Vaccine News

According to local news reporting, an official with the health ministry said that Pakistanis traveling through Iran are being screened for dengue fever.

“Health stations have been established in Mirjaveh and Rimdan borders, in Sistan-Baluchestan Province, to screen Pakistanis to prevent the entry of travel-associated infectious diseases to the country,” ISNA quoted Jafar Miadfar, head of Iran’s Emergency Organization.

These travelers are checked for clinical symptoms such as fever, chills, low consciousness, and skin rashes. Also, needed laboratory tests are implemented, and infected individuals will be prevented from entering Iran, the official added.

The Tehran Times reported on August 16, 2024, that thanks to effective border control measures and quality healthcare, the number of people entering the country with dengue fever has significantly decreased compared to the previous months.

In Europe, Aedes albopictus mosquitos transmit the virus to people.

While dengue screening is a new aspect of international travel, it is related to the increasing number of confirmed cases in Europe.

Dengue epidemics were first reported in the Eastern Mediterranean Region in 1998.

On August 16, 2024, the European Centre for Disease Prevention and Control (ECDC) confirmed local autochthonous (local) dengue cases in Europe this year.

The first dengue case that presented symptoms was in June in France. Overall, France reported six locally acquired dengue cases in 2024.

Previously, the ECDC reported locally acquired dengue virus outbreaks in Italy, Spain, and Croatia, as well as in Djibouti, Egypt, Oman, Pakistan, Saudi Arabia, Somalia, Sudan, and Yemen.

As of August 2024, the World Health Organization (WHO) does not endorse dengue virus testing for international travelers.

However, the WHO does recommend dengue vaccination one month before visiting outbreak areas, such as the Region of the Americas.

 BioNTech SE today announced top-line results from a Phase 3 clinical trial evaluating a mRNA influenza and COVID-19 vaccine candidate in healthy adults.

The combination vaccine comprises Pfizer’s mRNA-based influenza vaccine candidate with the companies’ licensed COVID-19 vaccine.

The Phase 3 trial measured two primary immunogenicity objectives (immunogenicity against the SARS-CoV-2 coronavirus and immunogenicity against influenza A and B), of which one objective was met.

The companies are evaluating adjustments to the combination vaccine candidate to improve immune responses against influenza B and will discuss next steps with health authorities.

“We are dedicated to developing combination vaccines that provide broader protection against multiple respiratory diseases,” said Prof. Ugur Sahin, M.D., CEO and Co-founder of BioNTech, in a press release on August 16, 2024.

“The insights gained from this combination vaccine trial are highly valuable and will play a crucial role in guiding the further development of Pfizer’s and our combination vaccine program against influenza and COVID-19."

"We are committed to drawing on our experience in developing mRNA-based vaccine candidates against multiple antigens and believe we can successfully accomplish this task in collaboration with our partner Pfizer.”

As of August, updated influenza vaccines for the 2024-2025 flu season in the United States became available at pharmacies.

The Public Health Agency of Sweden today announced a person who sought care at Region Stockholm had been diagnosed with mpox caused by the clade I variant.

According to the agency, on August 15, 2024, this person received care and rules of conduct, says Magnus Gisslén, state epidemiologist at the Public Health Agency of Sweden, in a press release.

The agency says this is the first case caused by the sexually-transmitted clade I virus to be diagnosed outside the African continent. The person was infected during a recent stay in that part of Africa.

Recently, the World Health Organization declared the clade I mpox outbreak in the Democratic Republic of Congo and neighboring countries a public health emergency of international concern.

The fact that a patient with mpox is treated in the country does not affect the risk to the general population, a risk that the European Centre for Disease Prevention and Control currently considers very low. A new assessment is expected shortly.

However, occasional imported cases like the current one may continue to occur.

In the United States, the Clade 2 mpox outbreak began in May 2022 and has substantially diminished in 2024. However, the JYNNEOS smallpox / mpox vaccine continues to be available at specific clinics and pharmacies in the U.S.

The World Health Organization (WHO) today announced an updated External Situation Report #17 on a multi-country outbreak of cholera.

Published on August 15, 2024, the global cholera response continues to be affected by a critical shortage of Oral Cholera Vaccines (OCV) as demand continues to outpace supply.

Since January 2023, 18 countries have requested 105 million doses, nearly double the 55 million doses produced in this period.

Furthermore, in January 2023, the WHO classified the global resurgence of cholera as a grade 3 emergency, the highest internal level for emergencies in WHO.

As of the end of July 2024, a cumulative total of 307,433 cholera cases and 2,326 deaths were reported from 26 countries across five WHO regions.

Based on the number of outbreaks and their geographic expansion, alongside the shortage of vaccines and other resources, WHO continues to assess the risk at the global level as very high, and the event remains classified as a grade 3 emergency.

As of August 2024, the WHO and other governments have authorized four OVCs.

For example, Valneva SE's DUKORAL® is an oral, inactivated vaccine for diarrhea prevention authorized in various countries.

