Merck has received the FDA's fast-tracked approval of a live, genetically modified Ebola vaccine which, according to its vaccine insert, can cause a novel new form of Ebola-type infection, resulting in immunosuppression and possible shedding of live virus to others.
On Dec. 20th, 2019, Merck announced it received FDA approval for an Ebola vaccine which contains the virus known as recombinant vesicular stomatitis virus–Zaire Ebola virus (rVSV-ZEBOV), and will be marketed under the name ERVEBO.
The rVSV-ZEBOV is a live, replication-competent virus, produced with the same African green monkey derived Vero cell line Merck used to create the Rotateq vaccine targeting rotavirus infections. The Vero cell line has been previously identified to carry at least two surreptitious simian endogenous retroviruses whose significant risks to human health have not yet been formally evaluated.
VSV-ZEBOV is produced through genetic modification, combining the vesicular stomatitis virus (which on its own can cause flu-like illness in humans) in which the gene for native envelope glycoprotein (P03522) is replaced with that from the Ebola virus (P87666), Kikwit 1995 Zaire strain.
In its recent press release, Merck acknowledged that the vaccine may result in the shedding of RNAs from the live virus in the blood, saliva, urine, and fluid from the skin of the vaccinated, and could result in the theoretical transmission of the vaccine virus to others (based on previous RT-PCR testing). The vaccine insert also states:
Transmission of vaccine virus is a theoretical possibility. Vaccine virus RNA has been detected in blood, saliva, or urine for up to 14 days after vaccination. The duration of shedding is not known; however, samples taken 28 days after vaccination tested negative. Vaccine virus RNA has been detected in fluid from skin vesicles that appeared after vaccination.
