Streptococcus

Summary of opinion: Apexxnar, 25/01/2024 Positive

Retrieved on: 
Sunday, February 4, 2024

On 25 January 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Prevenar 20.

Key Points: 
  • On 25 January 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Prevenar 20.
  • The marketing authorisation holder for this medicinal product is Pfizer Europe MA EEIG.
  • The CHMP adopted an extension to the existing indication for prophylaxis against pneumonia and acute otitis media caused by pneumococci and associated invasive disease, in infants, children and adolescents.
  • Active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older.

Summary of opinion: Apexxnar, 25/01/2024 Positive

Retrieved on: 
Monday, January 29, 2024

On 25 January 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Prevenar 20.

Key Points: 
  • On 25 January 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Prevenar 20.
  • The marketing authorisation holder for this medicinal product is Pfizer Europe MA EEIG.
  • The CHMP adopted an extension to the existing indication for prophylaxis against pneumonia and acute otitis media caused by pneumococci and associated invasive disease, in infants, children and adolescents.
  • Active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older.

New OmniSYS XiFin Pharmacy Solutions CareALERTS™ Data Demonstrate Critical Role Pharmacists Play as Healthcare Providers

Retrieved on: 
Friday, January 12, 2024

OmniSYS, the pharmacy division of XiFin, Inc., announced its 2023 end-of-year CareALERTS™ data, demonstrating how pharmacists as providers are closing healthcare gaps at the point of care.

Key Points: 
  • OmniSYS, the pharmacy division of XiFin, Inc., announced its 2023 end-of-year CareALERTS™ data, demonstrating how pharmacists as providers are closing healthcare gaps at the point of care.
  • OmniSYS released this data on National Pharmacist Day to celebrate pharmacists and urges all U.S. states to recognize pharmacists as providers of clinical services who can help address physician shortages and improve healthcare access for the nation’s most vulnerable and underserved communities.
  • "We deeply appreciate the vital role pharmacists play in enhancing the well-being of Americans, especially seniors facing healthcare challenges.
  • “The role of the pharmacy continues to evolve as millions of Americans rely on pharmacists as first-line providers of healthcare,” said XiFin chief pharmacy officer David Pope, PharmD, CDE.

Inventprise Completes Vaccination of Participants in a Phase 2 Dose Ranging Study of its 25 Valent Pneumococcal Vaccine Candidate

Retrieved on: 
Tuesday, January 2, 2024

Biotechnology company Inventprise Inc. today announced the completion of vaccination in their Phase 2 dose ranging study of its 25-valent pneumococcal conjugate vaccine (IVT PCV-25) in young adults.

Key Points: 
  • Biotechnology company Inventprise Inc. today announced the completion of vaccination in their Phase 2 dose ranging study of its 25-valent pneumococcal conjugate vaccine (IVT PCV-25) in young adults.
  • This Phase 2 study is an important step in the efforts to develop an affordable, expanded-coverage pneumococcal conjugate vaccine (PCV).
  • The Inventprise PCV includes 25 serotypes—expanding the potential to prevent several deadly and emerging serotypes not yet addressed by existing PCVs.
  • A Phase 2 study in older adults is also planned to take place in the second half of 2024.

Fascia: the most neglected part of our body is finally starting to receive attention

Retrieved on: 
Saturday, December 30, 2023

However, there is also a growing interest in one element of our anatomy that is often overlooked: our fascia.

Key Points: 
  • However, there is also a growing interest in one element of our anatomy that is often overlooked: our fascia.
  • Fascia is a thin casing of connective tissue, mainly made of collagen – a rope-like structure that provides strength and protection to many areas of the body.
  • It surrounds and holds every organ, blood vessel, bone, nerve fibre and muscle in place.
  • It is hard to see fascia in the body, but you can get a sense of what it looks like if you look at a steak.

When fascia gets damaged

  • Injury to fascia takes a long time to repair, probably because it possesses similar cells to tendons (fibroblasts), and has a limited blood supply.
  • Recently, fascia, particularly the layers close to the surface, have been shown to have the second-highest number of nerves after the skin.
  • Up to 30% of people with musculoskeletal pain may have fascial involvement or fascia may be the cause.

Fascia in disease

  • Aside from getting damaged, fascia can also provide paths that infections can travel along, within muscles.
  • This is a particular problem in the neck, where there are several layers of fascia for infections to travel along.
  • Fascia can also be implicated in more serious health conditions, such as necrotising fasciitis.

We can see it better now

  • One reason fascia has been overlooked in health and disease is because it was difficult to see using current imaging technology.
  • More recently, though, MRI and ultrasound imaging have been shown to be beneficial in visualising fascia, particularly in musculoskeletal conditions such as plantar fasciitis, and pathological changes in the fascia of the shoulder and neck.


Adam Taylor does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.

