Zika Breaking News

Zika breaking news brought to you by Zika News.

Aug 14, 2023 • 4:36 am CDT
ECDC global map of chikungunya outbreaks June 2023

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.

Aug 13, 2023 • 1:18 pm CDT
U.S. Department of Agriculture’s Animal and Plant Health Inspection Service August 2023

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.

Aug 13, 2023 • 12:51 pm CDT
US Service Dog Certifications 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.

Aug 13, 2023 • 9:20 am CDT
by David Mark

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.

Aug 12, 2023 • 1:35 pm CDT
JUAN SANTAMARÍA INTERNATIONAL AIRPORT - Costa Rica 2023

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.

Aug 11, 2023 • 4:02 pm CDT
WHO mpox 3-week case map August 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.

Aug 11, 2023 • 3:25 pm CDT
by Alit Saha

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.

Aug 11, 2023 • 1:45 pm CDT

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.

Aug 10, 2023 • 10:28 am CDT
by Nancy Jane

Vaxxinity, Inc. today announced The Lancet's eBioMedicine published results of Phase 2a clinical trial stating that UB-311 "was safe and well-tolerated," with early clinical data demonstrating a trend for slowing cognitive decline in mild Alzheimer's disease (AD).

In this 78-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter Phase 2a, Vaxxinity-funded study, UB-311 was reported to elicit a robust, rapid, and titrated antibody response to Aβ.

And UB-311 was generally well-tolerated, with no cases of ARIA-E and limited cases of asymptomatic ARIA-H.

"This publication supports the innovative work that we and our collaborators are conducting to advance UB-311 for the potential treatment, and even prevention, of Alzheimer's disease," said Mei Mei Hu, CEO of Vaxxinity, in a press release on August 10, 2023.

"Imagine expanding the addressable patient population of beta-amyloid immunotherapies by multiple orders of magnitude, potentially over 1,000x, and delivering life-changing medicine at a fraction of the cost. That is our vision for UB-311 and the potential power of active immunotherapies."

AD is the most common form of dementia, is a progressive neurodegenerative disorder that slowly destroys memory and cognitive skills and eventually the ability to carry out simple tasks.

UB-311 is a synthetic, peptide-based active immunotherapy that targets toxic beta-amyloid (Aβ) oligomers and fibrils and oligomers.

Two passive immunotherapies – monoclonal antibodies targeting Aβ – have recently been authorized by the U.S. FDA, validating Aβ as a target for disease-modifying immunotherapies of AD.

However, these passive immunotherapies have been associated with amyloid-related imaging abnormalities (ARIA), which can present as vasogenic edema or sulcal effusion (ARIA-E) or as hemosiderin deposits such as micro hemorrhages and superficial siderosis (ARIA-H).

Although the trial was not powered to make conclusions about efficacy, secondary efficacy outcomes on cognitive, functional, behavioral, and global assessments such as ADAS-Cog, MMSE, ADCS-ADL, and CDR-SB were evaluated.

Trends of slowing disease progression were observed across key cognitive and functional measures for UB-311-treated versus placebo-treated participants over 78 weeks of observation, including a 48% slowing of decline on CDR-SB in the UB-311 quarterly boosting group.

Furthermore, the U.S. FDA-licensed mAbs require IV infusions every two weeks and are priced at $26,500 annually, not including the cost of administering them or monitoring for ARIA.

In contrast, UB-311 has the potential to offer multiple competitive advantages, including lower rates of ARIA-E, improved convenience through less frequent dosing and ease of administration through intramuscular injection, and overall improved accessibility and cost-effectiveness for patients and health systems.

As of August 10, 2023, the U.S. FDA had not approved an Alzheimer's vaccine candidate.

Aug 10, 2023 • 8:52 am CDT
by Eldeen Thorne

The U.S. Department of State today confirmed visiting the Republic of Fiji is safe, but people should exercise normal precautions.

The State Department disclosed on August 9, 2023, a higher level of caution is suggested when visiting Colo I Suva Forest Park. Be aware of your surroundings and be extra vigilant along the trails when displaying items like jewelry, bags, and cell phones in public.

In July 2023, a security alert notified U.S. citizen victims of sexual assault are encouraged to contact the U.S. Embassy for assistance at + (679) 331-4466.

Fiji is an island country in Melanesia, part of Oceania in the South Pacific Ocean, where over 200,000 people visit annually.

If you decide to travel to Fiji, the no-cost Smart Traveler Enrollment Program is available to receive security messages and make it easier to locate you in an emergency.

From a health perspective, the U.S. CDC suggests visitors to Fiji speak with a healthcare provider about routine and travel vaccines, including the annual flu shot.

The CDC recently (July 2023) reissued a Travel Health Advisory for the Pacific Islands regarding various dengue outbreaks.

Aug 10, 2023 • 4:38 am CDT
from Pixabay

Meissa Vaccines announced positive safety and immunogenicity data for MV-012-968, the company's intranasal live attenuated Respiratory syncytial virus (RSV) vaccine candidate.

Meissa is developing MV-012-968 as a needle-free, adjuvant-free vaccine to protect infants and toddlers from the respiratory syncytial virus (RSV).

The company says RSV is the leading cause of infant hospitalization in the United States and is considered a "missing" pediatric vaccine.

The clinical study in RSV-naïve (seronegative) participants between the ages of six and 36 months enrolled 79 participants at multiple sites in the U.S. to evaluate the safety and immunogenicity of MV-012-968 (NCT04909021).

