vaccine in pneumococcal vaccine-naive adults. Vaccine. 2013;31:3577–84.
 

Jackson LA, Gurtman A, Rice K, et al. Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine in adults 70 years of age and older previously vaccinated with 23-valent pneumococcal polysaccharide vaccine. Vaccine. 2013;31:3585–93.
 

Tomczyk S, Bennett NM, Stoecker C, Gierke R, Moore MR, Whitney CG, et al. Use of PCV-13 and PPSV-23 vaccine among adults aged 65 and older: Recommendations of the ACIP. MMWR. 2014;63(37);822-825.
 

Tse A, Tseng HF, Greene SK, Vellozzi C, Lee GM; VSD Rapid Cycle Analysis Influenza Working Group. Signal identification and evaluation for risk of febrile seizures in children following trivalent inactivated influenza vaccine in the Vaccine Safety Datalink Project, 2010-2011. Vaccine. 2012 Mar 2;30(11):2024-31.
 

Wise RP, Iskander J, Pratt RD, Campbell S, Ball R, et al. Postlicensure safety surveillance for 7-valent pneumococcal conjugate vaccine. JAMA. 2004 Oct 13;292(14):1702-10.
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