Vaccine News

Valneva SE today reported positive antibody persistence data three years after vaccination with a single dose of its chikungunya vaccine IXCHIQ®.

Among the healthy adults still enrolled in a clinical trial, 96% maintained neutralizing antibody titers.

Announced on December 3, 2024, the results align with Valneva's expectations for the only U.S. FDA-approved chikungunya vaccine, confirming a strong and long-lasting antibody persistence across all age groups investigated.

IXCHIQ's three-year persistence data also align with positive twelve-month and two-year persistence data the Company reported in December 2022 and 2023, respectively.

These data are positive news for the Region of the Americas, where 412,094 mosquito-transmitted chikungunya cases and 204 related fatalities have been reported this year. 

In the United States, the Centers for Disease Control and Prevention reported 173 travel-related chikungunya cases in Territories and non-U.S. residents in 2024, led by Massachusetts (20) and Texas (20).

Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented in a press release, "We are extremely pleased about these three-year data, which further highlight IXCHIQ®'s differentiated product profile and ability to induce a robust, long-lasting antibody response in both younger and older adults with a single vaccination."

"Whether you're a traveler or live in an endemic region, the potential for long-term protection against a mosquito-borne disease with a single dose is crucial, particularly in low- and middle-income countries where vaccine access is often limited."

IXCHIQ® is the world's first and only licensed chikungunya vaccine approved in the U.S., Europe, and Canada to address this significant unmet medical need.

The Company expects a marketing authorization in Brazil, a chikungunya hot spot, before the end of 2024.

In the U.S., IXCHIQ is available at travel clinics and pharmacies, such as Passport Health in Tampa, Florida.

Grenada, located in the Caribbean's Windward Islands just north of South America, has emerged as a prime tourism destination in 2024. The island is now accessible from international airports in Miami, Toronto, and London.

With flight times of just over three hours and competitive pricing, visiting Grenada has never been easier.

Recent travel data indicates that the most significant number of visitors to Grenada are from the United States.

With continued support from the U.S. Government, the U.S. Embassy of Grenada will participate in the 11th Winternational on December 5, 2024, highlighting the island community's many advantages. 

However, before departing to the South Caribbean, the Centers for Disease Control and Prevention (CDC) and the U.K. Travel Health Pro suggest several routine and a few required vaccinations. 

Vaccines protect people from Chikungunya and Dengue, mosquito-transmitted diseases, and year-round risk in many parts of the Americas, including Granada.

And Typhoid vaccination is recommended for most travelers, especially those staying with friends or relatives or visiting smaller cities or rural areas.

The CDC says proof of Yellow Fever (YF) vaccination is required for travelers ≥1 year old arriving from countries with a risk for YF virus transmission (Brazil); this includes most airport transits or layovers in countries with a risk for YF virus transmission.

As of December 2, 2024, these vaccines are generally available at travel clinics and pharmacies in the U.S.

The European CDC recently confirmed cholera cases have continued to be reported in Africa and Asia in recent months, with outbreaks in parts of the Middle East and the Region of the Americas.

The Communicable Disease Threats Report for week #48 stated that since January 2024 and as of November 25, 2024, 490,700 cholera cases, including 3,693 deaths, have been reported worldwide.

New cholera deaths have been reported from Afghanistan, Burundi, the Democratic Republic of the Congo, Ethiopia, Ghana, Malawi, South Sudan, Sudan, the United Republic of Tanzania, and Zimbabwe.

Recent data from the WHO indicates the number of cholera-related deaths increased by 54% globally this year.

However, most European countries have escaped cholera outbreaks.

Nine EU/EEA countries reported 29 cases in 2022, two countries in 2021, and none in 2020.

In this context, the ECDC stated on November 29, 2024, that although the risk of cholera infection for travelers visiting these countries remains low, sporadic importation of cases to Europe is possible.

In the United States, nearly all cholera cases reported are acquired during international travel. As of the end of November 20224, seven cholera cases were reported to the CDC this year.

The CDC writes, 'Visit a healthcare provider or travel clinic to discuss cholera vaccination if you plan to visit an area where cholera is present, or where the water and food are unsafe to drink and eat.'

Recent data published in the Vaccines scientific journal indicates a significantly reduced risk of variant type 2 poliovirus (cVDPV2) emergence after administering the novel oral polio vaccine type 2 (nOPV2) when compared to the monovalent oral polio vaccine type 2 (mOPV2).

Published on November 22, 2024, this research evaluated data from vaccination campaigns conducted between May 2016 and August 2024, and the findings align with existing clinical and field evidence supporting the enhanced genetic stability of the nOPV2 vaccine.

While nOPV2 has resulted in new emergences of cVDPV2, the number of cVDPV2 emergences is estimated to be approximately four-fold lower than if mOPV2 had been used instead.

As of early August 2024, about 98% of the approximately 1.19 billion nOPV2 doses administered globally were in African countries.

The inactive polio vaccine has been offered in the United States since 2000.

The U.S. CDC says before traveling to any of these 37 destinations, adults who previously completed the full, routine polio vaccine series may receive a single, lifetime booster dose of the polio vaccine.

For the Federal Democratic Republic of Nepal's healthcare workers, the memories of dengue fever outbreaks are reawakened each monsoon: the country has seen large-scale dengue outbreaks in the Himalayan mountain's rainy season each year.

