Vaccine News

Florida Health recently published an updated Mosquito-Borne Disease Surveillance report that indicates there were three new cases of dengue confirmed last week in persons that had international travel.

As of May 27, 2023, seventy-seven travel-associated dengue cases have been reported in Florida during week #21.

And there have been two cases of locally acquired dengue in 2023.

As of June 1, 2023, the U.S. CDC reported 129 dengue cases in States and 256 dengue cases in U.S. Territories this year.

Other dengue outbreaks are posted at Vax-Before-Travel.

YS Biopharma Co., Ltd. today announced that its novel PIKA Rabies Vaccine was granted Phase 3 clinical trial approval from the Food and Drug Administration of the Philippines.

The Phase 3 clinical trial, which is planned to commence later in 2023, will include approximately 4,500 subjects in the Philippines, Singapore, and Pakistan.

The PIKA Rabies Vaccine has the potential to become the first accelerated three-visit one-week regimen, superior to the currently available vaccine with a five-visit one-month or three-visit three-week regimen.

The US FDA granted orphan-drug designation for preventing rabies infection, including post-exposure prophylaxis (PEP) for rabies.

The PIKA Rabies Vaccine is powered by YS Biopharma's proprietary PIKA adjuvant technology to induce accelerated immunity and produce a higher immune response.

Pending the successful completion of Phase 3 trials, the Company plans to launch the sales and marketing of the Vaccine in North America, as well as in countries throughout Asia, Africa, Europe, the Middle East, and Central and South America.

Rabies is a vaccine-preventable, zoonotic, viral disease affecting the central nervous system. It has a case-fatality rate of almost 100%.

According to the World Health Organization, about 59,000 people die of rabies annually in over 150 countries.

Over 30% of rabies victims are children.

The U.S. Centers for Disease Control and Prevention updated its recommendations for rabies preexposure prophylaxis for humans in June 2022, replacing the three-dose vaccination schedule with a two-dose program, intending to protect for about least three years.

As of June 1, 2023, there are various rabies vaccines approved.

Southern Africa is again weathering a season of cholera, with six countries in the region recording outbreaks in 2023, reported Derick Matsengarwodzi with GAVI.

As of May 25, 2023, Malawi is the worst affected, recording 36,943 cases and 1,210 associated deaths between March 2022 and February 2023, according to World Health Organization (WHO).

So far this year, Malawi has received three shipments of oral cholera vaccine (OCV) in response to applications to the Gavi-supported stockpile established in 2013.

The latest 1.4 million OCV dose shipment arrived in Lilongwe in April 2023.

On May 22, 2023, Gavi published a roadmap outlining critical actions needed to ensure the supply of OCV can meet growing demand from countries.

The roadmap describes how these organizations, manufacturers, and countries can work together towards ensuring global OCV supply can support large-scale preventive vaccination by 2026.

"Cholera vaccines have steadily become more available over the past decade, meeting rising country demand," said Dr. Derrick Sim, Managing Director for Vaccine Markets and Health Security at Gavi, in a media release.

"As a result, the good news is we have doses to meet all emergency demand despite the rise in outbreaks, which is expected to continue. But this trend underscores the increasing importance of preventing outbreaks before they occur."

"The ultimate solution to both sustainable OCV supply and cholera control lies in our collective ability to  step up our efforts on prevention programs."

As of May 31, 2023, various cholera vaccines have been approved but remain in limited supply.

Note: The U.S. CDC recently issued an Alert Level 2, Practice Enhanced Precautions, regarding polio outbreaks, which includes Malawi.

The U.S. CDC Morbidity and Mortality Weekly Report (MMWR) Podcast Briefing, published today, offers an overview of the latest scientific information regarding mpox vaccinations.

This podcast discusses three MMWR reports as of the week of May 15, 2023.

First, although the number of mpox cases has decreased since the peak of the U.S. outbreak in August 2022, the risk for future outbreaks remains.

And clinicians need to be alert for new cases, and people at risk should continue to take prevention measures.

Second, a new report looking at data from 12 U.S. jurisdictions shows Bavarian Nordic JYNNEOS® (MVA-BN) vaccine effectively prevents mpox in people at high risk for mpox.

Third, a study of mpox patients in New York provides evidence that the JYNNEOS vaccine is highly effective against mpox. 

However, the CDC and other health agencies in France, South Korea, and Spain previously reported various mpox breakthrough cases in 2023.

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.