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.
By Angus Liu
Source: fiercepharma.com
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