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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.
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."
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.
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.
The U.S. Department of State recently reissued its Level 2: Exercise Increased Caution for the Republic of Indonesia. On April 5, 2023, the State Department stated some areas in Indonesia had increased risk.
And reconsider visiting the provinces of Central Papua (Papua Tengah) and Highland Papua (Papua Pegunungan) due to civil unrest.
Furthermore, Indonesia’s revised criminal code, which takes effect in January 2026, includes penalties for defamation, blasphemy, cohabitation, and sex outside of marriage.
However, it is unclear how Indonesian authorities will implement the revised criminal code, says the State Department.
According to travel industry data, foreign tourist arrivals in Indonesia reached about 700 thousand in February 2023, amid several international events as the economy fully reopened from COVID-19 pandemic restrictions.
The United States, through the U.S. Agency for International Development (USAID), and the Indonesian Ministry of Health, recently celebrated their successful collaboration under the United States COVID-19 assistance program.
Throughout the pandemic, USAID helped deliver over 100 million vaccine doses to Indonesia, including 42 million donated directly from the United States.
“In the face of this unprecedented challenge, Indonesia and the United States stood together to confront the pandemic, and together, we have dramatically reduced deaths and severe illness,” said U.S. Deputy Chief of Mission Michael F. Kleine in a press release on April 5, 2023.
From a health-risk perspective, the U.S. Centers for Disease Control and Prevention (CDC) has issued several travel vaccination recommendations when planning to visit Indonesia.
These CDC Travel Alerts include measles and polio.
These travel vaccines are available in the U.S. at certified clinics and pharmacies.
BioSpace reported today Vivek Shinde, vice president of clinical development and lead for older adult influenza & RSV vaccines at Novavax Inc., delivered an update on the Company's COVID-influenza combination (CIC) candidate at the World Vaccine Congress 2023.
The Company presented CIC data and poster presentations on its COVID-19 prototype vaccine during this conference in Washington, DC.
Shinde confirmed that CIC formulations were immunogenic and induced strong functional antibody and CD4+ T cell responses against SARS-CoV-2 and multiple influenza strains on April 5, 2023.
"I think a combination vaccine is only going to hopefully boost compliance in those who intend to get both vaccines," he informed Heather McKenzie at BioSpace on April 7, 2023.
Novavax intends to use these data to inform an ongoing Phase II dose confirmation study. Results from this study are expected later in 2023.
Novavax's COVID-19 vaccine (Nuvaxovid™, CovoVax™, NVX-CoV2373) protein-based vaccine has received various authorizations from more than 43 countries.
