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On Sunday, the NY Times reported that an unnamed Ebola vaccine has been added to the FDA’s Fast Track, and will be injected into human subjects starting in September.
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That’s great news, except the FDA already had one such vaccine on a fast track, and now it took it off and pushed it way over to the slow track.
Are you thinking what we’re thinking? Somebody with pull got to the FDA? Can’t be…
Canadian pharmaceutical company Tekmira has been developing an Ebola treatment called TKM-Ebola, but its efforts have been hampered by the Food and Drug Administration, Vox reports.
Ebola mostly affects a low-income area of the world, so raising the needed funds to fight it is not easy. But TKM-Ebola has attracted the attention of the US Defense Department, which awarded it a contract for $140 million in 2010, after its vaccine proved completely effective in treating chimps.
The government’s motivation in vaccinating against Ebola comes from the need to prevent bioterrorism.
In January, TKM-Ebola began Phase One trials—testing if the drug is safe—on January 14, Vox reports.
In March, the drug was added to the FDA’s fast track schedule. With that designation, the drug makers can have more frequent meetings with FDA regulators, to speed up development.
But in July, the FDA halted the trials, requesting that Tekmira provide additional information about how the drug works, before the company can give trial subjects larger doses.
So the TKM-Ebola trial has been on hold, while Tekmira is busy pulling together the required information.
“Our team is working expediently to respond to the FDA, ” Tekmira chief executive Mark Murray said in a recent statement. “We are mindful of the need for this important therapeutic in situations such as the ongoing Ebola outbreak in West Africa.”
