Mpox | Jotup

Bavarian Nordic Submits Supplemental BLA Seeking U.S. FDA Approval of Freeze-Dried Formulation of Smallpox and Mpox Vaccine

Retrieved on:

星期五, 五月 31, 2024

Partnership, Transport, Licensure, OMX, USD, Food, Mpox, Exercise, FDA, Government, Vaccine, Smallpox, Smallpox vaccine, Development

The liquid-frozen formulation of JYNNEOS® was approved by the FDA in September 2019.

Key Points:

The liquid-frozen formulation of JYNNEOS® was approved by the FDA in September 2019.
It remains the only approved mpox vaccine anywhere in the world and the only non-replicating smallpox vaccine approved in the U.S.
This formulation of JYNNEOS® has specific cold-chain requirements, while the freeze-dried formulation provides more flexibility in terms of transportation, storage conditions and shelf life, thus being more suitable for long-term stockpiling.
Following a standard review time of 10 months for the sBLA, approval of the freeze-dried formulation could be obtained in the first quarter of 2025.

BioNTech and CEPI Expand Partnership to Strengthen Africa’s mRNA Vaccine Ecosystem

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星期三, 五月 29, 2024

CEPI is committing up to US $145 million1 to support BioNTech to establish mRNA vaccine R&D, clinical and commercial-scale manufacturing capabilities at the Company’s facility in Kigali, Rwanda.

Key Points:

CEPI is committing up to US $145 million1 to support BioNTech to establish mRNA vaccine R&D, clinical and commercial-scale manufacturing capabilities at the Company’s facility in Kigali, Rwanda.
This effort by BioNTech and CEPI has the potential to enable R&D activities for novel mRNA-based vaccine candidates against pathogens with epidemic or pandemic potential.
Our partnership with CEPI is an important next step in our comprehensive strategy towards sustainable mRNA vaccine manufacturing in Africa.
The power of partnership is what will make this project successful, and today is another great milestone towards creating vaccine equity.”
H.E.

Why using dating apps for public health messaging is an ethical dilemma

Retrieved on:

星期二, 五月 28, 2024

Online, Mpox, COVID-19, Prejudice, Tinder, Love, Privacy, HIV, Bullying, Pew, Ageing, Safety, Public, Health, Racism, Communication, Research, Economy, Systematic review, Medical device

They’re becoming increasingly important in the communication of public health messaging, particularly sexual health.

Key Points:

They’re becoming increasingly important in the communication of public health messaging, particularly sexual health.
In 2023, Harvard Public Health magazine suggested that dating apps could “become a key component in [sexually infectious diseases] prevention”.
A recent systematic review concluded that apps have multiple benefits for public health, including the ability to effectively target specific groups.
In the US, Building Healthy Online Communities is a successful example of collaborating with dating apps to promote sexual health.

Profit, privacy and prejudice

Labcorp Receives FDA Emergency Use Authorization for Mpox PCR Test Home Collection Kit

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星期三, 四月 10, 2024

FDA, Physician, Mpox, Laboratory, Food, CDC, Clinical Laboratory, LH, Collection, Polymerase chain reaction, CLIA, PCR, Patient, Privacy, Virus, Diagnosis, Monkeypox virus, Death, Infection

BURLINGTON, N.C., April 10, 2024 /PRNewswire/ -- Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, announced today the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its Mpox PCR Test Home Collection Kit to aid in the diagnosis of infection with non-variola Orthopoxvirus, including the monkeypox virus that causes monkeypox, also known as mpox. The test is the first mpox at-home collection kit authorized by FDA and is available to physicians to order for patients 18 years of age or older who are suspected of mpox infection.

Key Points:

The test is the first mpox at-home collection kit authorized by FDA and is available to physicians to order for patients 18 years of age or older who are suspected of mpox infection.
"The FDA's emergency authorization of Labcorp's Mpox PCR Test Home Collection Kit will enable us to play a vital role within the healthcare community in the early detection and management of mpox," said Dr. Brian Caveney, Labcorp's chief medical and scientific officer.
"The collection kit reflects our ongoing commitment to providing critical diagnostic tools to physicians and accessible and convenient testing options to patients."
Labcorp will send the test kit directly to patients for at-home collection.

Bavarian Nordic Announces Commercial Launch of Mpox Vaccine in the U.S.

Retrieved on:

星期二, 四月 2, 2024

Health, Advisory Committee, Disease, OMX, Partnership, Risk, Trust, Pharmacy, Public, Mpox, Infection, CDC, Vaccination, Vaccine, FDA, Government, ACIP, Pharmaceutical industry

Since 2022, in response to the global mpox outbreak, JYNNEOS has been made available through public health channels for individuals at risk of mpox infection.

Key Points:

Since 2022, in response to the global mpox outbreak, JYNNEOS has been made available through public health channels for individuals at risk of mpox infection.
According to estimates from the CDC, two (2) million U.S. individuals are eligible for vaccination against mpox4.
Recent data shows 60% of this population remains completely unvaccinated, and 15% have received only one dose of the vaccine5.
Through its existing nationwide vaccine distribution structure, Bavarian Nordic is now making the mpox vaccine commercially available across the nation.

