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Jul 5, 2023 • 6:20 am CDT
by Gerd Altmann

U.S. Senators Tammy Baldwin and Thom Tillis introduced the Disease X Act of 2023 to develop the necessary medical countermeasures (MCMs) to combat future pandemics.

The legislation filed on June 28, 2023, provides $40 million per year for five years specifically for Disease X MCMs and requires products developed using funding from the Disease X Program.

Even though deadly infectious disease epidemics can dramatically affect the American public, military personnel, and our economic and national security, there is currently no sustained funding, program, or strategy dedicated to accelerating the development of medical countermeasures for previously identified infectious disease threats with the greatest pandemic potential, referred to as Disease X, wrote these senators.

"The Disease X Act of 2023 empowers Biomedical Advanced Research and Development Authority (BARDA) to invest in modern technologies that will lead to new vaccines and drugs against pandemic–capable viruses."

The Disease X Act of 2023 protects Americans by establishing a Disease X Medical Countermeasures Program at BARDA in the Department of Health and Human Services by the following:

  • Providing funding of $40 million per year for five years specifically for Disease X MCMs;
  • Clarifying the HHS may award contracts, grants, and cooperative agreements, or enter into other transactions, to promote the development of Disease X MCMs;
  • Directing BARDA to accelerate and support the advanced research, development, and procurement of countermeasures and products to address Disease X threats; and
  • Requiring products developed using the Disease X Program funding be substantially manufactured in the United States.

"This Act would be a major leap forward in our collective efforts to stay ahead of the ever-evolving threat landscape," commented Anita Cicero, Deputy Director of the Johns Hopkins Center for Health Security, in a press release. 

"The Disease X Act of 2023 empowers BARDA to invest in modern technologies that will lead to new vaccines and drugs against pandemic–capable viruses."

Jul 4, 2023 • 7:56 pm CDT
from Pixabay

Following the reduced demand for access to digital COVID-19 test and vaccine records through the epass.ny.gov portal and the official ending of the pandemic in the U.S., the NYS Wallet that hosts the Excelsior Pass Plus vaccine credential was disconnected as of July 28, 2023.

Since the NYS Wallet app will be removed from app stores, new users cannot log in and register for it.

The app was launched in March 2021 and was eventually used by 11.5 million people.

Media reported various consulting contracts, with over $200 million in spending, are currently the subject of an investigation by the state Office of the Inspector General.

Hazel Crampton-Hays, a spokeswoman for New York Gov. Kathy Hochul, said in a statement reported by Joshua Solomon with the Times Union, "Going forward, the state will use the knowledge gained from this project to improve how New Yorkers can use technology to access services and benefits."

The Excelsior Pass Plus and the NYS Wallet Apps provided a secure digital copy of vaccination records, including vaccine type, site, and date of vaccination, validated by the State of New York.

The State of New York says the data collected continues to be private and secure.

The state has set up an "Excelsior Help Desk," which can be reached at 844-699-7277 from 8 a.m. to 4 p.m., to assist those with questions or concerns about their vaccination records.

Internationally, the World Health Organization confirmed launching a digital health partnership on July 1, 2023, that will help protect citizens worldwide from ongoing and future health threats, including pandemics.

Jul 4, 2023 • 3:06 pm CDT

The Tico Times recently reported the Republic of Costa Rica increased its value-added tax (VAT) rate established in Law No. 9882.

Beginning on July 1, 2023, the local VAT was increased from 8% to 13% on the tourism industry.

The list of services for which VAT must be charged is available at the Ministry of Finance (www.hacienda.go.cr). A VAT is a consumption tax assessed on the value added in each good or service production stage.

The Association of Tourist Transporters of Costa Rica (ASTRONATUR) president describes it as “painful” for businesses and consumers, emphasizing that it will take a toll on the tourism sector’s finances.

Regarding health concerns, the U.S. CDC issued a Level 2 - Practice Enhanced Precautions Travel Health Notice in April 2023 regarding a malaria outbreak in Costa Rica.

Other Costa Rica travel news regarding vaccinations, safety, and malaria and dengue outbreaks is posted by Vax-Before-Travel.

Jul 4, 2023 • 9:01 am CDT
WHO measles alert July 2023

The U.S. Centers for Disease Control and Prevention (CDC) recently expanded its Level 1 - Practice Usual Precautions, Travel Health Notice regarding measles outbreaks.

