Search API
Valneva SE today announced that the U.S. Food and Drug Administration (FDA) has revised the Prescription Drug User Fee Act (PDUFA) action date for the Biologics License Application (BLA) for VLA1553, a monovalent chikungunya virus vaccine candidate.
Valneva is committed to working with the FDA in its ongoing BLA review and potentially delivering the world's first chikungunya vaccine.
The previously communicated end of August PDUFA has been adjusted to the end of November 2023.
Valneva stated on August 14, 2023, the FDA extended the PDUFA date to allow sufficient time to align and agree on the phase 4 program necessary under the accelerated approval pathway.
Furthermore, no additional clinical data have been requested for the FDA approval process.
Juan Carlos Jaramillo, Chief Medical Officer of Valneva, said in a press release, "We appreciate and take pride in the fact that our BLA for VLA1553 if approved, will represent the first vaccine candidate to be approved under the accelerated approval pathway in an outbreak disease, and hence the necessary Phase 4 activities will set a future standard."
The Company reconfirms its previous guidance for potential BLA approval, initial launch, and potential award of a priority review voucher in 2023. This PDUFA extension does not impact Valneva's current regulatory submission in Canada or its planned submission with the European Medicines Agency.
VLA1553 is a single-dose, live-attenuated chikungunya vaccine candidate based on an infectious clone (CHIKV LR2006-OPY1) attenuated by deleting a gene encoding the non-structural replicase complex protein nsP3 protection against various Chikungunya virus phylogroups and strains.
Valneva's VLA1553 vaccine candidate is designed for prophylactic, active immunization against Chikungunya in humans over 1-year-old.
Chikungunya is a viral disease transmitted to humans through the bites of mosquitoes, causing outbreaks in 2023.
The European Centre for Disease Prevention and Control reported that as of July 26, 2023, approximately 300,000 cases and over 300 deaths have been reported worldwide due to Chikungunya virus disease.
Since rabies is a serious ongoing public health concern, the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) announced on August 4, 2023, its annual distribution of RABORAL V-RG®, an oral rabies vaccine (ORV) bait, would be distributed in select areas in the eastern United States to prevent the spread of raccoon rabies.
ORV baits are coated with a fishmeal attractant and are packaged in two-inch plastic sachets or one-inch square cubes.
The RABORAL V-RG vaccine is safe for many animals, including domestic dogs and cats. Humans and pets cannot get rabies from contact with the baits.
If adults or children come in contact with baits, immediately rinse the contact area with warm water and soap, says the APHIS.
While raccoons and dogs are high-risk rabies carriers, wild, infected bats are the leading cause of rabies in the U.S.
Rabies is found in more than 150 countries and territories, say the World Health Organization. And rabies infections are almost always fatal once symptoms appear, but deaths can generally be prevented with appropriate therapies.
The U.S. Centers for Disease Control and Prevention updated its recommendations for rabies preexposure prophylaxis for humans in 2022, now endorsing a two-dose program.
In the U.S., rabies vaccines are available in 2023.
When bringing a dog to the United States in 2023, people should continue to check federal regulations and the recently extended rabies vaccination requirements.
The U.S. Centers for Disease Control and Prevention (CDC) confirmed that effective August 1, 2023, it extended the temporary suspension of the importation of dogs from countries classified as high risk for dog rabies and countries that are not at high risk if the dogs have been in high-risk countries during the previous six months.
However, dogs vaccinated against rabies in the U.S. by a US-licensed veterinarian may re-enter the U.S. from a high-risk country without a CDC Dog Import Permit if the dog:
- has a current, valid US-issued rabies vaccination certificate;
- has ISO-compatible microchip;
- is at least 6 months old;
- is healthy upon arrival; and
- arrives at one of the 18 airports with a CDC quarantine station.
On July 6, 2023, the CDC published the “Notice of Extension of Temporary Suspension of Dogs Entering the United States from Countries with a High Risk of Rabies” in the Federal Register.
According to the CDC, most rabies cases in the U.S. follow bites by bats, not dogs.
An estimated 47,000–55,000 people successfully receive post-exposure prophylaxis each year in the U.S.
Unfortunately, a recent article published in Clinical Infectious Diseases presented the first documented failure of rabies-post-exposure prophylaxis in the Western Hemisphere.
This 84-year-old man died in 2021 about six months after a rabid bat bit his hand.
The United States IHR National Focal Point recently informed the PAHO/WHO of the first human infection with a novel influenza A(H1N2) variant virus (swine flu) identified in 2023.
According to the IHR announcement, a human infection caused by a novel influenza A virus subtype is an event that has the potential for high public health impact.
On July 29, 2023, the person sought medical care at an emergency department in Michigan, and an upper respiratory tract specimen tested positive for influenza A virus on the same day. Later, the patient received influenza antiviral treatment (Oseltamivir).
