Vaccine News

GC Biopharma announced today that it has applied to the Korean Ministry of Food and Drug Safety for the marketing approval of "GC1109", an anthrax vaccine jointly developed by the company and the Korea Disease Control and Prevention Agency (KDCA).

If approved, "GC1109" will be the world's first recombinant anthrax vaccine.

'GC1109' contains a protective antigen as its active pharmaceutical ingredient, produced by recombinant DNA technology. This delivers two types of proteins, comprising anthrax toxin, lethal factor, and edema factor, into cells.

In the Phase II clinical trial, the vaccine's immunogenicity and safety were demonstrated with healthy volunteers. Subjects who received intramuscular administration of GC1109 generated antibodies sufficient to neutralize anthrax toxins, while adverse drug reactions or solicited adverse events were similar to those of the placebo group.

In the animal efficacy study, GC1109 induced neutralizing antibody, which remained at a high level even six months after the 4th dose of the vaccine, with a high survival rate against the bacillus anthracis spore challenge.

GC Biopharma stated in a press release on November 5, 2023, "We believe in the significance of our journey to localize the anthrax vaccine in terms of securing vaccine sovereignty while promoting public health and national security."

"GC Biopharma will continue to lead the localization of critical medicines and contribute to the stable supply of basic medical supplies as it has been doing for other vaccines and blood products since the foundation of the company."

Since it is unethical to expose human volunteers to lethal Bacillus anthracis, and field trials are not feasible due to a low incidence of anthrax, human clinical efficacy studies for an anthrax vaccine cannot be conducted.

In such cases, under the "Animal Rule" of The Special Act for Promotion of the Development and Emergency Supply of Medical Products in Response to Public Health Crisis, animal efficacy data can be used to establish the vaccine's clinical benefit if the evidence from the animal studies provides substantial grounds for the product's effectiveness.

Anthrax, caused by Bacillus anthracis, is a Class 1 infectious disease by the Infectious Disease Control and Prevention Act, with a lethality rate of up to 97% if untreated.

To prepare against potential bioterrorism and consequent national crisis, GC Biopharma, under the research project supported by KDCA, has been developing a recombinant vaccine for anthrax since 2002.

GC Biopharma (formerly Green Cross Corporation) is a biopharmaceutical company that delivers life-saving and life-sustaining protein therapeutics and vaccines.

According to the U.S. CDC, people get infected with anthrax when spores get into the body. When this happens, the spores can be activated and become anthrax bacteria.

Then, the bacteria can multiply, spread out in the body, produce toxins (poisons), and cause severe illness.

The good news is anthrax is not contagious. 

You cannot catch anthrax from another person the way you might catch a cold or the flu.

In rare cases, person-to-person transmission has been reported with cutaneous anthrax, where discharges from skin lesions might be infectious, says the CDC.

The U.S. Food and Drug Administration (FDA) MedWatch Safety Alert recently published an advisory on X informing healthcare providers who administer the Moderna COVID-19 vaccine (SpikeVax® XBB.1.5) (2023-2024 Formula) to individuals six months through 11 years of age to ensure that the correct volume of the vaccine (0.25 mL) is withdrawn from the vial and that the correct dose is administered to the vaccine recipient.

On November 1, 2023, the FDA confirmed that it had become aware that some healthcare providers may not recognize that the single-dose vial of Moderna COVID-19 Vaccine (2023-2024 Formula) for use in individuals six months through 11 years of age contains notably more than 0.25 mL of the vaccine.  

Some healthcare providers may be withdrawing the entire contents of the vial to administer to an individual. 

The Dosage and Administration section of the Fact Sheet for Healthcare Providers Administering Vaccine has been revised to clarify that 0.25 mL should be withdrawn from the vial, and the vial and any excess volume should be discarded.

If healthcare providers, parents, or caregivers have questions, they may contact the FDA's Center for Biologics Evaluation and Research at  [email protected].

On November 2, 2023, Moderna, Inc. reported financial results and provided business updates for the third quarter of 2023, but these did not highlight this MedWatch advisory.

