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Real World Evidence Supports Protein-based COVID-19 Vaccination

Protein-based Nuvaxovid vaccine delivers measurable protection

April 12, 2024

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The latest report on measles cases in England shows a steady increase in numbers and a shift in geographical distribution.

According to the April 11, 2024 update from the U.K. Health Security Agency (UKHSA), 89 laboratory-confirmed cases have occurred in the past week, bringing the total number of confirmed cases since October 2023 to 1,023.

While the outbreak in the West Midlands initially caused the surge in measles cases, the latest data reveals that London now has the highest number of newly confirmed cases.

There have been 195 measles cases in the last month, 35% of which (69 cases) were reported in London and 32% (62 cases) in the West Midlands.

In a press release, Dr. Rob Verrecchia, UKHSA Health Protection Consultant, said, "We are continuing to see measles cases right across the country, with cases particularly high in London and the West Midlands."

"Measles is completely preventable with vaccination, but many thousands of children around the country are still not fully vaccinated and are at risk of serious illness or life-long complications."

England is not alone in the measles outbreak of 2024.

The U.S. CDC has identified measles outbreaks in 49 countries over the past year.

Additionally, the CDC recommends international travelers be fully immunized against measles. In the U.S., measles vaccines are available in clinics and community pharmacies in 2024.

Vaccine Treats:

Measles

Image:

Image Caption:

by Nitish Patel

Live Blog Update Author:

Karen McClorey Hackett

Location Tags:

London

Vaccine:

Priorix Vaccine

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Recent reports indicate that the yellow fever (YF) virus, which is transmitted by mosquitoes, will continue to have a severe impact on human health in 2024.

According to the U.K.'s Travel Health Pro reporting on April 4, 2024, in South America, there have been seven confirmed cases of YF, out of which four have been fatal, including three in Colombia and two in Guyana and Peru, respectively.

In Brazil, six cases of yellow fever, including four deaths, have been confirmed this year in Minas Gerais, Espírito Santo, and São Paulo.

While vaccination for YF is one of the most successful public health interventions to prevent the disease, most international travelers remain unprotected.

Public health leaders in the United Kingdom, the United States, and the World Health Organization recommend pre-trip yellow fever vaccination for all travelers aged nine months and above who are visiting areas with a risk of yellow fever unless the vaccine is not advised for medical reasons.

In 2017, the U.S. Centers for Disease Control and Prevention expanded its yellow fever vaccine recommendations for travelers to Brazil because of a large outbreak in multiple states.

As of April 11, 2024, the YF-VAX® vaccine is offered at certified clinics and pharmacies in the U.S. Internationally, the Stamaril vaccine is offered in various countries.

These vaccine providers also offer travel-related vaccination services for diseases such as dengue, influenza, measles, and polio.

Vaccine Treats:

Yellow Fever

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Image Caption:

US CDC yellow fever case map April 2024

Live Blog Update Author:

Don Hackett

Location Tags:

London

Vaccine:

YF-VAX Yellow Fever Vaccine

PIKA Rabies Vaccine

PIKA Rabies Vaccine Clinical Trials, Dosage, Indication, Side Effects

YS Biopharma Co., Ltd.'s PIKA Rabies Vaccine (Vero Cell) for Human use, Freeze-dried, utilizes YS Biopharma's proprietary PIKA adjuvant technology and is designed to produce a more robust immune response in an accelerated timespan compared to currently approved rabies vaccines. PIKA technology originated from research in a class of well-defined dsRNA molecules synthesized using our proprietary technology. In 2017, the U.S. Food and Drug Administration (FDA) granted the PIKA Rabies Vaccine Orphan Drug Designation to prevent rabies virus infection, including post-exposure prophylaxis (PEP) for rabies. This vaccine development project was named a "National Key Medicine Innovation" in 2013.

