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FDA approves Merck's new vaccine, marking a major change in pneumonia prevention

Merck, a global pharmaceutical company known as MSD outside of the United States and Canada, announced recently that its Capvaxive Pneumococcal 21-valent Conjugate Vaccine had obtained FDA approval. This immunisation aims to protect people from serious infections caused by Streptococcus pneumoniae bacteria.

Dr. Walter Orenstein of Emory University commented on the approval, saying, "Invasive pneumococcal disease complications can result in hospitalisation, organ damage, and even death." Many adult illnesses are caused by serotypes that are not covered by other vaccines. He emphasised that Capvaxive is designed to protect against the serotypes that cause adult invasive pneumococcal disease the most.

Capvaxive protects people over the age of eighteen from invasive infections and pneumonia caused by 21 different strains of Streptococcus pneumoniae. Unlike earlier immunisations, this one targets serotypes that are more prevalent in adult invasive pneumococcal disease (IPD) cases.

"Today's approval is a testament to our strategy behind Capvaxive, which demonstrated strong immune responses in various adult groups," said Merck Research Laboratories president Dr. Dean Y. Li. We are glad to introduce Capvaxive, a new option for adult protection against the majority of invasive pneumococcal disease-causing serotypes.

The approval is based on positive findings from a variety of clinical studies. In the Phase 3 STRIDE-3 research, adults who had never had a pneumococcal vaccine were compared to Capvaxive and PCV20. Strong immune responses to the immunisation resulted in approval.

The STRIDE-3 study was a controlled, randomised trial in which individuals had never received a pneumococcal vaccine. The major success indicator was opsonophagocytic activity, which assesses the vaccine's potential to elicit an immunological response. 

According to the CDC, the serotypes covered by Capvaxive were associated with more adult IPD cases than PCV20. Capvaxive, specifically, covers serotypes that account for approximately 84% of IPD cases in people aged 50 and up, whereas PCV20 covers approximately 52%. Capvaxive covers approximately 85% of IPD instances in people 65 and older, compared to 51% with PCV20.

With the FDA's approval of Capvaxive, infectious disease control, particularly pneumococcal disease control, is expected to improve dramatically. Because of the increased protection given by this vaccination, fewer hospitalisations and deaths from these severe diseases may occur. The CDC's Advisory Committee on Immunisation Practices will meet shortly to discuss adult capvaxive usage recommendations.

Overall, Capvaxive's release is a huge step forward in the fight against invasive pneumococcal diseases, with the potential to save many lives and reduce strain on healthcare systems.

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