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The US Centers for Disease Control and Prevention (CDC) confirmed today, the 2020-2021 flu season in the USA is coming to a quiet close. However, one age group has been found infectious with influenza viruses.
As of Week #22, ending June 5, 2021, the 0–4 years group reported increasing flu cases, while the remaining age groups were stable (change of ≤0.1%) compared with week #21.
The good news reported by the CDC is only (1) influenza-associated pediatric death has occurred during the 2020-2021 flu season.
And mortality surveillance data available on June 10, 2021, reveals 7.5% of the deaths during week #22 were due to pneumonia, influenza, and/or COVID-19 (PIC).
Among the 1,360 PIC deaths reported, 661 had COVID-19 listed as an underlying or contributing cause of death on the death certificate, and two listed influenza, indicating that current PIC mortality is due primarily to COVID-19 and not influenza.
Massachusetts-based Moderna, Inc. and Tabuk Pharmaceutical Manufacturing Company, a Saudi pharmaceuticals company, announced an agreement to commercialize the Moderna COVID-19 Vaccine and future variant-specific booster candidates in the Kingdom of Saudi Arabia.
“We are proud and excited at Tabuk to be partnering with Moderna to commercialize crucial vaccines to Saudi Arabia, building on our strategy to expand our specialty and innovative business and reinforces our leading position in the region. Our aspiration is to be the partner of choice to Moderna in the region and consider further strategic collaboration including local manufacturing in Saudi,” said Wisam Alkhatib Pharm., MBA., VP of Strategy and Business Development of Tabuk Pharmaceuticals, in a related press statement issued on June 11, 2021.
Moderna designs its mRNA vaccines using the virus's sequence, not on the virus itself.
Cambridge, MA-based Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology, and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and auto-immune diseases.
California-based AIVITA Biomedical Inc. announced data from its multi-center Phase 2 clinical trial of its personalized cancer vaccine, AV-GBM-1. The analysis focused on the 57 Phase 2 patients who received eight doses of AV-GBM-1 over approximately six months.
At the time of the analysis, surviving patients had completed therapy and followed between 10.1 and 27.6 months from enrollment. The median length of PFS was 10.4 months (95% confidence interval; 8.6 to 11.7 months), an improvement of approximately 50% compared to a median PFS of 6.9 months (95% confidence interval; 5.8 to 8.2 months) in the landmark STUPP study that established the standard of care for patients with newly diagnosed glioblastoma (GBM).
This represents a 42% reduction in the risk of progression or death at 6.9 months.
Median survival has not been reached and will be assessed after the final patient has a minimum follow-up of 15 months. Overall, the treatment was well tolerated. There were 54 serious adverse events among 28 of 57 patients, but none were attributed to the vaccine.
“The potential for AV-GBM-1 to significantly improve Progression Free Survival (PFS) in newly diagnosed GBM patients over and above the current standard of care is very encouraging,” commented Robert O. Dillman, M.D., chief medical officer of AIVITA, in a press release.
“We look forward to confirming this benefit in a randomized Phase 3 multi-center trial.”
AIVITA is currently conducting clinical studies in the United States investigating its platform immunotherapy in patients with GBM.
Glioblastoma, also referred to as a grade IV astrocytoma, is a fast-growing and aggressive brain tumor. It invades the nearby brain tissue but generally does not spread to distant organs.
AV-GBM-1 is a novel immunotherapy consisting of autologous dendritic cells loaded with autologous tumor neoantigens derived from self-renewing tumor-initiating cells isolated from tumors after routine surgical debulking. The treatment is administered to patients via subcutaneous injection. The treatment is uniquely pan-antigenic, targeting multiple antigens, including all neoantigens, from autologous tumor-initiating cells responsible for the tumor growth.
“This milestone is an encouraging first step in the fight against GBM, a disease that has a devastating impact on patients and their families,” said study principal investigator Daniela Bota, M.D., Ph.D., Director, University of California, Irvine (UCI) Alpha Stem Cell Clinical and medical director, UCI Health Comprehensive Brain Tumor Program.
AIVITA Biomedical was founded in 2016 by pioneers in the stem cell industry, AIVITA Biomedical, Inc. utilizes its expertise in stem cell growth and directed, high-purity differentiation to enable safe, efficient, and economical manufacturing systems which support its therapeutic pipeline.
Massachusetts-based Moderna, Inc. announced that it has requested an emergency use authorization (EUA) for its COVID-19 vaccine in adolescents with the U.S. Food and Drug Administration (FDA).
The Moderna COVID-19 Vaccine is currently Authorized for use under a EUA for active immunization to prevent COVID-19 caused by the SARS-CoV-2 beta coronavirus in individuals 18 years of age and older.
In May 2021, the Company announced that the Phase 2/3 TeenCOVE study of Moderna’s COVID-19 vaccine in adolescents met its primary immunogenicity endpoint, successfully bridging immune responses to the adult vaccination. However, the Moderna COVID-19 Vaccine may not protect all vaccine recipients.
Stéphane Bancel, CEO of Moderna, stated in a press release issued on June 10, 2021, “We are encouraged that the Moderna COVID-19 vaccine was highly effective at preventing COVID-19 and SARS-CoV-2 infection in adolescents."
"We have already filed for authorization with Health Canada and the European Medicines Agency, and we will file with regulatory agencies around the world for this important younger age population. We remain committed to helping to end the COVID-19 pandemic.”
The Moderna COVID-19 Vaccine is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein co-developed by Moderna and investigators from the National Institute of Allergy and Infectious Diseases’ Vaccine Research Center.
Cambridge, MA-based Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology, and manufacturing and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and auto-immune diseases.
