Cancer Vaccine Breaking News

When the U.S. Food and Drug Administration approved Pfizer Inc.'s ABRYSVO™ Respiratory Syncytial Virus vaccine on August 21, 2023, for use in pregnant women to prevent lower respiratory tract disease (LRTD) and severe LRTD caused by RSV in infants from birth through six months of age, it initiated questions regarding a previous FDA approval.

On July 17, 2023, the FDA approved AstraZeneca and Sanofi's Beyfortus™, a single-dose, long-acting monoclonal antibody (mAb) designed to protect children from LRTD through their first and second RSV season. 

Beyfortus has been approved in Canada, Europe, Japan, and the United Kingdom.

With two RSV prevention solutions approved by the FDA, expecting mothers are seeking guidance on 'best practices.'

Hopefully, the U.S. CDC's Advisory Committee on Immunization Practices (ACIP) meeting on September 22, 2023, will add clarity to this clinical decision.

Led by Dr. Grace Lee (Chair) and Dr. Sarah Long (RSV Workgroup Chair), this ACIP's meeting agenda will review and opine on preferred recommendations regarding RSV prevention for pregnant women.

Another consideration is 'when' to become immunized.

RSV seasons in the U.S. generally start in Florida and then spread nationwide.

This means that to optimize RSV protection, make a protection selection before this respiratory virus is detected in your area.

The ACIP develops recommendations regarding U.S. immunizations, which are then ratified or not by the CDC's Director Mandy K. Cohen, MD, MPH.

This ACIP digital meeting is open to the public at this IBM link and starts at 10:00 AM ET this Friday, September 22.

A contagious disease known for causing outbreaks on land and at sea may soon have an approved preventive vaccine. Noroviruses have emerged as the single most significant cause of gastroenteritis worldwide. 

According to the U.S. Centers for Disease Control and Prevention, most norovirus outbreaks in the United States happen from November to April. In years when there is a new strain of the virus, there can be 50% more norovirus illness.

While no vaccines are available today in the U.S., U.K., or Europe, a new funding event may accelerate an approval.

HilleVax, Inc. today announced the gross proceeds from an offering, before deducting discounts, commissions, and other expenses, are expected to be $100.0 million.

HilleVax stated in a press release on September 20, 2023, that it intends to use the net proceeds from the offering to fund the clinical development of HIL-214, including certain manufacturing activities, and for working capital and general corporate purposes.

HIL-214 is an investigational virus-like particle bivalent vaccine candidate for preventing moderate-to-severe acute gastroenteritis caused by norovirus in infants. 

The HIL-214 vaccine includes antigens from genotypes GI.1 and GII.4 to represent genogroups that cause most human illnesses.

HIL-214 has been studied in various clinical trials, collectively generating data from more than 4,500 subjects, including children. The ongoing phase 2/3 study was last updated in May 2023.

“HilleVax has continued to make excellent progress on our HIL-214 program, including the recent completion of enrollment of over 3,000 subjects in our NEST-IN1 clinical trial,” said Rob Hershberg, MD, PhD, Chairman and Chief Executive Officer of HilleVax, in a press release on May 12, 2023.

“We look forward to continuing to execute on our HIL-214 program and announcing top-line safety and clinical efficacy data in the first quarter of 2024 for our NEST-IN1 clinical trial.”

While other norovirus vaccine candidates are conducting clinical research, the HIL-214 vaccine appears to Precision Vaccinations to be the most advanced candidate.

Scientists recently announced they used genomics to reveal distinct sexual networks for syphilis transmission in England.

On September 15, 2023, The Lancet Microbe published a study by researchers with the UK Health Security Agency and the Wellcome Trust Sanger Institute, which revealed infectious syphilis diagnoses tripled since 2010.

In England, new diagnoses of early syphilis increased from 3,011 in 2012 to 8,011 in 2019.

About 50% of the cases were in the greater London area.

By comparing the bacterial genomes from different individuals, the researchers could identify single-letter changes in the DNA – known as single nucleotide polymorphisms – to distinguish one bacterium strain or sublineage of T. pallidum from another.

They show distinct transmission chains between individuals and significant resistance to a commonly prescribed class of antibiotics in England.

