Bavarian Nordic
Bavarian Nordic
Bavarian Nordic is preparing for a clinical trial to assess the immunogenicity and safety of their Moneypox vaccine in children from 2-12 years of age in the Democratic Republic of Congo and Uganda.
The “effectiveness” of Jynneos is far less than 100%.
https://www.youtube.com/watch?v=WRqm2-0_RyY&t=744s
FACT SHEET for healthcare providers administering vaccine:
Emergency use Authorization of Jynneos (smallpox and moneypox vaccine, live, non-replicating) for prevention of moneypox disease in individuals determined to be at high risk for moneypox infection
Serious Adverse Events
Across all studies, a causal relationship to JYNNEOS could not be excluded for 4 Serious Adverse Events, all non-fatal, which included Crohn’s disease, sarcoidosis, extraocular muscle paresis and throat tightness. (page 9)
Cardiac Adverse Events of Special Interest
Cardiac Adverse Events of Special Interest were reported to occur in 1.3% (95/7,093) of JYNNEOS recipients and 0.2% (3/1,206) of placebo recipients.
Among the cardiac AESIs reported, 6 cases (0.08%) were considered to be causally related to JYNNEOS vaccination and included tachycardia, electrocardiogram T wave inversion, electrocardiogram abnormal, electrocardiogram ST segment elevation, electrocardiogram T wave abnormal, and palpitations. (page 9)
8.4 Pediatric Use
The safety and effectiveness of JYNNEOS have not been assessed in individuals less than 18 years of age. (page 12)
8.5 Geriatric Use
Clinical studies of JYNNEOS did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.(page 12)
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
JYNNEOS has not been evaluated for carcinogenic or mutagenic potential, or for impairment of male fertility in animals. (page 12)
REFERENCES
Study 1: NCT01144637
Study 2: NCT00316524
Study 3: NCT00686582
Study 4: NCT00857493
Study 5: NCT00316589
Study 6: NCT00316602
Study 7: NCT00914732
Study 8: NCT01913353
https://finance.yahoo.com/quote/BAVA.CO/
Bavarian Nordic provides statement on mpox vaccine supply and collaboration with African and global stakeholders
As the majority of the current mpox cases in Africa occur in individuals younger than 18 years old, Bavarian Nordic recently submitted clinical data to EMA to potentially support the use of the mpox vaccine in adolescents (12–17-year-olds).
These data were generated through a collaboration with the NIAID, a division of the U.S. National Institutes of Health (NIH), on a clinical study in more than 300 individuals, 12-17 years of age (NCT05740982). ADDITIONAL DETAILS
Furthermore, through a collaboration with the Coalition for Epidemic Preparedness Innovations (CEPI), the company will shortly initiate a clinical trial to assess the immunogenicity and safety of MVA-BN in children from 2-12 years of age, aiming to further extend the indication of the vaccine into younger populations.
“We are also working with the WHO on a regulatory path to ensure access to all countries, while in parallel seeking approval for use in adolescents and conducting clinical studies in Africa to further expand the use to children,” said Paul Chaplin, President & CEO of Bavarian Nordic.
https://www.bavarian-nordic.com/media/media/news.aspx?news=6970
Bavarian Nordic submits data to the European Medicines Agency (EMA) to extend mpox/smallpox vaccine approval to adolescents
About the smallpox/mpox vaccine
MVA-BN or Modified Vaccinia Ankara-Bavarian Nordic is a non-replicating smallpox vaccine and the only mpox vaccine approved in the…U.S. and Switzerland (marketed as JYNNEOS®),
Canada (marketed as IMVAMUNE®), and the
EU/EEA and United Kingdom (marketed as IMVANEX®).
Originally developed in collaboration with the U.S. government to ensure the supply of a smallpox vaccine for the entire population, including immunocompromised individuals who are not recommended vaccination with traditional replicating smallpox vaccines, MVA-BN has been indicated for use in the general adult population (18 years and older) in individuals considered at risk for smallpox or mpox.
While currently only indicated for adults 18 years and older, the vaccine was granted an Emergency Use Authorization for use in adolescents by the FDA during the 2022 global mpox outbreak.
During the 2022-2023 mpox outbreak, the vaccine was granted an Emergency Use Authorization by the U.S. FDA for both pre- and post-exposure use in adolescents.
Interim results from clinical study show non-inferiority of immune responses from mpox/smallpox vaccination in adolescents and similar safety profile compared to adults, supporting the extension of current approval in Europe later in 2024.
It remains the only FDA and EMA-approved mpox vaccine.
Bavarian Nordic has submitted clinical data to the European Medicines Agency (EMA) to support the extension of the IMVANEX® (MVA-BN®) smallpox and mpox vaccine indication to include adolescents 12 to 17 years of age.
The submission is based on interim results from a clinical study (NCT05740982), sponsored by the U.S. National Institutes of Health’s (NIH) National Institutes of Allergy and Infectious Diseases (NIAID), in 315 adolescents 12-17 years of age and 211 adults aged 18 years and older, demonstrating non-inferiority of the immune responses as well as a similar safety profile, between both age groups after vaccination with two standard doses of the MVA-BN vaccine.
Bavarian Nordic is also preparing for a clinical trial to assess the immunogenicity and safety of MVA-BN in children from 2-12 years of age, aiming to further extend the indication of the vaccine into younger populations.
The trial, partially funded by the Coalition for Epidemic Preparedness Innovations (CEPI), is planned for initiation in the Democratic Republic of Congo and Uganda later this year, potentially also supporting a regulatory approval of MVA-BN in African countries, where mpox is endemic.
https://www.bavarian-nordic.com/media/media/news.aspx?news=6969
About Bavarian Nordic
Bavarian Nordic is a fully integrated vaccine company with a mission to protect and save lives through innovative vaccines. We are a global leader in smallpox and mpox vaccines, supplied to governments to enhance public health preparedness and have a strong portfolio of vaccines for travelers and endemic diseases. For more information visit www.bavarian-nordic.com
Contacts
Europe: Rolf Sass Sørensen, Vice President Investor Relations, rss@bavarian-nordic.com, Tel: +45 61 77 47 43
US: Graham Morrell, Paddock Circle Advisors, graham@paddockcircle.com, Tel: +1 781 686 9600
James Roguski
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JamesRoguski.substack.com/archive
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The dam has got to break. This is insanity when people think jabs are going to save the world because they aren't. Now they are turning children into experiments. Sounds like WWII. Stop making viruses. Stop trying to outdo mother nature. Stop fear mongering. Stop farma. When will people see farma only makes things worse. Advertise a healthy diet, exercise and good sleep. Advertise a cure via homeopathy with a qualified homeopath. It works. It's the biggest secret that farma doesn't want you to know about.
Unbelievable!! thanks for your research James and your attention to good writing. Eventually people will realize they have to stand up.