Vaccine News

According to a recent article published by npj vaccines, infection with high-risk human papillomavirus (HPV) is widely recognized as the primary cause of cervical and other malignant cancers.

While there are six licensed prophylactic vaccines against HPV, none of them show any significant therapeutic effect on pre-existing infections.

Thus, a prophylactic vaccine endowed with therapeutic activity would afford protection regardless of the vaccine recipient's HPV infection status.

The key to eliminating virus-infected cells lies in anti-early HPV-encoded proteins, particularly anti-E6 or anti-E7 T-cell responses. 

This article describes the refinement and further potentiation of a dual-purpose HPV nanoparticle vaccine (cPANHPVAX) relying on eight different HPV L2 peptide epitopes and the E7 oncoantigens from HPV16 and 18.

cPANHPVAX not only induces anti-HPV16 E7 cytotoxic T-cell responses in C57BL/6 mice, but also anti-HPV18 E7 T-cell responses in transgenic mice with the A2.DR1 haplotype.

These cytotoxic responses add to a potent, broad-coverage humoral (HPV-neutralizing) response.

cPANHPVAX safety was further improved by deleting the pRb-binding domains of E7.

These researchers wrote, 'this dual-purpose vaccine holds great potential for clinical translation as an immune-treatment capable of targeting active infections as well as established HPV-related malignancies, thus benefiting both uninfected and infected individuals.'

Zhao, X., Zhang, Y., Trejo-Cerro, O. et al. A safe and potentiated multi-type HPV L2-E7 nanoparticle vaccine with combined prophylactic and therapeutic activity. npj Vaccines 9, 119 (2024). https://doi.org/10.1038/s41541-024-00914-z. 

Appili Therapeutics Inc. recently announced a product update for the first quarter of its fiscal year 2025, which ended on June 30, 2024.

“In recent months, we’ve achieved significant milestones by engaging regulatory authorities for ATI-1701 and ATI-1801, and together with our partner, Saptalis Pharmaceuticals, we launched our leading asset, LIKMEZ™ (ATI-1501),” said Don Cilla, President and CEO of Appili, in a press release on August 13, 2024.

“These achievements, together with ATI-1701 U.S. Air Force Academy (USAFA) funding commitments, are expected to enable us to execute our infectious disease programs and advance their development to bring these products to market for the benefit of patients and shareholders.”

ATI-1701, a novel live-attenuated vaccine for preventing F. tularensis, has secured $14 million in awards from the USAFA.    Tularemia is a potentially serious illness caused by the bacterium Francisella tularensis. People can become infected in several ways, including tick and deer fly bites and contact with infected animals.

Under the USAFA Cooperative Agreement, Appili will manage a comprehensive development program, including nonclinical studies, CMC/manufacturing, clinical preparatory, and regulatory activities supporting an IND submission in 2025. Appili has engaged with the U.S. Food and Drug Administration (“FDA”) via a pre-IND meeting, confirming the development pathway for ATI-1701, and is incorporating suggested changes into the development plan.

ATI-1801, a novel topical formulation of paromomycin (15% w/w), is under advanced clinical development for treating cutaneous leishmaniasis, a Neglected Tropical Disease, is a disfiguring skin infection affecting hundreds of thousands globally. Cutaneous and mucosal leishmaniasis can cause substantial morbidity; visceral and mucosal leishmaniasis can be life-threatening.

Appili is currently engaging with the FDA. In 2024, it submitted a type-B meeting request to discuss linking previously generated Phase 3 data and agreeing on the necessary registration package for a New Drug Application submission. ATI-1801 has received an Orphan Drug Designation from the FDA for certain forms of cutaneous leishmaniasis. 

In September 2023, Appili and its U.S. partner, Saptalis Pharmaceuticals LLC., announced the approval by the U.S. FDA of LIKMEZ™ (ATI-1501), a proprietary taste-masked liquid suspension formulation of metronidazole. LIKMEZ is the first FDA-approved ready-made suspension of metronidazole, addressing the unmet need in both pediatric patients and patients with dysphagia. Saptalis launched LIKMEZ in November 2023, and the product is available to patients and doctors in the U.S.

Since the beginning of 2022 and as of late July 2024, a total of 37,583 mpox cases and 1,451 deaths (case fatality rate 3.9%) have been reported from 15 African Union Member States. In an attempt to reduce this outbreak, the U.S. FDA and EMA-approved mpox vaccine is being deployed.

Bavarian Nordic A/S recently announced a new order from the European Health Emergency Preparedness and Response Authority (HERA) for the MVA-BN® (JYNNEOS) vaccine.

HERA will procure 175,420 vaccine doses to donate to the Africa Centres for Disease Control and Prevention (ACDC) to support their strengthened response to the ongoing mpox outbreak in Africa.

Additionally, Bavarian Nordic will donate 40,000 doses to HERA, which will also be donated to the ACDC.

This larger donation follows a recent pledge from Bavarian Nordic for 15,000 doses as part of a coordinated response by Gavi, WHO, and UNICEF in the African region.

“Mpox is spreading at an alarming rate in Africa, calling for further action from the international community. We are proud to support HERA’s contribution of vaccines to the region and are pleased to announce an additional donation from Bavarian Nordic,” said Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic, in a press release on August 13, 2024.

