#FDA #Merck's #Ebola #Vaccine

FDA Approves Merck's New Live Ebola Vaccine Which It Says Can Shed and Cause Immunosuppression

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.” 

The clinical studies conducted on the vaccine included safety assessments, noting serious adverse effects which included life-threatening anaphylaxis. Another particularly concerning adverse effect of the ERVEBO vaccine was identified after white blood cell counts were assessed in 697 subjects: 

“Decreases in lymphocytes were reported in up to 85% of subjects and decreases in neutrophils were reported in up to 43% of subjects. No associated infections were reported.”

Considering the fact that Ebola virus infection causes the death of lymphocytes1 and neutrophils,2 the vaccine appears to induce the very same type of immunosuppressive effects that are associated with morbidity and mortality from the disease it is attempting to prevent. 

Moreover, according to Merck, the vaccine may interfere with laboratory tests intended to identify Ebola infection: 

“Interference with Laboratory Tests
Following vaccination with ERVEBO, individuals may test positive for anti-Ebola glycoprotein (GP) antibody and/or Ebola GP nucleic acid or antigens.”

In summary, the vaccine may:
1) produce widespread RNA virus infection within the tissues of those vaccinated
2) may shed and infect others 
3) produce immunosuppressive effects consistent with Ebola infection
4) produce immune effects that may prevent laboratory tests from discerning wild-type Ebola infection from vaccine-strain Ebola infection 

Additional references
1 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5897007/
2 https://www.sciencedaily.com/releases/2017/05/170524101419.htm

Disclaimer: This article is not intended to provide medical advice, diagnosis or treatment. Views expressed here do not necessarily reflect those of GreenMedInfo or its staff.