Cancer Vaccine Breaking News

Australia's Department of Health and Aged Care's report No. 9 recently confirmed some good news regarding the 2023 flu season.

Influenza-like-illness (ILI) activity in the community has stabilized in the last fortnight (2-weeks), while ILI presentations to ASPREN sentinel general practitioners have decreased as of August 6, 2023.

And there is currently not enough information to comprehensively assess the potential severity of the 2023 influenza season at this time, stated this report.

Since seasonal surveillance commenced in April 2023, 173 (7%) ICU admissions and 194 influenza-related deaths have occurred.

Furthermore, of the 2,449 samples referred during 2023, 98% of influenza A(H1N1) isolates, 83% of influenza A(H3N2) isolates, and 99% of influenza B/Victoria isolates characterized were antigenically similar to the corresponding vaccine components.

However, it is too early to assess influenza vaccine effectiveness for this flu season.

Valneva SE today announced that the U.S. Food and Drug Administration (FDA) has revised the Prescription Drug User Fee Act (PDUFA) action date for the Biologics License Application (BLA) for VLA1553, a monovalent chikungunya virus vaccine candidate.

Valneva is committed to working with the FDA in its ongoing BLA review and potentially delivering the world's first chikungunya vaccine.

The previously communicated end of August PDUFA has been adjusted to the end of November 2023.

Valneva stated on August 14, 2023, the FDA extended the PDUFA date to allow sufficient time to align and agree on the phase 4 program necessary under the accelerated approval pathway.

Furthermore, no additional clinical data have been requested for the FDA approval process.

Juan Carlos Jaramillo, Chief Medical Officer of Valneva, said in a press release, "We appreciate and take pride in the fact that our BLA for VLA1553 if approved, will represent the first vaccine candidate to be approved under the accelerated approval pathway in an outbreak disease, and hence the necessary Phase 4 activities will set a future standard."

The Company reconfirms its previous guidance for potential BLA approval, initial launch, and potential award of a priority review voucher in 2023. This PDUFA extension does not impact Valneva's current regulatory submission in Canada or its planned submission with the European Medicines Agency.

VLA1553 is a single-dose, live-attenuated chikungunya vaccine candidate based on an infectious clone (CHIKV LR2006-OPY1) attenuated by deleting a gene encoding the non-structural replicase complex protein nsP3 protection against various Chikungunya virus phylogroups and strains.

Valneva's VLA1553 vaccine candidate is designed for prophylactic, active immunization against Chikungunya in humans over 1-year-old. 

Chikungunya is a viral disease transmitted to humans through the bites of mosquitoes, causing outbreaks in 2023.

The European Centre for Disease Prevention and Control reported that as of July 26, 2023, approximately 300,000 cases and over 300 deaths have been reported worldwide due to Chikungunya virus disease.

When bringing a dog to the United States in 2023, people should continue to check federal regulations and the recently extended rabies vaccination requirements.

The U.S. Centers for Disease Control and Prevention (CDC) confirmed that effective August 1, 2023, it extended the temporary suspension of the importation of dogs from countries classified as high risk for dog rabies and countries that are not at high risk if the dogs have been in high-risk countries during the previous six months.

However, dogs vaccinated against rabies in the U.S. by a US-licensed veterinarian may re-enter the U.S. from a high-risk country without a CDC Dog Import Permit if the dog:

• has a current, valid US-issued rabies vaccination certificate;
• has ISO-compatible microchip;
• is at least 6 months old;
• is healthy upon arrival; and
• arrives at one of the 18 airports with a CDC quarantine station.

On July 6, 2023, the CDC published the “Notice of Extension of Temporary Suspension of Dogs Entering the United States from Countries with a High Risk of Rabies” in the Federal Register. 

According to the CDC, most rabies cases in the U.S. follow bites by bats, not dogs.

An estimated 47,000–55,000 people successfully receive post-exposure prophylaxis each year in the U.S.

Unfortunately, a recent article published in Clinical Infectious Diseases presented the first documented failure of rabies-post-exposure prophylaxis in the Western Hemisphere.

This 84-year-old man died in 2021 about six months after a rabid bat bit his hand.

The Republic of Costa Rica's Juan Santamaría International Airport recently reported over 2.8 million passengers passed through its facility during the first half of 2023.

As of June 2023, this activity represents a 4.3% increase in arriving and departing travelers compared to 2019.

The Tico Times reported on August 11, 2023, "The airport now hosts twenty-five airlines serving thirty-five destinations, enhancing global connectivity," said Erick Barboza, AERIS Business Development Director.

