Search API
Globally, nearly two million new COVID-19 cases and over 12,000 related fatalities were reported in the last 28 days, a decrease of 30% and 39%, respectively, compared to the previous 28 days, reported the World Health Organization (WHO).
As of June 1, 2023, the situation is mixed at the regional level, with increases in reported cases seen in the Western Pacific Region and the African Region and decreases in related fatalities in all six WHO regions.
During this 28-day reporting period, 150 of 243 (62%) countries and territories reported at least one COVID-19 case.
The European Region had the highest proportion of countries reporting data on new hospitalizations (19 countries; 31%).
Globally, XBB.1.5 has been reported from 115 countries since the variant emerged.
The journal PLOS One reported every 75 seconds, a child under five dies of malaria, and children bear the highest burden of malaria in Sub-Saharan Africa (SSA).
On May 31, 2023, the pooled prevalence of malaria among children aged 6–59 months was 27.41% (95% CI: 17.94%-36.88%) in SSA.
Infection rates range from 5.04% in Senegal to 62.57% in Sierra Leone.
This study revealed that older under-five children living in large families with low incomes in rural areas are most vulnerable to malaria infection.
To notify international travelers of their potential health risks, the U.S. CDC issued a Level 2 travel advisory focused on malaria outbreaks in Costa Rica.
While there are malaria vaccines available in June 2023, the deployment has yet to reach critical mass in SSA.
YS Biopharma Co., Ltd. today announced that its novel PIKA Rabies Vaccine was granted Phase 3 clinical trial approval from the Food and Drug Administration of the Philippines.
The Phase 3 clinical trial, which is planned to commence later in 2023, will include approximately 4,500 subjects in the Philippines, Singapore, and Pakistan.
The PIKA Rabies Vaccine has the potential to become the first accelerated three-visit one-week regimen, superior to the currently available vaccine with a five-visit one-month or three-visit three-week regimen.
The US FDA granted orphan-drug designation for preventing rabies infection, including post-exposure prophylaxis (PEP) for rabies.
The PIKA Rabies Vaccine is powered by YS Biopharma's proprietary PIKA adjuvant technology to induce accelerated immunity and produce a higher immune response.
Pending the successful completion of Phase 3 trials, the Company plans to launch the sales and marketing of the Vaccine in North America, as well as in countries throughout Asia, Africa, Europe, the Middle East, and Central and South America.
Rabies is a vaccine-preventable, zoonotic, viral disease affecting the central nervous system. It has a case-fatality rate of almost 100%.
According to the World Health Organization, about 59,000 people die of rabies annually in over 150 countries.
Over 30% of rabies victims are children.
The U.S. Centers for Disease Control and Prevention updated its recommendations for rabies preexposure prophylaxis for humans in June 2022, replacing the three-dose vaccination schedule with a two-dose program, intending to protect for about least three years.
As of June 1, 2023, there are various rabies vaccines approved.
Pfizer Inc. today announced that the U.S. Food and Drug Administration (FDA) had approved ABRYSVO™, the company’s bivalent Respiratory Syncytial Virus (RSV) prefusion F (RSVpreF) vaccine.
This FDA approval on May 31, 2023, prevents lower respiratory tract disease caused by RSV in individuals 60 years and older.
On May 3, 2023, the FDA approved the initial RSV vaccine, Arexvy™, which GSK produces.
According to statements, both RSV vaccines could be available for seniors in late 2023.
Other RSV vaccine candidates, including vaccines for pregnant women, are conducting late-stage clinical trials as of June 1, 2023.
The U.S. Centers for Disease Control and Prevention published a report on April 7, 2023, that indicated the 2022–23 RSV season started later than the 2021–22 season but earlier than the prepandemic seasons, suggesting a return toward prepandemic seasonality.
A study published by the Journal of Infectious Diseases determined that RSV-related fatalities in infants <1 year peaked at one month of age.
Over the 20-year study period, RSV, bronchiolitis, and influenza were listed as the underlying causes of death on 932, 1,046, and 52,293 death certificates, respectively.
Over 95% of these infections in children occur in low- and middle-income countries outside the U.S.
Southern Africa is again weathering a season of cholera, with six countries in the region recording outbreaks in 2023, reported Derick Matsengarwodzi with GAVI.
As of May 25, 2023, Malawi is the worst affected, recording 36,943 cases and 1,210 associated deaths between March 2022 and February 2023, according to World Health Organization (WHO).
So far this year, Malawi has received three shipments of oral cholera vaccine (OCV) in response to applications to the Gavi-supported stockpile established in 2013.
The latest 1.4 million OCV dose shipment arrived in Lilongwe in April 2023.
On May 22, 2023, Gavi published a roadmap outlining critical actions needed to ensure the supply of OCV can meet growing demand from countries.
