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Vaxcyte, Inc. today announced positive topline results from the Phase 1/2 study evaluating the safety, tolerability, and immunogenicity of VAX-31, the Company’s 31-valent pneumococcal conjugate vaccine (PCV) candidate designed to prevent invasive pneumococcal disease (IPD).
In this Phase 1/2 study, VAX-31 was observed to be well tolerated and demonstrated a safety profile at all doses studied through the full six-month evaluation period similar to Prevnar 20® (PCV20).
The VAX-31 vaccine candidate showed robust opsonophagocytic activity (OPA) immune responses for all 31 serotypes at all doses studied.
At the middle and high doses, VAX-31 met or exceeded the OPA response non-inferiority criteria for all 20 serotypes common with PCV20.
At the VAX-31 high dose, average OPA immune responses were greater for 18 of 20 serotypes compared to PCV20 (geometric mean ratio (GMR) greater than 1.0), with seven of these serotypes achieving statistically higher immune responses compared to PCV20.
At the middle dose, 13 of 20 serotypes had a GMR greater than 1.0, and five serotypes achieved statistically higher immune responses compared to PCV20. For all 11 incremental serotypes unique to VAX-31 and not in PCV20, all three doses met the superiority criteria.
Based on the strength of the results from this study, the Company has selected VAX-31 to advance to an adult Phase 3 program. The Company plans to select the VAX-31 dose before initiating the adult Phase 3 program.
Grant Pickering, Chief Executive Officer and Co-Founder of Vaxcyte commented in a press release on September 3, 2024, “Based on the strength and clarity of these data, we have selected VAX-31 for the adult indication and plan to initiate the pivotal, non-inferiority Phase 3 study by mid-2025 and announce topline data in 2026."
"We intend to initiate the remaining VAX-31 Phase 3 studies in 2025 and 2026 and submit a Biologics License Application subject to the results of these studies.”
Pneumococcal disease is an infection caused by Streptococcus pneumoniae bacteria, leading to thousands of hospitalizations yearly in the U.S.
Valneva SE and Pfizer Inc. today announced positive immunogenicity and safety data from their VLA15-221 Phase 2 study following a second booster vaccination of their Lyme disease vaccine candidate, VLA15, given one year after receiving the first booster dose.
VLA15 is an investigational multivalent protein subunit vaccine that uses an established mechanism of action for a Lyme disease vaccine. It targets the outer surface protein A of Borrelia burgdorferi, the bacteria that causes Lyme disease.
There are currently no approved human vaccines for Lyme disease, and VLA15 is the candidate that has advanced the furthest along the clinical development timeline, with two Phase 3 trials in progress.
Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented in a September 3, 2024, press release, "We are encouraged by these data, which support the potential benefit of booster doses across all examined age groups."
"As Lyme disease continues to spread, it represents a significant unmet medical need, affecting numerous individuals throughout the Northern Hemisphere."
"Each new set of positive data brings us one step closer to potentially bringing this vaccine to adults and children living in areas where Lyme disease is endemic."
Subject to positive Phase 3 data, Pfizer aims to submit a Biologics License Application to the U.S. FDA and a Marketing Authorization Application to the European Medicines Agency in 2026.
The Centers for Disease Control and Prevention (CDC) estimated that approximately 476,000 people in the U.S. are diagnosed and treated for Lyme disease yearly. This disease was first identified in Lyme, Connecticut.
On August 14, 2024, the CDC reported (Volume 30, Number 9—September 2024) that the overall incidence of Lyme disease was about seven times higher than that reported through public health surveillance.
Unfortunately, the northeastern United States is the leading area for Lyme disease-carrying ticks.
For example, the Pennslyvania Department of Health Tickborne Disease Dashboard shows that while cases of Lyme disease peak in June through August, the threat exists year-round, primarily in the northwestern section of the state.
The U.S. Centers for Disease Control and Prevention (CDC) has repeatedly stated that the majority of measles cases confirmed in the United States are linked to unvaccinated international travelers.
This assumption was reaffirmed in late August 2024 when the CDC reported that out of the 236 measles cases this year, 87% were in patients who were either unvaccinated or whose vaccination status was unknown, and most had contact with international travelers.
Various health agencies have recently updated their data to help determine where these measles viruses may have originated.
The Europen CDC recently reported that 30 EU/EEA Member States had reported a total of 17,949 measles cases of measles and 13 related deaths over the past year.
For example, in July 2024, Romania (382), Belgium (92), Italy (91), and Germany (84) reported the highest measles patient counts. Throughout 2024, Germany has reported 435 measles cases.
Other recent measles hot spots have been India, with about 24,000 measles cases over the past year.