An investigation by local public health officials identified swine exposure by the patient at an agricultural fair in late July.
No person-to-person transmission of influenza A(H1N2)v virus associated with this case has been identified, and no additional cases of human infection with A(H1N2)v virus have been identified as of August 10, 2023.
The WHO stated in a media release it does not advise special traveler screening at points of entry or restrictions about the current situation of influenza viruses at the human-animal interface.
For recommendations on safe trade in animals and related products from countries affected by these influenza viruses, refer to WOAH guidance.
Since 2005, there have been 512 influenza A variant virus infections (all subtypes), including 37 (human infections with influenza A (H1N2)v viruses reported in the U.S.
As of August 13, 2023, the U.S. FDA has not approved a swine flu vaccine.
The Republic of Costa Rica's Juan Santamaría International Airport recently reported over 2.8 million passengers passed through its facility during the first half of 2023.
As of June 2023, this activity represents a 4.3% increase in arriving and departing travelers compared to 2019.
The Tico Times reported on August 11, 2023, "The airport now hosts twenty-five airlines serving thirty-five destinations, enhancing global connectivity," said Erick Barboza, AERIS Business Development Director.
Recent AERIS analyses indicate increased Millennial (42%) and Generation X (32%) travelers to Costa Rica.
While in the U.S., the Transportation Security Administration's latest report indicated airport activity has not increased compared to 2019.
From a health perspective, Costa Rica was confronted with dengue, malaria, and Zika cases in 2023.
The World Health Organization (WHO) today reported that 15 countries had reported mpox outbreaks in the past three weeks.
As of August 9, 2023, the highest increase in mpox cases was reported in Mexico.
The most affected region was the Western Pacific Region, where 915 cases, the Region of the Americas (395 cases, 9 deaths), and the African Region (227 cases).
The ten most affected countries since May 2022 are the United States of America (30,446), Brazil (10,967), Spain (7,560), France (4,150), Colombia (4,090), Mexico (4,045), Peru (3,812), the United Kingdom (3,771), Germany (3,694), and Canada (1,496).
These countries account for 82.9% of the cases reported globally, says the WHO.
As of August 11, 2023, mpox vaccines remain available in most impacted countries.
The World Health Organization (WHO) today announced the current dengue surge in the Peoples' Republic of Bangladesh is unusual in terms of seasonality and the early sharp increase compared to previous years.
On August 11, 2023, the Ministry of Health and Family Welfare of Bangladesh reported 69,483 laboratory-confirmed dengue cases and 327 related deaths, with a case fatality rate (CFR) of 0.47% during 2023. The CFR so far this year is relatively high compared to previous years for the full-year period.
About 62% of these deaths were reported in July 2023.
Dhaka City Corporation is the most affected area in the Dhaka division, accounting for 78.9% of deaths.
The pre-monsoon Aedes survey shows that the density of disease-carrying mosquitoes and the number of potential hotspots is at the highest level in the past five years.
Globally, dengue outbreaks have been confirmed in numerous countries in 2023.
Dengue virus (DENV) has four serotypes, and infection with one serotype provides long-term immunity to the homologous serotype but not to the other serotypes; sequential infections with a different serotype put people at greater risk for severe dengue.
Many DENV infections produce only mild flu-like illness, and over 80% of cases are asymptomatic.
There is no specific treatment for cases and clinical management is based on supportive therapy.
Neither of the two approved dengue vaccines are currently available in Bangladesh.
The WHO says dengue risk at the national level in Bangladesh is assessed as 'High' due to the ongoing rapidly increasing number of cases and deaths with the peak not yet reached, the high CFR compared to the previous years, and the increasing geographical distribution of cases.
The National Center for Health Statistics (NCHS) Mortality Surveillance data available on August 10, 2023, shows that 5.9% of the deaths during week #31 in the U.S. were due to pneumonia, influenza, and/or COVID-19.
Among these reported deaths, 12 death certificates listed influenza.
Previously, 166 influenza-associated pediatric deaths occurred during the 2022-2023 flu season have been reported.
The recent peak in influenza fatalities was during the 2020-2021 flu season.
The U.S. CDC says these data presented are preliminary and may change as more data are received and processed.
The CDC recommends annual vaccination for most people over six months to mitigate influenza-related fatalities during the 2023-2024 flu season.
Flu is a contagious respiratory illness caused by influenza viruses that infect the nose, throat, and sometimes the lungs.
Most health experts believe that flu viruses are spread mainly by tiny droplets made when people with flu cough, sneeze, or talk. Recent findings suggest that, on average, about 8% of the U.S. population gets sick from the flu each season.
As of August 11, 2023, various flu shots are offered at health clinics and pharmacies in the U.S.
