Zika Breaking News

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Feb 27, 2023 • 10:50 am CST
U.S. CDC Skin Cancer 2023

Moderna, Inc. and Merck recently announced that mRNA-4157/V940, an investigational personalized mRNA cancer vaccine, in combination with KEYTRUDA, has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the adjuvant treatment of patients with high-risk melanoma following complete resection.

Personalized cancer vaccines are designed to prime the immune system so that a patient can generate a tailored antitumor response specific to their tumor mutation signature. 

The FDA granted Breakthrough Therapy Designation based on positive data from the Phase 2b KEYNOTE-942/mRNA-4157-P201 trial.

"The FDA's Breakthrough Designation for mRNA-4157/V940 in combination with KEYTRUDA reflects the excitement that we have for the potential promise of individualized cancer treatments," said Stephen Hoge, M.D., Moderna's President, in a press release on February 22, 2023.

"mRNA-4157/V940 in combination with KEYTRUDA provided the first demonstration of efficacy for an investigational mRNA cancer treatment in a randomized clinical trial and potentially represents a new frontier in treating melanoma and other cancers."

"We look forward to publishing the full data set and sharing the results at an upcoming oncology medical conference, as well as continuing discussions with health authorities."

mRNA-4157/V940 is a novel investigational mRNA-based personalized cancer vaccine consisting of a single synthetic mRNA coding for up to 34 neoantigens that is designed and produced based on the unique mutational signature of the patient's tumor. Upon administration into the body, the algorithmically derived and mRNA-encoded neoantigen sequences are endogenously translated and undergo natural cellular antigen processing and presentation, a key step in adaptive immunity.

KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body's immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

The FDA's Breakthrough Therapy Designation is granted to expedite the development and review of drugs that are intended to treat a serious condition, and when preliminary clinical evidence indicates that the product may demonstrate substantial improvement over available therapies on at least one clinically significant endpoint.

This news is essential since the rates of melanoma have been rising over the past few decades, with nearly 325,000 new cases diagnosed worldwide in 2020.

In the U.S., skin cancer is one of the most common types of cancer diagnosed, and melanoma accounts for a large majority of skin cancer deaths.

Feb 27, 2023 • 10:27 am CST
by Thorsten Frenzel

Xlear Inc. today announced it had supplemented the numerous scientific studies it has already provided the U.S. Department of Justice(DOJ)  and the Federal Trade Commission (FTC) in the government's lawsuit against Xlear.

The DOJ-FTC sued Xlear alleging prior statements about nasal hygiene and COVID-19 lacked adequate substantiation.

As of February 27, 2023, Xlear stated in a press release it provided additional studies showing that simple nasal sprays are effective in helping reduce the transmission of (the SARS-CoV-2 virus) COVID-19 and reduce the severity of illness when used by individuals already infected with the virus. 

One of the studies Xlear provided to DOJ is a peer-reviewed, double-blind, placebo-controlled, randomized clinical trial (RCT) involving 556 "high-risk healthcare professionals," finding that a nasal spray containing water, saline, and xylitol significantly reduced the transmission of COVID-19 and the severity of cases among those infected. 

Specifically, the study finds: "[The spray] significantly reduced SARS-CoV-2 infection compared to placebo [36 cases (13.1%) Vs. 97 cases (34.5%); OR 0.29 (95% CI; 0.18–0.45), p < 0.0001].

Fewer clinical symptoms were also seen in the test group [57 cases (17.6%) vs. 112 cases (34.6%); OR 0.40, (95% CI; 0.27–0.59), p < 0.0001].

No harmful effects were associated with taking the [nasal spray] . . . This represents a 62% relative risk reduction in infection rate."

"[T]he spray was administered up to three times per day with . . . 6–8 [hour] between doses."

The study concludes: "[The nasal spray] has been shown to significantly reduce SARS-CoV-2 infections in healthcare workers, with 62% fewer infections when compared to placebo."

The company says, 'This product is not intended to diagnose, treat, cure, or prevent any disease.'

