Vaccine News

Valneva SE today announced that the U.S. Food and Drug Administration (FDA) approved IXCHIQ®, the Company’s single-dose, live-attenuated vaccine indicated for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 18 years of age and older who are at increased risk of exposure to CHIKV.

This indication is approved under accelerated approval based on anti-CHIKV neutralizing antibody titers. Valneva had received a Priority Review Voucher from the FDA. 

“Infection with chikungunya virus can lead to severe disease and prolonged health problems, particularly for older adults and individuals with underlying medical conditions,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, in a press release on November 9, 2023.

“Today’s approval addresses an unmet medical need and is an important advancement in preventing a potentially debilitating disease with limited treatment options.”

Valneva reported final pivotal Phase 3 data for the vaccine in March 2022, showing a 98.9% seroresponse rate at 28 days with a single vaccination and final lot-to-lot consistency results in May 2022.

IXCHIQ-induced seroresponse was sustained over time with a 96.3% seroresponse rate six months post-vaccination.

The Company’s pivotal Phase 3 results were published in the Lancet in June 2023.

Valneva will continue to evaluate antibody persistence for at least five years. Continued approval for this indication is contingent upon verification of clinical benefit in confirmatory studies.

With this U.S. approval, IXCHIQ becomes the world’s first licensed chikungunya vaccine available to address this unmet medical need and the third vaccine Valneva has brought from early R&D to approval.

The Company will hold an analyst call and a webcast at 3:00 pm CET or 9:00 am EDT on November 13, 2023. The link will be available on the Company’s investor page.

Chikungunya outbreaks are primarily found in Africa, the Americas, Asia, and the Indian subcontinent. CHIKV outbreaks are related to other vaccine-preventable travel diseases, such as dengue, measles, and polio.

The U.S. CDC published Recommendations for  Chikungunya Vaccine Use Among Adult Travelers on October 26, 2023.

Brazil's Ministry of Agriculture and Livestock today announced it had extended the declaration of an animal health emergency for 180 more days across the country due to the identification of outbreaks of the highly pathogenic H5N1 avian influenza virus, mainly in wild birds.

This measure enables the implementation of preventive policies to protect commercial birds from contamination by the disease, also known as avian influenza.

Brazil initially declared an animal health emergency on May 22, 2023, a week after the first detection of contaminated migratory wild birds. Within six months, 139 outbreaks have been identified.

According to the World Organization for Animal Health protocol, as there have been no cases of commercial birds, Brazil maintains its status as an H5N1-free country.

Due to the virus's high mutation and adaptability capacity to new hosts, H5N1 represents a risk mainly to international trade in poultry products. It occasionally poses a threat to human and animal health. Brazil holds a 35% share of the global chicken meat market and is the world's largest exporter.

Although no human disease cases have been reported in Brazil, data from the Pan American Health Organization in 2023 indicate cases in the Americas, including the United States, Chile, and Ecuador.

As of November 9, 2023, bird flu outbreak news is posted by Precision Vax.

Furthermore, the U.S. FDA has approved various avian influenza vaccines since 2013, with newer bird flu vaccine versions approved in 2023.

A study led by Chicago Department of Public Health researchers published in the Journal of Infectious Diseases involved estimating rates of HIV, gonorrhea, and chlamydia among mpox patients.

This study was published on November 8, 2023, and identified factors related to mpox severity from June 2022 to March 2023.

These researchers concluded that sexually transmitted infections (STIs) could facilitate mpox transmission. 

Of the 1,124 mpox patients, 44% had HIV, and 70% had a previous or current STI, with 39% having had at least three previous STI episodes.

Of 335 vaccinated mpox patients, 55% had received one dose of the JYNNEOS® (MVA-BN) vaccine, and 45% had received two doses.

In total, 17.6% has received one or more JYNNEOS vaccination before mpox infection.

The U.S. Centers for Disease Control and Prevention (CDC) reported on October 25, 2023, that post-JYNNEOS vaccination reinfection cases have been published and that they are aware of less than 10 cases of probable reinfection.

The CDC reported Vaccine Effectiveness of JYNNEOS against mpox ranges from 36%–75% for 1-dose vaccination and 66%–89% for 2-dose vaccination.

"Future research should examine predictors of mpox infection among those with STIs, including other STIs, such as syphilis, HIV risk at STI screening or anatomical site of infection," wrote these researchers.

As of October 2023, there has been a significant increase in mpox outbreaks in the European Region.

In the last month, 21 countries reported mpox cases, with Portugal reporting the highest relative increase in cases (n = 86).

In a Lancet Respiratory Medicine news article published on November 6, 2023, Sean O'Leary, MD, chair of the American Academy of Pediatrics (AAP)'s Committee on Infectious Diseases, stated the nationwide shortage of Beyfortus™ (Nirsevimab-alip), a newly approved respiratory syncytial virus (RSV) monoclonal antibody, could have been predicted.

"I would've predicted pretty high demand. I think probably too much was made of vaccine hesitancy and refusal..." wrote Dr. OLeary.

Sanofi, the producer of Beyfortus, stated on October 26, 2023, 'Despite an aggressive supply plan built to outperform past pediatric immunization launches, demand for this product, especially for the 100 mg doses used primarily for babies born before the RSV season, has been higher than anticipated.'

Sanofi collaborates closely with the U.S. Centers for Disease Control and Prevention (CDC) to ensure equitable distribution of available doses through the Vaccines for Children Program.

The CDC recently issued an advisory with recommendations for clinicians to prioritize 100-milligram doses for infants younger than six months and those with underlying medical conditions that predispose them to severe RSV.

Beyfortus is the second monoclonal antibody developed to prevent RSV in young children.

The AAP has recommended Arexis AB's palivizumab (Synagis) for high-risk infants and young children during an active RSV season.

Synagis was approved for initial use in the U.S. by the FDA in 1998. It is not an RSV vaccine but can help passively protect children with monthly dosing.

As of November 7, 2023, the RSV season began in Florida and has spread throughout the United States, impacting certain areas.

The World Health Organization's (WHO) 2023 Global Tuberculosis (TB) report, announced today, shows the impact of this centuries-old disease.

The report, published on November 7, 2023, features TB outbreak data from 192 countries and areas and shows that 7.5 million people were diagnosed in 2022, the highest figure recorded since 1995.

According to the WHO, an estimated 10.6 million people fell ill with TB in 2022, up from 10.3 million in 2021.

And the total number of TB-related deaths (including those among people with HIV) was 1.3 million in 2022. TB continues to be the leading killer among people with HIV.

Geographically, most people who developed TB in 2022 were in South-East Asia (46%), Africa (23%), and the Western Pacific (18%), with smaller proportions in the Eastern Mediterranean (8.1%), the Americas (3.1%) and Europe (2.2%).

In a press release, Dr. Tereza Kasaeva, Director of WHO's Global TB Programme, commented, "This report provides key data and evidence on the status of the TB epidemic and a review of the progress that serves to inform the translation of these targets and commitments into action in countries."

"We need all hands on deck to make the vision of ending TB a reality."

TB is a vaccine-preventable disease, with about 16 different Bacille Calmette-Guérin (BCG) vaccines in use globally.

In the U.S., access to the BCG vaccine is limited and considered for people who meet specific criteria. Merck's TICE® BCG vaccine is an attenuated, live culture preparation of the BCG strain of Mycobacterium Bovis and is available in 2023.

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.