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Sanofi Takes SK Bio-partnered Pneumococcal Shot Into Phase 3

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Sanofi has moved ahead with plans to challenge Pfizer and MSD for a piece of the market for pneumococcal vaccines, taking a 21-valent shot licensed from SK Biosciences into phase 3 testing.

The pneumococcal conjugate vaccine – codenamed PCV21/GBP410 – has started pivotal trials in the prevention of both paediatric Streptococcus pneumoniae, which remains a major public health issue worldwide, with the first subject dosed last week.

At the moment, Pfizer's Prevnar franchise dominates the child and adult pneumococcal vaccine category, with sales of $4.85 billion in the first nine months of the year, slightly down on the same period of 2023. MSD (known as Merck & Co in the US and Canada), meanwhile, recorded $647 million with its rival conjugate vaccine Vaxneuvance and another $188 million from older, polysaccharide-based jab Pneumovax 23.

Pfizer's most up-to-date shot – Prevnar 20 – covers 20 S. Pneumoniae serotypes, while Vaxneuvance covers 15 serotypes. However, in June, MSD got the go-ahead from the FDA for a new vaccine, called Capvaxive, which spans 21 serotypes and is being targeted specifically at the over-50s age group.

Sanofi's new challenger is billed as a "next-generation" pneumococcal conjugate vaccine that, according to the company, is the first candidate with more than 20 serotypes in the category to enter phase 3 in infants and toddlers. It will also include serotypes that are not included in currently available conjugate vaccines.

It is part of a vaccines pipeline – including antibody-based Beyfortus for respiratory syncytial virus (RSV) prevention in infants – that Sanofi expects to add €10 billion to its annual sales by 2030.

In connection with the start of the phase 3 trials of PCV21, Sanofi has expanded its alliance with South Korea-based SK Bio, first signed more than a decade ago, paying an upfront fee of €50 million along with undisclosed development and commercial milestone payments.

The revised agreement covers PCV21 and follow-up pneumococcal conjugate vaccine candidates for both paediatric and adult populations. If approved, Sanofi will commercialise the vaccines worldwide except for South Korea, where SK Bioscience will have exclusive rights.

According to Evaluate Pharma data from June, the global pneumococcal vaccine market is projected to grow from around $8.2 billion in 2024 to $9.8 billion trillion in 2028, with a compound annual growth rate (CAGR) of 4.7%. The paediatric segment represents around two-thirds of the total market.

"Given the vast unmet public health needs in invasive pneumococcal disease (IPD), we're delighted to expand this collaboration and continue our pursuit of innovative work in PCV," remarked Sanofi's head of vaccines, Thomas Triomphe.

"Our collaboration leverages SK Bioscience's capabilities and Sanofi's expertise in developing and bringing innovative vaccines to people worldwide with the collective aim of reducing the global impact of pneumococcal disease."


Rising NVT Cases And Serotype Replacement Post-PCV13 In IPD

Photo Credit: Ktsimage

The following is a summary of "A nationwide study of two decades of invasive pneumococcal disease in the Faroe Islands, 2000–2023," published in the December 2024 issue of Infectious Disease by Kallsberg et al. 

Invasive pneumococcal disease (IPD) continues to be a significant public health issue, especially among vulnerable groups like the elderly, and this study examines trends in the Faroe Islands, where high vaccination coverage and geographic isolation provide a unique monitoring environment.  

Researchers conducted a retrospective study to investigate the prevalence, trends, and serotype distribution of IPD in the Faroe Islands from 2000 to 2023, with a focus on the impact of pneumococcal conjugate vaccines (PCVs) on disease incidence and serotype replacement.  

They analyzed 86 pneumococcal isolates, representing all IPD cases in the Faroe Islands during the study period. Data on patient demographics, serotype identification, and vaccination history were obtained from national health records. Temporal trends in vaccine-type (VT) and non-vaccine-type (nVT) serotypes were assessed, with particular focus on changes following the introduction of PCV13 in 2010.  

The results showed that after the introduction of the PCV13, a shift from VT to nVT serotypes occurred, while the overall IPD rate remained stable. A notable increase in IPD cases was observed among the elderly population. The analysis revealed that serotype replacement contributed to the rise in nVT cases despite a reduction in VT-related IPD.  

Investigators concluded the importance of continuous evaluation of pneumococcal vaccine formulations and alternative strategies to address the growing prevalence of nVT IPD, with higher-valency vaccines and sustained vaccination coverage being essential for mitigating serotype replacement and enhancing public health outcomes in the Faroe Islands. 

Source: tandfonline.Com/doi/full/10.1080/23744235.2024.2440033#abstract


Prognostic Value Of Neuroimaging In Severe Pneumococcal Meningitis

Photo Credit: KATERYNA

The following is a summary of "Intracranial complications in adult patients with severe pneumococcal meningitis: a retrospective multicenter cohort study," published in the December 2024 issue of Critical Care by Legouy et al. 

Researchers conducted a retrospective study to analyze the association between intracranial complications diagnosed on neuroimaging and neurological outcomes in adults with severe pneumococcal meningitis.  

They evaluated consecutive adults diagnosed with pneumococcal meningitis who required at least 48 hours of intensive care unit (ICU) stay and underwent neuroimaging between 2005 and 2021. The neuroimaging was reanalyzed for intracranial complications, categorized as an ischemic lesion, intracranial hemorrhage, abscess/empyema, ventriculitis, cerebral venous thrombosis, hydrocephalus, and diffuse cerebral edema. The primary outcome was an unfavorable outcome at 90 days after ICU admission, defined by a modified Rankin Scale (mRS) score > 2.  

The results showed that 68/220 (31%, 95% CI 0.25–0.37) of patients with neuroimaging at ICU admission and 75/110 (68%, 95% CI 0.59–0.77) during ICU stay had intracranial complications. At 90 days, 103 patients (44%, 95% CI 37–50) experienced unfavorable outcomes, including 71 deaths (30%). The most common complications were ischemic lesions (69/237, 29%), diffuse cerebral edema (43/237, 18%), and ventriculitis (36/237, 15%). Multivariable analysis revealed that intracranial complications (adjusted odds ratio [aOR] 2.88, 95% CI 1.37–6.21) were linked to unfavorable outcomes, along with chronic alcohol consumption (aOR 3.10, 95% CI 1.27–7.90), chronic vascular disease (aOR 4.41, 95% CI 1.58–13.63), focal neurological signs (aOR 2.38, 95% CI 1.11–5.23), and cerebrospinal fluid leukocyte count <1000 cells/microL (aOR 4.24, 95% CI 2.11–8.83). Competing risk analysis found chronic alcohol consumption (cause-specific hazard ratio 4.26, 95% CI 1.83–9.91) was significantly linked to persistent disability at 90 days, while other factors were associated with mortality.  

Investigators concluded the adults with severe pneumococcal meningitis, intracranial complications were independently associated with a significantly increased risk of poor functional outcome, emphasizing the importance of neuroimaging for both prognostication and patient management. 

Source: annalsofintensivecare.Springeropen.Com/articles/10.1186/s13613-024-01405-z 






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