Feb 26, 2023 • 12:30 pm CST
Mozambique cholera cases 19 February 2023

In Mozambique, an outbreak of cholera has been growing exponentially since December 2022. The World Health Organization (WHO) recently reported heavy rainfall in the first weeks of February 2023 threatens to further worsen the situation with geographic spread to new districts.

The WHO confirmed on February 23, 2023, the first case of cholera in the current outbreak was reported from the Lago district in Niassa province in mid-September 2022.

And as of February 19, 2023, a cumulative total of 5,237 suspected cholera cases and 37 deaths (Case Fatality Ratio (CFR) 0.7%) have been reported in 29 districts from six out of 11 provinces in the country.

The WHO considers the risk of further disease spread as very high at the national and regional levels. 

For example, the neighboring African country of Malawi is facing the deadliest cholera outbreak in its history.

A request for approximately 700,000 doses of Oral Cholera Vaccine was approved by the International Coordinating Group on Vaccine Provision, and a vaccination campaign in affected districts in Gaza, Niassa, Sofala, and Zambezia provinces is in preparation and will start in late February 2023.

Additionally, the U.S. CDC recommends people visiting Mozambique should be vaccinated against measles and polio in 2023.

These travel vaccines are generally available at certified travel; clinics and pharmacies in the U.S.

Feb 26, 2023 • 10:42 am CST
U.S. CDC dengue in the Americas 2023

The Florida Health Department recently reported nine cases of dengue in persons with international travel. As of February 18, 2023, 25 travel-associated dengue fever cases have been reported in Florida.

In 2022, 906 travel-associated dengue cases were reported.

Regarding local dengue cases, only one person has been confirmed this year.

During 2022, 68 cases of locally acquired were reported in Florida.

Dengue is the primary cause of acute febrile illness in US travelers returning from South-central and Southeast Asia, South America, Mexico, and the Caribbean.

According to the World Health Organization, dengue is now endemic in over 100 countries. As many as 3.6 billion people, or 40% of the world's population, reside in dengue-endemic areas. Each year, an estimated 21,000 deaths are attributed to dengue.

While one dengue vaccine (Dengvaxia) is approved, the U.S. Centers for Disease Control and Prevention (CDC) is reviewing a second vaccine with an acceptable safety profile.

On February 24, 2023, the CDC vaccine committee discussed the QDENGA® Tetravalent Dengue Vaccine Candidate (TAK-003) from Takeda.

Currently, Qdenga is approved for use in Indonesia, the EU, and the UK.

Learn more about dengue...how to prevent it, and what to do if you think you are infected atCDC'ss dengue page for travelers.

Feb 26, 2023 • 8:01 am CST
U.S. CDC FLu Report Feb 24, 2023

The U.S. Influenza Hospitalization Surveillance Network (FluSurv-NET) recently reported as of February 18, 2023, this flu season's weekly hospitalization rate was abnormal.

This week's cumulative hospitalization rate is the second-highest rate observed in week #7 during previous seasons, going back to 2010-2011, followed by the 2017-2018 season.

However, this in-season cumulative hospitalization rate is still lower than end-of-season hospitalization rates for five flu seasons going back to 2010-2011.

When examining rates among 2,485 hospitalized adults with information on underlying medical conditions, 96.7% had at least one reported underlying medical condition.

The most commonly reported were hypertension, cardiovascular disease, metabolic disorder, and obesity. 

Among 1,019 hospitalized children with information on underlying medical conditions, 65.6% had at least one reported underlying medical condition.

The most commonly reported condition was asthma, followed by neurologic disease and obesity.

Additionally, the CDC confirmed there has been 115 influenza-associated pediatric fatalities (about 30% were vaccinated) during the 2022-2023 flu season.

And a recent CDC analysis published on February 22, 2023, and in a related MMWR on February 24, 2023, stated 2022-2023 influenza vaccine preliminary effectiveness was about 68% protective of pediatric patients.

And it protected about 43% of adults against influenza-related hospitalization. 

Updated flu season news is posted at PrecisionVaccinations.

Feb 25, 2023 • 3:59 pm CST
U.S. CDC Feb. 2023 Equatorial Guinea

The World Health Organization (WHO today reported the cumulative number of Marburg virus disease (MVD) cases in Equatorial Guinea is nine, including one confirmed case, four probable cases, and four suspected cases.

