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Clinical and evidence-based considerations for choosing a pneumococcal conjugate vaccine in India: A narrative review
Vijay Yewale1, Pallab Chatterjee2, Sanjay M Marathe3
1Department of Pediatrics, Apollo Children's Hospital, Navi Mumbai, India.
Insights
Pneumococcal conjugate vaccines (PCVs) are vital for preventing pneumococcal disease in children. This review examines evidence for evaluating PCV effectiveness and impact beyond initial immunogenicity studies.
Area of Science:
- Pediatrics
- Immunology
- Public Health
Background:
- Pneumococcal disease poses a significant public health challenge in India, despite being vaccine-preventable.
- Pneumococcal conjugate vaccines (PCVs) have improved disease prevention, particularly in young children, by surpassing limitations of older polysaccharide vaccines.
- Evaluating the real-world effectiveness and impact of new PCVs is crucial after their approval.
Purpose of the Study:
- To consolidate evidence-based considerations for evaluating pneumococcal conjugate vaccines (PCVs).
- To discuss critical aspects, importance, and limitations in assessing PCV performance in real-world settings.
Main Methods:
- This review synthesizes existing literature and evidence on PCV evaluation.
- It focuses on bridging immunogenicity data to vaccine efficacy and post-approval effectiveness.
Main Results:
- Immunogenicity studies are currently used as a proxy for PCV approval.
- Bridging immunogenicity results to vaccine efficacy requires robust post-approval effectiveness data.
- Real-world data is essential for a comprehensive understanding of PCV impact.
Conclusions:
- Establishing post-approval effectiveness and impact is critical for new PCVs.
- A thorough evaluation of PCVs must consider real-world performance beyond initial immunogenicity.
- This review provides a framework for evidence-based PCV assessment.
Abstract:
Immunization plays a crucial role in protecting children from life-threatening conditions such as pneumococcal disease. Pneumococcal disease can affect multiple organ systems and manifest as an invasive or noninvasive disease. Despite being preventable by vaccines, it remains a public health concern in India. The development of pneumococcal conjugate vaccines (PCVs) has helped reduce the burden of pneumococcal disease by overcoming the limitations of polysaccharide vaccines, especially in young children. Although immunogenicity is used as a proxy for the evaluation and approval of PCVs, results from immunogenicity studies have been bridged back to vaccine trial efficacy. Post-approval effectiveness and impact of new PCVs must be established. This review aims to consolidate evidence-based considerations that play a role in the evaluation of PCVs. Critical aspects related to the assessment of vaccines, their importance, and limitations in real-world contexts are discussed in this review.
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