Bavarian Nordic announced the U.S. Biomedical Advanced Research and Development Authority has ordered an additional 500,000 doses of its monkeypox vaccine, Jynneos.
Bavarian Nordic announced Friday morning that the U.S. Biomedical Advanced Research and Development Authority, part of the U.S. Department of Health and Human Services, has ordered an additional 500,000 doses of its vaccine, Jynneos, the only U.S. Food and Drug Administration-approved vaccine against monkeypox.
According to the Centers for Disease Control and Prevention, there are currently 44 confirmed cases of monkeypox that have occurred in the United States, with the majority of cases being in New York. The outbreak reportedly began in the U.S. in late May, with the first case occurring after a man traveled to Canada.
Worldwide, the World Health Organization stated it has received reports of 780 laboratory-confirmed monkeypox cases across 27 non-endemic countries, as of June 2, 2022. This represents an increase of 523 laboratory-confirmed cases since the disease outbreak news was published on May 29, when a total of 257 cases were reported.
Monkeypox, which causes a flu-like illness and lesions that spread across the body, is transmitted through direct contact with bodily fluids, sores from an infected person or contact with materials that contain bodily fluids from an infected person. In the U.S., there are no specific approved treatments for the disease, making prevention the best thing concerned citizens can do.
Bavarian Nordic is leading prevention efforts in the U.S. with Jynneos, a live non-replicating vaccine. Previously, the U.S. ordered doses from the company in 2020 for the U.S. Strategic National Stockpile. 500,000 more doses will be delivered sometime this year, bringing the U.S. supply to some two million doses of the vaccine.
In late May, the CDC announced vaccines that are currently stockpiled would soon be distributed to adults who are at high risk of contracting the disease, such as health care workers who have had contact with patients and people at high risk for severe disease outcomes.
BARDA also previously exercised its option under a contract with Bavarian Nordic for the manufacturing of freeze-dried versions of Jynneos in a deal that won the company $119 million. Following an FDA inspection of Bavarian Nordic’s freeze-drying facility this year, commercial manufacturing will begin in 2023.
Other companies are also vying for a chance to put a monkeypox vaccine on the market. Tonix Pharmaceuticals recently presented data from its candidate TNX-801, which showed the vaccine’s efficacy at preventing animals from being infected with monkeypox. Moderna also announced on Twitter that it planned to investigate potential monkeypox vaccines at a preclinical level.
Some companies are focusing on developing effective treatments for the disease. Hyundai Biosciences recently approached the FDA to request fast-track processing for its antiviral drug candidate, CP-COV03, which showed efficacy in treating monkeypox in animal models.
Additionally, although it’s only approved to treat smallpox in the U.S., TPOXX from SIGA Technologies is approved to treat monkeypox in the European Union, leading the U.S. to stock up on the drug for off-label use.
Currently, the CDC has raised the alert status of monkeypox to level 2, which alerts citizens to “practice enhanced precautions”. Despite rising cases, the regulatory authority maintains the risk to the general public is low.