The CDC identified 38 countries with active measles outbreaks on June 29, 2023.

The leader is India, with over 73,000 measles cases.

Historically, measles outbreaks in the U.S. are rare, generally related to unvaccinated travelers. This year, the CDC has reported 15 measles cases in eleven jurisdictions.

Measles is caused by a highly contagious virus that spreads through the air by direct contact with infectious droplets or by airborne spread when an infected person breathes, coughs, or sneezes. Furthermore, the measles virus can live for up to two hours in airspace after an infected person leaves an area.

And infected people can spread measles up to four days before and four days after a rash appears.

The good news is measles is a vaccine-preventable disease.

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

Jul 3, 2023 • 4:52 am CDT
European Commission July 1, 2023

Reuters recently reported the European Commission secured purchase agreements with New York-based Pfizer Inc. and several European drugmakers to reserve the capacity to produce up to 325 million vaccines per year in case of a future global health emergency.

On June 30, 2023,  Reuters confirmed this new agreement covers mRNA, vector-based and protein-based vaccines and does not relate to existing COVID-19 vaccine agreements.

The Commission helps to shape the European Union's (EU) overall strategy, proposes new laws and policies, monitors their implementation, and manages the budget. It also plays a significant role in supporting international development and delivering aid.

To facilitate safe free movement during the COVID-19 pandemic, the EU established the EU Digital COVID Certificate in 2023, based on the EU Global Health and World Health Organization (WHO) Global Strategies on digital health.

On July 1, 2023, the WHO took up the EU system of digital COVID-19 certification (passports) to establish a global system that will help protect citizens worldwide from on-going and future health threats, including pandemics.

Jul 2, 2023 • 3:19 pm CDT
by Pexels from Pixabay

The U.S. Embassy in Paris recently issued another Security Alert regarding demonstrations in the greater Paris region and other major urban centers in France.

As of June 30, 2023, the embassy is aware of potential security risks surrounding events expected to occur in Paris and the Paris region.

The embassy urges U.S. citizens to avoid these events and follow general guidelines regarding gatherings.

Previous Security Alerts can be found on this website.

The U.S. Embassy in Paris can be contacted at +33 (1) 43 12 22 22 or [email protected]. Additionally, U.S. citizens are encouraged to enroll in the Smart Traveler Enrollment Program to receive security updates from the Department of State.

As of June 2, 2023, the U.S. Department of State's Level 2 advisory says visitors to France should exercise increased caution due to civil unrest.

And incidents such as pickpocketing and phone snatchings occur frequently and can happen anywhere, especially in crowded areas such as airports, train stations, subway and train cars, and near tourist attractions.

As always, it is a good practice to notify friends or family of your whereabouts, says the U.S. government.

From a health perspective, the CDC suggests various travel vaccinations when visiting France in 2023.

This article was updated on June 3, 2023, with State Department reference and link.

Jul 2, 2023 • 3:00 pm CDT
U.S. CDC measles map June 29, 2023

Measles is an ongoing risk worldwide in the summer of 2023, often due to low vaccination rates, says the U.S. Centers for Disease Control and Prevention (CDC).

To alert travelers, the CDC recently reissued and expanded its Level 1 - Practice Usual Precautions, Global Measles Travel Health Notice.

On June 29, 2023, the CDC identified 38 countries with active measles outbreaks, which are declared when the number of cases is higher than expected.

The unfortunate leaders are India (73,536) and Yemen (19,312).

Historically, measles outbreaks in the U.S. are rare, generally related to unvaccinated travelers.

However, in 2019, 1,274 measles cases were confirmed in 31 U.S. states.

This year, the CDC reported 15 measles cases in jurisdictions such as Illinois, Kentucky, Ohio, and Utah.

Measles is caused by a highly contagious virus that spreads through the air by direct contact with infectious droplets or by airborne spread when an infected person breathes, coughs, or sneezes.

The measles virus can live for up to two hours in airspace after an infected person leaves an area.

People can spread measles up to four days before and four days after a rash.

Several groups are more likely to suffer from measles complications, including children younger than five years of age, pregnant women, and people with compromised immune systems, such as leukemia or HIV infection, says the CDC.

