Japan approves KM Biologics’ smallpox vaccine for monkeypox.

The approval comes days after the label expansion gained the backing of the Pharmaceutical Affairs and Food Sanitation Council’s (PAFSC) Second Committee on Drugs, a de-facto decision-making organ for marketing approval, on July 29. According to the WHO, several observational studies have demonstrated that vaccination against smallpox is some 85% effective in preventing monkeypox.

The vaccine’s expanded label notes that for contacts of monkeypox cases, the WHO’s guidance recommends appropriate vaccinations within four days of first exposure (within 14 days in the absence of symptoms).

As clinically significant adverse reactions, the label lists “shock and anaphylaxis (frequency unknown),” while also specifying that cases of allergic dermatitis and erythema multiforme have been reported. The label also carries precautions for pregnant women and nursing mothers as well as women of reproductive age.

For monkeypox, LC16 “KMB” has been given to 50 healthcare workers at the National Center for Global Health and Medicine (NCGM) as a pre-exposure prophylaxis (PrEP) under the framework of clinical research. The Ministry of Health, Labor and Welfare (MHLW) is considering a plan to offer voluntary vaccinations with the vaccine as a PrEP.