Bavarian Nordic monkeypox vaccine gets preliminary nod from EU drug regulator
Advertisement
Copenhagen: Danish biotechnology company Bavarian Nordic said on Friday the European Union's drug regulator had recommended its Imvanex vaccine be approved to also include protection against monkeypox on its label.
The European Medicines Agency (EMA) had "adopted a positive opinion recommending that the marketing authorisation for the company's smallpox vaccine, IMVANEX, is extended to include protecting people from monkeypox disease," Bavarian said.
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.
But the company has supplied the vaccine to several EU countries during the current monkeypox outbreak for what is known as "off-label" use.
"The extension of the label will help to improve access to the vaccine throughout Europe and strengthen the future preparedness against monkeypox," Bavarian CEO Paul Chaplin said in a statement.
The recommendation from the EMA will be referred to the European Commission for final approval shortly, the company said.
Read also: EU regulator begins review of Bavarian Nordic smallpox vaccine Imvanex for monkeypox
Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.