These health officials believe the increase in syphilis cases reflects increased sexually transmitted disease testing and transmission.

Dr. Ana Cehovin, Senior Research Manager of Infectious Disease at Wellcome, commented in a press release, "Genomic surveillance is an invaluable tool for understanding how diseases are spreading, what populations are at increased risk, and which strains are developing drug resistance."

"Similarly, realizing the potential of genomic surveillance to identify and monitor drug resistance can help decision makers to implement necessary mitigation measures to control the spread of resistant strains, reducing the chance of disease escalation and protecting at-risk communities."

Syphilis is a sexually transmitted infection caused by T. pallidum.

While the genomes of T. pallidum are highly conserved compared to other bacterial pathogens - as they tend to transmit more frequently than they mutate - subtle differences can still exist as it spread through a population.

By comparing how genetically related T. pallidum samples are between individuals with a syphilis diagnosis, scientists hope to pinpoint the source of syphilis outbreaks and construct networks that capture its spread.

As of September 18, 2023, there are no approved syphilis vaccines.

Additionally, about 20 mpox patients were confirmed during 2023 in a similar population subset in London. And various poliovirus samples were confirmed in London in 2022.

Results from a recent real-world evidence (RWE) study across three consecutive flu seasons in the United States showed that vaccination with cell-based influenza vaccines resulted in lower test-confirmed influenza rates than traditional egg-based vaccines. 

This retrospective test-negative designed study showed the clinical value of cell-based quadrivalent influenza vaccines (QIVc) compared with traditional egg-based quadrivalent influenza vaccines (QIVe) in preventing outpatient test-confirmed influenza. 

The analysis found that QIVc showed a clinical benefit compared to QIVe in the prevention of test-confirmed influenza in the outpatient care setting, with estimated relative vaccine effectiveness (rVEs) (95% CI) of 14.8% (7 – 22) in 2017–-18, 12.5% (4.7 – 19.6) in 2018-–19 and 10% (2.7 – 16.7) in 2019–-20.

"Vaccines remain one of our greatest tools for fighting influenza, a disease that continues to result in substantial morbidity and mortality worldwide," commented Raja Rajaram, Head of Global Medical Strategy, CSL Seqirus, in a press release on September 19, 2023.

"At CSL Seqirus, we are committed to advancing the science of influenza prevention, and these studies show the benefits of innovative vaccine technologies, including cell-based and adjuvanted influenza vaccine technology, on reducing the burden of flu."

The RWE study was conducted over three consecutive influenza seasons characterized by different circulating influenza viruses and degrees of egg adaptation and aligned with previously published QIVc relative effectiveness studies for the same seasons.

This review of real-world data allows for evaluating trends in the effectiveness of QIVc over time and the context of season-over-season changes, given the variability of influenza viruses.

This data complements randomized controlled trial research, assessing influenza vaccine effectiveness continually and providing an ever-growing data set on real-world outcomes.

Influenza is a contagious seasonal respiratory disease that may cause severe illness and life-threatening complications in some people. Influenza can lead to clinical symptoms varying from mild to moderate respiratory illness to severe complications, hospitalization, and, in some cases, death, says the U.S. CDC.

Study: Stein AN et al. Superior Effectiveness of Cell-Based Versus Egg-Based Quadrivalent Influenza Vaccines Against Outpatient Test-Confirmed Influenza Over Three Consecutive Seasons in the U.S. Presented at ESWI 2023.

As the global mpox outbreak continues impacting people in 2023, a leader in mRNA vaccines intends to enter the market with an innovative vaccine.

This announcement is essential since numerous vaccine breakthrough cases related to currently approved mpox vaccines have been reported worldwide in 2023.

BioNTech SE today announced a strategic partnership with the Coalition for Epidemic Preparedness Innovations (CEPI) to advance the development of BNT166 for the prevention of mpox.

CEPI will provide up to $90 million to support the development of mRNA-based vaccine candidates.

BNT166 is part of BioNTech's efforts to develop novel prophylactic vaccines for various infectious diseases with a high medical need.

