Europe agrees to the anti -cottage vaccine vaccine

MSD He declared that the European Commission (EC) has agreed to its new anti -cottage vaccine for active immunization to prevent gaseous diseases and pneumonia in individuals 18 years or more. that it Anti -gun vaccine Specially designed to help protect adults from serous patterns that cause most cases Invasive (Eni).

This decision allows marketing Among the vaccine in the 27 European Union member states (EU), as well as in Iceland, Liechtenstein and Norway. for him Available in every country It will depend on several factors, including compliance with payment procedures. The vaccine was approved in the United States in June 2024 and Canada in July 2024 and in Australia in January 2025.

“the Pneumonia He continues to represent a High risk For adults in Europe, especially for those who are 65 years old or age The third stage of Stride Clinical Program dataThe vaccine provides coverage against serous patterns responsible for most cases of invading disease in adults, which makes this approval of the European Union in an important step to help protect adults from pneumococcal disease. “

“When focusing on the serous patterns that were responsible for most cases of invasive pulmonary pneumonia in adults, this vaccine helps us to protect adults specifically.” Paula AnonziatoFirst Vice President for Infectious and Vaccine Diseases, the global clinical development of research laboratories MSD. “We are proud to provide this vaccine to adults in Europe so that they can benefit from their wide protection, and we are excited to continue working with the organizational authorities to expand the availability of vaccine around the world.”

CE decision follows Positive Drugs Committee for Human Use (CHMP) Subordinate European Pharmaceutical Agency (EMA)Issued in January 2025, based on the results of the third stage of Stride-3 (NCT05425732), which valued the V116 compared to adults over the age of 18 and who have not previously received an anti-aura vaccine. 23 value) In adults 50 years or more who have not received an anti -cottage vaccine. Approval is also supported by the results of the third stage Stride-4 (NCT054644420), Stride-5 (NCT05526716), Stride-6 (NCT05420961), and Stride-7 (NCT05393037) (see “clinical data that supports approval CE” for more details).

Clinical data that supports EC approval

CAPVAXIXE has been approved by CE based on the data that included clinical studies for the third stage designed to evaluate their security and immunity file in a variety of adult population. These studies included:

• Stride-3 (NCT05425732): A dual blind study of the third stage that evaluated the V116 compared to PCV20 in people who are 18 years or more who have not received an anti -cottage vaccine. The 50 -year -old participants were appointed to the 1 (n = 2,362) and the participants from 18 to 49 years to regiment 2 (N = 300). They were randomly chosen for the participants to receive a unique dose of V116 or PCV20.
• Stride-10 (NCT05569954): A dual random study of the third stage, which valued the V116 compared to PPSV23 in people between the ages of 50 or more who have not received by an anti -observation vaccine (n = 1,484).
• Stride-4 (NCT05464420)A dual random study of the third stage of consistency between the pieces that were evaluated in people between the ages of 18 to 49 who have not received an anti -cottage vaccine (n = 2,162). They were randomly chosen for the participants to receive a unique dose of one of three V116 or PPSV23 (anti -Oraldi anti -cottage vaccine 23).
• Stride-5 (NCT05526716): A random and double study of the third stage, which valued the V116 when it was managed simultaneously or sequentially (after 30 days) with the QIV vaccine in adults 50 years or more (n = 1.080).
• Stride-6 (NCT05420961): A random descriptive study of the third stage that evaluated V116 in people 50 years or more who previously received an anti -joining vaccine at least one year before employment. Participants enrolled in one of the three groups, depending on their previous history of anti -cottage vaccination (Vovel 1: PPSV23 (PPSV23 (PCV13 anti -azurecase vaccine, PPSV23 preceded by PCV15 (anti -stolen vaccine in 15 value), or PCV15 alone). They were randomly chosen from participants in Coprote 1 To receive V116 (n = 231) or PCV15 (n = 119), they were randomly chosen from the participants of the 2nd Vup. ≥4 increased in OPA responses from start to one month after vaccination.
• Stride-7 (NCT05393037)A dual blind study of the third stage that evaluated the V116 in people who are 18 years old or older with HIV (HIV) (N = 304) did not receive an anti -rhythm vaccine or with previous experience with the vaccine before studying. They were randomly chosen for the participants to receive V116 or PCV15 + PPSV23.