On April 9, 2024, the Company announced interim results indicating that the PIKA Rabies Vaccine has successfully met the primary endpoints of the Phase 3 Clinical Trial and has the potential to achieve best-in-class accelerated protection and meet the World Health Organization (WHO) goal of a one-week rabies vaccine regimen to replace the conventional three- or four-week regimens. The data, which comes from the first 900 participants enrolled in the Trial, revealed that the RVNA seroconversion rate of the PIKA Rabies Vaccine was twice that of the comparator by Day 7, showing the superiority of PIKA rabies vaccine to offer quick onset of protection against virus infection. This accelerated and higher seroconversion rate came at no cost to safety, with the safety profile of the PIKA Rabies Vaccine remaining highly tolerable.

YS Biopharma Co., Ltd. is a global biopharmaceutical company located in Gaithersburg, MD., dedicated to discovering, developing, manufacturing, and commercializing new generations of vaccines and therapeutic biologics for infectious diseases and cancer.

PIKA Rabies Vaccine Clinical Trials

The Phase 3 Clinical Trial (NCT05667974) is a randomized, comparator-controlled, double-masked, multicenter trial with 4,500 participants from the Philippines and Pakistan. It is designed to assess the immunogenicity, safety, and lot-to-lot consistency of three lots of the PIKA Rabies Vaccine in healthy adults using a 7-day vaccine schedule versus a globally marketed comparator following the standard 28-day regimen. The primary immunogenicity endpoints of the study were geometric mean titers (GMTs) of rabies virus neutralizing antibodies (RVNA) and RVNA seroconversion rate at Day 14 in the first 900 participants. The secondary immunogenicity endpoints were RVNA seroconversion rate and GMTs of RVNA at Day 28, Day 42, Day 90, and Day 180 in the first 900 participants and RVNA seroconversion rate at Day 7 and Day 365 in all participants. Last Update Posted on January 24, 2024.

PIKA Rabies Vaccine News

April 9, 2024 - Dr. Zenaida Mojares, Chief Medical Officer of YS Biopharma, commented, "The interim results of the pivotal Phase 3 Trial provide compelling evidence of the robust immunogenicity and favorable safety profile of the PIKA Rabies. The PIKA Rabies Vaccine can potentially improve rabies treatment and compliance by providing a shortened treatment regimen without sacrificing safety or compliance. At present, the long and inconvenient regimen length for existing rabies vaccines represents a major barrier to treatment completion, and we are eager to see how the enhanced speed of the PIKA Rabies Vaccipositively impacts patients. We are proud of our team for the hard work and dedication that got us to this point, and we are excited to see how our advances will contribute to the ongoing global fight against rabies."

November 2, 2023 - Study: Potential option for rabies post-exposure prophylaxis: New vaccine with PIKA adjuvant against diverse Chinese rabies strains - these results indicate that the PIKA vaccine for rabies shows potential as a highly efficacious approach, resulting in a significant enhancement of the efficacy of rabies vaccines.

June 1, 2023 - YS Biopharma Co., Ltd. announced that its novel PIKA Rabies Vaccine was granted Phase 3 clinical trial approval from the Food and Drug Administration of the Philippines.

January 4, 2017 - Yisheng Biopharma announced that the U.S. FDA granted orphan drug designation for its lead vaccine candidate, PIKA rabies vaccine.

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Manufacturer:

Reviewer:

Vaccine:

VIS:

Drug Class:

Vero Cell vaccine

Clinical Trial Phase III:

NCT05667974

Condition:

Rabies

Last Reviewed:

Thursday, May 9, 2024 - 10:05

Brand:

PIKA Rabies Vaccine

Accession Number:

DB17963

Status:

Authorized

Manufacturer Country ID:

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The World Health Organization (WHO) has issued Disease Outbreak News (DON513) after confirming Timor-Leste's first fatal human case of rabies by its Ministry of Health and Ministry of Agriculture, Fishery and Forestry.

As of late March 2024, 29 suspected rabies cases in humans exposed to dogs had been reported in Oecusse Municipality this year.

The public health response is ongoing and includes dog vaccination and ensuring the availability of rabies vaccines and human rabies immunoglobulin.

As of April 10, 2024, the available information suggests a high risk of rabies at the national level, whereas the risk at regional and global levels is low, according to the WHO's assessment.

The WHO noted that Oecusse is an enclave of Timor-Leste located within Indonesia East Nusa Tenggara province (NTT), where six human rabies deaths have been recorded.

