Travel Vaccine Breaking News

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.

The U.S. Food and Drug Administration (FDA) recently issued a draft guidance titled: Diabetes Mellitus: Efficacy Endpoints for Clinical Trials Investigating Antidiabetic Drugs and Biological Products Guidance for Industry.

This draft guidance provides a 15-year update to the FDA's previous recommendations on efficacy endpoints for such products.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The draft guidance outlines the FDA's general recommendations around evaluating the efficacy of antidiabetic drugs for adults and children with type 1 and/or type 2 diabetes.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.

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 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.

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.

The U.S. Centers for Disease Control and Prevention (CDC) today confirmed some US residents returning from Mexico were diagnosed with suspected fungal meningitis infections that have led to severe illness and death.

In a Level 2, Practice Enhanced Precautions advisory issued on May 26, 2023, the CDC stated travelers with these infections had medical or surgical procedures that involved injection of an anesthetic into the area around the spinal column (i.e., epidural) performed at clinics in Matamoros, including River Side Surgical Center and Clinica K-3.

If you had a procedure involving an epidural injection of an anesthetic in Matamoros, Mexico, any time since January 1, 2023, learn what additional steps you should take, says the CDC.

There are millions of fungal species, but only a few hundred of them can make people sick. Fungal meningitis infections are not contagious and are not transmitted from person to person.

Although anyone can get fungal meningitis, people with weakened immune systems are at increased risk.

Certain health conditions, medications, and surgical procedures may weaken the immune system. Symptoms of fungal meningitis infections include fever, headache, stiff neck, nausea, vomiting, confusion, or sensitivity to light.

Fungal meningitis is treated with IV (injected through a vein) and oral medications. The CDC says that treatment length can vary depending on the fungus type.

The U.K. Health Security Agency (UKHSA) today published an analysis focused on the resurgence of mpox in England.

As of May 24, 2023, the UKHSA reported 20 new cases of mpox.

 Of these, 19 were in England (10 cases were presumed to have acquired mpox in the U.K., eight were acquired outside the U.K., and one was waiting for classification), and one was in Scotland.

The UKHSA did not disclose the vaccination status of the mpox cases.

During 2022, there were 3,732 confirmed and highly probable mpox cases reported in the U.K. Of these, 3,553 were in England.

Before 2022, cases diagnosed in the U.K. had been imported from countries where mpox is endemic or contacts with documented epidemiological links to imported cases. Between 2018 and 2021, there were 7 cases of mpox in the U.K. 

Anyone eligible for mpox vaccination in the U.K. is urged to come forward for the vaccine in the coming months to protect themselves before the summer of 2023.

Steve Russell, NHS director of vaccinations and screening, stated in March 2023, "There is still time to get your first and second doses if you haven't already, which will provide long-term protection against the virus and any possible future outbreaks, so please do book an appointment while the offer is available on the NHS."

Bavarian Nordic's JYNNEOS® (MVA-BN) vaccine is offered in the U.K. as well as in the U.S.

Last week, the U.S. Centers for Disease Control and Prevention confirmed a cluster of mpox infections in mostly vaccinated men in the Chicago, Illinois area.

Mpox is a sexually transmitted disease, similar to HPV and hepatitis, that is vaccine-preventable.