Currently, two African countries have granted Emergency Use Authorization for the MVA-BN vaccine.

Seperately, the WHO Director-General issued the following statement on August 14, 2024, "In light of the expanding outbreak in east and central Africa, and the potential for further international spread within and outside Africa, I have convened this Emergency Committee under the International Health Regulations to advise me on whether the outbreak represents a public health emergency of international concern."

"When I declared an end to the previous mpox PHEIC last year (2023), I issued standing recommendations under the IHR, which are due to expire next week. I have decided to extend them for another year to support countries in responding to the chronic risk of mpox."

"Were I to decide, on your advice, that the current situation represents a public health emergency of international concern, I would issue temporary recommendations by the IHR, again on your advice."

The JYNNEOS vaccine is available in the United States at designated clinics and pharmacies.

According to a recent Morbidity and Mortality Weekly Report, more than half of school-aged children in American Samoa have evidence of a dengue fever virus infection. 

The estimated seroprevalence among all students aged 7–16 years was 59% (95% CI = 47%–71%) and was 60% (95% CI = 48%–72%) among those age-eligible for vaccination (i.e., those aged 9–16 years).

Dengue seroprevalence was lowest among children aged 8 (46%; 95% CI = 32%–60%).

The U.S. CDC's Notes from the Field (73(31);686–688) published on August 8, 2024, suggests American Samoa exceeds the minimum 20% threshold established for the introduction of recommended dengue vaccines to reduce the risk of hospitalization and severe dengue in seronegative children and adolescents.

The authors concluded, "In American Samoa, dengue vaccines could be part of a broader strategy for dengue control."

As of August 13, 2024, access to dengue vaccines in the United States is very limited.

American Samoa is located in the Pacific Ocean, halfway between Hawaii in the north and New Zealand in the south. The CDC recommends checking the vaccines and medicines list and visiting your healthcare provider at least a month before your trip to American Samoa to get necessary supplies. 

These authors disclosed no potential conflicts of interest.

Pfizer Inc. today announced positive top-line safety and immunogenicity results from substudy B of the ongoing pivotal Phase 3 clinical trial.

The trial is evaluating two doses of the ABRYSVO™ vaccine in immunocompromised adults aged 18 and older at risk of developing severe respiratory syncytial virus (RSV)- associated lower respiratory tract disease.

ABRYSVO was well-tolerated during the trial, showing a safety profile consistent with findings from other vaccine studies.

While the company evaluated two doses, a single 120 µg dose of ABRYSVO generated a strong neutralizing response against both subtypes of RSV, RSV-A, and RSV-B across all cohorts and age groups in the study.

Pfizer plans to share these findings at an upcoming scientific conference, publish them in a peer-reviewed scientific journal, and submit the data to the regulatory agencies for review.

“Immunocompromised adults, such as patients with cancer or autoimmune disorders, have a substantially increased risk of experiencing severe complications from RSV, yet there are currently no vaccines approved for those aged 18 to 59 in the U.S.,” said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer, in a press release on August 12, 2024.

“We are encouraged by the positive top-line data from this study, which provide important evidence that ABRYSVO has the potential to address a significant unmet need in this vulnerable population.”

These most recent data in immunocompromised adults build on the body of evidence supporting the profile of ABRYSVO in high-risk adults. 

As of early August 2024, three RSV vaccines have been approved for use in the U.S., and several vaccine candidates are conducting late-stage studies.

Additionally, the U.S. CDC reported on August 9, 2024, that RSV sections were generally low, except for the state of Florida.

Throughout 2024, the Florida Department of Health has reported various mosquito-transmitted diseases infecting people. Florida has confirmed that 14 species of Anopheles mosquitoes transmit diseases to humans. 

While Dengue fever gets most of the media headlines, diseases such as Chikungunya, Malaria, and West Nile virus have also been detected this year.

For example, on August 5, 2024, a locally acquired case of West Nile Virus was confirmed in Broward County.

As a direct response, the Broward County Mosquito Control Section recently announced it would spray organic larvicide as part of an integrated pest management approach. Truck-mounted larviciding will be performed between August 5 - 22, 2020.

This month, portions of Hollywood, Pembroke Pines, Davie, and Southwest Ranches are being targeted in southeast Florida.

The larvicide used is VectoBac WDG, which is not harmful to humans, pets, bees, aquatic habitats, or environmentally sensitive areas. The active ingredient is Bacillus thuringiensis israelensis (Bti, strain AM6552), a naturally occurring, biodegradable bacterial mosquito larvicide.

Broward County Mosquito Control Section continues to work closely with the Florida Department of Health and Code Enforcement partners in Broward's 31 municipalities to reduce the population of mosquitoes and their habitats. Any Broward County resident experiencing mosquito problems can request service by calling 311.

Regarding disease prevention, the U.S. Centers for Disease Control and Prevention (CDC) recently recommended Valneva SE's IXCHIQ®, a monovalent, single-dose, live-attenuated chikungunya vaccine. Vaccination is advised for international travelers since five chikungunya cases with onset in 2024 have been reported in individuals with a travel history to Brazil.

As of August 10, 2024, the CDC has not issued vaccination requirements for Florida residents or visitors.