As of August 2024, 12,481 measles cases had been confirmed in the Region of the Americas.
The overall measles vaccination average in the Americas is about 85% coverage for the first MMR vaccine dose, indicating millions of unprotected people in the Americas.
While MMR vaccination is not a requirement to visit the U.S., the CDC recommends that all international travelers speak with a travel vaccine provider about their options to protect themselves from this highly transmittable virus.
The European CDC Communicable Disease Threats Report, published on August 30, 2024, disclosed that France had reported three autochthonous (locally-acquired) chikungunya virus disease cases in the Department of La Réunion from the same neighborhood.
The last major chikungunya outbreak in La Réunion was from 2005 to 2006.
The ECDC says the risk of chikungunya infection for residents and travelers to La Réunion is currently low. This mosquito-transmitted disease activity has been reduced as it's winter in La Réunion.
However, further cases cannot be excluded, says the ECDC.
La Réunion is an island in the Indian Ocean east of Madagascar and Africa that welcomes over 350,000 visitors annually.
As of September 2, 2024, the U.S. CDC had not issued a Travel Healht Advisory regarding La Réunion's chikungunya outbreak.
From a disease prevention option, Valneva SE's IXCHIQ® single-dose, live-attenuated chikungunya vaccine has been approved by the U.S. FDA and throughout Europe. Travel vaccination services are offered throughout the United States at certain pharmacies and Passport Health USA.
OVAX Inc. is now emerging from stealth mode with an initial $10 million seed funding backed by its team, concerned parents, and mission-aligned investors. According to Pitchbook reporting, no enterprise valuation was disclosed.
OVAX is developing Fentanyl Armour nasal spray vaccine technology designed to stop fentanyl overdoses. Illicit fentanyl kills approximately 200 Americans daily.
Fentanyl is a synthetic opioid that is often added to illegal drugs, says the U.S. CDC.
The company offers a defense system that immediately neutralizes fentanyl upon exposure and blocks the euphoric effects, enabling the healthcare industry to prevent overdoses leading to death.
On June 24, 2024, the company's media statement confirmed, 'Our vaccines (candidates) are designed to be taken a few times per year with several options in development, including a convenient nasal spray designed to be administered in the comfort of one's home, eliminating the requirement for a needle injection.'
The company licensed intellectual property from the University of Houston, Texas, which completed pre-clinical evaluations.
According to Ovax executives' comments, they plan to launch human clinical trials of Fentanyl Armour in 2025.
'We recognize that achieving our mission will require significant capital investment and a dedicated team. Additionally, OVAX will work alongside key collaborators at non-profits, governments, and communities dedicated to solving the fentanyl crisis,' wrote the company.
As of September 2024, there are no approved vaccines targeting fentanyl overdosing.
The U.S. Centers for Disease Control and Prevention (CDC) recently updated its annual vaccination recommendations for the 2024-25 flu season, noting two fundamental changes.
On August 29, 2024, the CDC stated (73(5);1–25) the primary updates include the following two topics: the composition of 2024–25 seasonal influenza vaccines with the return to trivalent vaccines and updated recommendations for vaccination of adult solid organ transplant recipients.
The CDC recommends that everyone six months and older, with rare exceptions, receive an annual flu shot beginning in the Fall of 2024—decisions about timing need to consider the unpredictability of the flu season.
As of September 2, 2024, various flu shots are available at most pharmacies in the United States. Last flu season, over 157 million influenza vaccines were distributed in the U.S.
A new study from researchers at Wake Forest University School of Medicine sheds light on how the U.S. news media recently portrayed scientific evidence and the uncertainty surrounding unproven therapeutics.
The research team analyzed news reports on how scientific evidence, evidence details and limitations, safety, efficacy, and sources of authority were portrayed to the public.
“We found that 67% of news reports included scientific evidence, but only 24% mentioned scientific publications or journals,” said the study’s corresponding author in a press release on August 29, 2024.
Zubin Master, Ph. D., associate professor of social sciences and health policy at Wake Forest University School of Medicine, commented, “This period of time (the recent pandemic) was when medical specialists and the general public were anxiously scrambling to learn as much as possible about prevention and treatments because there were yet no proven therapeutics or vaccines."
"This makes for an ideal case study to examine how the news media portrays scientific evidence.”
According to the American Press Institute, only 40% of the public read news articles beyond headlines or lead paragraphs.
“It’s crucial, especially with controversial science topics, that the evidence and uncertainty are featured more prominently,” Master said.
The study authors also noted that science can be strengthened by acknowledging limitations and by portraying science as a process that is constantly changing and being corrected as additional knowledge is gained.
These findings appear online in the Journal of Medical Internet Research Infodemiology.