DUKORAL contains four different inactivated strains of V. cholerae serotype O1 and part of a toxin from one of these strains as active substances. Valneva recently announced that DUKORAL®  sales totaled €14.9 million for the first half of 2024.

In the United States, cholera vaccines are in limited supply in 2024, but available at certain travel vaccine pharmacies.

Eisai Co., Ltd. and Biogen Inc. announced that the Ministry of Health and Prevention in the United Arab Emirates (UAE) has approved humanized anti-soluble aggregated amyloid-beta monoclonal antibody LEQEMBI® (lecanemab) for the treatment of Alzheimer’s disease (AD).

LEQEMBI is the first approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline through this mechanism. 

In the UAE, AD is considered the most common cause of dementia, typically accounting for 60-70% of cases. It is reported that 4.09% of people over 60 years old have dementia.

As of August 13, 2024, LEQEMBI is also approved in the U.S., Japan, China, South Korea, Hong Kong, and Israel and is being marketed in the U.S., Japan, and China. 

Eisai has also submitted applications for approval of LEQEMBI in 11 countries and regions.

In the United States, a supplemental Biologics License Application for intravenous maintenance dosing was submitted to the U.S. FDA in March 2024 and was accepted in June 2024. The rolling submission of a Biologics License Application for maintenance dosing of a subcutaneous injection formulation, which is being developed to enhance patient convenience, was initiated in the U.S. under FDA Fast Track status in May 2024.

With one approved chikungunya vaccine already available, the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the Biologics License Application (BLA) for Bavarian Nordic A/S CHIKV VLP, a vaccine candidate for immunization to prevent disease outbreaks caused by chikungunya virus infection in individuals 12 years of age and older.

The Priority Review designation means the FDA aims to complete its review within six months. The FDA has assigned a target action date for the Prescription Drug User Free Act of February 14, 2025.

CHIKV VLP is an adjuvanted VLP-based vaccine candidate for active immunization to prevent disease caused by CHIKV infection.

Paul Chaplin, President and CEO of Bavarian Nordic, said in a press release on August 13, 2024, “The FDA review, along with the ongoing review of our CHIKV VLP vaccine by the European Medicines Agency, represent the first regulatory reviews of a chikungunya vaccine for adolescents, potentially providing a broader usage by populations at risk of this debilitating disease.”

CHIKV VLP is currently also under accelerated assessment review with the EMA, potentially supporting approval of the vaccine by the European Commission in the first half of 2025.

Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus (CHIKV). The disease typically presents with acute symptoms, including fever, rash, fatigue, headache, and often severe and incapacitating joint pain.

While mortality is relatively low, morbidity is high; nearly 50% of individuals with CHIKV disease have debilitating long-term symptoms that can intensify with age.

Over the past few decades, CHIKV has emerged in several previously non-endemic regions in Asia, Africa, southern Europe, and the Region of the Americas, often causing large, unpredictable outbreaks. 

As of August 8, 2024, the Pan American Health Organization (PAHO) reported over 371,167 CHIKV cases in the Americas this year. Between 2013 and 2023, the PAHO reported more than 3.7 million CHIKV cases in the Americas. 

The U.S. CDC reported from 2006 to 2023, 4,590 travel-related CHIKV cases were reported in the U.S., in areas such as Florida.

However, Locally acquired cases have not been reported in U.S. states or territories since 2019.

Valneva SE today reported its consolidated financial results for the first half of the year, which ended June 30, 2024. On August 13, 2024, Valneva reported total revenues of €70.8 million, Net Profit of €34.0 million, and Cash position of €131.4 million.

Valneva’s commercial portfolio consists of three travel vaccines: IXIARO®/JESPECT®, DUKORAL®, and the recently launched IXCHIQ®, the first monovalent, single-dose, live-attenuated chikungunya vaccine approved by the U.S. Food and Drug Administration.

The Company recently confirmed that IXCHIQ's two-year antibody persistence data were published in the Lancet Infectious Diseases and reported positive six-month data for the Phase 3 adolescent study of IXCHIQ; it expects to submit label extensions for 12 to 17 years in the U.S., Europe, and Canada in the second half of 2024.

In a press release, Peter Bühler, Valneva’s Chief Financial Officer, commented, “Our first half sales performance is in line with our expectations."

"We aim to further capitalize on the travel industry recovery as we focus on ramping up sales for IXCHIQ® to support our commercial growth while continuing to execute on our key R&D and regulatory milestones."

The Company also distributes certain third-party products in countries where it operates its own marketing and sales infrastructure.

For example, the Company has an exclusive worldwide license for the S4V Shigella vaccine candidate, adding an attractive Phase 2 clinical asset to Valneva’s R&D pipeline without impacting full-year or mid-term financial guidance.

The half-year financial report, including the condensed consolidated interim financial report and the half-year management report, is available on the Company’s website (Financial Reports—Valneva). 

On August 13, 2024, Valneva CEO Thomas Lingelbach spoke on YouTube about the Company’s half-year results and plans for the rest of 2024.