On March 23, 2014 the WHO release news of a rapidly evolving outbreak of Ebola virus disease (Ebola Hemorrhagic Fever) in forested areas south eastern Guinea, West Africa. At that date Ministry of Health (MoH) of Guinea were aware of 49 cases with 29 deaths, concluding a case fatality rate of an alarming 59%! The very next day on March 24, 2014 it was communicated “a total of 86 suspected cases in-cluding 59 deaths” providing a case fatality ratio of 69%! [1, 2, 3, 4, 6, 7]
On July 31, 2015 it was reported the “World on the verge of an effective Ebola vaccine”, where Phase III trials of developed of VSV-EBOV were claimed to be ” highly effective against Ebola”, used in a “ring vaccination protocol”. The vaccine was developed by the Public Health Agency of Canada, then licensed to NewLink Genetics, and on November 24, 2014 to Merck & Co. [5] The ring vaccination protocol provided an alternative to using a placebo!
The vaccine trial design group “included Professor Donald A. Henderson of John Hopkins University, who led the WHO smallpox eradication effort by using the ring vaccination strategy”.
In 2003 the WHO stated: “The Ebola virus was first identified in a western equatorial province of Sudan and in a nearby region of Zaire (now Democratic Republic of the Congo) in 1976“. “Ebola haemorrhagic fever (EHF) is one of the most virulent viral diseases known to humankind, causing death in 50-90% of all clinically ill cases…[it] is transmitted by direct contact with the blood, body fluids and tissues of infected persons”. Just like smallpox, transmission by direct contact, is indicated to quarantine of the sick to reduce transmission.
Virologist Jean-Jacques Muyembe-Tamfum from the Democratic Republic of the Congo (DRC), at age 34 in 1976, was the first virologist ever to see an Ebola patient, in 2019 vowed to end Congo’s Ebola epidemic. [8, 9]
In August 2019 Dr Anthony Fauci of NIAID, announced the early stopping of an Ebola trial using three antibody preparations and one antiviral drug (remdesivir), carried out in the DRC. Two treatments “showed strong signs of being able to save patients’ lives”, but remdesivir was withdrawn early, as it proved to increase mortality.
The Ebola outbreak of 2014-15 was as strong catalyst used by the World Health Organisation in 2015 to justify the creation of an R&D Blueprint to accelerate “research and development in epidemics or health emergency situations where there are no, or insufficient, preventive, and curative solutions,” to “spearheaded a global movement to avert full-blown epidemic” or today pandemics! [10, 11]
An important component of accelerated response was ensure National Regulatory Authorities (NRAs) were prepared for public health emergencies (of international concern) – to avoid having to put “emergency regulatory processes in place in the heat of the moment”.
On March 29, 2018 Australia’s legislation, the Therapeutic Goods Act 1989 was amended to include a clause for Provisional Registration – a fast track registration pathway, pushed as an avenue for cancer drugs, and used for brand new, novel drugs like gene transfer technology products classified as “COVID-19 vaccines”.