Recent AERIS analyses indicate increased Millennial (42%) and Generation X (32%) travelers to Costa Rica.

While in the U.S., the Transportation Security Administration's latest report indicated airport activity has not increased compared to 2019.

From a health perspective, Costa Rica was confronted with dengue, malaria, and Zika cases in 2023.

The World Health Organization (WHO) today announced the current dengue surge in the Peoples' Republic of Bangladesh is unusual in terms of seasonality and the early sharp increase compared to previous years.

 On August 11, 2023, the Ministry of Health and Family Welfare of Bangladesh reported 69,483 laboratory-confirmed dengue cases and 327 related deaths, with a case fatality rate (CFR) of 0.47% during 2023. The CFR so far this year is relatively high compared to previous years for the full-year period.

About 62% of these deaths were reported in July 2023.

Dhaka City Corporation is the most affected area in the Dhaka division, accounting for 78.9% of deaths. 

The pre-monsoon Aedes survey shows that the density of disease-carrying mosquitoes and the number of potential hotspots is at the highest level in the past five years.

Globally, dengue outbreaks have been confirmed in numerous countries in 2023.

Dengue virus (DENV) has four serotypes, and infection with one serotype provides long-term immunity to the homologous serotype but not to the other serotypes; sequential infections with a different serotype put people at greater risk for severe dengue.

Many DENV infections produce only mild flu-like illness, and over 80% of cases are asymptomatic.

There is no specific treatment for cases and clinical management is based on supportive therapy.

Neither of the two approved dengue vaccines are currently available in Bangladesh.

The WHO says dengue risk at the national level in Bangladesh is assessed as 'High' due to the ongoing rapidly increasing number of cases and deaths with the peak not yet reached, the high CFR compared to the previous years, and the increasing geographical distribution of cases.

Vaxxinity, Inc. today announced The Lancet's eBioMedicine published results of Phase 2a clinical trial stating that UB-311 "was safe and well-tolerated," with early clinical data demonstrating a trend for slowing cognitive decline in mild Alzheimer's disease (AD).

In this 78-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter Phase 2a, Vaxxinity-funded study, UB-311 was reported to elicit a robust, rapid, and titrated antibody response to Aβ.

And UB-311 was generally well-tolerated, with no cases of ARIA-E and limited cases of asymptomatic ARIA-H.

"This publication supports the innovative work that we and our collaborators are conducting to advance UB-311 for the potential treatment, and even prevention, of Alzheimer's disease," said Mei Mei Hu, CEO of Vaxxinity, in a press release on August 10, 2023.

"Imagine expanding the addressable patient population of beta-amyloid immunotherapies by multiple orders of magnitude, potentially over 1,000x, and delivering life-changing medicine at a fraction of the cost. That is our vision for UB-311 and the potential power of active immunotherapies."

AD is the most common form of dementia, is a progressive neurodegenerative disorder that slowly destroys memory and cognitive skills and eventually the ability to carry out simple tasks.

UB-311 is a synthetic, peptide-based active immunotherapy that targets toxic beta-amyloid (Aβ) oligomers and fibrils and oligomers.

Two passive immunotherapies – monoclonal antibodies targeting Aβ – have recently been authorized by the U.S. FDA, validating Aβ as a target for disease-modifying immunotherapies of AD.

However, these passive immunotherapies have been associated with amyloid-related imaging abnormalities (ARIA), which can present as vasogenic edema or sulcal effusion (ARIA-E) or as hemosiderin deposits such as micro hemorrhages and superficial siderosis (ARIA-H).

Although the trial was not powered to make conclusions about efficacy, secondary efficacy outcomes on cognitive, functional, behavioral, and global assessments such as ADAS-Cog, MMSE, ADCS-ADL, and CDR-SB were evaluated.

Trends of slowing disease progression were observed across key cognitive and functional measures for UB-311-treated versus placebo-treated participants over 78 weeks of observation, including a 48% slowing of decline on CDR-SB in the UB-311 quarterly boosting group.

Furthermore, the U.S. FDA-licensed mAbs require IV infusions every two weeks and are priced at $26,500 annually, not including the cost of administering them or monitoring for ARIA.

In contrast, UB-311 has the potential to offer multiple competitive advantages, including lower rates of ARIA-E, improved convenience through less frequent dosing and ease of administration through intramuscular injection, and overall improved accessibility and cost-effectiveness for patients and health systems.

As of August 10, 2023, the U.S. FDA had not approved an Alzheimer's vaccine candidate.