The World Health Organization (WHO) has published its first guidelines for Ebola virus disease therapeutics, issuing ‘strong recommendations’ for the use of two monoclonal antibodies.
The U.S. Food and Drug Administration (FDA) has approved Regeneron’s Inmazeb for treatment of Ebola. The antibody cocktail was developed using the same ‘rapid response’ technologies as Regeneron’s investigational COVID-19 antibody combination.
Shortly after EMA’s approval, the US FDA follows with a positive nod for Ervebo, the first vaccine to receive approval for the prevention of Ebola virus disease.
Gavi establishes an Ebola vaccine program for the next five years, with a stockpile of vaccines created to be made available to low- and middle-income countries free of charge.
Unofficial reports suggested that individuals in Tanzania were exhibiting Ebola-like symptoms, but the WHO reports not receiving detailed information from the country.
The US HSS will provide funding to Merck for a year’s supply of its investigational Ebola vaccine for use in DR Congo to combat the repeated outbreaks of the virus.
The National Institute of Allergy and Infectious Diseases is enrolling volunteers for a first-in-human experimental treatment trial for its mAb to treat the Ebola virus.
An Ebola viral vector vaccine in development by Profectus BioSciences works in monkeys against the virus strain currently infecting humans in West Africa.
A doctor whose thumb was punctured by a needle while working with Ebola patients in Sierra Leone received Merck & Co.’s vaccine candidate and did not develop the virus.
Manufacturers developing Ebola vaccines will be immune from lawsuits following a decision by US HHS (Health and Human Services) to issue a declaration on the matter.
The WHO has accused biopharma firms of failing to invest in R&D to tackle Ebola due to the disease’s prevalence in poor African nations, as the death toll surpasses 4,000.
ZMapp, the experimental Ebola therapy given to a handful of infected patients in West Africa, is being produced in tobacco plants for Mapp Biopharmaceutical by CMO Kentucky Bioprocessing in collaboration with drugmaker Defyrus.
G-CON has responded to the ongoing Ebola virus outbreak in West Africa by retooling its “vaccine facility in a box” PODs as patient isolation units to help stop the spread of the disease.
As the death toll from the world’s most expansive Ebola outbreak nears 1,000, multiple companies are stepping up efforts to bring antibodies and other vaccines to human trials, though none seem likely to be ready until 2015 at the earliest.
Two Americans stricken with the Ebola virus in Liberia were flown back to the US following treatment with an unapproved treatment manufactured from tobacco plants in Kentucky. Manufacturing of the treatment is expected to ramp up as the patients improve.