"Through this quarter, we demonstrated our ability to increase our share in the U.S. market (Spikevax's U.S. market share to date increased to 45% from 36% in 2022). We now expect this year's vaccination rate to be similar to last fall," commented Stéphane Bancel, Moderna's CEO, in a press release.

"In the third quarter, we significantly resized our manufacturing infrastructure to make our COVID-19 franchise profitable for 2024 and beyond.

The Company reported $1.8 billion in Spikevax® vaccine sales in the third quarter of 2023. This led to $3.9 billion in vaccine sales for the year through the third quarter.

Moderna believes that the U.S. market for fall 2023 will be at least 50 million doses, supporting total 2023 Spikevax sales of at least $6 billion. 

The Coalition for Epidemic Preparedness Innovations (CEPI) and the University of Oxford announced the launch of a new project to initiate early development of prototype vaccines against the Junín virus.

CEPI confirmed on October 2, 2023, that it would provide up to $25 million to Oxford for preclinical and Phase I clinical development of a vaccine against the Junín virus using Oxford's ChAdOx platform

This seldom-discussed virus was selected as an exemplar of the Arenavirus family, which includes the Lassa virus, Junin virus, Machupo virus, Guanarito virus, and lymphocytic choriomeningitis virus. 

Arenavirus infections are responsible for multiple deadly hemorrhagic fevers with epidemic and pandemic potential. Junín virus can cause Argentine Haemmorhagic Fever, with symptoms including muscular pain, dizziness, rashes, and a 15-30% case fatality.

Dr. Richard Hatchett, CEO of CEPI, commented in a press release, "This new project will harness the University of Oxford's extensive vaccinology experience and its innovative ChAdOx vaccine technology – one of only a handful of vaccine platforms proven to work at speed, scale, and low cost – to expand the world's scientific knowledge on arenavirus vaccines."

"The project will generate vital resources for the proposed Global Vaccine Library, helping accelerate efforts to reduce vaccine development timelines to 100 days when faced with future threats."

The data and materials generated by this new project could give the world a head start in rapidly developing safe and effective vaccines against Arenaviruses within 100 days of their identification, potentially stopping a future pandemic in its tracks, wrote CEPI.

For the second time in a month, the mosquito-transmitted dengue fever virus has been confirmed in a person in Southern California.

On November 1, 2023, the City of Long Beach Department of Health and Human Services (Health Department) reported one case of dengue in a resident who has not traveled outside the U.S.

This is the first non-travel-related case of dengue in Long Beach, which has reported five travel-related cases.

Long Beach is home to approximately 466,000 Californians.

According to the Health Department, the risk of local exposure remains low.

"The health and well-being of the community is our most important priority," commented Long Beach Mayor Rex Richardson in a press release.

"We are working closely with health officials and doing everything we can to prevent more (dengue) cases. We ask that everyone do their part by removing standing water on their property to help us control the mosquitoes in our neighborhoods."

For more local information, people are encouraged to visit longbeach.gov/dengue. 

According to reports, over 4.2 million infections and about 3,000 dengue outbreak-related deaths have been reported from 79 countries/territories in the past year.

In the U.S., the state of Florida has reported the most travel-related and local dengue cases in 2023.

An earlier locally-acquired dengue case was reported in Pasadena, California.

Dengue is a disease that is spread by the bites of Aedes species mosquitoes. When a mosquito bites someone with one of dengue's four viruses in their blood, it can spread the virus to others.

The best way to protect oneself from dengue and other diseases spread by mosquitoes is to avoid mosquito bites.

Dengue vaccines are available in 2023, but there are various geographic limitations and/or testing requirements. 

Novavax, Inc. today announced the European Commission has approved the Nuvaxovid™ XBB.1.5 COVID-19 vaccine for individuals aged 12 and older.

This decision follows a positive opinion on approval from the European Medicines Agency's Committee for Medicinal Products for Human Use.

Novavax is working closely with EU member states that have requested doses through the advance purchase agreement to confirm timing of dose delivery on a country-by-country basis.

Novavax's vaccine is authorized for use in the U.S.

"Today's approval of the only updated protein-based non-mRNA COVID-19 vaccine in the EU is an important milestone as the need for vaccination continues," said John C. Jacobs, President and Chief Executive Officer, Novavax, in a press release on October 31, 2023.

