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ABSTRACT
Introduction: A number of pneumococcal vaccines have long been available and have been used to reduce the medical, social, and economic problems associated with Streptococcus pneumoniae-related diseases.
Areas covered: The main purpose of this review was to analyze what has been, until recently, the established doctrine regarding the safety and tolerability of pneumococcal vaccines that have been used in the past and are currently being used in children.
Expert opinion: Pneumococcal vaccines available on the market are all safe and are highly recommended in clinical practice. In children, pneumococcal conjugate vaccines (PCVs) are considered the preparations of choice because of their enhanced immunogenicity and superior ability to impact nasopharyngeal carriage. All PCVs are considered safe because the incidence of severe adverse events (AEs) is marginal. Nonetheless, evidence has emerged from post-marketing surveillance regarding the occurrence of very rare but significant potential AEs following PCV administration. Therefore, post-marketing surveillance should be maintained to confirm the existence of these AEs. Over the next few years, other pneumococcal vaccines will be developed. When these new products are licensed and reach the market, new technologies and innovative epidemiological methods will permit a more rapid and more effective evaluation of AEs.
Article highlights
To reduce the medical, social, and economic problems related to S. pneumoniae diseases, a number of safe and effective pneumococcal vaccines have been developed.
For pneumococcal vaccines as well as for all the other vaccines, initial safety monitoring should be followed by long-term post-marketing surveillance to confirm the safety of vaccines and rapidly identify rare health conditions that pre-licensure trials may not have had the power to detect.
Although the PPV23 is still advised during the second year of life to provide broader serotype coverage in children at risk of IPD, PPV23 use in children is debated because of the hypothesis that PPV23 can impair serum anticapsular antibody response to subsequent doses of PCVs and further, when PCVs are administered after PPV23, there may be a reduced ability to mount a memory response.
Although data on PPV23 safety in the pediatric population are scant, its overall safety and tolerability appears to be acceptable and not substantially different from those reported after the administration of PCVs.
PCV7 and PCV13 are both safe and well-tolerated vaccines even when administered concomitantly with other pediatric routine vaccines, although post-licensure surveillance has highlighted a possible increased risk of KD and febrile seizures following PCV13 administration.
PCV10 has demonstrated a high tolerability and safety, although an increased risk of fever is possible when administered concomitantly with other pediatric routine vaccines.
A firm clarification of the safety and tolerability of PCVs through post-marketing surveillance is critical to maintain the public’s confidence in and acceptance of these vaccines and avoid the risk that opponents of vaccination will find evidence that can be used to reduce vaccination coverage.
Alternative vaccine candidates that are based on conserved antigens, whole cell pneumococci, and recombinant bacteria expressing pneumococcal antigens are expected to have much lower production costs and significantly higher efficacy.
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Declaration of interest
This paper has been supported by Italian Ministry of Health (Bando Giovani Ricercatori 2009 GR-2009-1596786). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed