Friday, May 20, 2022

Monkeypox vaccine company Bavarian Nordic

 



As monkeypox cases emerge in US and Europe, Bavarian Nordic inks vaccine order

By Angus LiuMay 19, 2022 10:25am

A monkeypox outbreak is emerging in the U.S. and Europe, and at least one country is amping up countermeasure preparedness.

Bavarian Nordic has secured a contract with an unnamed European country to supply its smallpox vaccine, called Imvanex in Europe, in response to the emergence of monkeypox cases, the Danish company said Thursday.

The vaccine is approved under the brand name Jynneos in the U.S. with a label that also specifically covers monkeypox. Because monkeypox virus is closely related to the variola virus that causes smallpox, smallpox vaccines can also protect against monkeypox, the Centers for Disease Control and Prevention (CDC) says.

Since the first monkeypox case in the current outbreak was reported in England on May 7 from a person who had traveled from Nigeria, more than 20 cases have been confirmed across England, Portugal and Spain. More cases are under investigation.

Massachusetts officials on Wednesday also confirmed the first monkeypox case in the U.S. this year from an adult male who had recently traveled to Canada. Officials in Montreal are investigating up to 13 potential cases.

Monkeypox is an infectious disease that can cause a severe rash, fever, headache, muscle aches and swollen lymph nodes. Data have suggested that smallpox vaccines like Bavarian Nordic’s Jynneos are at least 85% effective at preventing monkeypox before exposure, according to the CDC. Experts believe that post-exposure vaccination could also either prevent or reduce symptoms, the agency says on its website.

Health officials have yet to pinpoint exactly when and where the virus emerged. But “the speed of which these have evolved, combined with the potential for infections beyond the initial case going undetected, calls for a rapid and coordinated approach by the health authorities,” Bavarian Nordic CEO Paul Chaplin said in a statement.

The outbreaks come as Bavarian Nordic is in the process of rolling out a freeze-dried version of Jynneos to the Department of Health and Human Services’ (HHS') Biomedical Advanced Research and Development Authority (BARDA) for the Strategic National Stockpile.

Wednesday, the company said BARDA has exercised a $119 million option to manufacture the freeze-dried doses in 2023 and 2024 to replace current stock of bulk vaccine. It’s part of a $299 million agreement to replace existing liquid-frozen vaccine with the new version, which has longer shelf-life.

Once complete as expected by 2025, the contract would cover about 13 million freeze-dried doses of Jynneos, Bavarian Nordic said.

So far, Bavarian Nordic has supplied nearly 30 million doses of the liquid-frozen option to BARDA, with the vast majority delivered for emergency use before a full FDA nod in 2019.

Meanwhile, U.S. company Emergent BioSolutions also has an FDA-approved smallpox vaccine, ACAM2000, which isn’t available in the EU. Emergent nabbed an award worth up to $2 billion to deliver ACAM2000 to the Strategic National Stockpile over 10 years. Last July, the HHS exercised its second option of that contract.

Monday, Emergent unveiled a deal to buy FDA-approved smallpox oral antiviral Tembexa from Chimerix for $225 million upfront. Emergent is also on the hook for an additional $100 million in milestone payments tied to future procurement by the U.S. government.

In the smallpox antiviral realm, Tembexa competes with Siga Technologies’ Tpoxx. Thursday, Siga said the FDA cleared an intravenous formulation of Tpoxx, which has been offered in oral capsules. The company labeled the new version as an important option for people who can’t swallow the drug.

The infused formulation of Tpoxx was cited in the Biden administration’s latest budget request to treat the confirmed U.S. monkeypox patient, Siga noted. The drug’s European label also covers treatment of monkeypox, cowpox and complications from immunization with vaccinia. 



Bavarian Nordic A/S is a fully integrated biotechnology company focused on the development, manufacturing and commercialization of vaccines for infectious diseases and cancer immunotherapies. The company is headquartered in Hellerup, Denmark, with a manufacturing facility in Kvistgård, and an additional site in Hørsholm.[3] The company has a research and development facility in Martinsried, Germany, and offices in Zug, Switzerland and Morrisville, North Carolina. The company uses viral vectors in its research and development.

MVA-BN is a proprietary technology developed by Bavarian Nordic. It is derived from the Modified vaccinia Ankara virus. MVA-BN is characterized by the inability to replicate in human cells,[7] contrary to other vaccinia-based vaccines, which may replicate in humans, thus potentially causing severe and life-threatening side effects. Developed as the non-replicating smallpox vaccine, Imvamune, it is approved in Canada[8] and in the European Union, where it is marketed as Imvanex.[9] The vaccine is being supplied for emergency use to the U.S. Strategic National Stockpile as well as other government stockpiles.

The Jynneos smallpox and monkeypox live, non-replicating vaccine[10] was approved by the U.S. Food and Drug Administration (FDA) in September 2019.[11] Jynneos was formerly known as MVA-BN.[12][13]

https://en.wikipedia.org/wiki/Bavarian_Nordic


The infection reported Wednesday in Massachusetts is the first case of monkeypox identified in the United States this year, health officials said. Texas and Maryland reported one infection each last year in “people with recent travel to Nigeria,” the Massachusetts Department of Public Health said.
https://www.washingtonpost.com/health/2022/05/18/monkeypox-faq/

Wednesday was 5/18/22 
5+18+20+22 = 65 
"pandemic" = 65 (English Ordinal)
"Bavaria Germany" = 65 (Full Reduction)




Where else has monkeypox been identified this month?
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Germany, France and Belgium have confirmed their first cases of monkeypox, as the European nations join a growing list of countries where cases have popped up in recent days.

The first case in Germany was registered in Bavaria on Thursday “in a patient with characteristic skin lesions,” according to the Bundeswehr Institute of Microbiology, a military research facility of the German Armed Forces. German Health Minister Karl Lauterbach said he was confident that an outbreak could be contained if authorities act quickly.
https://www.washingtonpost.com/health/2022/05/18/monkeypox-faq/

"Bavarian Nordic" = 131 (English Ordinal)
"Hellerup" = 119 (Reverse Ordinal)
"Hellerup Denmark" = 73 (Full Reduction)
Headquarters co-ordinates 
"55° 44′ 0″ N, 12° 34′ 0″ E" = 38 (Full Reduction)
"pandemic" = 38 (Full Reduction)
"55.733333, 12.566667" = 71 (English Ordinal)

"Bavarian Nordic A/S" = 1111 (Jewish)
"Bavarian Nordic A/S" = 711 (Satanic)
"Bavarian Nordic A/S" = 70 (Full Reduction)
"Bavarian Nordic A/S" = 151 (English Ordinal)

Hellerup (Danish pronunciation: [ˈhelˀəʁɔp]) is a very affluent district of Gentofte Municipality in the suburbs of Copenhagen, Denmark. The most urban part of the district is centred on Strandvejen and is bordered by Østerbro to the south and the Øresund to the east. It comprises Tuborg Havn, the redeveloped brewery site of Tuborg Breweries, with the Waterfront Shopping Center, a marina and the headquarters of several large companies. Other parts of the district consist of single family detached homes. Local landmarks include the science centre Experimentarium and the art Øregaard Museum.

Notable sites in Hellerup include "Store og Lille Tuborg", which later lent the name to the Tuborg breweries that opened on the site and operated until the merger of the companies brewing operations with Carlsberg. As of 1996, it has been a residential area with numerous apartments overlooking the harbour. The site is also home to the headquarters of several Danish and international companies.

Hellerup is home to the science center Experimentarium.
https://www.experimentarium.dk/

Tranegårdskolen is a state school located in Hellerup. Among others it is attended by the four children of the Danish Crown Prince and Crown Princess.[4]
Frederik, Crown Prince of Denmark, Count of Monpezat, RE, SKmd (Frederik André Henrik Christian;[a] born 26 May 1968) is the heir apparent to the Danish throne. He is the elder son of Queen Margrethe II and Prince Henrik.
https://en.wikipedia.org/wiki/Frederik,_Crown_Prince_of_Denmark
Mary, Crown Princess of Denmark, Countess of Monpezat, R.E. (born Mary Elizabeth Donaldson on 5 February 1972) is the wife of Frederik, Crown Prince of Denmark. Frederik is the heir apparent to the throne, which means that should he succeed, Mary will automatically become queen consort of Denmark.

The couple met at the Slip Inn, a pub in Sydney when the prince was visiting Australia during the 2000 Summer Olympics. Their official engagement in 2003 and their marriage the following year was the subject of extensive attention from Australian and European news media, which portrayed the marriage as a modern "fairytale" romance between a prince and a commoner.[2]

Since her marriage, the Crown Princess has carried out engagements on behalf of her mother-in-law the Queen and currently serves as patron of over 30 charitable organisations, including the United Nations Population Fund, the European regional office of the World Health Organization, the Danish Refugee Council and Julemærkefonden. She founded her award-winning social organisation the Mary Foundation in 2007. In 2019, she was made a rigsforstander which allows her to act as regent when the Queen and Crown Prince Frederik are abroad.
https://en.wikipedia.org/wiki/Mary,_Crown_Princess_of_Denmark
The United Nations Population Fund UNFPA, formerly the United Nations Fund for Population Activities, is a UN agency aimed at improving reproductive and maternal health worldwide.[1] Its work includes developing national healthcare strategies and protocols, increasing access to birth control, and leading campaigns against child marriage, gender-based violence, obstetric fistula, and female genital mutilation.[1]
The UNFPA supports programs in more than 144 countries across four geographic regions: Arab States and Europe, Asia and the Pacific, Latin America and the Caribbean, and sub-Saharan Africa. Around three-quarters of the staff work in the field. It is a founding member of the United Nations Development Group, a collection of UN agencies and programmes focused on fulfilling the Sustainable Development Goals.[
https://en.wikipedia.org/wiki/United_Nations_Population_Fund


Rygaards International School is located in Hellerup. Hellerup School is also located in Hellerup. It's known as the school of the future partially because of the open layout, international contacts and project-based education. It also runs a 5-year Math and Science program in collaboration with Gammel Hellerup Gymnasium.

Gammel Hellerup Gymnasium is a public secondary school that was attended by Prince Felix of Denmark from 2018 to 2021.

Øregård Gymnasium was founded in 1903 as Plock Ross School. In 1919, Gentofte municipality took over the school, which was renamed Øregård Gymnasium. In 1924, the school moved into a new main building designed by architects GB Hagen and Edward Thomsen.[5]







After dark on 5/18 








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