Mpox Vaccines: Regulatory Approvals and Funding Updates

Nations First Mpox Virus Test Product Approved for Market

The U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to the first mpox virus test product, developed by the Centers for Disease Control and Prevention (CDC). This test, known as the CDC Orthopoxvirus Real-time PCR Kit 2022, is a molecular diagnostic test that can detect mpox virus DNA in clinical specimens.

WEB WHO Issues Invitation for Mpox Vaccine Submissions

The World Health Organization (WHO) has issued an invitation for manufacturers of mpox vaccines to submit an Expression of Interest (EOI) for prequalification. This EOI is part of WHO's efforts to accelerate the development and availability of safe and effective mpox vaccines.

CEPI Provides Funding for mRNA-Based Vaccine Development

The Coalition for Epidemic Preparedness Innovations (CEPI) has announced that it will provide up to $90 million in funding to support the development of an mRNA-based mpox vaccine. This vaccine candidate, being developed by Moderna, is expected to enter clinical trials in the coming months.

Mpox Infection Confirmation

Confirmation of monkeypox virus infection is based on nucleic acid amplification testing (NAAT), which detects the presence of viral DNA or RNA in clinical specimens. Specimens for NAAT should be collected as soon as possible after the onset of symptoms and should include lesions, swabs, or fluid.

Tecovirimat Approved for Smallpox

The antiviral drug tecovirimat has been approved by the FDA for the treatment of smallpox. This approval was based on animal studies and expert opinion, as there have been no controlled clinical trials of tecovirimat in humans with smallpox.