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Immorna today announced that the first subject had been dosed in the Company's First-In-Human Phase 1 multi-center study of JCXH-105, a self-replicating RNA (srRNA) vaccine being developed for the prevention of Shingles.
The U.S. Food and Drug Administration (FDA) cleared its investigational new drug application on January 9, 2023, to conduct a Phase 1 multi-center study of JCXH-105.
NgocDiep Le, M.D., Ph.D., Global Chief Medical Officer of Immorna, commented in a press release on May 30, 2023, "If proven successful in clinical studies, JCXH-105 may become a valuable alternative to current standard-of-care to meet the large world-wide medical need for Shingles prevention."
"Due to its self-replicating nature, JCXH-105 may be effective at a significantly reduced dose level compared to non-replicating conventional mRNA vaccines and thereby may cause less reactogenicity and substantially reduce the cost of production."
"In addition, due to the synthetic nature of all JCXH-105 vaccine components, there are no raw material limitations or production bottlenecks."
This Phase 1 study is a randomized, double-blinded, multi-center, active-controlled study to assess the safety, immunogenicity, and determine the Recommended Phase 2 Dose for JCXH-105 for seniors.
In this study, JCXH-105 will be compared to GSK's U.S. FDA-approved Shingrix® vaccine.
Other shingles vaccine development news is posted by Precision Vaccinations.
Valneva SE today announced filing a regulatory application with Health Canada for marketing approval of the single-shot chikungunya vaccine candidate, VLA1553.
If accepted by Health Canada, VLA1553 would become available for persons aged 18 years and above.
VLA1553 is currently the only chikungunya vaccine candidate worldwide for which regulatory review processes are underway. It could become the first licensed chikungunya vaccine to address this unmet medical need if approved.
A Biologic License Application is currently under priority review by the U.S. Food and Drug Administration with a Prescription Drug User Fee Act review goal date at the end of August 2023.
VLA1553 received FDA Fast Track and Breakthrough Therapy designations in 2018 and 2021, respectively. The program was also granted PRIority MEdicine designation by the European Medicines Agency in 2020.
Furthermore, Valneva plans to make regulatory submissions for VLA1553 in Europe in the second half of 2023.
Juan Carlos Jaramillo, MD, Chief Medical Officer of Valneva, commented in a press release on May 30, 2023, "Chikungunya represents a major threat for people traveling to or living in areas where chikungunya virus and the mosquitos that transmit it are present, including popular destinations for U.S. and Canadian travelers."
"No vaccine or specific treatments are currently available for this debilitating disease, and we will continue to work diligently to bring VLA1553 to different territories as soon as possible."
Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus, transmitted by Aedes mosquitoes.
An infection leads to symptomatic disease in 72-92% of humans after four to seven days following the mosquito bite. While mortality is low, morbidity is high.
Beginning in 2014, chikungunya virus disease cases were reported among U.S. travelers returning from affected areas in the Americas, and local transmission was identified in Florida, Texas, Puerto Rico, and the U.S. Virgin Islands, says the U.S. CDC.
The high-risk areas of infection for travelers included the Americas, parts of Africa, and Southeast Asia, and the virus has spread to more than 110 countries.
The U.S. Food and Drug Administration (FDA) recently issued a draft guidance titled: Diabetes Mellitus: Efficacy Endpoints for Clinical Trials Investigating Antidiabetic Drugs and Biological Products Guidance for Industry.
This draft guidance provides a 15-year update to the FDA's previous recommendations on efficacy endpoints for such products.
"Diabetes is a common disease that affects nearly 40 million people in the U.S. and is projected to affect more in the coming years. Therefore, the need for more antidiabetic treatment options is clear," said Lisa Yanoff, M.D., deputy director of the Office of Cardiology, Hematology, Endocrinology, and Nephrology in the FDA's Center for Drug Evaluation and Research, in a press release on May 26, 2023.
The draft guidance outlines the FDA's general recommendations around evaluating the efficacy of antidiabetic drugs for adults and children with type 1 and/or type 2 diabetes.
As of May 29, 2023, the FDA has not approved a diabetes preventive vaccine.
S.K. Chemicals' SKYCovion COVID-19 vaccine has been authorized by the U.K.'s Medicines and Healthcare Products Regulatory Agency (MHRA).
This authorization is for use as a primary vaccination in those aged 18 and over. Decisions on which COVID-19 vaccines are deployed in the U.K. are taken by the Joint Committee on Vaccination and Immunisation.
As of May 26, 2023, it becomes the 8th COVID-19 vaccine authorized by the U.K.
The SKYCovion vaccine combines a part of the SARS-CoV-2 virus spike protein with an 'adjuvant' – an additional ingredient designed to trigger a more robust immune response. It is given as two injections, four weeks apart.
