Mpox Vaccines

Mpox Vaccines 2024

The World Health Organization (WHO) Strategic Advisory Group of Experts on Immunization has recommended vaccines against mpox disease. As of September 2024, four vaccines are in use to protect people against mpox. A review published by John D. Grabenstein and Adam Hacker summarizes the human and pivotal animal data establishing safety and efficacy for MVA-BN and LC16m8, including real-world evidence gathered during mpox outbreaks from 2022 through July 2024. The WHO Director-General announced on August 7, 2024, that he had triggered the process for Emergency Use Listing of mpox vaccines. As of August 17, 2024, the WHO says mass vaccination is not recommended. According to the WHO, travelers who may be at risk based on an individual assessment with their healthcare provider may wish to consider mpox vaccination.

The United States Food and Drug Administration (FDA) Approved the JYNNEOS® (MVA-BN, IMVANEX®, IMVAMUNE®) Smallpox and Mpox Vaccine on September 24, 2019. The U.S. began offering Bavarian Nordic's JYNNEOS® vaccine to healthcare staff in Boston on May 24, 2022.

Japan's K.M. Biologics' LC16 "KMB" freeze-dried smallpox vaccine is approved by Japan's Ministry of Health, Labor, and Welfare and other countries to prevent mpox disease.

ACAM2000® live vaccinia virus vaccine is authorized to prevent mpox and smallpox infections in various countries, including the U.S. The safety profile of ACAM2000 vaccination includes side effects and risks.

The State Research Center of Virology and Biotechnology Vector Laboratories produces the OrthopoxVac vaccine.

Mpox Vaccine Candidates

The Sinopharm mpox vaccine candidate clinical trial was approved in China in September 2024. The Beijing Institute of Biological Products Co., Ltd. (BIBP) (Sinopharm) confirmed China's drug authority granted permission to launch a mpox vaccine based on replication-defective mpox viruses that cannot spread but can grant a person immunity. China classified mpox as a Class B infectious disease in 2022.

Moderna Inc. mpox vaccine candidate mRNA-1769 prevented severe disease and reduced virus levels in monkeys. The study results were published in Cell on Sept 4, 2024.

Tonix Pharmaceuticals Holding Corp confirmed developing TNX-801 as a vaccine candidate targeting mpox. As of August 2024, Tonix has completed non-human primate studies showing protection from the Clade 1 mpox virus. TNX-801 is an attenuated live-virus vaccine based on synthesized horsepox that has been shown to provide single-dose immune protection against a monkeypox challenge with better tolerability than 20th-century vaccinia live-virus vaccines in animals. On August 26, 2024, Tonix partnered with Bilthoven Biologicals on vaccine development.

Serum Institute of India, Reliance Life Sciences, and Dr Reddy's Laboratory are among the firms collaborating to produce a vaccine for the MPox virus in India. The Indian Council of Medical Research (ICMR) began this initiative on July 27, 2022: Collaboration for developing In-Vitro Diagnostic Kits and Vaccine candidates against the MPox virus.

Emergex Vaccines Holding Limited announced on October 18, 2022, that it has formulated and confirmed the synthesis and assembly of a CD8+ T cell Adaptive Vaccine for smallpox and mpox, comprised predominantly of early "eclipse phase" antigens.

EpiVax, Inc.'s "Epitope-Driven Vaccine" is a smallpox vaccine candidate predicted to be highly effective against mpox. The development of VennVax, a DNA-prime, peptide-boost multi-T-cell epitope poxvirus vaccine, was funded by the U.S. National Institutes of Health (SBIR grant #R43AI058376).

Mpox Virus Disease

Monkeypox is a viral zoonotic virus that is transmitted from one person to another by physical contact with lesions, body fluids, respiratory droplets, and contaminated materials. The monkeypox virus causes monkeypox disease, a member of the Orthopoxvirus genus in the family Poxviridae. According to the WHO, the monkeypox virus has two distinct genetic clades: the Congo Basin and WesAfrican.