Merck & Co. Inc. (NYSE:MRK) and Johnson & Johnson (NYSE:JNJ) said they are ready to make their respective Ebola vaccines available to the World Health Organization (WHO), which announced Wednesday an Ebola virus outbreak in the Democratic Republic of the Congo.
WHO spokesperson Tarik Jašarević said the organization is discussing the use of vaccines to combat the outbreak. WHO plans to deploy vaccination support teams, clinicians and other experts "in the coming days."
Merck is developing rVSV-ZEBOV (V920), and told BioCentury that the company has a stockpile of more than 300,000 emergency use dose equivalents. J&J is developing its vaccine regimen of Ad26.ZEBOV and MVA-BN Filo, and said it has a stockpile of 2 million regimens ready to be deployed.
In a 11,841-subject Phase III trial, final data published in The Lancet showed that rVSV-ZEBOV led to no Ebola cases after 10 or more days post-vaccination compared with 23 cases in subjects who did not receive the vaccine. Interim data from the WHO-sponsored trial were published in 2015 (see BioCentury Extra, July 31, 2015).
rVSV-ZEBOV was developed by the Public Health Agency of Canada, which retains non-commercial rights under a 2010 deal granting NewLink Genetics Corp. (NASDAQ:NLNK) rights to the product. Merck has exclusive, worldwide rights to develop, commercialize and manufacture the vaccine from NewLink under a 2014 deal (see BioCentury Extra, Nov. 24, 2014).
In 2016, FDA granted breakthrough therapy designation and EMA granted PRIority MEdicines (PRIME) designation to rVSV-ZEBOV to prevent Ebola virus infection.
Also in 2016, WHO accepted for review an application for Emergency Use Assessment and Listing (EUAL) for rVSV-ZEBOV to vaccinate against the Ebola Zaire species. The EUAL process is designed to expedite the availability of vaccines for public health emergencies while further clinical data are collected for formal review by a national regulatory agency.
Merck said Wednesday it is still awaiting WHO's EUAL decision. rVSV-ZEBOV is a recombinant vesicular stomatitis virus (rVSV) vaccine expressing an Ebola virus protein.
The regimen of Ad26.ZEBOV and MVA-BN Filo is in Phase III testing to vaccinate against Ebola virus infection. J&J has exclusive, worldwide rights from Bavarian Nordic A/S (CSE:BAVA) to MVA-BN Filo.
In 2016, J&J's Janssen Vaccines & Prevention B.V unit submitted a EUAL application for the regimen. J&J said Wednesday it is still under review.
Ad26.ZEBOV is a human adenovirus type 26 vector carrying Zaire Ebola virus glycoprotein and MVA-BN Filo is a modified vaccinia Ankara (MVA) multivalent vaccine.
J&J and partner Biocartis Group N.V. (Euronext:BCART) are also developing the diagnostic Idylla Ebola Virus Triage Test.
In 2016, FDA granted emergency use authorization (EUA) to the test to detect Ebola Zaire virus. The automated test uses the Biocartis Idylla real-time, reverse transcription-PCR system to detect the virus within 100 minutes. Biocartis co-developed the product with J&J’s Janssen Diagnostics division of Janssen Pharmaceutica N.V. and the Institute of Tropical Medicine (Antwerp, Belgium).
J&J said the diagnostic is ready to be deployed.
In 2015, FDA approved a clinical protocol to treat Ebola-infected patients in the U.S. with the Aethlon Hemopurifier from Aethlon Medical Inc. (NASDAQ:AEMD). The product is an extracorporeal device that selectively absorbs viruses and immunosuppressive toxins from blood. Aethlon did not respond in time for publication.
Ad5-EBOV, a recombinant human adenovirus type 5 vector based vaccine expression Ebola virus glycoprotein (GP) from CanSino Biologics Inc. (Tianjin, China), is approved in China to treat Ebola virus infection.