The New England Journal of Medicine published an article on June 10, 2021, stating 'the global burden of dengue, a mosquito-borne viral acute febrile illness common throughout the tropics is worsening. Approximately 5% of patients have progression to severe dengue, including plasma leakage, shock, and hemorrhage, but they may also present with acute cholecystitis.'
As dengue continues to expand outside the tropics, more frequent importation and local transmission of DENV in the United States is expected.
In evidence of this, in 2019, a total of 413 dengue cases were probably imported to Florida, including 14 cases of severe dengue (3.4%), predominantly in the Miami area. Most travel-associated cases reported recent travel to Cuba and were infected with dengue virus serotype 2 (DENV-2).
Ensuring appropriate patient care management, including close clinical monitoring and judicious use of intravenous fluids, can reduce dengue case-fatality rates. Clinicians should suspect dengue and order molecular testing for patients with acute febrile illness and relevant epidemiologic exposure because knowledge of this infection may alter clinical care.
To alert international travelers, the U.S. CDC issued a Level 1 Travel Alert in May 2021, stating 'Dengue is an ongoing risk in many parts of Central and South America, Mexico, and the Caribbean. Travelers to these areas of risk should protect themselves by preventing mosquito bites.
The CDC suggests people interested in dengue vaccination speak with a healthcare provider before traveling to at-risk areas. As of June 10, 2021, one dengue vaccine (Dengvaxia) is authorized in the USA and (1) a late-stage dengue vaccine candidate, TAK-003.
On May 5, 2021, the CDC's Advisory Committee on Immunization Practices presented updated dengue lab testing considerations required for Dengvaxia vaccination.
As of June 2, 2021, the CDC had confirmed 12 dengue cases in the USA and 254 dengue cases reported in Puerto Rico.
France-based Valneva SE announced that it had completed recruitment for the clinical lot-to-lot consistency Phase 3 trial of its single-shot chikungunya vaccine candidate, VLA1553.
VLA1553 is the only chikungunya vaccine candidate conducting Phase 3 clinical trials as of June 10, 2021.
The lot-to-lot consistency Phase 3 trial runs parallel to the ongoing, pivotal Phase 3 trial, VLA1553-301, for which the Company already announced recruitment completion in April 2021.
Juan Carlos Jaramillo, Chief Medical Officer of Valneva, commented in a press release, “We are pleased to have reached this new recruitment milestone. We’ve now enrolled all participants for both our pivotal Phase 3 trial and lot-to-lot consistency trial so our VLA1553 program is progressing extremely well. Chikungunya virus is a major, growing public health threat, and we are looking forward to our top-line data this summer”.
Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus (CHIKV), a Togaviridae virus, transmitted by Aedes mosquitoes. An infection leads to symptomatic disease in 72-92% of humans after 4 to 7 days following the mosquito bite. As of September 2020, there were more than 3 million reported cases in the Americas.
There are no preventive vaccines or effective treatments available and, as such, chikungunya is considered to be a major public health threat.
The Company has also received confirmation for its proposal to seek licensure under the accelerated approval pathway from the FDA. Under this pathway, Valneva plans to seek licensure of the vaccine based on a surrogate of protection agreed with the FDA that is reasonably likely to predict protection from chikungunya infection.
The program was granted Fast Track designation by the FDA in December 2018 and PRIME designation by the European Medicines Agency in October 2020.
Valneva is a specialty vaccine company focused on developing and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical needs.
In a cohort study published by JAMA Oncology on June 4, 2021, of 1,891 Black breast cancer survivors, higher waist-to-hip ratio and body adiposity at approximately 10 months after diagnosis were associated with significantly worse overall and breast cancer cancer-specific survival.
The New Jersey State Cancer Registry was used to identify women living in 10 counties in New Jersey recruited from March 2006 to February 29, 2020, and followed up until September 2, 2020.
This study’s findings suggest 'although measurements using dual-energy x-ray absorptiometry or computed tomography may be ideal when evaluating the association of body composition with breast cancer prognosis, the findings of the present study suggest that simple measures of central obesity (waist circumference and WHR) and body composition (percent body fat and FMI using a portable bioelectrical impedance analysis scale) are clinically useful tools for identifying Black breast cancer survivors at higher risk of death.'
These findings may be particularly relevant for primary care physicians, who are typically responsible for the long-term care of breast cancer survivors and clinical settings with limited resources.
The Government of Hong Kong SAR Centre for Health Protection (CHP) of the Department of Health confirmed a human case of avian influenza A(H5N6) in Chengdu, the capital of southwestern China's Sichuan province.
This new case involved a 49-year-old woman living in Chengdu. She developed symptoms on May 13, 2021, and was admitted for treatment on May 16th. The patient is now in serious condition, stated the press statement issued on June 8, 2021.
"All novel influenza A infections, including H5N6, are notifiable infectious diseases in Hong Kong," a spokesman for the CHP wrote.
Furthermore, ' Travellers to the Mainland or other affected areas must avoid visiting wet markets, live poultry markets or farms. They should be alert to the presence of backyard poultry when visiting relatives and friends. They should also avoid purchasing live or freshly slaughtered poultry, and avoid touching poultry/birds or their droppings.'
And, 'They should strictly observe personal and hand hygiene when visiting any place with live poultry.'
Since 2014, there have been 31 human cases of avian influenza A(H5N6) reported by the Mainland health authorities.
As of May 27, 2021, a total of 239 cases of human infection with avian influenza A(H5N1) virus have been reported from countries within the WHO's Western Pacific Region since January 2003. Of these cases, 134 were fatal, resulting in a case fatality rate of 56%.
Zoonotic influenza occurs when humans are infected with influenza viruses circulating in animals, such as birds or pigs. Human infections are primarily acquired through direct contact with infected animals or contaminated environments. This type of infection does not result in the efficient transmission of these viruses between humans.
