Travel Vaccine Breaking News

The Florida Health Department reported as of week #13, there had been 59 travel-associated dengue cases. And, as of April 8, 2023, there are now 2 locally acquired dengue cases confirmed in 2023. 

In 2022, Florida reported 903 travel-associated and 68 locally-acquired dengue cases.

In the Region of the Americas, 46 countries and territories reported dengue cases in 2022. For example, dengue was reported in 28 of 32 Mexico states last year.

These countries confirmed about 2.8 million dengue cases, representing a two-fold increase compared to 2021.

Dengue is a vaccine-preventable disease, and as of April 13, 2023, two vaccines are authorized in various countries.

The yellow fever virus (YFV) is a reemerging global health threat in 2023, driven by several factors, including the increased spread of the mosquito vector.

Although protective YFV vaccines exist, recent outbreaks in South America indicate a void in treatment options in countries such as Brazil.

To establish innovative treatment options for patients with severe YFV infection, researchers recently tested 37 YFV-specific neutralizing monoclonal antibodies (mAbs) isolated from previously vaccinated humans.

They identified two capable of potently neutralizing multiple pathogenic primary YFV isolates.

Using hamster and nonhuman primate models of lethal YFV infection, they demonstrate that a single administration of either potently neutralizing mAbs during acute infection fully controlled viremia.

And it prevented severe disease and death in treated animals.

'Given the potential severity of YFV-induced disease, these results show that these antibodies could effectively save lives and fill a much-needed void in managing YFV cases during outbreaks, wrote these researchers in a Science Translational Medicines article published on March 29, 2023.

In the U.S., the YF-Vax® vaccine is available as of April 13, 2023, at certified clinics and travel pharmacies. 

Furthermore, the International Certificate of Vaccination, known as the yellow card, is required to enter certain countries in 2023.

The University of Oxford today announced the R21/Matrix-M™ malaria vaccine was licensed for use in Ghana by the country’s Food and Drugs Authority.

This announcement marks the first regulatory clearance for the R21/Matrix-M malaria vaccine for use in any country for children at the highest risk of death from malaria.

According to the press release on April 13, 2023, the R21/Matrix-M vaccine has demonstrated high levels of efficacy and safety in Phase II trials, including amongst children who received a booster dose of R21/Matrix-M at one year following a primary three-dose regime.

The R21/Matrix-M malaria vaccine is a low-dose vaccine that can be manufactured at scale and modest cost, enabling as many as hundreds of millions of doses to be supplied to African countries which are suffering a significant malaria burden.

According to the U.S. Centers for Disease Control and Prevention, malaria is a vaccine-preventable mosquito-borne disease caused by a parasite. Malaria vaccines like Mosquirix™ and R21 have been reported effective at preventing disease. 

As of April 13, 2023, these malaria vaccines are unavailable in the U.S.

INOVIO today announced that an abstract had been accepted for presentation for INO-4201 as an Ebola booster for Merck's Ervebo® (rVSV-ZEBOV) vaccine at the 33rd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID).

"We are pleased that lead investigator Dr. Angela Huttner will have the opportunity to share important new humoral and cellular response data at ECCMID from our recently completed Phase 1b trial of INO-4201 as an Ebola booster vaccine candidate for Ervebo," said Dr. Laurent Humeau, INOVIO's Chief Scientific Officer, in a press release on April 12, 2023.

INO-4201 is a DNA vaccine targeting Zaire Ebola virus (ZEBOV) glycoprotein, designed to prevent infection.

INO-4201 encodes for a synthetic consensus antigen encompassing ZEBOV genetic variability from various outbreak strains to broaden immune coverage for divergent ZEBOV variants.

The Ebola virus family includes four virus species that cause periodic outbreaks of a highly contagious and lethal human infectious disease called Ebola Virus Disease (EVD).

New research suggests dormant Ebola virus in a previously infected survivor could re-emerge up to nearly five years later and again allow human-to-human transmission.

The Ebola virus is classified as a Category A Priority Pathogen by the U.S. Centers for Disease Control and Prevention.

Also, the World Health Organization lists EVD as a priority for research and development in emergency contexts and coordinates planning to prevent and respond to Ebola epidemics.

Ebola vaccines have been approved and deployed in Africa.

Moderna Inc. recently confirmed it has five influenza vaccine candidates in clinical development. As of April 11, 2023, these flu shots include:

• mRNA-1010, a seasonal quadrivalent vaccine using strains recommended by the World Health Organization,
• mRNA-1011/1012, a seasonal penta-/hexa-valent vaccine candidate that includes more hemagglutinin antigens (e.g. H3, H1) to expand strain matching,
• mRNA-1020/1030, a seasonal vaccine candidate that includes neuraminidase antigens to target more conserved regions of the virus.

