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In western Kentucky, the Jefferson County Public Schools (JCPS) began conducting measles vaccination clinics for about 10,000 students this week.
Students at Iroquois High School were offered the Measles, Mumps, and Rubella (MMR) vaccine and the COVID-19 and Flu vaccines.
On January 18, 2023, local media reported additional on-campus measles clinics at Marion C. Moore School on January 25, Newcomer Academy on January 31, and Fern Creek High School on February 7, 2023.
JCPS Health practitioner Angela Hayes informed WLKY, "The U.S. CDC has named Kentucky an at-risk state."
"At this point, we are not excluding students from classes if they are not up to date for their vaccinations," said Hayes.
"However, if there is an outbreak, those 10,000-plus students may have to be excluded from the school for a certain amount of time to help protect them and others."
Measles is an acute viral respiratory illness. It is characterized by a prodrome of fever (as high as 105°F), malaise, cough, coryza, and conjunctivitis, as reported by the Kentucky Board of Health.
Measles is one of the most contagious infectious diseases.
The virus is transmitted by direct contact with infectious droplets or by airborne spread when an infected person breathes, coughs, or sneezes.
The measles virus can remain in the air for up to two hours after an infected person leaves.
The Louisville-Jefferson County Metro Government publishes local measles information.
The JCPS's actions relate to the recent measles outbreak in the Columbus, Ohio, area, where about 85 children/students have contracted measles, with over 30 hospitalized.
Both Kentucky and Ohio require most students to be protected against measles before attending classes.
Nationwide, there were a total of 118 measles cases reported by six jurisdictions in 2022. This total increased from 2021 when only 49 measles cases were reported to the U.S. CDC.
Since the Mpox outbreak began in May 2022, over 1.1 million doses of the Jynneos® vaccine have been administered in the United States (U.S.).
The city of Boston began offering Jynneos vaccinations to healthcare staff on May 24, 2022, followed by New York City (NYC).
In September 2022, NYC Health began offering second doses of Jynneos to qualifying people.
As of January 17, 2023, 57 U.S. Jurisdictions have offered first and second doses to men and women at no charge.
From an effectiveness perspective, the U.S. Centers for Disease Control and Prevention (CDC) posted data on December 8, 2022, suggesting the effectiveness of a single dose of Jyennos was 87% protective.
Overall, the CDC has confirmed 30,026 Mpox cases and 23 related fatalities, a case-fatality rate of less than 1%.
Demetre Daskalakis, M.D., deputy coordinator of the CDC's pox response efforts in the U.S., recently posted on Twitter, 'Supply is there! We need to keep the drumbeat going for demand even as cases go down.'
'Getting vaccinated for #mpox now means protection in the future! Oh… that means two doses of the vaccine!
Find out where to obtain the Jynneos vaccine at http://mpoxvaxmap.org or your local/state health department.
ImmunityBio, Inc. today announced positive results in its fully-enrolled metastatic pancreatic cancer study in third-line or greater subjects (QUILT 88), showing that the overall survival (OS) rate for patients continues to be double compared to historical survival rates after two or more prior lines of therapy.
The median OS in this highly advanced group of patients, up to seven lines (N=83) of treatment, was 5.8 months (95% CI: 4.9, 6.4 months), exceeding the approximately 2- to 3-month historical median OS.
In the third-line setting (N=41), the median OS in this group was 6.3 months (95% CI: 5.0, 7.2 months), more than doubling the historical OS.
The baseline median CA 19-9 level (a marker of metastatic pancreatic disease) of the enrolled subjects (N=83) was very high at 4120 IU/ml, a significant increase from normal levels of 40 IU/ml.
In subjects with CA 19-9 levels less than 4120 IU/ml (N=40), the median OS was 6.9 months (95% CI: 5.7,10.9).
"We are encouraged by the positive results in these patients with 3rd, 4th, 5th, and even 7th line advanced pancreatic cancer and the considered and helpful feedback from the FDA," said Patrick Soon-Shiong, M.D., Executive Chairman, and Global Chief Scientific and Medical Officer at ImmunityBio, in a press release on January 19, 2023.
"Treatments for pancreatic cancer in the advanced setting remain an unmet need."
"We are committed to confirming our hypothesis that orchestrating the innate and adaptive immune system will advance the care of these patients."
This therapy is essential since pancreatic cancer is the fourth leading cause of cancer-related death in the U.S. and has one of the highest mortality rates of all major cancers, taking nearly 50,000 lives in the U.S. annually.
The QUILT 88 study results were presented at the American Society of Clinical Oncology Gastrointestinal conference on January 19-21, 2023.
ImmunityBio also announced that it held two productive Type B meetings with the U.S. FDA in December 2022.
