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The U.S. Food and Drug Administration (FDA) recently issued a draft guidance titled: Diabetes Mellitus: Efficacy Endpoints for Clinical Trials Investigating Antidiabetic Drugs and Biological Products Guidance for Industry.

This draft guidance provides a 15-year update to the FDA's previous recommendations on efficacy endpoints for such products.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The draft guidance outlines the FDA's general recommendations around evaluating the efficacy of antidiabetic drugs for adults and children with type 1 and/or type 2 diabetes.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

According to Japan's National Institute of Infectious Diseases reported on May 14, 2023, the number of syphilis patients totaled 5,164 in 2023. The data for the same period in 2022 was 3,630.

The IDWR Surveillance Data Table week #19 confirmed Tokyo had the most cases at 1,332, followed by Osaka with 699 cases and Fukuoka with 257 cases.

According to the Institute, cases of congenital syphilis have been increasing in recent years, with 20 cases reported in 2022. In 2023, six patients were confirmed by early April.

Congenital syphilis is caused by the bacterium Treponema pallidum, which can be passed from mother to child during fetal development or at birth. Up to half of all babies infected with syphilis in the womb die shortly before or after birth.

"There is a possibility that cases of congenital syphilis will increase along with those of syphilis," commented Prof. Satoshi Takahashi, who heads the Japanese Society for Sexually Transmitted Infections, according to local media on May 24, 2023.

"Syphilis is a curable disease, so people should get tested without hesitation if they have worrisome symptoms or concerns."

As of April 11, 2023, the U.S. Centers for Disease Control and Prevention reported 176,713 syphilis cases in 2021 and 2,855 congenital syphilis cases, resulting in 220 stillbirths and infant deaths, a YOY increase of 32%. 

Unfortunately, the U.S. Food and Drug Administration has not approved a syphilis vaccine as of May 27, 2023.

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.

Biofabri and IAVI recently announced signing an agreement for the end-to-end development of tuberculosis (TB) vaccine candidate MTBVAC. This agreement provides a framework for the future collaboration that the partners first announced in 2021.

After securing sufficient funding, IAVI plans to begin an efficacy clinical trial in 2024. 

MTBVAC is a highly promising vaccine candidate that has the potential to be used as an alternative to BCG vaccination in infants and for the prevention of TB disease in adolescents and adults. 

"The world urgently needs a new, effective vaccine that can prevent TB disease in adults, adolescents, and infants," said Dr. Mark Feinberg, president, and CEO of IAVI, in a press release on May 17, 2023.

"We are honored to work with Biofabri and our other collaborators to advance MTBVAC."

"In addition, we are actively seeking the support of global health funders and other partners, public and private, to ensure that this promising vaccine candidate has the potential to be part of a solution to ending the TB epidemic." 

Should MTBVAC be safe and efficacious, Biofabri will ensure that the TB vaccine is manufactured and supplied in sufficient quantities globally and is accessible at affordable prices in low- and middle-income countries.

Precision Vaccinations post other TB vaccine and outbreak news.

Prensa Latina recently reported Cuba's COVID-19 vaccines, Soberana 02, Soberana Plus, and Abdala, received the sanitary registration granted by the Center for State Control of Medicines, Medical Equipment, and Devices for their proven efficacy.

The experts and scientists ratified the safety that characterizes Cuba's COVID-19 vaccines, firstly due to the very nature of the technological platforms used and secondly, because they have high thermo-stability.

Unlike others requiring special storage conditions, Cuba's vaccines can be stored between two and eight degrees Celsius at freezing temperatures.

During the clinical studies, vaccine efficacy was higher than 90%.

As of May 24, 203, Cuba is among the world's top 10 countries with most citizens immunized against the SARS-CoV-2 coronavirus, which raises the level of protection to more than 90% of Cuban inhabitants.