Bavarian Nordic

By Dominic Chopping Bavarian Nordic AS said Monday that its Imvanex smallpox vaccine has been approved for use against monkeypox by the European Commission.

The company's Imvanex vaccine is approved for use against monkeypox by the U.S. and Canada, and Bavarian Nordic has signed several contracts with undisclosed countries for the vaccine, resulting in the company raising its full-year guidance six times in two months. Bavarian Nordic AS said Monday that its Imvanex smallpox vaccine has been approved for use against monkeypox by the European Commission. The approval follows last week's positive opinion by the European Medicines Agency's Committee for Medicinal Products for Human Use and is valid in all European Union member states as well as in Iceland, Liechtenstein and Norway, it said.

The decision comes days after the WHO declared the monkeypox outbreak a global health emergency and said risk from the disease in Europe was “high.”

That’s how many cases of monkeypox have been identified throughout the European region (which includes non-EU countries like the U.K. and Russia) as of Tuesday, according to data from the European Center for Disease Prevention and Control and the World Health Organization. Almost all cases, 99.5%, were reported among men. In the European region, the risk of monkeypox is “high,” Tedros cautioned, noting a “clear risk of further international spread.” Other regions are of moderate risk, he added. The vaccines are in critically short supply, which has hampered efforts to control the virus. Bavarian Nordic’s shot is the only vaccine in the world authorized specifically for use against monkeypox. Bavarian Nordic told Forbes the company is exploring ways to boost production. The monkeypox outbreak “has spread around the world rapidly” and “through new modes of transmission, about which we understand too little,” Tedros said.

EMA approves Bavarian Nordic smallpox vaccine Imvanex for monkeypox, as WHO declares the outbreak a public heath emergency.

In June said it had received orders for 1.5 million doses of the shot from an unidentified European country and was scheduled to start deliveries in the fourth quarter. The Danish biotech said that the shot benefited from two decades of support from the US government, showing the importance of “investments and structured planning” for biological preparedness. Imvanex has been approved in the EU since 2013 for smallpox, a virus related to monkeypox, and according to the CHMP should not be approved to protect adults from monkeypox disease.

Copenhagen: Bavarian Nordic announced on Monday that the European Commission (EC) has extended the marketing authorization for the Company's smallpox ...

The development of IMVANEX was made possible through significant investments from the U.S. government for the past two decades, leading the way for other governments to develop plans and prioritize for the future to protect their citizens against public health threats. The EC approved the full IMVANEX indication as: Active immunisation against smallpox, monkeypox and disease caused by vaccinia virus in adults. The label extension was approved after submission of a rolling type-II variation application in June 2022, in alignment between Bavarian Nordic and the European Medicines Agency’s Emergency Task Force (ETF), Rapporteurs and the European Health Emergency Preparedness and Response Authority (HERA).

Danish biotechnology company Bavarian Nordic BAVA.CO said on Monday the European Commission had given permission for its Imvanex vaccine to be marketed as ...

By using our Site, you agree to the use of cookies and similar technologies. This information is used to compile reports and help us to improve the site. Google Analytics is Google’s analytics tool that helps our website to understand how visitors engage with their properties. It is recommended that you leave on all cookies if you are not sure whether you need them or not, in case they are used to provide a service that you use. For more information on Google Analytics cookies, see the official Google Analytics page. We will also share how you can prevent these cookies from being stored however this may downgrade or ‘break’ certain elements of the Site’s functionality.

Bavarian Nordic , the Danish company behind the vaccine being used to try to stem a global outbreak of monkeypox, is in talks to potentially expand ...

In Nigeria, an outbreak has been ongoing since 2017. read more The Copenhagen-based vaccine maker has a vaccine that goes by the brand name Jynneos, Imvamune or Imvanex - depending on geography.

“The availability of an approved vaccine can significantly improve nations' readiness to fight emerging diseases, but only through investments and structured ...

Bavarian’s vaccine, the only one to have won approval for the prevention of monkeypox disease in the United States and Canada, has in the EU so far only been approved to treat smallpox. The approval is valid in all European Union Member States as well as in Iceland, Liechtenstein, and Norway, Bavarian Nordic said in a statement. Monkeypox vaccine from Bavarian Nordic wins EU approval

The European Commission approved the use of the drug just days after the WHO called the spread of monkeypox a global health emergency.

The approval is valid in all European Union Member States as well as in Iceland, Liechtenstein, and Norway, Bavarian Nordic said in a statement. But the company has supplied the vaccine to several EU countries during the current monkeypox outbreak for what is known as "off-label" use. Bavarian's vaccine, the only one to have won approval for the prevention of monkeypox disease in the United States and Canada, has in the EU so far only been approved to treat smallpox.

By Natalie Grover LONDON (Reuters) - A Danish company behind themonkeypox vaccine being used to stem the rapidly spreading global outbreak is in discu...

Bavarian Nordic says the EC has extended the marketing authorization for the company's smallpox vaccine to include protection from monkeypox.

With this approval, we look forward to working closer with the EU and its member states to solve this important task.” The availability of an approved vaccine can significantly improve nations’ readiness to fight emerging diseases, but only through investments and structured planning of the biological preparedness. During the ongoing 2022 outbreak of monkeypox, Bavarian Nordic has worked with several governments to fulfill the immediate demand for the vaccine through a number of supply agreements and is working to secure manufacturing of vaccines to fulfill the demand in the medium- to long term. The virus can spread through large respiratory droplets or by coming into close contact with a contagious skin rash. The vaccine was approved by the European Commission in 2013 for immunization against smallpox in adults aged 18 years and older and has subsequently gained regulatory approvals in Canada (marketed as IMVAMUNE) and the U.S. (marketed as JYNNEOS) where the approvals have been extended to include the monkeypox indication as the only vaccine having obtained this to-date. The condition is typically mild, but can threaten pregnant women, young children, and people with weakened immune systems.

As the WHO declared the monkeypox outbreak to be a global health emergency, Bavarian Nordic obtained an expanded European label for its smallpox vaccine to ...

Monday’s approval will likely help boost supply of the vaccine across Europe just a few days after the WHO raised the monkeypox alert level to its highest classification Saturday, officially declaring the outbreak a global health emergency. Last week, Europe secured another supply deal for Bavarian Nordic’s shot, ordering 54,000 doses to bring its total stash to 160,000. Bavarian Nordic has said it’s seen “overwhelming” interest in the vaccine, and its stock price $BVRNY has followed in short order — shares are up 124% since the first monkeypox case was detected on May 6.

Bavarian Nordic A/S, the only company with a vaccine approved for monkeypox, said it's preparing to run production through the night to meet surging demand ...

Imvanex to include protection from monkeypox and diseases caused by vaccinia virus - News - PharmaTimes.

Meanwhile, the EC approved the full Imvanex indication as an active immunisation against smallpox, monkeypox and disease caused by vaccinia virus in adults. With this approval, we look forward to working closer with the EU and its Member States to solve this important task,” he added. The availability of an approved vaccine can significantly improve nations’ readiness to fight emerging diseases, but only through investments and structured planning of the biological preparedness.

As the monkeypox outbreak presses on, the World Health Organization has declared the disease a public health emergency.

The European Commission has extended the marketing authorization for Bavarian Nordic's smallpox vaccine, Imvanex, to include protection from monkeypox and ...

The availability of an approved vaccine can significantly improve nations’ readiness to fight emerging diseases, but only through investments and structured planning of the biological preparedness. The vaccine was originally developed in collaboration with the US government as part of national biological preparedness plans against smallpox. The vaccine has been approved in Europe for prevention of smallpox since 2013, although has been used off-label against monkeypox.

The European Commission (EC) has extended Bavarian Nordic's smallpox vaccine Imvanex (MVA-BN or Modified Vaccinia Ankara-Bavarian Nordic) marketing ...

Bavarian Nordic president and CEO Paul Chaplin said: “We are pleased to receive the approval from the European Commission, broadening the label of our vaccine to include monkeypox. The move to expand the marketing authorization for Imvanex to include protection from monkeypox and disease caused by the vaccinia virus comes after the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) provided a positive opinion. The European Commission (EC) has extended Bavarian Nordic’s smallpox vaccine Imvanex (MVA-BN or Modified Vaccinia Ankara-Bavarian Nordic) marketing authorisation to offer protection from monkeypox.