In 2023, a total of 30 human rabies deaths were reported from NTT province.

Rabies is a vaccine-preventable, zoonotic, viral disease affecting the central nervous system. The WHO procured 1,000 doses of human rabies vaccines and distributed them to Timor-Leste hospitals and health clinics.

In the United States, various rabies vaccines have been approved.

Furthermore, a rabies vaccine candidate (PIKA Rabies Vaccine) reported very positive results from a phase 3 clinical study.

Vaccine Treats:

Rabies

Image:

Image Caption:

by Nicholas_Demetriades

Live Blog Update Author:

Don Hackett

Vaccine:

Rabies Vaccines

Dengue Outbreaks Continue in the Caribbean

San Juan Puerto Rico is a dengue hot spot

April 10, 2024

Fact checked by Robert Carlson, MD

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As the world battles the resurgence of measles outbreaks, most vaccination campaigns are reactive.

According to an announcement by Ginkgo Bioworks, an AI-enabled measles forecasting model may soon empower proactive public health measures, such as immunization campaigns.

Announced today, Ginkgo's epidemiological modeling experts and Northeastern University researchers were awarded a grant from the Bill & Melinda Gates Foundation to develop a forecasting model to assess the risk of measles outbreaks and inform decision-making for timely interventions.

This innovative model will draw upon traditional and non-traditional data, including public health reports, travel patterns, economic activity, and other factors, and utilize AI approaches such as machine learning and deep learning to structure and analyze a multitude of data sources to produce actionable insights.

Matt McKnight, General Manager for Biosecurity at Ginkgo Bioworks, commented in a press release on April 10, 2024, "If we wait until large pockets of measles show up in hospital systems to launch public health responses, we are missing a critical window to act and slow the spread of this debilitating and highly contagious disease."

"Modern data and AI tools can shift the biosecurity and public health paradigm from reactive to proactive by helping global health leaders make more timely, effective decisions to prevent outbreaks from happening in the first place."

Measles is a highly contagious and often severe disease that most commonly affects children. While the widespread availability of measles vaccines has dramatically reduced the disease burden over the past several decades, cases are on the rise in the U.S. in 2024.

The majority of measles cases imported into the United States occur in unvaccinated residents who become infected during international travel, says the U.S. CDC.

For example, a substantive, ongoing measles outbreak has occurred in Chicago, Illinois, over the past two months.

Vaccine Treats:

Measles

Image:

Image Caption:

US CDC measles outbreaks 2024

Live Blog Update Author:

Don Hackett

Location Tags:

Boston

Vaccine:

Priorix Vaccine

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A next-generation rabies vaccine candidate could soon replace current options. Despite being a vaccine-preventable disease, rabies persists in over 150 countries and territories.

YS Biopharma Co., Ltd. today announced positive interim results from the ongoing Phase 3 clinical trial of its PIKA Rabies Vaccine.

The study's interim results indicate that the PIKA Rabies Vaccine has successfully met the primary endpoints of the Trial and has the potential to achieve best-in-class accelerated protection and meet the goal of a one-week rabies vaccine regimen to replace the conventional three- or four-week regimens.

The PIKA Rabies Vaccine utilizes YS Biopharma's proprietary PIKA adjuvant technology and is designed to produce a more robust immune response in an accelerated timespan than existing rabies vaccines.

The PIKA Rabies Vaccine was granted U.S. FDA orphan drug designation for prevention of rabies virus infection, including post-exposure prophylaxis for rabies.

Dr. David Shao, CEO of YS Biopharma, stated in a press release on April 9, 2024, "We remain committed to working closely with drug regulatory agencies in various countries, including the Philippines, Pakistan, Singapore, China, and other jurisdictions regarding the product registration and marketing application."

"We eagerly anticipate the early approval of this innovative therapy for the benefit of patients worldwide."

According to the World Health Organization, two types of vaccines protect people against rabies: nerve tissue and cell culture vaccines.

In the United States, rabies vaccines have been U.S. FDA-approved.

Bats are one of the most commonly reported rabid animals in the U.S. and are the leading cause of rabies deaths in people, says the U.S. CDC.

