GlobeNewswire by notified

Bavarian Nordic Receives U.S. and EU Approvals of its Fill and Finish Vaccine Manufacturing Facility

Share
  • U.S. approval follows successful pre-approval inspection of the facility by the U.S. FDA
  • EU approval obtained after submission of application to EMA in June 2022

COPENHAGEN, Denmark, July 27, 2022 – Bavarian Nordic A/S (OMX: BAVA) announced today that the Company has received approvals from the U.S. and EU regulatory authorities to manufacture JYNNEOS®/IMVANEX® smallpox and monkeypox vaccine at the Company’s fill and finish facility in Denmark. With the approvals of the final drug production – the process by which the vaccine is formulated and filled into vials – the Company is now allowed to deliver drug product manufactured at its own site to the U.S. and EU market.

An expedited pre-approval inspection (PAI) was conducted by the U.S. Food and Drug Administration (FDA) at the facility at the beginning of July 2022. The inspection included the final drug production of JYNNEOS®, which was previously performed at a contract manufacturer. The inspection was successfully completed with no observations made, which has led to the approval of Bavarian Nordic as the new drug product manufacturer of JYNNEOS.

The approval by the European Medicines Agency (EMA) was granted upon assessment by the Committee for Medicinal Products for Human use (CHMP) of a type II-variation application submitted in June 2022, which, similar to the FDA approval, acknowledges Bavarian Nordic as the new drug product manufacturer of the IMVANEX vaccine, in supplement to the inspection, and approval earlier granted, by the Danish Medicines Agency,

The expedited approvals have been made possible through close interactions between Bavarian Nordic and the regulatory authorities on the data package and the submission strategy and marks the final step for the Company in fulfilling the strategy to become a best-in-class vaccine manufacturer, controlling the entire value chain from manufacturing, filling, packaging and release to distribution of vaccines.

Paul Chaplin, President and CEO of Bavarian Nordic said: “We are proud to announce the successful completion of the FDA’s inspection and subsequent approval of our state-of-the-art fill and finish facility along with EMA’s approval. This achievement, which underscores the excellence of our manufacturing site and our ability to deliver high quality vaccines for improving and saving lives, was made possible through the dedication and commitment of our talented employees. We are thankful to both FDA and EMA for accelerating their review, during this monkeypox outbreak, which now has been named a public health emergency of international concern by the WHO, and we look forward to continuing our work with health authorities around the globe to ensure supply of vaccines against monkeypox.”

About Bavarian Nordic
Bavarian Nordic is a fully integrated vaccines company focused on the development, manufacturing and commercialization of life-saving vaccines. We are a global leader in smallpox vaccines and have been a long-term supplier to the U.S. Government of a non-replicating smallpox vaccine, which has been approved by the FDA, also for the protection against monkeypox. The vaccine is also approved in Europe and Canada. Our commercial product portfolio furthermore contains market-leading vaccines against rabies and tick-borne encephalitis. Using our live virus vaccine platform technology, MVA-BN®, we have created a diverse portfolio of proprietary and partnered product candidates designed to save and improve lives by unlocking the power of the immune system, including an Ebola vaccine, which is licensed to the Janssen Pharmaceutical Companies of Johnson & Johnson. We are also committed to the development of a next generation COVID-19 vaccine. For more information visit www.bavarian-nordic.com.

Contacts
Europe: Rolf Sass Sørensen, Vice President Investor Relations, Tel: +45 61 77 47 43
US: Graham Morrell, Paddock Circle Advisors, graham@paddockcircle.com, Tel: +1 781 686 9600

Attachment

To view this piece of content from www.globenewswire.com, please give your consent at the top of this page.
To view this piece of content from ml-eu.globenewswire.com, please give your consent at the top of this page.

About GlobeNewswire by notified

GlobeNewswire by notified
GlobeNewswire by notified
One Liberty Plaza - 165 Broadway
NY 10006 New York

https://notified.com

GlobeNewswire by notified is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.

Subscribe to releases from GlobeNewswire by notified

Subscribe to all the latest releases from GlobeNewswire by notified by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from GlobeNewswire by notified

Some 350 World Leaders From 157 Nations With Diplomatic Relations With North or South Korea Attended the August 11-15, Conference14.8.2022 17:11:38 CEST | Press release

International Leadership Summit Addresses Korean Reconciliation, Religious Freedom, and New Peace Alliances in Africa and the World Washington, DC, Aug. 14, 2022 (GLOBE NEWSWIRE) -- FOR IMMEDIATE RELEASE UPF International Leadership Summit Addresses Korean Reconciliation, Religious Freedom, and New Peace Alliances in Africa and the World Condolences Expressed for late Prime Minister Shinzo Abe International leaders at the Universal Peace Federation’s (UPF) Summit 2022 and Leadership Conference affirmed their support for global peacebuilding, especially on the Korean Peninsula. Sessions addressed the universal right to religious freedom and called for more education of youth in Africa. Some 350 world leaders from the 157 nations with diplomatic relations with either North or South Korea attended the August 11-15, 2022, conference, either in person or virtually, at Jamsil Lotte Hotel in Seoul, to discuss “Toward Peace on the Korean Peninsula: Toward a World Culture of Peace.” In his welc