At the highest dose tested, no serious adverse events related to vaccination were reported with no evidence of any lower respiratory tract symptoms, no Grade 2 or 3 fever observed, and low level, transient vaccine shedding detected.

All RSV-naïve infants and toddlers demonstrated a vaccine response to two doses of 107 PFU.

Serum-neutralizing antibody responses to MV-012-968 were robust and comparable to those seen with previous live attenuated RSV vaccine candidates demonstrating high efficacy against medically-attended RSV disease.

Moreover, MV-012-968 demonstrated significantly greater tolerability to date than these previous candidates.

"With this outstanding safety and robust serum antibody response, we believe Meissa's live attenuated vaccine has the potential to be a best-in-class solution to protect infants and toddlers from RSV, and we are now preparing to advance MV-012-968 into a Phase 2/3 clinical trial next year (2024)," said Martin Moore, Ph.D., co-founder and Chief Scientific Officer, Meissa Vaccines, in a press release on August 8, 2023.

"These data also demonstrate the power of our AttenBlock platform to generate live attenuated vaccines with outstanding safety and immunogenicity – something that we've not seen with other platforms."

As of August 10, 2023, the U.S. FDA has approved RSV vaccines for seniors and antibody therapies for infants.

Aug 10, 2023 • 4:21 am CDT
from Pixabay

The World Health Organization (WHO) published Influenza Update N° 451 that stated virus detections remained low, with activity in many countries in the southern hemisphere now decreasing after having peaked in recent weeks.

And no exceptional flu outbreaks were confirmed over the past two weeks.

On August 7, 2023, the WHO reported that influenza activity decreased in Oceania, Central America, and temperate South America, with influenza A viruses predominant.

Furthermore, in the temperate zones of the northern hemisphere, influenza activity was reported at low levels or below the seasonal threshold in most reporting countries.

And in the Caribbean countries, influenza activity remained low overall.

As of August 10, 2023, over 100 million flu shots are available at most health clinics and pharmacies in the U.S.

Aug 10, 2023 • 4:04 am CDT
by Alexa P.

SK bioscience recently announced that it secured 6.5 million shares of common stock through a private placement investment in Novavax, a global company advancing protein-based vaccines with its novel Matrix-M™ adjuvant.

Concurrent with the equity investment announcement, SK bioscience and Novavax have extended their current license agreement, adding Novavax's updated COVID-19 vaccine ((Nuvaxovid, CovoVax, NVX-CoV2373)

The agreement serves as a strategic shift of partnership from the pandemic period to the endemic phase, in which SK bioscience will obtain exclusive rights to Novavax's COVID-19 variant vaccine in South Korea and non-exclusive rights in Thailand and Vietnam to supply and commercialize the vaccine.

Jaeyong Ahn, CEO of SK bioscience said in a press release on August 8, 2023, "We believe that the strategic equity investment and the continuous cooperation between SK bioscience and Novavax, which are among the few companies that focused on developing COVID-19 vaccines during the pandemic, will create a powerful synergy."

Through the enhanced partnership, SK bioscience will explore potential future collaborations with Novavax such as utilizing Novavax's adjuvant, Matrix-M. Novavax also develops COVID-Influenza combination, stand-alone influenza, and high-dose COVID-19 vaccine candidates.

Aug 9, 2023 • 6:00 pm CDT
by Frank Chang

Taiwan's Centers for Disease Control (TCDC) today reported seven new mpox cases. The patients develop symptoms like fever, swollen lymph nodes, and blistering rash between July 24 and August 1, 2023.

As of August 7, 2023, a total of 266 mpox cases (250 local cases and 16 imported cases) have been diagnosed.

The TCDC stated that according to the research, mpox vaccination (Jynneos) could effectively reduce the risk of infection.

In July, Taiwan expanded its mpox immunization drive at 125 medical institutions, especially those who have been "infected with sexually transmitted diseases.

According to statistics from the TCDC, as of August 7, 2023, a total of 77,809 Mpox vaccination services have been completed, including 447 post-exposure prophylaxis vaccinations and 77,362 pre-exposure prophylaxis vaccinations.

About 25,803 people have completed two vaccinations, and 19,510 people received only one dose. 

Aug 9, 2023 • 5:01 pm CDT
U.S. CDC vaccines during pregnancy 2023

As influenza and respiratory syncytial virus (RSV) seasons approach the U.S., health leaders focus on pregnant women's vaccination needs.

The Centers for Disease Control and Prevention (CDC) will conduct a Clinician Outreach and Communication Activity (COCA) webinar on August 10, 2023, to share updated clinical vaccination guidance for pregnant women.

The CDC and the American College of Obstetrics and Gynecology emphasize the importance of vaccinations for pregnant women and recommend vaccinations against pertussis, flu, and COVID-19 to protect themselves and their babies during the first few months of life.

The CDC says there have been recent declines in vaccination coverage for Tdap (tetanus, diphtheria, and pertussis) and flu shots and low uptake of COVID-19 vaccines among pregnant women.

During Thursday's COCA Call, presenters (Naima T. Joseph MD, MPH, Tara C. Jatlaoui, MD, MPH) will give a comprehensive overview of the timing and promotion of vaccines people should receive during pregnancy and provide an update on RSV vaccine candidates for pregnant women. 

This one-hour webinar is scheduled for Thursday, August 10, 2023, 2:00 PM – 3:00 PM ET, at Webinar Link:
https://www.zoomgov.com/j/1604412918; ID: 160 441 2918; Passcode: 650748. Note: Zoom recently modified its privacy policies

Updated August 10, 2023 - presentation slides.