Prevnar 13 VRBPAC Adult Indication Briefing Document
The data from the pivotal clinical trials support the following perspectives on the use of 13vPnC in adults:
www.fda.gov/.../VaccinesandRelatedBiologicalProductsAdvisoryCommittee/UCM279680.pdf
Prevnar 13 VRBPAC Adult Indication Briefing Document
The data from the pivotal clinical trials support the following perspectives on the use of 13vPnC
in adults:
• 13vPnC elicits an improved immune response compared to 23vPS when administered to
pneumococcal vaccine-naïve adults ?50 years of age.
• 13vPnC elicits an improved immune response compared to 23vPS and is the preferred
choice for reimmunization to enhance protection for adults ?70 years of age who have
been previously immunized with
• Whenever possible, 13vPnC should be administered first to pneumococcal vaccine-naïve
and 23vPS-experienced adults to take full advantage of the immunologic benefit afforded
by the conjugate vaccine. 13vPnC establishes immune memory and permits revaccination
to maintain an optimum functional anti-pneumococcal antibody response in both
pneumococcal vaccine-naïve and -experienced adults. 13vPnC permits immunization to
begin at 50 years of age and continue over an extended period of risk. By contrast, 23vPS
fails to induce immunologic memory, has a negative immunologic impact on a second
dose, and is therefore likely incapable of providing durable protection or comparable
protection with revaccination.
• Serotype-specific IgG and OPA immune responses to 13vPnC administered
concomitantly with TIV were lower for at least some serotypes compared to responses
when 13vPnC was given alone in adults 50 to 59 years of age and adults ?65 years of
age. Concomitant use of 13vPnC and TIV should be dictated by clinical circumstances.
• The safety profile of 13vPnC is acceptable in pneumococcal vaccine-naïve and
pneumococcal vaccine-preimmunized adults.
In conclusion, the 13vPnC vaccine has met the requirements for licensure as agreed with both
US and EU regulators. In addition, the specific requirement set forth by the FDA to demonstrate
potential benefit for older adults who have previously been vaccinated with the 23vPS vaccine
was met. The immunologic data support the likelihood that 13vPnC will address the unmet
medical need of providing greater protection against pneumococcal disease, including
community-acquired pneumonia, over a longer age range of adult risk. These observations and
conclusions support the introduction of 13vPnC into the public health system to satisfy an
important unmet medical need for protection of adults against pneumococcal disease, prior to
completion of the confirmatory community-acquired pneumonia efficacy trial.