All these viral hemorrhagic fever cases have died as of February 21, 2023.

MVD previously had a case-fatality ratio of up to 88%. 

These MVD cases occurred between early January and February 7, 2023, in two villages in the Nsock Nsomo, eastern province of Kie-Ntem, Río Muni Region. 

And the Ministry of Health and Social Welfare of Equatorial Guinea confirmed one fatality was in a health facility, and there are no cases among healthcare workers.

However, thirty-four close contacts are currently under follow-up as of February 25, 2023.

Additionally, other African countries are on alert for MVD cases.

WHO assesses the risk posed by the MVD outbreak as high at the national level, moderate at the regional level, and low at the global level.

To notify international travelers of their health risks, the U.S. CDC issued a Watch - Level 1, Practice Usual Precautions notice regarding Equatorial Guinea's MVD outbreak.

The CDC says Marburg virus disease symptoms include fever, chills, headache, muscle pain, rash, sore throat, diarrhea, vomiting, stomach pain, chest pain, and unexplained bleeding or bruising.

And there are no specific treatments or approved vaccines for MVD, says the WHO.

Recent news indicates Marburg vaccine candidates are accelerating their clinical research as of February 25, 2023.

Feb 25, 2023 • 3:20 pm CST
by Jose Aitor Pons Buigues

A new study conducted in Las Vegas suggests that when testing for the SARS-CoV-2 coronavirus, the results may actually overestimate the virus's local health risks.

The findings from an Original Investigation suggest the continual influx of tourists in vacation destinations may distort clinical testing relevance.

While wastewater surveillance is a valuable complement to clinical tools and can provide time-sensitive data for decision-makers and policymakers, this study represents a novel approach to quantifying the confounding effects of mobile populations on wastewater surveillance data.

Furthermore, the detection of SARS-CoV-2 RNA in wastewater does not indicate infectivity, so while a significant viral load may be contributed by visitors (>60% in this study), this does not necessarily prove that visitors are a significant contributor to local COVID-19 transmission. 

Researchers from the University of Nevada collaborated with the Southern Nevada Water Authority on the study published by the JAMA Network Open on February 23, 2023.

Note: This study's conclusions may apply to other tourist destinations such as Paris, Miami, New York, London. and Tokyo.

Feb 24, 2023 • 2:14 pm CST
by Lawrence Olawale-Roberts

The Nigeria Centre for Disease Control and Prevention (NCDC) today announced it is aware of the Marburg virus disease (MVD) outbreak announced in Equatorial Guinea on February 13, 2023.

As of February 24, 2023, there are no cases of MVD in Nigeria.

However, the NCDC, relevant Ministries, Departments, Agencies, and partners have taken proactive measures to mitigate the risk of cross-border importation.

Based on available data, the overall risk of importation of the Marburg virus and the impact on the health of Nigerians has been assessed as MODERATE for the following reasons:

  • The extent of the outbreak in Equatorial Guinea has not yet been ascertained.
  • The likelihood of importation to Nigeria is high due to the direct flight between Nigeria and Equatorial Guinea.
  • The proximity of Equatorial Guinea to Nigeria.
  • The likelihood of spread in Nigeria following importation is high due to the gatherings and travel associated with upcoming national elections.
  • The case fatality rate of MVD ranges between 24 to 88%.
  • MVD does not currently have an effective drug for treatment or a licensed vaccine for prevention.

The NCDC's risk assessment also shows that Nigeria has the technical, human (health workforce), and diagnostic capacity to respond effectively during an MVD outbreak.

To alert international travelers, the U.S. CDC issued a Watch - Level 1, Practice Usual Precautions alert in mid-February 2023, confirming MVD is a viral hemorrhagic fever.

Its symptoms include fever, chills, headache, muscle pain, rash, sore throat, diarrhea, vomiting, stomach pain, chest pain, and unexplained bleeding or bruising. Infection with the Marburg virus is often fatal.

Furthermore, there is no specific treatment or approved vaccine for MVD.

