In response to recent simultaneous outbreaks of Marburg virus in Tanzania and Equatorial Guinea the United States EPA has engaged the Emerging viral Pathogens Policy (EVP). The Ministry of Health and Social Welfare for Equatorial Guinea first announced the outbreak on February 7, 2023. Since the announcement, 15 cases and 11 deaths have been confirmed in Equatorial Guinea. Subsequently in Tanzania, the first case was confirmed on March 21, 2023. According to a health alert posted by the CDC on April 6, 2023, five of the eight laboratory confirmed cases in Tanzania have been fatal. Despite the timing, there is no indication that the origination of these outbreaks is connected and at present it appears they are not epidemiologically linked.

The emerging viral pathogens policy allows registrants to make indirect, off-label claims against Marburg virus to help arm consumers with important information on proper disinfection to protect against the virus.

For a list of disinfectants which have existing claims against emerging viral pathogens claims, please refer to EPA List Q.

Marburg Virus Disease

Marburg virus disease presents as a viral hemorrhagic fever caused by infection with the Marburg or Ravn virus. It is a zoonotic disease, meaning the virus can be transferred from animals to humans, with the host reservoir being Egyptian fruit bats. Marburg virus is a small, enveloped virus of the Filoviridae family, it is closely related to Ebolavirus in both viral structure and clinical presentation. Transmission of the virus is spread through direct contact with infected bodily fluids or contaminated surfaces. The virus is not spread by airborne transmission. Symptoms of the virus include fever, head and body aches, GI upset, and unexplained bleeding. There are currently no FDA approved vaccines for Marburg virus disease. Early diagnosis and supportive care remains the most effective clinical response.

The Pathway to Make Off-Label Claims Against Marburg Virus

EPA engaged the Emerging Viral Pathogens Policy (EVP) for off-label claims against Marburg virus. This policy allows registrants to make indirect, off-label claims against Marburg virus, if they have previously demonstrated their product is effective against one or more viruses that are harder to inactivate than the emerging virus. Indirect claims convey to the user that the product is anticipated to be effective against the emerging viral pathogen based on a product’s demonstrated efficacy against viruses similar to the emerging virus.

For example, an indirect, off-label claim may look something like the below tweet:

 

Marburg virus is an enveloped virus, which is the easiest to kill virus type. To qualify to make indirect, off-label claims a registration must have an approved emerging viral pathogen claim against at least one small or one large non-enveloped virus (please contact SRC for more information regarding virus classification).

 Testing Against Marburg Virus

To make on-label claims against Marburg virus, efficacy testing must be completed on the virus. To date, no surrogate virus has been approved for testing by EPA. Due to the biosafety level required to work with this virus (BSL-4) it will not be available for testing at most contract laboratories. SRC will continue to monitor this situation and provide updates regarding options for testing and claims.

 

 

Samantha Kappel

Consulting Specialist II

Posted 05/02/2023