Vaccine News

While dengue virus outbreaks in the Caribbean have received a lot of attention, travelers visiting the Pacific Islands and Asia should also be vigilant.

According to the U.S. Centers for Disease Control and Prevention (CDC), countries such as Cambodia, Indonesia, Laos, Malaysia, Singapore, and Sri Lanka are reporting dengue outbreaks in 2024.

For example, Singapore's National Environment Agency reported over 5,000 dengue cases in the first quarter of 2024, more than double the 2,360 cases reported in the same period in 2023.

On April 18, 2024, the CDC reissued a Level 1—Practice Usual Precautions, Travel Health Advisory for the western Pacific area. Dengue can become severe within a few hours and is a medical emergency that usually requires hospitalization.

Because infected mosquito bites spread dengue, all travelers to high-risk areas should prevent mosquito bites by using an EPA-registered insect repellent, wearing long-sleeved shirts and long pants when outdoors, and sleeping in an air-conditioned room or room with window screens or under an insecticide-treated bed net, says the CDC.

Furthermore, adults traveling to the areas should speak with a travel vaccine advisor about one month before departure regarding vaccination options.

As of April 25, 2024, there are two approved dengue vaccines and several conducting late-stage clinical research.

ImmunityBio, Inc. today announced positive overall survival results in the QUILT 3.055 study of 2nd- and 3rd-line Non-small cell lung cancer (NSCLC) patients who progressed after checkpoint inhibitor therapy and standard-of-care chemotherapy.

The clinical study's results continue to reinforce ImmunityBio's belief in the unique mechanism of action of ANKTIVA® (N-803) and its potential efficacy as a next-generation immunotherapy across multiple solid and liquid tumor types.

The positive overall survival data of patients enrolled in QUILT 3.055, a basket trial across multiple tumor types in which checkpoint inhibitors failed, will be discussed, along with the status of launch readiness for ANKTIVA for its recently approved indication in Non-Muscle-Invasive Bladder Cancer. (NMIBC) on an investor conference call on April 26 at 8 am PDT.

"The results we noted with the completion of the QUILT 3.055 basket trial across multiple tumor types in patients with late-stage cancers for whom the standard of care plus checkpoints failed validates our hypothesis that orchestration of NK cells with killer T cells and memory T cells could result in meaningful clinical improvements to current standards of care."

"We hypothesized that activation and proliferation of natural killer cells through IL-15 stimulation could rescue T cells after checkpoint failure, regardless of tumor type or location. As with non-muscle invasive bladder cancer, we believe that ANKTIVA enhanced the NK and T cell activity critical for targeting and killing cancer cells which have entered the phase of tumor evasion and resistance," said Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio, in a press release on April 25, 2024.

"The findings of a significant extension of overall survival in 2nd—and 3rd-line lung cancer affirm that combination therapy, with the orchestration of the innate and adaptive immune system, could potentially lead to the evolution of immunotherapy beyond T cells for all cancer patients."

"We are committed to pursuing additional indications for ANKTIVA in our pipeline with a mission to deliver new hope to patients with serious, advanced cancers where standard therapies have failed."

In NSCLC patients who relapsed or were refractory to checkpoint inhibitors, ANKTIVA was administered together with the same checkpoint inhibitor.

The addition of ANKTIVA resulted in the rescue of the checkpoint therapy efficacy, with significant prolongation of overall survival.

These positive results were noted regardless of the patient's PD-L1 status, consistent with the mechanism of action of ANKTIVA in activating and proliferating natural killer cells and stimulating CD8+ Killer Memory T cells.

This prolongation of survival in NSCLC following checkpoint failure is consistent with ImmunityBio's findings of durable, complete responses following BCG failure in NMIBC.

A meeting with the U.S. FDA has been scheduled for June 2024 to discuss the company's overall survival results in PD-L1 negative and positive patients and registration plans for 2nd-line and 3rd-line NSCLC patients whose cancer did not respond or continue to respond to checkpoint therapy and for whom few alternative therapies are available.

PharmaJet® today announced that the journal Nature published results from Gennova Biopharmaceutical's Phase 2/3 clinical trial. The trial was conducted to evaluate the safety and immunogenicity of its novel samRNA-based Covid-19 vaccine booster.

The study's results demonstrated that GEMCOVAC-OM, administered exclusively with Tropis®, is well-tolerated with no related serious adverse events and significantly boosts immune responses against the Omicron variant.

GEMCOVAC®-OM samRNA vaccine low dose was licensed under emergency use authorization in 2023.

This new study is the first time a samRNA vaccine has been developed with a lipid nano-emulsion, and the data show that intradermal administration of this vaccine is safe and well-tolerated.

Furthermore, the April 18, 2024 publication cited that the self-amplifying, thermostable mRNA platform delivered intradermally with Tropis provides a framework for next-generation vaccines that can improve accessibility and global equity.

