Monday 18 July 2022

U.S. Government Orders 2.5 Million Doses of Monkeypox Vaccines from Bavarian Nordic




Bavarian Nordic A/S announced that the U.S. BARDA also known as Biomedical Advanced Research and Development Authority, part of the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services, has ordered an additional 2.5M (Million) doses of liquid-frozen JYNNEOS, a non-replicating smallpox vaccine and the only vaccine against monkeypox, which is approved by the FDA. 


So far, approximately 1,470 cases of monkeypox, which can cause skin lesions and flu-like symptoms, have been reported in the country, mostly among men who have sex with men. 


Health officials forecast an increase in cases in the coming days due in part to increased reporting of the disease and more testing, US CDC Director Rochelle Walensky uttered in a press briefing.


No cases of monkeypox have been identified among adolescents in the country since testing was expanded to commercial labs last week, she said.


The new order follows a couple of previous orders from the Biomedical Advanced Research and Development Authority in June and July 2022 for 500,000 and 2.5 Million doses respectively, together with an order from the Biomedical Advanced Research and Development Authority in 2020 for 1.4 million doses, will bring the total deliveries in 2022 and 2023 to around 7 million doses.


This extra order will be filled at the US-based contract manufacturer using bulk vaccines already manufactured and invoiced under previous contracts with Biomedical Advanced Research and Development Authority and currently stored at Bavarian Nordic. A tech transfer of the process to the contract manufacturer will begin promptly, with the aim to manufacture all doses under this contract in 2022.


According to Paul Chaplin, President, and CEO of Bavarian Nordic, “Enhancing our manufacturing potential into the US enables the company to deliver more vaccines of Monkeypox in order to match the immediate worldwide requirement for JYNNEOS. This immediate response to a serious health crisis is only possible because the Government of the US is diligent in long-term planning for their national preparedness.”


About Bavarian Nordic:

Bavarian Nordic, is a fully integrated vaccine firm that is focused on the manufacturing, development, and commercialization of life-saving vaccines. Bavarian Nordic is a global leader in smallpox vaccines and has been a prolific supplier to the Government of the U.S of a non-replicating smallpox vaccine, authorized by the Food and Drug Administration, also for the protection against monkeypox. The vaccine is also authorized in order to protect against smallpox and monkeypox in Canada, and as a smallpox vaccine in Europe. The company's commercial product portfolio furthermore contains the top-most vaccines against tick-borne encephalitis and rabies. Using their live virus vaccine program, MVA-BN, they have established a diverse portfolio of proprietary and partnered product candidates designed in order to save and improve lives by unfastening the power of the defense system, including an Ebola vaccine, licensed to the Janssen Pharma Companies of Johnson & Johnson. Bavarian Nordic is also committed to the development of a next-generation vaccine for COVID-19.



Wednesday 6 July 2022

Factors Associated with Adherence to Oral Kahler's Disease Therapy





Shortfall of adherence to cancer treatment comprising oral therapies can contribute to poor treatment findings, and researchers carried out a study to probe factors that may be associated with lack of adherence to oral agents. 

Wilbur Rutter, Ph.D., PharmD, of CVS Health in Lincoln, Rhode Island, and colleagues presented the study’s outcomes in a poster at the American Society of Clinical Oncology Annual Meeting 2022.

In this carried out study, Dr. Rutter and colleagues did a retrospective review of records from patients with newly diagnosed Kahler's Disease also named multiple myeloma (MM) who were being treated with the help of oral agents during the time span of 01/09/2016, through 01/09/2020. 


Adherence to therapy was the finding of interest, which was elaborated as having an annual medicine possession ratio of 0.8-1.2. A socioeconomic status (SES) composite index (created by researchers), was developed from data acquired at the zip-code level.


Researchers did a multivariable regression investigation of adherence with factors including the socioeconomic status-index and demographic deets.


On behalf of the socioeconomic status index, patients were grouped as Very Low, Low, Medium, High, and Very High groups. It reflected rising levels of zip code-based median household income as socioeconomic status-index values rose from very low to very high. It also aligned with US CDC Social Vulnerability Index (SVI) scores, reflecting greater vulnerability with minor socioeconomic status.


Carried out study included a total of 6602 patients, 64.5 percent of whom were adherent. Adherent patients were compared with non-adherent patients. 


The multivariable evaluation suggested several evaluated factors demonstrated significant, independent link-ups with adherence. Regarding adherence based on socioeconomic status-index scores, the researchers considered patients with a very low socioeconomic status index to show a significantly lower rate of adherence than seen in patients having a very high socioeconomic status index.


The increasing age was related to greater adherence, although polypharmacy was related to less adherence.


Compared with lacking polypharmacy, patients with mild polypharmacy were less likely to be adherent. Moderate polypharmacy was also related to nonadherence, as was significantly polypharmacy.


Conclusion: Researchers concluded there were not any specific relationships with adherence across maximum socioeconomic status indexes, but that patients in Very Low socioeconomic status zip codes demonstrated less adherence than patients in Very High socioeconomic status zip codes did. Polypharmacy and younger age were other factors researchers considered linked to worse adherence.