Yesterday evening Merck announced that the US FDA has authorized Enflonsia, its vaccine to prevent respiratory syncytial virus (RSV) infections in infants.
This approval will put Enflonsia in direct competition with Beyfortus, Sanofi's equivalent product, whose sales in the United States are expected to decline by 10% this year, analysts predict.
Analysts expect Beyfortus' market share to come under further pressure with the arrival of this new alternative.
However, the green light for Enflonsia comes amid regulatory uncertainty, with US Health Secretary Robert F. Kennedy Jr. recently dismissing all 17 members of the Advisory Committee on Immunization Practices (ACIP).
Kennedy has promised to reconstitute the panel, and the next ACIP meeting, scheduled for 25-27 June, is expected to go ahead as planned, but some observers fear a possible delay that could affect the vaccine distribution schedule.
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Merck KGaA is one of the world's leading pharmaceutical and chemical groups. Net sales break down by family of products as follows:
- solutions and products for scientific and biotechnological research (42.6%);
- pharmaceutical products (40.8%): prescription drugs for the treatment of diabetes, cancer, multiple sclerosis, infertility, cardiovascular disease, central nervous system disorders, inflammatory disorders, etc.;
- performance materials for the electronics industry (16.6%): semiconductor materials, liquid crystals, pigments and additives, carbon-based organic materials, etc.
Net sales are distributed geographically as follows: Germany (4.8%), Switzerland (1.9%), Europe (23.7%), the United States (24.8%), North America (1.3%), China (13.7%), Asia/Pacific (19.2%), Latin America (6.9%), Middle East and Africa (3.7%).
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