Novavax, Inc. recently announced that Nuvaxovid™ had been recommended for full Marketing Authorization (MA) for use as a primary series in individuals aged 12 and older and as a booster in individuals aged 18 and older for the prevention of COVID-19 in the European Union (EU) following a positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency.
The European Commission is expected to make a final decision on the MA.
Novavax COVID-19 vaccine Nuvaxovid was the first protein-based vaccine engineered from the genetic sequence of the SARS-CoV-2 beta coronavirus.
"The positive CHMP Opinion for full Marketing Authorization for our COVID vaccine brings us one step closer to full authorization and will provide an approval pathway for an updated vaccine in time for the fall," said John C. Jacobs, President and Chief Executive Officer, Novavax, in a press release on May 25, 2023.
In the EU, Nuvaxovid has been conditionally authorized as a two-dose primary series in adults and adolescents and as a booster dose in adults.
Novavax's COVID vaccine is authorized for use in more than 40 markets worldwide.
The trade name Nuvaxovid has not yet been approved by the U.S. Food and Drug Administration.
Novavax's vaccine is known as CovoVax™ and NVX-CoV2373 globally.
The Pan American Health Organization (PAHO) recently reported Respiratory Syncytial Virus (RSV) cases in Latin America and the Caribbean for Epidemiological Week #18 of 2023.
As of May 24, 2023, the PAHO confirmed RSV activity has remained low throughout most of the Americas.
However, in Brazil and Southern Cone, RSV activity, after showing an increase in recent weeks, a decreasing trend has been observed.
In the U.S., Florida’s RSV season is longer than the rest of the nation and has distinct regional patterns. However, as of late May 2023, Florida has not reported an RSV outbreak.
RSV is a common respiratory virus that usually causes mild, cold-like symptoms.
However, according to the Florida Department of Health, young children and older adults, especially those with certain underlying health conditions, are at higher risk for severe illness from RSV.
RSV is a vaccine-preventable disease in older adults, and RSV monoclonal antibody therapies were approved for infants in 2023.
The U.S. Centers for Disease Control and Prevention recently released preliminary Tuberculosis (TB) cases data that the U.S. is also experiencing a disease resurgence.
The CDC reported that TB disease cases increased by 5% in 2022 to 8,300 cases.
TB cases have recently increased in California, New York, and Texas.
Healthcare providers and communities disproportionately affected by TB are recommended to.... Think. Test. Treat TB.
According to the WHO 2022 Global TB Report, an estimated 1.6 million people died from TB, an increase of 4.5% in one year.
As of May 29, 2023, the 100-year-old Bacille Calmette-Guérin (BCG) vaccine is not widely used in the U.S. However, it is often given to infants and small children in other countries where TB is common.
There are over ten versions of the BCG vaccine used globally.
The U.S. CDC reissued it's Alert - Level 2, Practice Enhanced Precautions travel advisory regarding U.S. residents returning from Matamoros, Mexico, who were diagnosed with suspected fungal meningitis infections that have led to severe illness and death.
As of May 26, 2023, the CDC stated people should cancel any elective procedure that involves an epidural injection of an anesthetic in Matamoros, Mexico until there is evidence that there is no longer a risk for infection at these clinics.
Furthermore, all medical and surgical procedures carry some risk, and complications can occur regardless of where treatment is received.
The risk of complications depends on the destination, the facility where the procedure is being performed, and whether you are in good physical and psychological condition for the procedure(s).
And learn how to minimize risks if you are considering traveling to another country for medical care, says the CDC.
After a lull of nearly two months throughout the country, the resurgence of avian influenza (bird flu) in France's South West in May 2023 has triggered an immediate response.
Reuters reported on May 26, 2023, France announced an avian influenza (bird flu) vaccination program would launch in late 2023.
Marc Fesneau, Minister of Agriculture and Food Sovereignty, called on May 22, 2023, for all avenues to be explored to improve the fight against highly pathogenic avian influenza (HPAI), foremost among which is vaccination.
On April 6, 2023, France launched a tender for 80 million doses of bird flu vaccines.
Temporary authorization for use has recently been submitted for vaccines for poultry species currently being assessed by the French Agency for Veterinary Medicinal Products and the European Medicines Agency.
To date, only one vaccine for chickens (Gallus gallus species) has marketing authorization in France (2006).
In the U.S., the Department of Agriculture's Agricultural Research Service recently confirmed they are testing several bird flu vaccine candidates. On May 16, 2023, the emergency use of an HPAI vaccine candidate to prevent additional deaths of California Condors.
Additional avian and human bird flu vaccine development news as of May 27, 2023, is posted by Precision Vaccinations.