The first case of dengue infection in Nepal was reported in 2004. Two years later, in 2006, 32 cases were reported in Chitwan district, which qualified as the country's first indigenous outbreak.

According to reports released by Nepal's Epidemiology and Disease Control Division, the country faced its first major outbreak in 2010, with 917 cases and five deaths.

In 2022, the WHO confirmed 28,109 suspected and confirmed cases of dengue fever, including 38 confirmed deaths (CFR 0.13%), were reported from all seven provinces of Nepal, affecting all 77 districts.

In an op-ed published in the Kathmandu Post on October 26, 2024, Dr. Pun wrote, "the virus has become more complex and dangerous" over the years. But it's also hard to predict the virus's course."

To continue reading Pragya Timsina's unedited article, click here.

In 2024, the U.S. CDC reported that the countries listed in the WHO Western Pacific Region report higher-than-usual dengue cases, and travelers visiting these countries may be at increased risk.

Nepal's government data reveals that 96,305 persons visited the high-altitude mountain country in September 2024, compared with about 72,000 the previous month. Based on the information available for this dengue outbreak, the WHO does not recommend that any general travel or trade restrictions be applied to Nepal.

As of November 30, 2024, the CDC and the WHO say dengue outbreaks remain a global health threat.

GSK plc today announced that the European Commission (EC) had approved a single-vial, fully liquid presentation of Menveo (Meningococcal Group A, C, W-135, and Y conjugate vaccine, MenACWY vaccine) to help protect against invasive meningococcal disease (IMD) caused by bacterial serogroups A, C, W, and Y.

Philip Dormitzer, GSK Head of Global Vaccines Research & Development, commented in a press release on November 27, 2024, “As a leader in meningococcal vaccines, GSK is dedicated to finding innovative solutions that simplify immunization and support vaccine uptake. We remain committed to safeguarding individuals from bacterial meningitis and will persist in our efforts to prevent this devastating disease among at-risk populations in the European Union.”

IMD is an unpredictable, serious illness that can cause life-threatening complications. Despite treatment, among those who contract IMD, up to one in six will die, sometimes in as little as 24 hours.

One in five survivors may suffer long-term consequences such as neurological damage6, amputations, hearing loss, and nervous system problems.

Although anyone can get IMD, babies, young children, and those who are in their late teens and early adulthood are amongst the groups at higher risk.

This single-vial presentation of Menveo is now licensed for active immunization of children from 2 to adolescents and adults. It offers healthcare providers an option that does not require reconstitution before use. More than 82 million doses of this vaccine have been distributed worldwide since 2010.

With over 100 countries reporting chikungunya virus outbreaks this year, more international travelers may soon have access to an essential vaccine.

Valneva SE  today announced that it has submitted a label extension application to the U.S. Food and Drug Administration (FDA) to potentially extend the use of the only chikungunya vaccine (IXCHIQ®) currently approved in adults and adolescents aged 12 to 17 years.

The application also includes adding the two-year antibody persistence data to the product label, a key differentiator for IXCHIQ®.

This FDA application follows the submission of label extension applications to the European Medicines Agency and Health Canada two months ago. Both Canada and the EMA have already approved IXCHIQ.

Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented in a press release on November 26, 2024, “Given the substantial risk that chikungunya presents to individuals residing in or traveling to endemic regions, it’s imperative to ensure the vaccine is available to all age groups. This broader accessibility would certainly help provide protection and mitigate the burden of this debilitating illness which is currently spreading in areas that were previously unaffected."

"The long-term durability of the immune response from a single shot is also extremely important, especially for endemic countries where access to immunization can be difficult.”

As of November 22, 2024, the Pan American Health Organization reported over 412,089 chikungunya cases and 204 related deaths in the Americas this year. 

In the U.S., travel-related chikungunya cases have increased by about 16% in 2024.

The Lancet Infectious Diseases recently published an article showing that IXCHIQ was well tolerated in adolescents 28 days after a single injection, regardless of previous CHIKV infection.

In addition to the adolescent data, the U.S. and Canadian label extension applications included IXCHIQ®’s long-term antibody persistence data, which showed that the vaccine’s immune response was sustained by 97% of participants after 24 months and was equally durable in younger and older adults.

IXCHIQ® was launched in the U.S. at the beginning of March 2024, with launches in France and Canada underway.

In the U.S., IXCHIQ is available at travel clinics and pharmacies.

Valneva expects a marketing authorization in Brazil before the end of 2024 and expanded its partnership with The Coalition for Epidemic Preparedness Innovations (CEPI) earlier this year to support broader access to the vaccine in Low and Middle-Income Countries, post-marketing trials and potential label extensions in children, adolescents and pregnant women.

CEPI will provide Valneva with up to $41.3 million of additional funding over the next five years, with support from the European Union’s Horizon Europe program.

Chikungunya is a mosquito-borne viral disease spread by the bites of infected Aedes mosquitoes, which causes fever, severe joint and muscle pain, headache, nausea, fatigue, and rash. Joint pain is often debilitating and can persist for weeks to years.

A study published by MDPI on October 19, 2024, determined the incidence of post-chikungunya chronic rheumatism and its impact on quality of life and chronic fatigue in adults reached seven years.