FDA Grants Priority Review to Merck’s New Biologics License Application for V116, an Investigational, 21-valent Pneumococcal Conjugate Vaccine Specifically Designed to Protect Adults

Retrieved on: 
Tuesday, December 19, 2023

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has accepted for priority review a new Biologics License Application (BLA) for V116, the company’s investigational 21-valent pneumococcal conjugate vaccine specifically designed to help prevent invasive pneumococcal disease and pneumococcal pneumonia in adults.

Key Points: 
  • Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has accepted for priority review a new Biologics License Application (BLA) for V116, the company’s investigational 21-valent pneumococcal conjugate vaccine specifically designed to help prevent invasive pneumococcal disease and pneumococcal pneumonia in adults.
  • The FDA grants priority review to medicines and vaccines that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment or prevention of a serious condition.
  • The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action date, of June 17, 2024.
  • “If approved, V116 would be the first pneumococcal conjugate vaccine specifically designed to address the serotypes that cause most adult invasive pneumococcal disease.

Merck’s V116, an Investigational, 21-valent Pneumococcal Conjugate Vaccine Specifically Designed to Protect Adults, Demonstrated Superior Immunogenicity for 10 of 11 Unique Serotypes Compared to PCV20 in Adults 50 Years of Age and Older

Retrieved on: 
Tuesday, November 28, 2023

The trial evaluated the immunogenicity, tolerability and safety of V116 compared to PCV20 (pneumococcal 20-valent conjugate vaccine) in adults who had not previously received a pneumococcal vaccine.

Key Points: 
  • The trial evaluated the immunogenicity, tolerability and safety of V116 compared to PCV20 (pneumococcal 20-valent conjugate vaccine) in adults who had not previously received a pneumococcal vaccine.
  • In adults 18 to 49 years of age (Cohort 2), V116 elicited non-inferior immune responses (immunobridged) compared to adults 50 to 64 years of age, as assessed by serotype-specific OPA GMTs 30 days post-vaccination.
  • If approved, V116 would be the first pneumococcal conjugate vaccine specifically designed for adults.
  • Participants administered V116 and PCV20 who reported at least 1 adverse event (AE) were 61.7% and 67.2%, respectively.

Longhorn Vaccines and Diagnostics Presents Targeted Vaccine Approach for Mycobacterium Tuberculosis with LHNVD-301

Retrieved on: 
Wednesday, November 15, 2023

Longhorn Vaccines and Diagnostics , a One Health company developing vaccines and diagnostic tools for global public health and zoonosis concerns, today presented new data from an animal study of LHNVD-301, the company’s lead tuberculosis vaccine candidate.

Key Points: 
  • Longhorn Vaccines and Diagnostics , a One Health company developing vaccines and diagnostic tools for global public health and zoonosis concerns, today presented new data from an animal study of LHNVD-301, the company’s lead tuberculosis vaccine candidate.
  • The data showed that a mycobacterium tuberculosis (MTB) vaccine could generate broader protection against other pathogens susceptible to antimicrobial resistance (AMR).
  • LHNVD-301 is an unconjugated, peptide-based vaccine that combines a MTB heat shock protein epitope and a peptidoglycan (PGN) epitope.
  • It represents a novel approach that combats AMR, while targeting tuberculosis by combining multiple epitopes specific to MTB and common to gram-positive bacteria into a peptide vaccine.

Major new vaccines initiative aims to fight deadly airborne infections

Retrieved on: 
Monday, December 18, 2023

The aim is to create new or improved vaccines for some of the deadliest respiratory diseases, including tuberculosis (TB) and influenza.

Key Points: 
  • The aim is to create new or improved vaccines for some of the deadliest respiratory diseases, including tuberculosis (TB) and influenza.
  • Developed in partnership with the University of Copenhagen, it is the first vaccines initiative globally to focus solely on understanding how to generate immunity in the airway itself.
  • "The development of the Covid-19 vaccines demonstrated the extraordinary possibilities when interdisciplinary vaccine research and development are prioritised," says Krogsgaard Thomsen.
  • "We hope that NIVI's work can help prepare us for the next pandemic or even help consign airborne epidemics to history."

Major new vaccines initiative aims to fight deadly airborne infections

Retrieved on: 
Monday, December 18, 2023

The aim is to create new or improved vaccines for some of the deadliest respiratory diseases, including tuberculosis (TB) and influenza.

Key Points: 
  • The aim is to create new or improved vaccines for some of the deadliest respiratory diseases, including tuberculosis (TB) and influenza.
  • Developed in partnership with the University of Copenhagen, it is the first vaccines initiative globally to focus solely on understanding how to generate immunity in the airway itself.
  • "The development of the Covid-19 vaccines demonstrated the extraordinary possibilities when interdisciplinary vaccine research and development are prioritised," says Krogsgaard Thomsen.
  • "We hope that NIVI's work can help prepare us for the next pandemic or even help consign airborne epidemics to history."