A Step Forward in Human-Robot Collaboration: Han's Robot Opens A New Era of Intelligent Collaborative Robots13.8.2022 02:39:12 CEST | Press release

SHENZHEN, China, Aug. 12, 2022 (GLOBE NEWSWIRE) -- Wang Guangneng, general manager of Han's Robot, said that repetitive, mechanical, and dull work had left us no time to take care of our family and real life. Collaborative robots came into being to solve this issue, allowing robots and workers to work together to improve efficiency. However, this is only the first step. Han’s Robot is developing intelligent collaborative robots that do not require secondary development which users can buy and use according to their needs and costs. Han's Robot is invested and established by Han's Laser, the world's leading industrial laser processing and automation solution provider. It has attracted over 500 top global talents from 25 countries and regions. The core technology R&D team has accumulated more than ten years of industrial experience and mastered the core key technologies of intelligent robots. The product has the advantages of intelligent perception, zero-code programming, zero-sliding wh

Volta Finance Limited: Net Asset Value as at 31 July 202212.8.2022 18:15:00 CEST | Press release

Volta Finance Limited (VTA / VTAS) –July2022 monthly report NOT FOR RELEASE, DISTRIBUTION, OR PUBLICATION, IN WHOLE OR PART, IN OR INTO THE UNITED STATES ***** Guernsey, 12August2022 AXA IM has published the Volta Finance Limited (the “Company” or “Volta Finance” or “Volta”) monthly report for June. The full report is attached to this release and will be available on Volta’s website shortly (www.voltafinance.com). PERFORMANCE and PORTFOLIO ACTIVITY July saw a recovery from the losses faced the previous two months. The fund gained +4.5%, mainly driven by EUR CLO equity holdings (+2,7% contribution in NAV performance). Through asset classes, the monthly performances** were: -2.8% for Bank Balance Sheet transactions, +5% for CLO equity tranches; +2.3% for CLO debt; -5% for Cash Corporate Credit and ABS (together representing 2.3% of NAV). In the footsteps of most markets (July was one of the best months for the High Yield bonds market since years), the loan markets rallied and therefore C

CONDITIONS FOR RIKSBANK BID PROCEDURE KOMMUNINVEST BONDS12.8.2022 16:20:00 CEST | Press release

Bid procedure, 2022-08-16BondsKOMMUNINVEST I SVERIGE: 2410. SE0010469205. 2024-10-02 KOMMUNINVEST I SVERIGE: 2706, SE0016829048, 2027-06-15 BidsBids on interest and volume are entered via Bloomberg Bond Auction SystemBid date2022-08-16Bid times10.00-11.00Requested volume (corresponding nominal amount)2410: 200 mln SEK +/-100 mln SEK 2706: 200 mln SEK +/-100 mln SEK Highest permitted bid volume (corresponding nominal amount)2410: 200 mln SEK per bid 2706: 200 mln SEK per bid Lowest permitted bid volume (corresponding nominal amount)SEK 50 million per bidExpected allocation timeNot later than 11.15 (CET/CEST) on the Bid dateDelivery and payment date2022-08-18Delivery of bondsTo the Riksbank's account in Euroclear Sweden AB's securities settlement system 1 4948 6383General Terms and ConditionsGeneral Terms and Conditions General Terms and Conditions för the Riksbank’s Purchases of Bonds via Bid Procedure 2020:3. dated 20 November 2020 (see the Riksbank´s web). Stockholm, 2022-08-12 This i

CONDITIONS FOR RIKSBANK REVERSED AUCTIONS SEK GOVERNMENT BONDS12.8.2022 16:20:00 CEST | Press release

Bid procedure, 2022-08-19BondsSWEDISH GOVERNMENT: 1065. SE0017830730. 2033-11-11 Bid date2022-08-19Bid times09.00-10.00 (CET/CEST) on the Bid dateRequested volume (corresponding nominal amount)1065: 500 mln SEK +/-250 mln SEK Highest permitted bid volume (corresponding nominal amount)1065: 500 mln SEK per bid Lowest permitted bid volume (corresponding nominal amount)SEK 50 million per bidExpected allocation timeNot later than 10.15 (CET/CEST) on the Bid dateDelivery and payment date2022-08-23Delivery of bondsTo the Riksbank's account in Euroclear Sweden AB's securities settlement system 1 4948 6383 Stockholm, 2022-08-12 This is a translation of the special terms and conditions published on www.riksbank.se. In the case of any inconsistency between the English translation and the Swedish language version, the Swedish language version shall prevail. Complete terms and conditions can be retrieved at www.riksbank.se.