The good news is measles is a vaccine-preventable disease, and approved measles vaccines are generally available at health clinics and community pharmacies in the U.S.

Furthermore, the CDC suggests confirming with a healthcare provider international travelers need an extra measles vaccination before visiting an outbreak country.

Jul 2, 2023 • 10:18 am CDT
by Kjrstie P.

The European Centre for Disease Prevention and Control (ECDC) recently reported the global cholera outbreak continues into the summer of 2023. While cholera in travelers is sporadic, outbreak settings do pose health risks.

The ECDC confirmed 412,137 cholera cases, including 2,130 related deaths, have been reported worldwide as of June 21, 2023.

In comparison, only 400 cholera deaths were reported during the same period in 2022.

In the Region of the Americas, Haiti continues to lead in cases and deaths.

Since January 2023 and as of early June 2023, over 26,000 cases, including 253 deaths, have been reported in Hati.

In comparison, in 2022, no cases were reported.

The good news is the island of Hispanola's eastern neighbor, the Dominican Republic, has reported very few cholera cases in 2023.

Visitors to Haiti should avoid unsafe food and water and wash their hands often to help prevent cholera, says the U.S. CDC.

Cholera is a vaccine-preventable disease. However, vaccination against cholera is not routinely recommended because most travelers do not visit areas of active transmission.

During 2023, cholera vaccines are in limited supply in the U.S.

Jul 2, 2023 • 7:21 am CDT

The BMJ Journal recently published an Editorial confirming the rates of sexually transmitted infections (STI) are rising in Canada, the United Kingdom, and the United States (U.S.)

Published on June 30, 2023, these researchers stated ...We have the tools to respond (to these increases) and must deploy them urgently!

In June 2023, the U.K. Health Security Agency reported a 23.8% increase in STI diagnoses in 2022 compared with 2021, including chlamydia (24.3%), gonorrhea (50.3%), and syphilis (15.2%).

Similar trends have emerged in the U.S., where syphilis diagnoses rose by 28.6%.

And in Canada, where rates of syphilis rose by 20%.

This situation is important for a few reasons, wrote Patrick O’Byrne, full professor and nurse practitioner, University of Ottawa, School of Nursing, Lauren Orser, doctoral candidate, and Abigail Kroch, director, Ontario HIV Treatment Network.

Firstly, STIs cause harm, including pelvic inflammatory disease, disseminated gonococcal infection, and neurosyphilis.

Secondly, drug-resistant gonorrhea is now being reported internationally, showing the spread of antimicrobial resistance. 

To read the full editorial, please visit this BMJ link.

Furthermore, there have been frequent reassurances of mpox cases and vaccine (JYNNEOS® (MVA-BN, IMVANEX®) breakthrough confirmations in 2023.

As of Ju;y 2023, mpox outbreaks have been identified in Chicago, Denver, London, New York, Paris, Seoul, and Tokyo.

In the U.S., the Food and Drug Administration has approved vaccines that can prevent certain sexually transmitted diseases caused by bacteria, viruses, or parasites. As of July 2, 2023, a STI vaccine overview was updated by Precision Vaccinations.

Jul 1, 2023 • 10:33 am CDT
U.S. CDC Africa polio case map

The U.S. Centers for Disease Control and Prevention (CDC) says polio is a vaccine-preventable disease that often impacts children. And to reduce poliovirus transmission, 31 countries have been administering a new vaccine in Africa.

Since 2022, the World Health Organization has recommended the nOPV2 vaccine when responding to circulating vaccine-derived poliovirus type 2 outbreaks in Africa.

As of late June 2023, over 670 million people have been vaccinated with this vaccine.

This single-dose vaccine has been 'triple-locked' using genetic engineering to prevent it from becoming harmful. As a result, nOPV2 is reported to be genetically more stable than existing oral polio vaccines, with a lower risk of reversion to neurovirulence.

As of July 1, 2023, the nOPV2 vaccine is not offered in the U.S.

The Global Polio Eradication Initiative recently published nOPV2 Frequently Asked Questions, Fact Sheet, and polio outbreak country list. 

And the WHO reconfirmed on May 12, 2023, poliovirus outbreaks remained a Public Health Emergency of International Concern.

Jul 1, 2023 • 7:35 am CDT
by Anja P.