The roadmap describes how these organizations, manufacturers, and countries can work together towards ensuring global OCV supply can support large-scale preventive vaccination by 2026.
"Cholera vaccines have steadily become more available over the past decade, meeting rising country demand," said Dr. Derrick Sim, Managing Director for Vaccine Markets and Health Security at Gavi, in a media release.
"As a result, the good news is we have doses to meet all emergency demand despite the rise in outbreaks, which is expected to continue. But this trend underscores the increasing importance of preventing outbreaks before they occur."
"The ultimate solution to both sustainable OCV supply and cholera control lies in our collective ability to step up our efforts on prevention programs."
As of May 31, 2023, various cholera vaccines have been approved but remain in limited supply.
Note: The U.S. CDC recently issued an Alert Level 2, Practice Enhanced Precautions, regarding polio outbreaks, which includes Malawi.
Immorna today announced that the first subject had been dosed in the Company's First-In-Human Phase 1 multi-center study of JCXH-105, a self-replicating RNA (srRNA) vaccine being developed for the prevention of Shingles.
The U.S. Food and Drug Administration (FDA) cleared its investigational new drug application on January 9, 2023, to conduct a Phase 1 multi-center study of JCXH-105.
NgocDiep Le, M.D., Ph.D., Global Chief Medical Officer of Immorna, commented in a press release on May 30, 2023, "If proven successful in clinical studies, JCXH-105 may become a valuable alternative to current standard-of-care to meet the large world-wide medical need for Shingles prevention."
"Due to its self-replicating nature, JCXH-105 may be effective at a significantly reduced dose level compared to non-replicating conventional mRNA vaccines and thereby may cause less reactogenicity and substantially reduce the cost of production."
"In addition, due to the synthetic nature of all JCXH-105 vaccine components, there are no raw material limitations or production bottlenecks."
This Phase 1 study is a randomized, double-blinded, multi-center, active-controlled study to assess the safety, immunogenicity, and determine the Recommended Phase 2 Dose for JCXH-105 for seniors.
In this study, JCXH-105 will be compared to GSK's U.S. FDA-approved Shingrix® vaccine.
Other shingles vaccine development news is posted by Precision Vaccinations.
Valneva SE today announced filing a regulatory application with Health Canada for marketing approval of the single-shot chikungunya vaccine candidate, VLA1553.
If accepted by Health Canada, VLA1553 would become available for persons aged 18 years and above.
VLA1553 is currently the only chikungunya vaccine candidate worldwide for which regulatory review processes are underway. It could become the first licensed chikungunya vaccine to address this unmet medical need if approved.
A Biologic License Application is currently under priority review by the U.S. Food and Drug Administration with a Prescription Drug User Fee Act review goal date at the end of August 2023.
VLA1553 received FDA Fast Track and Breakthrough Therapy designations in 2018 and 2021, respectively. The program was also granted PRIority MEdicine designation by the European Medicines Agency in 2020.
Furthermore, Valneva plans to make regulatory submissions for VLA1553 in Europe in the second half of 2023.
Juan Carlos Jaramillo, MD, Chief Medical Officer of Valneva, commented in a press release on May 30, 2023, "Chikungunya represents a major threat for people traveling to or living in areas where chikungunya virus and the mosquitos that transmit it are present, including popular destinations for U.S. and Canadian travelers."
"No vaccine or specific treatments are currently available for this debilitating disease, and we will continue to work diligently to bring VLA1553 to different territories as soon as possible."
Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus, transmitted by Aedes mosquitoes.
An infection leads to symptomatic disease in 72-92% of humans after four to seven days following the mosquito bite. While mortality is low, morbidity is high.
Beginning in 2014, chikungunya virus disease cases were reported among U.S. travelers returning from affected areas in the Americas, and local transmission was identified in Florida, Texas, Puerto Rico, and the U.S. Virgin Islands, says the U.S. CDC.
The high-risk areas of infection for travelers included the Americas, parts of Africa, and Southeast Asia, and the virus has spread to more than 110 countries.
The Pan American Health Organization (PAHO) recently reported Respiratory Syncytial Virus (RSV) cases in Latin America and the Caribbean for Epidemiological Week #18 of 2023.
As of May 24, 2023, the PAHO confirmed RSV activity has remained low throughout most of the Americas.
However, in Brazil and Southern Cone, RSV activity, after showing an increase in recent weeks, a decreasing trend has been observed.
In the U.S., Florida’s RSV season is longer than the rest of the nation and has distinct regional patterns. However, as of late May 2023, Florida has not reported an RSV outbreak.
RSV is a common respiratory virus that usually causes mild, cold-like symptoms.
However, according to the Florida Department of Health, young children and older adults, especially those with certain underlying health conditions, are at higher risk for severe illness from RSV.
RSV is a vaccine-preventable disease in older adults, and RSV monoclonal antibody therapies were approved for infants in 2023.