Feb 24, 2023 • 5:32 am CST
by Steven Arnold

In the United States, influenza activity began earlier than usual this season, increasing in October 2022. However, influenza infections have steadily diminished since a peak in late December 2022.

According to a Morbidity and Mortality Weekly Report (MMWR) published today by the U.S. CDC, Influenza A(H3N2) represented most of the viruses detected and subtyped during this period.

The best news is that this virus is the same genetic subclade as and antigenically similar to the viruses included in the 2022–23 Northern Hemisphere influenza vaccine.

This is important since the effectiveness of seasonal flu shots varies by season, as influenza virus subtype and antigenic match with circulating viruses.

This MMWR interim report used data from two concurrent studies conducted in Wisconsin from October 23, 2022–February 10, 2023, to estimate influenza vaccine effectiveness (VE).

Overall, VE was 54% against medically attended outpatient acute respiratory illness associated with laboratory-confirmed influenza A among patients aged six months–64 years.

In a community cohort of children and adolescents aged <18, VE was 71% against symptomatic laboratory-confirmed influenza A virus infection.

Furthermore, these interim analyses indicate that influenza vaccination substantially reduced the risk for medically attended influenza among persons aged <65 years and for symptomatic influenza in children and adolescents.

The CDC says 'annual influenza vaccination is the best strategy for preventing influenza and its complications, and recommends that health care providers continue administering it to persons aged ≥6 months as long as influenza viruses are circulating.

As of February 24, 2023, various flu shots remain available at pharmacies throughout the U.S.

Moreover, most flu shots are offered at no cost to the person.

Feb 23, 2023 • 3:53 pm CST
U.S. CDC Cambodia Feb. 2023

Cambodia's Secretary of State of the Ministry of Health today confirmed that an emergency response found 12 people infected with Highly Pathogenic Avian Influenza (HAPI) A(H5N1) in Prey Veng province.

As reported by the Khmer Times on February 23, 2023,  this news follows a recent death of an 11-year-old girl from 'bird flu' in Roleang village, Romlech commune, Sithor Kandal district, Prey Veng province.

Panharith Seng, director of the Prey Veng provincial health department, told VOA Khmer on February 23, 2023, that chickens and ducks found in the area where the girl lived had recently died of the H5N1 virus.

According to the Ministry of Health, the girl is the first person to die of H5N1 since 2014.

The Ministry of Health added that bird flu has been endemic in Cambodia since 2005, with a total of 57 infections and 38 deaths.

As of February 2, 2023, the World Health Organization reported a total of 240 cases of human infection with avian influenza A(H5N1) virus had been reported from four countries within the Western Pacific Region since January 2003.

Of these cases, 135 were fatal. 

Globally, seven human influenza A H5N1 2.3.4.4b infections were reported in Ecuador, China, Vietnam, the U.K., Spain (2), and Colorado during 2022-2023.

Bird Flu (Avian influenza) is a disease caused by influenza type A viruses that occur naturally among birds and domestic poultry.

The Eurasian H5N1 strain appeared in North America in January 2022 and has impacted 47 states, leading to the loss of over 58 million birds as of early February 2023.

Additionally, bird flu infections have been confirmed in various mammals, such as bears, foxes, and seals.

In the event of a human-based bird flu outbreak, the U.S. government has already approved the Audenza™ vaccine.

And the U.S. CDC had not issued a travel alert regarding Cambodia's bird flu outbreak.

This is an active event with VOA updates inserted. As of February 24, 2023, Cambodia reported a second human case of H5N1 bird flu.

Breaking bird flu news is posted here.

Update: Feb. 26, 2023 - This case was Clade 2.3.2.1c avian influenza virus has been endemic in Southeast Asia for ~10 years, and human-human transmission ability has not been established.

Feb 23, 2023 • 2:00 pm CST
U.S. CDC ACIP Feb. 23, 2023

The U.S. Centers for Disease Control and Prevention (CDC) vaccine advisory committee today presented an overview of a successful childhood vaccination program.