About 5,000 animal rabies cases are reported annually. Human rabies cases in the U.S. are rare, with only 1 to 3 cases reported annually.

Rabid bats have been found in all 49 continental states. Only Hawaii is rabies-free.

Worldwide, infected dogs cause approximately 59,000 rabies deaths.

Vaccine Treats:

Rabies

Image:

Image Caption:

from Pixabay

Live Blog Update Author:

Karen McClorey Hackett

Location Tags:

Gaithersburg

Vaccine:

Rabies Vaccines

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Transgene and NEC Corporation today announced that new data will be presented on TG4050, an individualized neoantigen cancer vaccine, at the American Association for Cancer Research (AACR) Annual Meeting.

TG4050 is being evaluated in a randomized multicenter Phase I/II trial as a single agent in the adjuvant treatment of HPV-negative head and neck cancers.

Key findings of the poster presentation obtained in the Phase I part of the trial (NCT04183166) include, but are not limited to, the following:

All 16 patients who received TG4050 are disease-free after a median 18.6-month follow-up. Out of the 16 patients in the control observation arm, three patients have relapsed. For this head and neck cancer patient population and with the current standard of care (chemoradiotherapy), approximately 40% of patients are expected to relapse within 24 months following surgery and adjuvant therapy. Also, the tumor immune contexture, expression of immune factors, mutational burden, and tumor infiltrates are associated with challenging prognoses.

Specific cellular immune responses were detected in the 16/17 patients who received TG4050 (16 patients from the treatment arm and one from the observation arm treated after relapse) using stringent testing conditions.

TG4050 induced persistent immune responses against multiple targets in several patients. T-cell responses were maintained beyond 211 days (7 months) after the initiation of the treatment.

Dr Oliver Lantz, Head of the clinical immunology laboratory at Institut Curie, commented in the April 9, 2024, press release, "The immunological data generated by TG4050 demonstrate a robust and specific cellular immune response, even under stringent measurement criteria."

"The diversity, depth, and duration of these responses were most certainly a key factor in preventing relapse in the patients treated with TG4050."

According to statements, Transgene and NEC are preparing a randomized Phase II extension of this trial, slated to start in the second quarter of 2024.

The U.S. CDC says cancers of the head and neck include cancers that start in several places in the head and throat. Cancer is a disease in which cells of the body grow out of control.

About 70% of cancers in the oropharynx (which includes the tonsils, soft palate, and base of the tongue) are linked to human papillomavirus, a common sexually transmitted virus, says the CDC.

Vaccine Treats:

Cancer

Image:

Image Caption:

US CDC 2024

Live Blog Update Author:

Karen McClorey Hackett

Location Tags:

Tokyo

Vaccine:

TG4050 Cancer Vaccine

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During the recent pandemic in the United States, leading public health officials noted a shift in the attitudes of pregnant and recently pregnant women towards vaccination.

As per an Original Investigation published by The JAMA OPEN Network today, during the first waves of the SARS-CoV-2 coronavirus outbreak, 76% of pregnant women received the COVID-19 vaccination.

Study participants were about 31 years of age and enrolled in the U.S. CDC's Vaccine Safety Datalink and were asked about their vaccination status.

Response rates were 43.5% for wave 1 (652 of 1500 individuals sampled) and 39.5% for wave 2 (575 of 1456).

Overall, 76.8% (95% confidence interval, 71.5%- 82.2%) reported having received one or more COVID-19 vaccinations.

Spanish-speaking Hispanic respondents had the highest weighted proportion of respondents with one or more vaccinations.

Additionally, these women were asked if they agreed with the statement that 'COVID-19 vaccines are safe.'

These researchers wrote on April 9, 2024, that there is decreasing confidence in COVID-19 vaccine safety in diverse pregnant and recently pregnant insured populations, which is a public health concern.

This study was supported by the U.S. CDC, contract number 200-2012-53581-0011, and no industry conflicts of interest were highlighted.

Vaccine Treats:

COVID-19

Image:

Image Caption:

by Brian Odwar

Live Blog Update Author:

Karen McClorey Hackett

Location Tags:

Austin

Vaccine:

Novavax COVID-19 Vaccine