Poland's Chief Veterinary Office recently confirmed 29 samples of avian influenza A(H5N1) were tested, 20 of which came from cats from Gdańsk, Gdynia, Poznań, Lublin, Pruszcz Gdański, Nowy Dwór Mazowiecki, Bydgoszcz, Wrocław, the Rzeszów district and the vicinity of Zamość.

As of June 30, 2023, Poland's State Veterinary Institute in Puławy reported these infections. Previously, a team of scientists from the Faculty of Veterinary Medicine of the Warsaw University of Life Sciences examined one of the samples.

Since June 23, 2023, media sources have referred to at least 70 domestic cat deaths in Poland, for which investigations are ongoing, reported the European Centre for Disease Prevention and Control (ECDC).

'Several uncertainties currently exist regarding the source of infection, the potential of feline-to-feline and feline-human transmission of the particular A(H5N1) influenza virus strain, and the severity of the disease.

Furthermore, no human cases have been reported related to this (cat) event in Poland, wrote the ECDC.

The U.S. CDC published an updated report on June 30, 2023, to include information on additional sporadic human cases and activity in wild birds, poultry, and other animals.  

The overall risk to human health associated with the ongoing outbreaks of highly pathogenic A(H5N1) viruses in wild birds and poultry has not changed and remains low at this time, says the CDC.

Bird flu outbreaks have been confirmed worldwide.

According to the CDC FluView dashboard, 54 countries reported bird flu outbreaks to the World Health Organization from 2021 through June 2023. 

As of July 1, 2023, the U.S. government continues to fund bird flu vaccines.

Jun 30, 2023 • 2:10 pm CDT
Dallas County map - West Nile Spraying - June 30, 2023

The Dallas County Health and Human Services (DCHHS) laboratory has confirmed mosquito samples that have tested positive for West Nile Virus (WNV).

As of June 27, 2023, the mosquito samples were collected from the 75019 zip code in Coppell, 75146 in Lancaster, and 75159 in Seagoville, TX.

Unfortunately, there are no vaccines to prevent or medications to treat WNV in people.

“It’s important to prevent mosquito bites that can cause West Nile Virus infection. As people are getting outside more, remember the four Ds: DEET, Dress, Drain, and Dusk to Dawn”, commented Dr. Philip Huang, Director of DCHHS, in a press release.

In response to these detections, weather permitting, DCHHS has scheduled ground spraying.

Spraying will not be conducted in wind speeds over ten mph or inclement weather.

Click on the link to view a map of the spraying areas as of June 30, 2023: http://www.dallas.leateamapps.com/PublicMap/.

Dallas area residents should remain inside during the time sprayers are in the area.

furthermore, WNV is a major health risk in Europe.

As of June 30, 2023, European Union, European Economic Area, and EU-neighbouring countries have confirmed 1,340 locally acquired human cases of West Nile virus, including 104 related deaths, in 2022.

According to the U.S. CDC, WNV is the leading cause of mosquito-borne disease in the continental United States. 

It is most commonly spread to people by the bite of an infected mosquito. Cases of WNV occur during mosquito season, which starts in the summer and continues through fall.

Fortunately, most people infected with WNV do not feel sick. About 1 in 5 infected people develop a fever and other symptoms.

About 1 out of 150 infected people develop a serious, sometimes fatal, illness.

In severe cases, patients often need to be hospitalized to receive supportive treatment, such as intravenous fluids, pain medication, and nursing care, says the CDC.

Jun 30, 2023 • 1:51 pm CDT
AirNow Fire and Smoke Map June 30, 2023

The U.S. Centers for Disease Control and Prevention (CDC) today published a Health Alert Network (CDCHAN-00495) reminding healthcare professionals seeing patients affected by wildfire smoke to be alert to the possible adverse effects, particularly among individuals at higher risk of severe outcomes.

Wildfire smoke exposure may exacerbate respiratory, metabolic, and cardiovascular chronic conditions like asthma, chronic obstructive pulmonary disease, and congestive heart failure.

Furthermore, people can be impacted even if they are not near the fire source due to exposure to particles of PM2.5, which are inhalable air pollutants with aerodynamic diameter ≤2.5 microns.

The acute signs and symptoms of smoke exposure include headache, eye, and mucous membrane irritation, dyspnea (trouble breathing), cough, wheezing, chest pain, palpitations, and fatigue.

