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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.
The U.S. Centers for Disease Control and Prevention (CDC) today announced a previously unscheduled meeting of the Advisory Committee on Immunization Practices (ACIP) focused on COVID-19 vaccinations.
According to the CDC's website, on April 12, 2023, the ACIP will digitally meet on April 19, 2023, at 11 am EST. This meeting's agenda has yet to be posted for public review, and no registration is required to watch the webcasts.
A summary of recent changes (last updated March 16, 2023) is posted on this CDC page.
Updated on April 19, 2023, with the meeting's agenda.
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 Republic of Equatorial Guinea (EG) health agency today confirmed another death related to its ongoing Marburg virus disease (MVD) outbreak.
As of April 10, 2023, there have been fifteen MVD cases, eleven related fatalities, and over 60 people under monitoring.
This is the first-ever outbreak of MVD in EG, located on Africa's west coast.
The index case died in early January 2023, with cases confirmed from the province of Kié-Ntem, four from the Litoral, and two from Centre- Sur provinces. These areas are about 150 kilometers apart, suggesting comprehensive virus transmission.
The U.S. CDC issued an Alert - Level 2, Practice Enhanced Precautions on April 6, 2023, to notify international travelers regarding EG's outbreak.
The CDC says Marburg is a viral hemorrhagic fever, with symptoms including fever, chills, headache, muscle pain, rash, sore throat, diarrhea, vomiting, stomach pain, chest pain, and unexplained bleeding or bruising.
As of April 11, 2023, Marburg has no approved vaccines or treatments. However, there are vaccine candidates conducting research studies.
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.
According to the Washington Post, the U.S. administration is launching a $5 billion program to accelerate the development of new coronavirus vaccines and treatments, seeking to better protect against a still-mutating virus and other coronaviruses currently impacting humans, such as Middle East respiratory syndrome (MERS).
Announced on April 10, 2023, the “Project Next Gen” approach intends to partner with private sector companies to expedite the development of vaccines and therapies.
The Post reported this new effort would focus on creating long-lasting monoclonal antibodies, accelerating the development of vaccines that produce what is known as mucosal immunity, and speeding efforts to develop pan-coronavirus vaccines.
Note: The U.S. FDA has not approved a MERS vaccine as of April 11, 2023, but several vaccine candidates are conducting clinical trials.
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.
Sanofi today announced in a press release it had simplified its contractual arrangements relating to the development and commercialization of Beyfortus® (nirsevimab) in the United States (U.S.).
As of April 11, 2023, Beyfortus is an investigational long-acting antibody designed to protect all infants against Respiratory Syncytial Virus (RSV) infections from birth through their first RSV viral season with a single dose.
Under the new and updated arrangements, Sanofi has complete commercial control of Beyfortus in the U.S.
Concerning territories outside the U.S., the existing Collaboration Agreement between AstraZeneca and Sanofi continues to govern that relationship.
The new and updated contractual agreements do not impact Beyfortus registration and launch in the U.S., where all parties remain committed to making Beyfortus available for all infants in time for the 2023/24 RSV season.
Beyfortus is a monoclonal antibody (mAbs) that does not require immune system activation to confer direct and rapid protection against infection.
Beyfortus has already received marketing authorization in the European Union to prevent lower respiratory tract disease caused by RSV in neonates and infants from birth during their first RSV season.
This RSV mAbs pending approval in the U.S. is independent of the Food and Drug Administration's efforts to authorize RSV vaccines in 2023.