Morris & Dickson is the First U.S. Distributor for Bavarian Nordic’s JYNNEOS®, the Only FDA-approved Mpox Vaccine

Retrieved on:

星期三, 四月 3, 2024

Infectious Diseases, Pharmaceutical, Health, Disease, Smallpox, Virus, Mpox, Viral disease, Infection, CDC, Bavarian Nordic, Family, FDA, Pharmaceutical industry

Morris & Dickson is proud to announce it is the first U.S. distributor of Bavarian Nordic’s newly launched mpox vaccine, JYNNEOS®.

Key Points:

Morris & Dickson is proud to announce it is the first U.S. distributor of Bavarian Nordic’s newly launched mpox vaccine, JYNNEOS®.
As the only FDA-approved mpox vaccine, JYNNEOS is now commercially available in the U.S., marking a significant expansion for access.
Bavarian Nordic announced its commercial entry into the US on April 2, noting the ongoing need for the vaccine.
“We are proud to be a key partner in expanding access to this first-to-market vaccine,” says Layne Martin, head of Specialty at Morris & Dickson.

Global Monkeypox Diagnostics Market Research Report 2024: Market Analysis & Forecasts 2022-2026 with Executive & Consultant Guides - ResearchAndMarkets.com

Retrieved on:

星期五, 三月 1, 2024

Biotechnology, Infectious Diseases, Hospitals, Health, Medical Supplies, Place, COVID-19, Mpox, Growth, Genomics

The "Global Monkeypox Diagnostics Market by Assay, Country, Product, and Place, with Executive & Consultant Guides and Market Analysis & Forecasts 2022-2026" report has been added to ResearchAndMarkets.com's offering.

Key Points:

The "Global Monkeypox Diagnostics Market by Assay, Country, Product, and Place, with Executive & Consultant Guides and Market Analysis & Forecasts 2022-2026" report has been added to ResearchAndMarkets.com's offering.
This report forecasts the market size out to 2026.
Growth is coming from basic factors but the COVID-19 pandemic has changed the market landscape now and for the foreseeable future.
The two key trends of Rapid Diagnostics and the Genomics Revolution are merging to create new diagnostic opportunities.

Global Continuing Medical Education Market Outlook Report 2023-2028 - Increasing Demand for Short-Term CME Courses

Retrieved on:

星期四, 二月 22, 2024

DUBLIN, Feb. 22, 2024 /PRNewswire/ -- The "Global Continuing Medical Education Market - Outlook & Forecast 2023-2028" report has been added to ResearchAndMarkets.com's offering.

Key Points:

DUBLIN, Feb. 22, 2024 /PRNewswire/ -- The "Global Continuing Medical Education Market - Outlook & Forecast 2023-2028" report has been added to ResearchAndMarkets.com's offering.
The healthcare education market has a massive demand for physicians and other medical staff, where the supply is scarce.
North America is one of the leading regions in the global continuing medical education market, accounting for a higher market share.
In 2022, North America accounted for approximately 36% of the market share in the global continuing medical education market and dominated the other regions.

CDC awards Truveta a real-world data contract to study COVID, maternal health, and pediatric care

Retrieved on:

星期一, 一月 22, 2024

Patient, Risk, Health, Policy, Natural history, COVID, Mpox, Public, Infection, CDC, Disease, COVID-19, Coronavirus, SARS-CoV-2, EHR, Vaccine

Truveta will provide real-world data for CDC researchers to conduct respiratory virus surveillance, including COVID-19, as well as data to facilitate studies on maternal health and pediatric care.

Key Points:

Truveta will provide real-world data for CDC researchers to conduct respiratory virus surveillance, including COVID-19, as well as data to facilitate studies on maternal health and pediatric care.
Truveta Data will help facilitate the CDC's COVID response and surveillance efforts as it enables CDC scientists to access representative patient-level data, without delays, for statistically significant populations.
"As the coronavirus pandemic began ravaging our country and the world, Truveta was formed in 2020 to bring together data that would enable faster answers and better care,” said Truveta CEO Terry Myerson.
We are honored that our unique data will help the CDC advance its mission of working 24/7 to save lives and protect people."

GeoVax Expands Rights Under NIH COVID-19 License to Include Mpox and Smallpox

Retrieved on:

星期二, 十二月 19, 2023

The amendment expands GeoVax’s commercial license to include Mpox and smallpox as additional indications.

Key Points:

The amendment expands GeoVax’s commercial license to include Mpox and smallpox as additional indications.
Modified Vaccinia Ankara (MVA) is the vaccine currently used and stockpiled in the U.S. Strategic National Stockpile for immunization against the Mpox and smallpox viruses.
The addition of the Mpox and smallpox indications to our NIAID License Agreement complements GeoVax’s license agreement with COH for GEO-CM04S1, which we also recently amended to obtain development and commercialization rights against orthopoxviruses in addition to SARS-CoV-2.
For those regions/populations where Mpox and/or smallpox may be of a concern, we believe our COVID-19 vaccine will be a better choice.”