Cancer Vaccine Breaking News

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.

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.