Prevnar 13 Vaccine Description
Prevnar 13 is a sterile suspension of saccharides of the capsular antigens of Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, individually linked to non-toxic diphtheria CRM197 protein.
PCV13 (pneumococcal conjugate vaccine) protects against 13 of the approximately 90 types of pneumococcal bacteria that can cause the most serious types of pneumococcal disease, including pneumonia, meningitis, and bacteremia. Prevnar 13 does not protect against diseases caused by S. pneumoniae serotypes that are not in the vaccine.
The U.S. FDA issued its approval for Prevnar 13 in 2010. In July 2016, the FDA expanded the age indication to include adults 18 through 49 years of age, in addition to the already approved indication for adults 50 years and older.
Prevnar 13 Vaccine Indication
Prevnar 13 is a vaccine indicated in children 6 weeks through 17 years (before 18th birthday) for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F. For children 6 weeks through 5 years of age (before the 6th birthday) to prevent otitis media caused by 7 of the 13 serotypes in the vaccine.
In adults 18 years of age and older, Prevnar 13 is indicated for active immunization to prevent pneumonia and invasive disease caused by S. pneumoniae serotypes in the vaccine, with certain health conditions.
The CDC’s Advisory Committee on Immunization Practices (ACIP) suggests that adults aged 65 years or older should receive only the 23-valent pneumococcal polysaccharide vaccine (PPSV23) with a few exceptions. This ACIP announcement was issued on November 22, 2019, because the pneumococcal vaccination recommendations had undergone several changes, confusing for those who need to select a preventive vaccine.
In 2014, the ACIP recommended that older adults receive the 13-valent pneumococcal conjugate vaccine (PCV13) first, then the PPSV23 at least 1 year later. Since then, widespread childhood vaccination with PCV13 and its predecessor, the 7-valent pneumococcal conjugate vaccine, have “led to sharp declines in pneumococcal disease among unvaccinated children and adults,” according to the ACIP’s review of the evidence.
Based on that review, the ACIP voted to remove the recommendation for routine use of PCV13, followed by PPSV23 in this senior population.
“Incidence of PCV13-type disease has been reduced to historically low levels among adults aged ≥65 years through indirect effects from pediatric PCV13 use,” the authors wrote.
The PPSV23 vaccine contains 12 serotypes in common with PCV13 and an additional 11 serotypes, for which there are no indirect effects from PCV13 use in children.
But, adults aged 19 years or older with an immunocompromising condition, cerebral spinal fluid leak, or cochlear implant should continue to receive both vaccines, the ACIP recommends.
And, some adults aged 65 years or older may have a greater risk of exposure to strains of Streptococcus pneumoniae covered by the PCV13 vaccine, such as those seniors living in nursing homes or long-term care facilities, people living in areas with low rates of pediatric vaccination with PCV13, or those traveling to areas with no childhood PCV13 vaccination program.
Prevnar 13 Vaccine Dosage
Prevnar 13 is administered as an intramuscular injection only. Visit Pfizer Prevnar 13 for detailed prescribing information.
Prevnar 13 News
March 10, 2021 - Pneumonia vaccine may affect the course of COVID-19. "Kaiser Permanente members who received the PCV13 vaccine appeared to be diagnosed with COVID-19 less often, and when they were, they seemed to have less severe outcomes, overall," said the senior author, Sara Y. Tartof, PhD, MPH, a scientist with the Kaiser Permanente Southern California Department of Research & Evaluation.
November 27, 2019 – Pneumococcal vaccination recommendations have undergone several changes in recent years, confusing for those who need to select a preventive vaccine.
October 15, 2019 – A new study has found a bacterial infection that can lead to pneumonia or meningitis is linked to weakened immune systems in children.
September 9, 2019 – Pfizer announced positive preliminary results of a Proof-of-Concept Phase 2 clinical study assessing its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate, PF-06482077.
Prevnar 13 Clinical Trials
Clinical Trial NCT03642847: Trial to Evaluate the Safety and Immunogenicity of Multivalent Pneumococcal Vaccines in Japanese Adults 18 to 49 Years of Age
This Phase 1b will describe the safety and immunogenicity of 2 multivalent pneumococcal conjugate vaccine formulations in healthy Japanese adults in the United States.
Clinical Trial NCT00205803: Study Evaluating Pneumococcal Vaccine in Healthy Infants
The purpose of this Phase 2 study is to evaluate the safety and immunogenicity of the 13-valent pneumococcal conjugate vaccine (13vPnC) in healthy infants. This is the first study with this vaccine in infants.
Clinical Trial NCT00500266: Study Evaluating Safety of 13-Valent Pneumococcal Conjugate Vaccine in Healthy Elderly Subjects
To evaluate the safety of 13-valent pneumococcal conjugate vaccine (13vPnC) in elderly subjects who were vaccinated with one or more doses of 23-valent pneumococcal polysaccharide vaccine (23vPS) at least 3 years before study enrollment.
Clinical Trial NCT01095471: 13 Valent Pneumococcal Conjugate Vaccine - Follow-on Study
This is a follow-on, multi-center, open-label, clinical trial. The purpose of this trial is to investigate the concentrations of serotype-specific antibodies to IgG included in PCV13 in children who have received either the PCV7 or PCV13 primary immunization at 2, 4, and 12 months of age. We intend to recruit all interested participants who completed the Wyeth-sponsored PCV13 infant trial study (6096A1-007) at selected study sites (i.e., those that recruited most of the children in the original study). The study will start in March 2010, at which time the eldest participants in the 6096A1-007 study will be approximately 42 months of age. There will be two visits per participant, 1 month apart from each other. At visit one, all participants will have a blood test and receive a dose of PCV13. At visit 2, all participants will have a blood test and will be offered the remaining pre-school booster vaccinations unless they have already received them.
Prevnar 13 vaccine news is published by Precision Vaccinations.com.