The CDC suggests people in effected areas stay indoors and limit time outdoors. If you must go outside when smoke is visible or can be smelled, reduce your smoke exposure by wearing an N95 or P100 respirator.

And keep track of smoke near you using AirNow’s “Fire and Smoke Map” or the AirNow app or by listening to the Emergency Alert System and National Oceanic and Atmospheric Administration Weather Radio.

Jun 30, 2023 • 1:38 pm CDT
NPR

Vaxxinity, Inc. recently announced positive results from Part B of its Phase 1 clinical trial of UB-312, an investigational vaccine for Parkinson's disease (PD).

On June 22, 2023, the Company confirmed in a press release that UB-312 was well-tolerated and induced anti-alpha-synuclein (aSyn) antibody responses in participants with early PD, meeting the trial's primary objectives.

UB-312 is an investigational synthetic peptide vaccine targeting toxic aggregated aSyn forms to address PD and other synucleinopathies. Alpha-synuclein plays a central role in synaptic functions and regulation of neurotransmitter release.

The accumulation and aggregation of misfolded aSyn in the brain are key factors in PD's development and progression.

"This positive Phase 1 results demonstrate several important features necessary for an immunotherapy against Parkinson's disease and other synucleinopathies to be successful and represent a further proof-of-principle for Vaxxinity's platform in chronic disease," said Mei Mei Hu, CEO of Vaxxinity.

"UB-312 was observed to safely break immune tolerance, inducing antibodies against toxic aggregated forms of alpha-synuclein."

"Importantly, these antibodies crossed the blood-brain barrier, and the data also suggest potential target engagement in the periphery, where pathological alpha-synuclein is known to be concentrated."

"Together, these results support the further development of UB-312 in a Phase 2 clinical trial."

"We continue to view UB-312 as a promising candidate for the prevention or disease modification of Parkinson's disease globally."

This announcement is important since PD affects approximately one million people in the U.S. and more than 10 million worldwide.

The U.S. NIH says PD is a chronic brain and progressive neurodegenerative disorder that affects predominately dopamine-producing neurons in the substantia nigra area of the brain. 

Additionally, The Michael J. Fox Foundation is funding a 2-year collaborative project between Vaxxinity, the Mayo Clinic, and the University of Texas Houston. This work evaluates the potential of protein misfolding cyclic amplification to assess target engagement and will also aim to characterize the anti-aSyn antibodies produced after UB-312 administration.

Jun 30, 2023 • 1:19 pm CDT
by マサコ アーント

SK bioscience today announced positive results from its Phase II clinical trials in infants of its 21-valent pneumococcal conjugate vaccine candidate, 'GBP410' (SP0202), evaluating its safety and immunogenicity.

Given that GBP410 includes 21 serotypes, it is anticipated to offer broader serotype coverage than the existing pneumococcal conjugate vaccines.

The Phase II study demonstrated comparable immunogenicity of GBP410 compared to the control vaccine, following the primary vaccination at 2, 4, and 6 months of age as well as the booster vaccination for ages of 12 to 15 months.

The data also showed a well-tolerated safety profile, with a similar reactogenicity profile to the control vaccine and no vaccine-related serious adverse events.

Furthermore, GBP410 did not interfere with the immunogenicity and safety profile of the co-administered recommended pediatric vaccines, such as tetanus, diphtheria, pertussis, polio, and Haemophilus influenzae type b vaccines.

Based on the positive safety and immunogenicity data from the Phase II clinical trial, SK bioscience and its development partner Sanofi plan to start Phase III in H1 2024, expecting to secure the final data in 2027.

In preparation for the commercialization of GBP410, SK bioscience intends to enter the U.S. and European markets with Sanofi by making significant investments in manufacturing facilities.

Jean-Francois Toussaint, Global Head of Vaccines R&D at Sanofi, said in a press release on June 29, 2023, "We are pleased with our very productive partnership with SK bioscience as we work to raise the bar in pneumococcal disease."

"With an innovative carrier that breaks the glass ceiling of serotype compositions, our 21-valent pneumococcal conjugate vaccine is designed to offer expanded protection against this devastating disease."

"We believe that today's results offer us a strong path to Phase 3 and then to licensure."