"Novavax is working closely with national authorities to have our updated vaccine delivered and available in Europe in the coming weeks."

Nuvaxovid™ XBB.1.5 (recombinant, adjuvanted) (NVX-CoV2601) approval was based on non-clinical data showing that Novavax's updated COVID-19 vaccine induced functional immune responses against XBB.1.5, XBB.1.16 and XBB.2.3 variants.

Additional non-clinical data demonstrated that Novavax's vaccine-induced neutralizing antibody responses to newly emerging subvariants BA.2.86, EG.5.1 FL.1.5.1 and XBB.1.16.6 as well as CD4+ polyfunctional cellular (T-cell) responses against EG.5.1 and XBB.1.16.6.

These data indicate that Novavax's vaccine can stimulate both arms of the immune system and may induce a broad response against circulating variants.1,2

In clinical trials, the most common adverse reactions to Novavax's prototype COVID-19 vaccine (NVX-CoV2373) were headache, nausea or vomiting, muscle pain, joint pain, injection site tenderness, injection site pain, fatigue, and malaise.

Throughout 2023, the global dengue outbreak has exceeded 4.2 million cases from 79 countries/territories, with the region of the Americas reporting the majority of cases.

Through September 2023, most dengue cases in the region were reported from Brazil and Peru; the latter is experiencing one of the most significant dengue outbreaks in its history, says the European Centre for Disease Prevention and Control.

In the United States, the state of Florida leads in reporting travel-related and locally acquired dengue cases.

As of October 28, 2023, Florida's Health Department confirmed its 513th dengue case of 2023. 

Florida's Arbovirus Surveillance Report #43 confirmed 31 new travel-associated dengue cases. In 2023, 415 dengue cases associated with international travelers were reported. Two hundred and six of these cases are related to travel from Cuba.

From a long-term health perspective, health officials are very focused on the increase in locally acquired dengue cases.

Last week, 20 new cases of locally acquired dengue were reported in South Florida, increasing this year's total to 98.

Miami-Dade County has reported 91 of these locally acquired cases.

According to the U.S. Centers for Disease Control and Prevention, dengue is a vaccine-preventable disease that can progress to a severe condition.

As of October 31, 2023, two dengue vaccines are available globally, but only one is licensed in the U.S.

Dengvaxia is U.S. Food and Drug Administration-approved and indicated for preventing dengue virus serotypes 1, 2, 3, and 4. The Dengvaxia® vaccine is available for certain people following a pre-delivery diagnostic test review.

According to Reuters, the new respiratory syncytial virus (RSV) vaccine's usage has surged since its launch in the summer of 2023.

According to IQVIA data seen by Reuters, as of October 30, 2023, GlaxoSmithKline Biologicals (GSK) AREXVY™ RSV vaccine accounts for about two-thirds of RSV immunizations delivered to adults aged 60 years in the United States.

GSK's market advantage could be related to its relationship with CVS Health, the dominant pharmacy chain in the U.S.

In Canada, which approved AREXVY on August 4, 2023, RSV vaccine awareness is leveraging a hockey superstar's endorsement.

"The Arexvy ad featuring Wayne Gretzky aims to dispel the misperception that RSV is only a concern for young children and encourages adults aged 60 and older, who are among those at greater risk, to speak to their healthcare provider about RSV prevention, including the Arexvy vaccine," a GSK spokesperson told Fierce Pharma Marketing yesterday.

In Europe, the European Commission authorized AREXVY in June 2023, followed by the U.K.'s Medicines and Healthcare products Regulatory Agency in July 2023.

On July 26, 2023, GSK estimated that nearly 80 million adults in the U.S. could receive an RSV shot for the first time.

On October 31, 2023, Pfizer Inc. reported U.S. revenues from its RSV vaccine ABRYSVO™, which contributed $375 million since May 2023.

RSV vaccine uptake is influenced by the impact on adults during each RSV season. 

The World Health Organization Influenza Update N° 456, published in October 2023, reported early signs of RSV activity in parts of the European region.