BioNTech aims to develop a prophylactic mRNA-based mpox vaccine with a favorable safety profile that can be manufactured at scale.

"The 100 Days Mission aims to accelerate the development of a vaccine against a novel virus with pandemic potential to just 100 days. BioNTech's world-class scientists, technology, and facilities can make a vital contribution. Achieving this mission and potentially preventing the next pandemic will require gathering a wealth of knowledge and data about the performance of the latest vaccine platforms, like mRNA, which can enable rapid responses to emerging infectious threats across a broad range of viruses," commented Richard Hatchett, M.D., Chief Executive Officer of CEPI in a press release on September 18, 2023.

The BNT166 vaccine candidates encode surface antigens expressed in the monkeypox virus's two infectious forms to efficiently fight virus replication and infectivity.

The phase 1/2 clinical trial will evaluate the safety, tolerability, reactogenicity, and immunogenicity of two mRNA-based multivalent vaccine candidates for active immunization against mpox.

This study will enroll participants with and without prior known or suspected smallpox vaccination history.

Since eradicating smallpox in 1980, the global population-level immunity against the Orthopoxvirus viral family, including mpox, has been waning. 

Mpox is a vaccine-preventable, sexually transmitted disease caused by a member of the Orthopoxvirus viral family, an infectious disease that can lead to severe, life-threatening complications.

BioNTech and CEPI also confirmed today that they are committed to enabling equitable access to the outputs of this partnership. Any licensed vaccines developed due to this strategic partnership are expected to be available at affordable prices in low- and middle-income countries.

China has now classified mpox as a Class B infectious disease as cases surged in August 2023.

The South China Morning Post reported on September 15, 2023, that The Class B category also includes diseases such as COVID-19, HIV/Aids, dengue, and rabies.

The National Health Commission of the People's Republic of China announced the change would take effect next week with upgraded prevention and control measures against mpox spreading in the local population.

Data from the Chinese Centre for Disease Control and Prevention (CCDC) website indicates there were 501 confirmed mpox cases across 25 provinces in August 2023. That compared with 491 cases in July and 106 in June.

The CCDC website says Mpox is a zoonotic infectious disease caused by the monkeypox virus (MPXV) and is characterized by fever, a rash, and swollen lymph nodes. The virus was first isolated from a specimen of a suspected smallpox patient from the Democratic Republic of the Congo in 1970.

Suspected and confirmed cases of mpox should be promptly transported to medical institutions for isolation and treatment. If their clinical symptoms improve significantly and the lesions have scabbed, they can opt to stay at home in China until the scabs fall. 

During home quarantine, patients should reside in a single room and avoid immediate contact with family members, says the CCDC.

The website says there is no vaccine available on the Chinese mainland to prevent mpox as of September 2023.

As of September 2023, over 1.2 million (1st and 2nd) JYNNEOS® (MVA-BN, IMVANEX®, IMVAMUNE®) vaccine doses had been administered in the U.S.

Mpox outbreaks in 2023 include countries in Africa, the Americas, France, Japan, Portugal, South Korea, Spain, and Taiwan. And in cities such as Chicago, Denver, London, and New York City.

There was one state reporting above-average influenza detections last week.

According to the U.S. Centers for Disease Control and Prevention (CDC) week #36 report, last week's seasonal flu rates were low nationally, with 253 (.07%) positive specimens.

However, the Texas Department of State Health Services (DSHS) reported (1.01%) of influenza samples tested were positive as of September 15, 2023.

The number of Texas regions reporting increased flu activity was four, while three reported decreased activity.

While the 2023-2024 flu season has not officially begun, the current season continues producing related fatalities.

As of September 14, 2023, the National Center for Health Statistics Mortality Surveillance listed pneumonia as an underlying or contributing cause of death on 1,029 death certificates and 12 listed influenza last week.

During the current flu season, 174 influenza-associated pediatric deaths have occurred.

Last season, Texas reported a total of 9,871 pneumonia and influenza-related deaths.

For most persons older than six months, only one dose of an influenza vaccine is recommended by the CDC. And vaccination should ideally be offered during September or October.

However, the CDC says vaccinations should continue throughout the flu season as long as viruses are circulating.