"Approval of this vaccine by the FDA represents another important milestone in the global response to Ebola virus disease and stands as a tremendous accomplishment by a unique global partnership", Dr. Roger M. Perlmutter, president of Merck Research Laboratories, said in a statement Friday.
"Whereas the danger of Ebola virus illness within the US stays low, the USA authorities stays deeply dedicated to combating devastating Ebola outbreaks in Africa, together with the present outbreak within the Democratic Republic of the Congo", Anna Abram, FDA Deputy Commissioner for Policy, Legislation, and International Affairs, stated in a press launch.
The Ebola virus causes hemorrhagic fever and spreads from person to person through direct contact with body fluids. Rare cases of people sickened with EVD after with direct contact with the wild infected animals have been reported which can lead to EVD outbreaks.
On Thursday, the FDA approved the Ervebo vaccine made by the pharmaceutical giant Merck for the Zaire strain of virus, which killed more than 11,000 people in the 2014 outbreak in West Africa. In 2010, NewLink Genetics obtained marketing rights, and then in 2014, it signed a deal with Merck that helped advance the vaccine to clinical trials and scaled up manufacturing. While initial symptoms can be sudden, they also tend toward the mild, but can rapidly evolve into vomiting, diarrhea, rash, impaired kidney and liver function, or bleeding. "The newly approved vaccine, as well as investigational therapeutics and other tools supported by the USA government, is playing a huge role in saving lives during the current Ebola outbreak in the Democratic Republic of the Congo".
In the United States, Ebola infections are rare.
The Erverbo approval by the FDA is a major step to protect the Zaire ebolavirus. A particularly troubling strain is the Zaire variant and the Ervebo vaccine has proven to be 100% effective if administered correctly.
Studies supporting its approval included one with 900 subjects in Canada, Spain and the US, where antibody responses matched with those seen elsewhere. The research approach used to check the safety and effectiveness of the Erverbo will help to create a model for advanced future studies. This vaccine's approval process, though rigorous, was done in relatively short order thanks to the efforts of the FDA and associated medical and scientific groups due to the urgent need for this vaccine as outbreaks continue to occur.