One stockpiled Ebola vaccine can be given to Americans with no proof of safety or effectiveness under the Animal Rule and Accelerated pathway


The NCBI on two of the stockpiled Ebola vaccines Merck’s V920 (rVSVΔG-ZEBOV-GP) and Janssen Vaccines & Prevention B.V.’s Ad26-ZEBOV/MVA-BN-Filo prime-boost vaccine, both nearing consideration for licensure.

Janssen Vaccines & Prevention B.V. will get a licence without any need to demonstrate clinical efficacy in human beings (that although four years have passed since the Ebola outbreak giving plenty of time for proper trials). I

t was developed in US bioweapons labs like the Merck vaccine also being stockpiled.

..

Janssen Vaccines & Prevention B.V. is pursuing FDA licensure through an Animal Rule/Accelerated pathway that will require demonstration of clinical efficacy through the establishment of an immune correlate within a nonhuman primate animal model. Both the V920 and the Ad26-ZEBOV/MVA-BN-Filo prime-boost vaccine candidates have been, or are being, evaluated in multiple Phase I, II, and III clinical trials.

Ultimately, the early development of these medical countermeasures was led by collaborative efforts across multiple organizations and countries. For example, early development of both vaccines and therapeutics can be attributed to organizations such as the National Institutes of Allergy and Infectious Diseases (NIAID), the US Army Medical Research Institute of Infectious Diseases (USAMRIID), the Defense Threat Reduction Agency (DTRA), the Medical Countermeasure Systems-Joint Vaccine Acquisition Program (MCS-JVAP), and the Public Health Agency Canada (PHAC).

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5886391/

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