The Janssen Pharmaceutical Companies of Johnson & Johnson and a consortium of global partners announced the results of an independent, scheduled data review of the Phase 3 Mosaico study of Janssen's investigational HIV vaccine regimen.
The study's independent Data and Safety Monitoring Board (DSMB) determined that the regimen was ineffective in preventing HIV infection compared to placebo.
In light of the DSMB's determination, the Mosaico clinical trial was discontinued.
Mosaico began in 2019 and completed vaccinations in October 2022.
The study included approximately 3,900 cisgender men and transgender people who have sex with cisgender men and/or transgender people, who represent groups and populations vulnerable to HIV, at over 50 trial sites in Argentina, Brazil, Italy, Mexico, Peru, Poland, Puerto Rico, Spain, and the U.S.
"We are disappointed with this outcome and stand in solidarity with the people and communities vulnerable to and affected by HIV," said Penny Heaton, M.D., Global Therapeutic Area Head, Vaccines, Janssen Research & Development, LLC., in a press release on January 18, 2023.
"We remain steadfast in our commitment to advancing innovation in HIV, and we hope the data from Mosaico will provide insights for future efforts to develop a safe and effective vaccine."
The Mosaico findings align with developments in the Phase 2b “Imbokodo” clinical trial, which tested a similar HIV vaccine regimen in women in sub-Saharan Africa.
That DSMB determined in August 2021 that the experimental vaccine regimen was also ineffective in protecting against HIV acquisition.
As of January 19, 2023, the U.S. Food and Drug Administration had not approved an HIV vaccine candidate.
LinKinVax and Gustave Roussy today announced a collaboration to conduct a first-in-human Phase I/IIa clinical trial with CD40HVac, a new therapeutic vaccine candidate against head and neck cancer associated with human papillomavirus (HPV).
LinKinVax develops CD40HVac based on an innovative technology directly targeting dendritic cells, which play a crucial role in the immune system by stimulating and regulating immune responses.
Although many HPV-induced tumors can be cured with modern multidisciplinary treatment approaches, it is essential to develop new and effective therapeutic vaccines against HPV-associated malignancies to better address the needs of patients, says LinkinVax.
The objectives of the study (EUCT n° 2022-502930-25-00), sponsored by Gustave Roussy, are to demonstrate the safety and immunogenicity of the CD40HVac vaccine candidate with the Poly-ICLC adjuvant (Hiltonol®) against oncogenic HPV in patients with head and neck cancer and to determine the recommended Phase 2 dose based on the safety profile of the vaccine candidate and its ability to induce immune responses.
Several exploratory objectives are also planned to estimate progression-free survival and overall survival.
Prof. Yves Levy, Chief Medical and Scientific Officer LinKinVax, commented in a press release on January 19, 2023, "This partnership ... represents a bridge between basic research and clinical research designed to accelerate innovation for the benefit of patients."
"Together with Gustave Roussy, we look forward to making what we hope will be a major contribution to treating HPV-related cancers."
A recent U.S. population-based study by the Centers for Disease Control and Prevention showed that 66% of cervical cancers, 55% of vaginal cancers, 79% of anal cancers, and 62% of oropharyngeal cancers are attributable to HPV 16 and 18.
LinKinVax's vaccine platform is built around a humanized monoclonal antibody fused with regions of pathogens of interest, targeting the CD40 molecule expressed by dendritic cells.
The results demonstrate this strategy's benefits due to the small number of antigens required to activate the immune system, with or without an adjuvant, and its ability to trigger a lasting cellular and humoral and immune response.
The platform also benefits from the experience and safety profile of the protein-based vaccines that have been widely used for over 30 years.
Evaxion Biotech A/S recently announced that the U.S. Food and Drug Administration (FDA) determined that the Company may proceed with its Phase 2b clinical trial of EVX-01 targeting malignant melanoma.
The Phase 2b study will be conducted at clinical sites across the U.S., Europe, and Australia and in collaboration with Merck, supplying its PD-1 inhibitor KEYTRUDA®.
The trial was first initiated in Australia with the enrollment of the first patient in September 2022.
In November 2022, the Company submitted an Investigational New Drug Application along with a Fast Track designation application to the FDA for a Phase 2b clinical trial.
The Company anticipates a response from the FDA to the Fast Track designation submission in the first quarter of 2023.
“Receiving a green light from the FDA is a tremendous boost for our personalized cancer vaccine program. EVX-01 is already actively enrolling patients in Australia, and the FDA approval expands our ability to move forward quickly with our lead program in malignant melanoma. Moreover, the FDA is a universally recognized national authority, and its endorsement is an important step towards demonstrating a clinically meaningful benefit of our first personalized cancer vaccine,” says Erik Heegaard, Chief Medical Officer at Evaxion, in a press release on January 3, 2023.
