The medicines regulator has endorsed Merck’s 21-valent pneumococcal vaccine for adults.
The active substance of Capvaxive works by triggering an immune response against 21 serotypes that cause most invasive pneumococcal disease cases.
At its January meeting, the EMA’s Committee for Medicinal Products for Human Use accepted immunobridging data demonstrating the vaccine’s effectiveness.), which evaluated the vaccine’s safety, tolerability, and immunogenicity. The study found that Merck’s Capvaxive was noninferior to Pfizer’s Prevenar 20 for the 10 serotypes common to both vaccines.The vaccine is supplied as a solution for injection in a prefilled syringe.
The EMA’s recommendation will now be sent to the European Commission for final approval. If authorized for EU use, it will mark the fourth approval for Capvaxive in this indication. The vaccine was greenlit in the United States and Canada in 2024 and in Australia earlier this month. Peter Russell has been a journalist for 40 years covering international news, health, medicine, and national politics on radio, TV, and online. He is based in the United Kingdom.All material on this website is protected by copyright, Copyright © 1994-2025 by WebMD LLC. This website also contains material copyrighted by 3rd parties.
Vaccine Vaccines Pneumococcal Vaccine Pneumococcal Immunization Pneumococcal Immunisation Patient Safety Europe European Adverse Effects Side Effects Adult Vaccines Myalgia Muscle Pain Pain Management Bacteria Bacterial Infection Canada Canadian Children Child Childhood Pediatrics Kids Clinical Research Clinical Trials Clinical Studies Pre-Clinical Trial
United States Latest News, United States Headlines
Similar News:You can also read news stories similar to this one that we have collected from other news sources.
Israel’s full Cabinet meets on Gaza ceasefire deal after security Cabinet recommends approvalThe deal has drawn fierce resistance from Netanyahu’s far-right coalition partners, but their objections could destabilize his government.
Read more »
European Regulator Recommends Approval for Alzheimer's Drug Lecanemab After ReversalThe European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for Lecanemab, a drug used to treat early Alzheimer's disease. This follows a reversal of an initial rejection in July 2024 due to concerns about side effects. The CHMP now recommends approval for patients with one or no copies of the apolipoprotein epsilon 4 (APOE4) gene variant, with risk minimization measures in place to address potential amyloid-related imaging abnormalities (ARIA).
Read more »
Cozy Products for Cold WeatherThis article recommends cozy products perfect for staying warm and comfortable during the colder months.
Read more »
Dogecoin's Price Action at 26 EMA: Three Possible ScenariosDogecoin is currently testing the 26 EMA resistance level, a crucial point for its future price movement. This article explores three potential scenarios based on how DOGE interacts with this resistance: a breakout, a rejection, or a sideways movement. Each scenario outlines its implications for the price, including potential target ranges and market sentiment.
Read more »
EUR/USD Dips Below 100-Day EMA; Bearish Outlook PersistsThe EUR/USD pair weakens on Monday, trading near 1.0315. The anticipation of further ECB interest rate cuts weighs on the Euro. Technical indicators suggest a bearish bias, with the pair trading below the 100-day EMA and RSI indicating downward momentum.
Read more »
Islands to Visit in 2025This article recommends several islands to visit in 2025, highlighting their unique attractions and cultural experiences.
Read more »