Mona Marin, M.D., with the CDC Advisory Committee on Immunization Practices, presented '25 Years of Varicella Vaccination Program in the United States: Health and Economic Impact during 1995–2019' on February 23, 2023.

Historically, varicella was considered a disease of little consequence, too mild to warrant prevention.

However, Varicella is an illness with a characteristic maculopapular, vesicular rash.

During the pre-vaccine era, varicella infected almost everyone during childhood, who accounted for more than 90% of the cases, two-thirds of the hospitalizations, and about half of the deaths, wrote researchers in a related article.

Varicella, known as chickenpox, is also highly infectious, with 61% and 100% secondary attack rates among susceptible household contacts, says the CDC.

As other causes of infectious disease burden in children in the U.S. were controlled through vaccination (e.g., measles, diphtheria, poliomyelitis), varicella assumed more importance as a preventable cause of mortality and morbidity.

Based on a documented continuing disease, the U.S. was the first country to implement a routine varicella vaccination program following the licensure of the live, attenuated varicella vaccine (VARIVAX®, Merck & Co, Inc) in 1995.

Expansion of the U.S. vaccination program to include a second VARIVAX dose led to further declines in disease incidence, outbreaks, hospitalizations, and deaths.

Twenty-five years after the introduction of the varicella vaccine, the disease has declined overall by about 97%.

An additional benefit of the varicella vaccination program is the impact on HZ.

Recent data show a lower HZ risk among healthy and immunocompromised children. This is reflected in stepwise declines in HZ incidence at the population level as the age groups became dominated by persons born during the varicella vaccination program.

Moreover, the decline in HZ incidence in children provides tentative reassurance that, over time, HZ rates will decline as vaccinated children age.

The Journal of Infectious Diseases published the unedited article in November 2022.

Note: Varivax and the HZ-prevention vaccines (Shingrix) are generally available at clinics and pharmacies in the U.S.

Feb 23, 2023 • 10:49 am CST
PharmaJet Systems Feb. 2023

In a review article recently published in Vaccines Journal referenced over 25 studies and discussed multiple injection delivery methods, including PharmaJet's needle-free precision delivery systems.

This study found that needle-free delivery enhanced the clinical performance of DNA-based vaccines.

Currently, 250 vaccine programs are invested in DNA vaccines and therapeutics because of their potential benefits.

"We are enthused to see that pre-clinical results have translated into more effective clinical responses in human trials," said Chris Cappello, President and CEO of PharmaJet, in a press release on February 23, 2023. 

"We currently have eighty-three studies ongoing with novel pharmaceuticals focusing on nucleic acid technology and other new vaccine technology platforms."

"We believe that our precision delivery devices have the potential to increase the performance and therefore the probability of regulatory success of many of these candidate vaccines."

Several DNA candidate vaccines in combination with PharmaJet devices are in development, including for a COVID-19 bivalent booster, HIV, Zika, influenza, poxvirus, hantavirus, and dengue infections.

Feb 22, 2023 • 8:03 pm CST
by Fernando Zhiminaicela

Gilead Sciences, Inc. today announced data evaluating lenacapavir in combination with broadly neutralizing antibodies (bNAbs) teropavimab and zinlirvimab as a potential long-acting HIV treatment regimen with twice-yearly dosing.

Results from the Phase 1b clinical trial demonstrated the investigational combination was generally well tolerated with high efficacy in select virologically suppressed participants living with HIV.

At Week 26, 90% of participants receiving the complete study regimen (n=18/20) maintained virologic suppression (HIV-1 RNA ≤50 copies/mL). 

“Novel long-acting HIV treatment options will drive the next chapter in care and may help meet the therapy needs and preferences of people living with HIV. In this study, we found that lenacapavir and bNAbs in a combination approach may have a significant role to play in the future treatment of HIV,” said Dr. Joseph Eron, MD, lead study investigator and the Chief of the Division of Infectious Diseases at the University of North Carolina School of Medicine, in a press release on February 21, 2023.

“As a clinician who strives to support the people living with the virus under my care, it will be exciting to continue evaluating the combination regimen as a potential twice-yearly long-acting HIV treatment option.”

