LC16 KMB Monkeypox Vaccine
LC16 KMB Monkeypox Vaccine (LC16m8)
Japan-based KM Biologics LC16 KMB is formulated as a
freeze-dried cell culture smallpox and monkeypox vaccine. LC16 is a 3rd
generation, live attenuated vaccine containing live vaccinia virus (LC16m8
strain) used to prevent smallpox (market authorized for all ages in 1975 in
Japan / licensed under the emergency investigational new drug program in the
U.S. The LC16m8 was an attenuated cell culture–adapted Lister vaccinia smallpox
vaccine missing the B5R protein.
In contrast to replication-deficient vaccines such as
Modified Vaccinia Ankara, LC16m8 retains most of the vaccinia genome.
Therefore, it can replicate at the inoculation site, producing a "take
lesion" in vaccinees.
On August 2, 2022, Japan's Ministry of Health, Labour, and
Welfare (MHLW) announced the approval of this smallpox vaccine for voluntary
vaccinations as pre-exposure prophylaxis (PrEP) against the monkeypox virus.
This approval followed an advisory committee review. On August 3, 2022, Meiji
Holdings announced 'Notification of Additional Approval of Indication for
"Monkeypox Prevention for Freeze-dried Cell Culture Smallpox Vaccine LC16
KMB." On August 31, 2022, Indonesia's National Agency of Drug and Food
Control is reviewing authorization.
In 2017, a study concluded that 'Inoculation of LC16m8 into
humans induced neutralizing antibodies against smallpox virus, and the effect
was similar to that of the ACAM2000 smallpox vaccine. The results were
presented at the 19th ACVVR Congress (WHO) in 2017.' Since 1976, the Japanese
government has discontinued the national vaccination program for smallpox.
KM Biologics (SVRG Kaketsuken) is a unit of Japanese food
and pharmaceuticals company Meiji Holdings, based in Kumamoto, 860-8568, Japan.
Click here for the Meiji Group 2026 Vision.
LC16 KMB Monkeypox Vaccine Indication
LC16 KBM vaccine has been approved in Japan for smallpox and
monkeypox pre-exposure prophylaxis (PrEP).
LC16 KBM Vaccine Storage
The long-term storage stability of LC16m8 (formulation: 10
years, drug substance: 5 years) confirmed the high storage stability of LC16m8.
LC16 KBM Vaccine Dosage
LC16m8 is administered as a single dose using the
traditional scarification method.
Japan Smallpox Vaccine
The Japanese government decided that all residents should be
immunized with a smallpox vaccine in 1876, and a vaccination law against
smallpox started in 1910. In the twenty years from 1889 to 1908, 171,500 cases
of smallpox, and in 1908 there were 18,139 cases. The present immunization law
was implemented in 1948 under occupation by the USA. In 2002, a study was
published on Japan's smallpox vaccination program.
LC16 KMB Clinical Trials
A single-arm clinical study to evaluate the immunogenicity
and safety of smallpox vaccine as vaccination to monkeypox in healthy Japanese
adults (MKP-3 study). The outline of this study and results have been published
in the Clinical Research Implementation Plan and Research Outline Disclosure
System (jRCT). In addition, Japan's health ministry vaccinated 50 medical
workers at the National Center for Global Health and Medicine for research
purposes in July 2022.
2017 - Research on the efficacy, safety, and productivity
improvement of cell-cultured smallpox vaccines developed and stockpiled in
Japan and on the ideal countermeasures against bioterrorism in Japan and
overseas. We analyzed the ability of LC16m8 to induce neutralizing antibodies
against the smallpox virus through joint research by the US CDC and this
research group. Stability results of LC16m8 during long-term cryopreservation
were obtained. In addition, a study on the post-exposure inoculation effect of
LC16m8 was carried out.
LC16 KMB Vaccine News
August 31, 2022 - Director of Bio Farma Honesti Basyir said
Indonesia's government is targeting three monkeypox vaccines, including LC16M8
(SVRG Kaketsuken Japan).
August 5, 2022 - Australian media reported: The only other
non-replicating vaccine is the LC16m8 from Japan, and scaling up production is
difficult, so supplies are limited.
August 2, 2022 - Japan's MHLW presented Plan for Monkeypox
Vaccinations with KM Biologics' smallpox vaccine.
August 2, 2022 - WHO Monkeypox Research - What study designs
can be used to address the remaining knowledge gaps for monkeypox vaccines?
June 14, 2022 - The Ministry of Health, Labour, and Welfare
published a press release: Vaccines and immunization for monkeypox: Interim
guidance.
February 3, 2021 - PLOS Pathogens published a RESEARCH
ARTICLE: A highly attenuated vaccinia virus strain LC16m8-based vaccine for
severe fever with thrombocytopenia syndrome.
April 28, 2015 - ASM Journals published: Use of the LC16m8
Smallpox Vaccine in Immunocompromised Individuals Is Still Too Risky.
March 11, 2009 - The JAMA Network published: Clinical and Immunological Response to Attenuated Tissue-Cultured Smallpox Vaccine LC16m8. Conclusion Administration of an attenuated tissue-cultured smallpox vaccine (LC16m8) to healthy adults was associated with high levels of vaccine take and seroconversion in those vaccinia-naive and yielded an effective booster response in some previously vaccinated individuals.
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