The Company's first vaccine candidate against influenza is mRNA-1010, developed in adults and is currently being evaluated in two Phase 3 trials.

The first Phase 3 trial (P301) was conducted in the Southern Hemisphere to evaluate the safety and non-inferior immunogenicity compared to a licensed flu vaccine.

The previously announced interim results from the P301 trial indicated that mRNA-1010 demonstrated superiority in geometric mean titers (GMT) for A/H3N2 and non-inferiority in GMT for A/H1N1.

However, mRNA-1010 did not meet non-inferiority for both influenza B/Victoria- and B/Yamagata-lineage strains.

But, mRNA-1010 demonstrated an acceptable safety and tolerability profile in the trial, and the independent Data and Safety Monitoring Board (DSMB) for P301 did not identify any safety concerns.

The second Phase 3 trial (P302) is being conducted in the Northern Hemisphere to evaluate the safety and non-inferior efficacy compared to a licensed flu vaccine.

The independent DSMB has completed the first interim analysis of efficacy and informed the Company that mRNA-1010 did not meet the statistical threshold necessary to declare early success and recommended that the trial continues with efficacy follow-up towards the next analysis.

The DSMB did not identify any safety concerns, and blinded follow-up for safety and efficacy is ongoing in this trial.

A preliminary immunogenicity analysis from a subset of participants in the P302 trial has also been completed.

In this analysis, mRNA-1010 demonstrated geometric mean titer ratios consistent with superiority against both influenza A strains (A/H1N1, A/H3N2) and consistent with non-inferiority against both influenza B strains (B/Victoria, B/Yamagata) relative to the licensed comparator.

The P302 study did not pre-specify success criteria for immunogenicity endpoints.

Additionally, the Company announced it had developed an update to mRNA-1010 that is expected to have improved immunogenicity against influenza B strains. It also announced plans to initiate a confirmatory Phase 3 trial in 2023.

Stéphane Bancel, Chief Executive Officer of Moderna, commented in a related press release, "With mRNA-1010, our first investigational vaccine against seasonal flu, we are encouraged by the consistently strong immunogenicity results against influenza A, and titers consistent with non-inferiority against influenza B strains in the most recent Phase 3 trial."

"With our mRNA platform and technology, as well as our agile manufacturing capabilities, we are confident that we can quickly develop safe and effective vaccines to address critical unmet needs."

The U.S. government today issued a single sentence that announced the termination of the COVID-19 pandemic in the United States.

Posted on Twitter on April 10, 2023, this statement confirmed H.J.Res.7, terminates the national emergency related to the COVID-19 pandemic.

 More than 1.13 million people in the U.S. have died from COVID-19 over the last three years, according to the Centers for Disease Control and Prevention, reported NPR on April 11, 2023.

Moderna, Inc. today announced clinical program updates focusing on Lyme disease, a global health issue impacting about 120,000 people in the U.S. and Europe annually.

To address Lyme's biological complexity, Moderna is advancing a seven-valent approach with two Lyme disease vaccine candidates that will be developed in parallel.

Moderna announced on April 11, 2023, new vaccine candidates, mRNA-1982 and mRNA-1975, represent the Company's first application of its mRNA technology to bacterial pathogens such as Lyme disease.

"Our mRNA platform has changed medicine and will continue to have a major impact on global health. Today we are excited to announce multiple new vaccine candidates, including for enteric viruses, such as norovirus, and targeting Lyme disease, our first bacterial vaccine," said Stéphane Bancel, Chief Executive Officer of Moderna, in a related press release.

mRNA-1982 is designed to elicit antibodies specific for Borrelia burgdorferi, which causes almost all Lyme disease in the U.S.

While mRNA-1975 is designed to elicit antibodies specific for the four major Borrelia species causing disease in the U.S. and Europe.

Lyme disease burden follows a bimodal age distribution, affecting mainly children under 15 and older adults. Patients can develop a rash, fever, headaches, fatigue, joint pain, swelling, stiffness, and headaches.

Older adults appear to have higher odds of unfavorable treatment response than younger patients, and neurologic manifestations are more common at presentation for this more aging adult population.

Currently, the U.S. Food and Drug Administration has not approved a Lyme disease vaccine.

However, VLA15, a multivalent Lyme disease vaccine candidate produced by Pfizer In. and Valneva SE, is conducting late-stage clinical research.