PharmaJet has partnered with Gennova to improve the performance and outcomes of their samRNA platform with PharmaJet's breakthrough delivery technology. 

The PharmaJet pioneering technology unlocks the rich potential of the human dermis, paving the way for enhanced immune responses.

Chris Cappello, President and Chief Executive Officer, PharmaJet, commented in a press release on April 24, 2024, "This new data adds to the evidence base indicating Tropis needle-free ID administration is an enabler for vaccine platforms."

Tropis intradermal administration and Stratis® SC/IM (for intramuscular and subcutaneous administration) are the only commercially scaled needle-free technologies that enhance the performance of several vaccines and therapeutics.

Since its launch, Tropis has performed over 10 million vaccinations in several countries.

Moderna, Inc. and OpenAI today announced their ongoing collaboration to co-innovate with a shared vision of AI's transformative potential in the future of business and healthcare.

Moderna is a digital-first company that has leveraged the power of machine learning since its beginnings.

This strong data foundation and its robust learning culture position the Company to responsibly and seamlessly integrate generative AI into its operations and capitalize on next-generation AI innovation.

The organizations began their collaboration in early 2023 by launching Moderna's instance of ChatGPT, called mChat, internally built on top of OpenAI's API.

With more than 80% internal adoption since its debut, this initial success accelerated an AI culture that led to the deployment of ChatGPT Enterprise and its enhanced capabilities such as Advanced Analytics, Image Generation and GPTs.

These GPTs are now embedded across Moderna's business functions - from legal, to research, to manufacturing, to commercial - and are purpose-built as assistants that work beside Moderna's employees, augmenting their roles through personalized support.

With these tools serving as an extension to Moderna's team, the Company can advance its mission to deliver the greatest possible impact to people through mRNA medicines.

Stéphane Bancel, Chief Executive Officer of Moderna, commented in a press release on April 24, 2024, "Moderna has an ambitious plan to launch multiple products over the next few years, and collaborations with companies like OpenAI are critical to our ability to scale and maximize our impact on patients."

Since the first dengue-like epidemic was suspected in 1635 in the Caribbean Islands, this mosquito-transmitted disease has impacted the health of millions of people throughout the Region of the Americas.

According to new data, the year 2024 may set an all-time record. 

The Pan American Health Organization (PAHO) recently issued Situation Report No. 14 confirming that 4,820,955 suspected cases of Dengue (an increase
of 260% from 2023) and 1,733 deaths have been registered as of mid-April 2024.

As of April 23, 2024, Brazil has reported the most Dengue cases this year.

To alert international travelers, the U.S. Centers for Disease Control and Prevention (CDC) reissued its Level 1 Travel Health Advisory for the Americas on April 18, 2024. The countries listed have reported higher-than-usual dengue cases.

The CDC says travelers to these Caribbean, Central, and South American countries may be at increased risk.

Within the U.S., the CDC reported that 37 jurisdictions have reported 929 dengue cases as of April 2024.

The unfortunate leader is Puerto Rico, which has 644 dengue cases, followed by the state of Florida, which has 106 travel-associated cases and five locally acquired dengue cases this year.

From a prevention perspective, two dengue vaccines have been approved. To learn about vaccination options, the CDC says travelers should speak with a vaccine advisor at least one month before traveling abroad.

As of April 23, 2024, travel vaccines are offered at specialty clinics and certified pharmacies in the U.S.

The Florida Department of Health published Arbovirus Surveillance Update #15, which discloses various mosquito-borne diseases reported this year.

As of April 13, 2024, countries in southern Florida confirmed these mosquito-transmitted diseases:

• Chikungunya - Three cases of chikungunya that began in 2024 have been reported in individuals with a travel history to Brazil, and four cases were confirmed in 2023.
• Dengue Fever - In 2024, 106 travel-associated dengue cases have been reported, mainly by visitors from Cuba. In 2023, 609 travel-associated dengue cases were reported, primarily in people arriving from Brazil and Cuba. Five cases of locally acquired dengue were reported from Miami-Dade (4) and Pasco counties in 2024. 
• Malaria - In 2024, nineteen cases of malaria with onset in 2024 have been reported in individuals with a travel history to malaria-endemic areas in Africa. In 2023, 78 malaria cases were reported.

To learn where these diseases are spreading, the U.S. CDC issued Travel Health Notices to inform travelers about global health risks.

While the U.S. FDA recently approved an innovative chikungunya vaccine, its availability in Florida is pending. Access to the approved dengue vaccine has specific requirements.

Furthermore, two approved malaria vaccines are unavailable in the U.S.

Visit a local travel clinic, such as Passport Health USA Tampa, to learn more about these and other travel vaccine options.