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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."
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.
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.
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.
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."
The MedAfrica Times recently reported that the Republic of Brazil donated 80 thousand vaccines against HPV and yellow fever to Cabo Verde.
The Cape Verdean Ministry of Health announced on June 27, 2023, 50 thousand doses of HPV and 30 thousand doses of yellow fever arrived in Praia.
"The yellow fever vaccine is used to prevent yellow fever, a disease caused by an arbovirus. It is recommended for prevention in endemic areas or for travelers", said this article.
The U.S. CDC recently wrote that no (health) notices are currently in effect for Cape Verde.
However, the CDC suggests prospective visitors to Cape Verde speak with a healthcare provider regarding travel vaccinations, such as yellow fever and medicines.
Located 900 miles south of the Canary Islands and 350 miles from the African mainland, Cape Verde's nine inhabited islands offer vacationers many relaxing options.
Cabo Verde has witnessed significant economic progress since 1990, driven in large part by the rapid development of tourism (25% of GDP).
And remember to pack essential health supplies in case of travel delays, says the CDC.
