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Merck’s Next-Generation Pneumonia Vaccine Gets FDA Approval

XTalks

Merck has scored US Food and Drug Administration (FDA) approval for its next-generation pneumonia vaccine Vaxneuvance that covers 15 different strains of the pneumococcal bacteria that causes the infection. Both next-gen shots offer enhanced protection against bacteria that can cause pneumonia, blood infections and meningitis.

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Merck’s Capvaxive Wins FDA Approval as First Pneumonia Vaccine Designed for Adults

XTalks

Capvaxive’s approval was partially based on data from four Phase III trials including the STRIDE-3 study, which found that the vaccine was non-inferior to comparator vaccine Prevnar 20. According to a November 2023 readout, Capvaxive also elicited superior immune responses for ten of the 11 serotypes not covered by Prevnar 20.

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Vaxcyte trains its sight on a lucrative market with pneumococcal vaccine

Pharmaceutical Technology

What’s more, VAX-24 achieved a higher immune response to 16 of the 20 serotypes it shares with Prevnar 20. The company says that these four serotypes represent roughly 10–15% of bacteria causing pneumococcal disease in adults. This is in addition to its long-available pneumococcal polysaccharide vaccine PPSV23.

Vaccine 162
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Prevention of Invasive Pneumococcal Disease in Adults 18 Years and Older Caused by 15 Serotypes

The Pharma Data

Clinical Data Supporting Approval Demonstrated Non-Inferior Immune Responses for the Serotypes Shared with PCV13 (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F). VAXNEUVANCE Elicited Superior Immune Responses for Serotypes 3, 22F and 33F Compared to PCV13, Which Are Major Causes of Disease.

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Understanding the microbiome as an ‘overlooked critical organ’

pharmaphorum

The biotech is eligible to receive a further $125 million if the FDA approves the drug and could receive another $225 million in commercial milestones. If approved by the FDA, the treatment would become the first microbiome-based treatment to receive approval. Compelling advantages.

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U.S. FDA Approves PREVNAR 20™, Pfizer’s Pneumococcal 20-valent Conjugate Vaccine for Adults Ages 18 Years or Older

The Pharma Data

Food and Drug Administration (FDA) has approved PREVNAR 20 (Pneumococcal 20-valent Conjugate Vaccine) for the prevention of invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes in the vaccine in adults ages 18 years and older. Following today’s FDA approval, the U.S.

Vaccine 52
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2021 Year in Review: Leveraging New Technologies to Drive Innovation in the Life Sciences

XTalks

Developing a highly effective vaccine against malaria has been technically challenging because malaria has a large and complex genome, and it’s why it’s generally more difficult to develop a vaccine against parasites than smaller viruses and bacteria.