The combination of lenacapavir with teropavimab and zinlirvimab will advance to a Phase 2 study later in 2023 in virologically suppressed people living with HIV.

Lenacapavir is being developed as a foundation for future HIV therapies to offer long-acting oral and injectable options with several dosing frequencies, combined with other antiretroviral agents for treatment or as monotherapy for prevention, that help address individual patient needs and preferences.

Sunlenca® (lenacapavir), alone or in combination, is not approved by any regulatory authority outside the United States, United Kingdom, Canada, or the European Union for any use.

Note: bNAbs are not preventive vaccines. Furthermore, the U.S. FDA has not approved any HIV vaccine candidate.

Feb 22, 2023 • 4:48 pm CST
U.S. CDC polio alert Feb. 2023

The U.S. Centers for Disease Control and Prevention (CDC) today announced it had renewed and expanded its Alert - Level 2, Practice Enhanced Precautions focused on polio outbreaks and the continued detections of poliovirus.

On February 21, 2023, the CDC stated some international destinations have circulating poliovirus.

At present, only two countries remain with the indigenous transmission of wild poliovirus type 1, Afghanistan and Pakistan. 

And before traveling to any at-risk destination, the CDC recommends that adults who previously completed the routine polio vaccine series receive a single, lifetime booster dose of polio vaccine.

Furthermore, children should also be up to date on their routine polio vaccines.

Polio is a crippling and potentially deadly disease that affects the nervous system. 

Because the virus that causes polio lives in the feces of an infected person, people infected with the disease can spread it to others. People can also be infected if they drink water or eat food contaminated with infected feces.

In 2022, poliovirus was detected in wastewater systems in travel hotspots, including New York, London, Canada, and Israel.

In rare cases, polio infection causes permanent loss of muscle function. And polio can be fatal if the muscles used for breathing are paralyzed or if there is an infection of the brain.

Polio is a vaccine-preventable disease, says the CDC.

Approved polio vaccines are generally available in the U.S. at travel clinics and pharmacies.

Feb 22, 2023 • 5:32 am CST
by Gerd Altmann

LinKinVax today announced the interim results of a double-blind, Phase I clinical trial evaluating CD40.HIVRI.Env, a preventive HIV vaccine candidate.

The ANRS VRI06 study's initial results, published on February 22, 2023, show that the vaccine candidate was safe and induced an early, significant, and sustained immune response.

The vaccine yielded high levels of antibodies directed against the HIV envelope: 

  • 80-100% at Week 6,
  • 100% at Week 26 in all groups (0.3, 1, and 3 mg).
  • These levels remained stable or dropped slightly until Week 48.
  • Antibodies targeting a specific area of the HIV envelope (V1/V2 region) were also produced.

Furthermore, at Week 26, neutralizing antibodies were detected in 50% of subjects in the 0.3 mg group and 100% of subjects in the other two groups.

The observed counts of CD4+ T cells targeting specifically the HIV envelope protein produced after the vaccination remained stable until Week 48.

Prof. Yves Lévy, Executive Director of the Vaccine Research Institute and CMSO of LinKinVax, commented in a press release, "The immune response profile generated by this vaccine (antibody response and activation of polyfunctional CD4+ T cells) was the one associated with a reduced risk of HIV infection in the RV144 trial."

"However.... the efficacy of this vaccine will only be evaluated in the Phase II/III studies."

LinKinVax's vaccine platform is built around a humanized monoclonal antibody, which is merged with regions of pathogens of interest, targeting the CD40 molecule expressed by dendritic cells, DC, which play a key role in stimulating the immune system. 

André-Jacques Auberton-Hervé, Co-founder and CEO of LinKinVax, added, "We are pleased with these very promising immunogenicity results, which demonstrate the robustness of our DC Targeting vaccine platform and confirm its safety."

"This important milestone paves the way for the upcoming Phase II/III clinical studies that we will conduct once the final Phase I results has been obtained."

"These studies will aim to demonstrate the efficacy of the vaccine, the "Everest of vaccine strategies," which has been the elusive goal of HIV research for the past 40 years."

Other HIV vaccine development news is posted at Precision Vaccinations.